From SARS to Coronavirus (S. Hrg. 116-583, March 4, 2020)
Summary
Transcript of the Senate hearing "From SARS to Coronavirus: Examining the Role of Global Aviation in Containing the Spread of Infectious Disease," S. Hrg. 116-583, before the Subcommittee on Aviation and Space of the Committee on Commerce, Science, and Transportation on March 4, 2020, with Senator Ted Cruz presiding. Witnesses are Joel Szabat, Acting Under Secretary for Policy at the U.S. Department of Transportation; Stephen Redd of the Centers for Disease Control and Prevention; and William Ferrara of U.S. Customs and Border Protection. The opening statement by Senator Cruz recounts that on December 30, 2019, Dr. Li Wenliang of Wuhan Central Hospital warned friends about a SARS-like illness. The appendix includes a prepared statement of Nancy Messonnier and responses by Stephen Redd to questions from Marsha Blackburn and Amy Klobuchar.
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[Senate Hearing 116-583]
[From the U.S. Government Publishing Office]
S. Hrg. 116-583
FROM SARS TO CORONAVIRUS: EXAMINING THE ROLE OF GLOBAL AVIATION IN
CONTAINING THE SPREAD OF INFECTIOUS DISEASE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON AVIATION AND SPACE
of the
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
__________
MARCH 4, 2020
__________
Printed for the use of the Committee on Commerce, Science, and
Transportation
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available online: http://www.govinfo.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
52-669 PDF WASHINGTON : 2023
SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ROGER WICKER, Mississippi, Chairman
JOHN THUNE, South Dakota MARIA CANTWELL, Washington,
ROY BLUNT, Missouri Ranking
TED CRUZ, Texas AMY KLOBUCHAR, Minnesota
DEB FISCHER, Nebraska RICHARD BLUMENTHAL, Connecticut
JERRY MORAN, Kansas BRIAN SCHATZ, Hawaii
DAN SULLIVAN, Alaska EDWARD MARKEY, Massachusetts
CORY GARDNER, Colorado TOM UDALL, New Mexico
MARSHA BLACKBURN, Tennessee GARY PETERS, Michigan
SHELLEY MOORE CAPITO, West Virginia TAMMY BALDWIN, Wisconsin
MIKE LEE, Utah TAMMY DUCKWORTH, Illinois
RON JOHNSON, Wisconsin JON TESTER, Montana
TODD YOUNG, Indiana KYRSTEN SINEMA, Arizona
RICK SCOTT, Florida JACKY ROSEN, Nevada
John Keast, Staff Director
Crystal Tully, Deputy Staff Director
Steven Wall, General Counsel
Kim Lipsky, Democratic Staff Director
Chris Day, Democratic Deputy Staff Director
Renae Black, Senior Counsel
------
SUBCOMMITTEE ON AVIATION AND SPACE
TED CRUZ, Texas, Chairman KYRSTEN SINEMA, Arizona, Ranking
JOHN THUNE, South Dakota BRIAN SCHATZ, Hawaii
ROY BLUNT, Missouri TOM UDALL, New Mexico
JERRY MORAN, Kansas GARY PETERS, Michigan
CORY GARDNER, Colorado TAMMY DUCKWORTH, Illinois
MARSHA BLACKBURN, Tennessee JON TESTER, Montana
SHELLEY MOORE CAPITO, West Virginia JACKY ROSEN, Nevada
MIKE LEE, Utah
C O N T E N T S
----------
Page
Hearing held on March 4, 2020.................................... 1
Statement of Senator Cruz........................................ 1
Statement of Senator Sinema...................................... 3
Statement of Senator Cantwell.................................... 4
Statement of Senator Gardner..................................... 28
Statement of Senator Lee......................................... 33
Statement of Senator Schatz...................................... 35
Statement of Senator Sullivan.................................... 37
Statement of Senator Tester...................................... 39
Statement of Senator Capito...................................... 41
Statement of Senator Duckworth................................... 43
Statement of Senator Rosen....................................... 45
Statement of Senator Thune....................................... 47
Statement of Senator Markey...................................... 49
Witnesses
Hon. Joel Szabat, Acting Under Secretary for Policy, U.S.
Department of Transportation................................... 6
Prepared statement........................................... 8
Dr. Stephen Redd, Director, Office of Public Health Preparedness
and Response, Centers for Disease Control and Prevention....... 10
Prepared statement........................................... 11
William Ferrara, Executive Assistant Commissioner for Operations
Support, U.S. Customs and Border Protection.................... 20
Prepared statement........................................... 22
Appendix
Nancy Messonnier, M.D., Director, Centers for Disease Control and
Prevention's (CDC) National Center for Immunization and
Respiratory Diseases, prepared statement....................... 57
Response to written questions submitted to Dr. Stephen Redd by:
Hon. Marsha Blackburn........................................ 67
Hon. Amy Klobuchar........................................... 70
FROM SARS TO CORONAVIRUS: EXAMINING
THE ROLE OF GLOBAL AVIATION IN
CONTAINING THE SPREAD OF
INFECTIOUS DISEASE
----------
WEDNESDAY, MARCH 4, 2020
U.S. Senate,
Subcommittee on Aviation and Space,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:30 p.m. in
Anteroom SR-253, Russell Senate Office Building, Hon. Ted Cruz,
Chairman of the Subcommittee, presiding.
Present: Senators Cruz [presiding], Thune, Blunt, Moran,
Gardner, Blackburn, Capito, Lee, Sinema, Schatz, Udall,
Duckworth, Tester, Cantwell, Sullivan, Markey, and Rosen.
OPENING STATEMENT OF HON. TED CRUZ,
U.S. SENATOR FROM TEXAS
Senator Cruz. This hearing is called to order.
On December 30, 2019, Dr. Li Wenliang, a 34-year-old
ophthalmologist at Wuhan Central Hospital, took to a group chat
he was in with some friends from medical school to discuss a
SARS-like illness that had recently been sickening people
around the city.
He posted a snippet of a lab analysis that had found SARS
Coronavirus and extensive bacteria colonies in a patient's
airways and said this new illness had even led his hospital to
quarantine some patients in the emergency department.
So frightening, a member of the group chat replied. Is SARS
coming again? Suffice to say the Chinese Communist Government,
which like all authoritarian regimes, is often more concerned
about protecting its image than the life and safety of its
citizens, was not pleased, and even as dedicated public health
experts scrambled to warn each other and to collect more
information on what was happening, China's Security Services
were busy trying to stop them.
In probably the starkest example, on January 1, the Wuhan
Public Security Bureau summoned eight doctors, including Dr.
Wenliang, for posting and spreading ``rumors'' about Wuhan's
hospital's receiving SARS-like cases.
While Dr. Wenliang was eventually released two days later,
it wasn't before he was forced by police to sign statements
acknowledging that his warnings had been ``illegal behavior.''
Meanwhile, even as the City of Wuhan and the Nation of
China were getting sicker and sicker, business as usual didn't
stop. Community events, political parades, public gatherings
and global commerce, including, most importantly for this
hearing on global aviation, continued, allowing this virus to
spread first within the City of Wuhan and within the rest of
China and finally out to the rest of the world.
At 2:58 a.m. on February 7 in the City of Wuhan, Dr.
Wenliang died from the very virus he had tried to warn about, a
virus which, as of today, has infected almost 95,000 men,
women, and children across the globe, including right here in
the United States, and has killed more than 3,200 people,
including nine who are in Senator Cantwell's home state of
Washington.
What we now know is that the virus Dr. Wenliang and others
were warning about and the virus that took his life wasn't SARS
but it was similar. It's the novel Coronavirus now known as
COVID-19.
The spread of this virus across the globe has had and
continues to have tremendous and far-reaching impacts. Commerce
has slowed, faith in government has been shaken, and people are
understandably scared.
This virus has also called into real question the efficacy
of international organizations, like the World Health
Organization and the ICAO, both of which we reached out to to
participate in this hearing but both of which either declined
to participate or didn't respond.
The ICAO, International Civil Aviation Organization, for
instance, excluded Taiwan from its information sharing
regarding the virus. This despite the fact that viruses like
this, as SARS showed us, spread overwhelmingly by air travel
and Taiwan has the 11th busiest airport in the world.
The WHO, for its part, has praised at every turn the
response of the Chinese Communist Government, despite the
mountain of evidence showing that they played down the
seriousness of the virus and the extent of the spread for more
than a month.
If these organizations are going to look out for the
broader global interests and are going to instead praise
authoritarian regimes, it begs the question if it's time to re-
evaluate our participation in them or at the very least to make
a concerted effort to push reforms.
COVID-19 is a real and serious challenge and we need cool
heads and fact-based decisions, not panic, not hysteria.
Unfortunately, some in the media, whether intentionally or not,
seem to be inciting panic in Americans over the virus. That's a
large part of the reason why we convened this hearing, to give
the American public the opportunity to hear straight from
officials on the front lines without spin or partisan bias.
So here's what we know. This is a rapidly changing
situation. Every day, and on some days every hour, we're
learning more about the virus, where it has spread and how the
human body responds.
So far, the mortality rate has been around 3 percent and
most of the deaths have been in the elderly and those with
underlying health conditions. The virus appears more
transmissible than a typical seasonal flu but so far reports
indicate the vast majority of cases are moderate to mild,
requiring little to no medical attention.
Early on, the Administration acted and acted swiftly to
limit travel to and from the affected regions and to quarantine
Americans that had been to those regions and to deny entry to
foreign nationals from those regions. This was the right thing
to do and those actions have proven critical for slowing the
spread of the virus to the United States and it's bought us
additional time to prepare, but now the virus is here and it's
spreading and we must be ready for the fight ahead.
There is more that can be done. There is more that should
be done. Communication between agencies and municipalities is
vital to containing the spread of the virus.
In San Antonio, communication was lacking and a patient was
released from Lackland Air Force Base prior to testing
positive. After testing positive, the patient was returned to
quarantine and is currently under the supervision of the CDC.
I urge the CDC to stay vigilant in keeping lines of
communications open with all localities to ensure the safety of
the public health in Texas and all across the United States. We
must do everything we can to marshal every resource necessary
to protect the safety and lives of Americans.
So I look forward to hearing about the facts. I look
forward to hearing about the medical science. I look forward to
hearing about what we know, what we're doing, and what more we
can and should be doing.
And with that, I recognize Senator Sinema for her opening.
STATEMENT OF HON. KYRSTEN SINEMA,
U.S. SENATOR FROM ARIZONA
Senator Sinema. Thank you, Chairman Cruz, and thank you to
our witnesses who are here today for your efforts to protect
Americans from infectious diseases, like the Coronavirus.
While they're not testifying today, I'd also like to
acknowledge the efforts of our U.S. air carriers and the
transportation industry. In the face of a public health crisis,
we must work together to share the burden of keeping Americans
safe both here and abroad from a potential global pandemic.
Today's hearing will focus on the current systems in place
to collect contact data from travelers entering into the United
States and to close gaps where they may exist. We need a timely
and orderly way for travelers to input detailed contact
information based on criteria the CDC has outlined.
I spoke with Vice President Pence yesterday about an
opportunity to quickly develop and implement a method to
collect this information and I sent him a follow up letter this
morning.
Our public health officials need to ensure that we have a
direct link to travelers and to eliminate gaps that allow
travelers to enter the United States without public health
officials being able to reach them in the case of potential
risk or exposure.
I represent Arizona. We have confirmed Coronavirus cases.
It's critical that Congress pass a bicameral and bipartisan
supplemental package that devotes necessary resources to
developing vaccines and treatments that reimburses states and
local governments and that ensures the safety of our frontline
workers, our seniors, and other vulnerable populations who are
most at risk.
Although we do not yet know the long-term impacts of
Coronavirus, the impact we've seen thus far calls for action
now to protect and to reassure the public. As this situation
continues to evolve, the government must continue to work
together. We must coordinate with states and communicate with
our industry partners.
I look forward to hearing today's testimonies and, Mr.
Chairman, I yield back.
Senator Cruz. Thank you, Senator Sinema.
I now recognize Senator Cantwell, the Ranking Member of the
Full Committee.
STATEMENT OF HON. MARIA CANTWELL,
U.S. SENATOR FROM WASHINGTON
Senator Cantwell. Thank you, Mr. Chairman, and thank you
and Ranking Member Sinema for holding what I consider to be one
of the most important subcommittee hearings we could possibly
ever have.
I want to take a moment and send my deepest sympathies to
the people of Washington State, the families who've lost loved
ones and to the health care workers who are continuing to work
diligently to respond to this epidemic.
We are working hard in the state of Washington but even the
numbers, Mr. Chairman, continue to increase. We now have 10
people who have died from the Coronavirus and we now have 39
confirmed cases. 231 people are being monitored by public
health officials and we've had schools and businesses and even
a Federal facility that have been shut down temporarily as more
people have been detected as possibly being exposed to the
Coronavirus. All the while, people are experiencing symptoms
and yet not getting tested.
This is the main focus I believe we need to communicate
today, that we need to have a robust testing regime, all
academic and commercial facilities across the United States
participating in a testing process. This will give us better
information and it will give us more information about the
spread, the community spread of this disease.
Until last Friday, those suspected of COVID-19 in my state
were required to have their tests sent to the CDC to obtain
results and now since the update FDA's actions on last
Saturday, we will be able to run more aggressive tests, but I
still think we're only at a few hundred tests per day in the
state of Washington. We need to be in the thousands, if not
more.
So I hope that we will get this right for the future of
other states who are going to deal with this dilemma and figure
out how to have a clarion call to all labs to please, please
develop these test kits in compliance but get the kits
developed and do the testing because people are calling with
what they think are symptoms and they want to be able to be
tested.
I think that today's hearing, too, is a perfect example of
why that's so important. We now have 14 states that have
confirmed cases and one of the persons is a person from North
Carolina who tested positive after visiting the nursing home in
Washington State that has been the subject of so much attention
and then traveled home to North Carolina on a plane.
This underscores the importance of making sure the aviation
sector is also prepared in how we mitigate the impacts of virus
spread. After all, there are more than 44,000 flights in this
country every day and more than 2.7 million people fly in and
out of our U.S. airports.
We have just sent a letter to the major airlines and
airports asking them for their plans to meet this challenge.
Further guidance, I think, hopefully we'll hear today, on how
we can keep the flying public safe. The airports and the
airlines in the spirit of cooperation need to understand
measures that can be taken to help us in dealing with the
Coronavirus and they should not be left wondering from the
Federal Government what they should be doing. We should be very
clear about what measures we can take or what measures we
should take to help keep the flying public safe.
So I hope the Department of Transportation and the CDC will
shed some light on that here today in this hearing.
I look forward to hearing more about their answers and, Mr.
Chairman and Ranking Member, coordinating with you how we can
get this information out to the public in a timely fashion.
The public wants to do everything they can do, too, but we
have to get crisper on our answers about what we should be
doing today.
Thank you.
Senator Cruz. Thank you, Senator Cantwell, and please know
that the people of America across the country are lifting up in
particular Washington State and the families who are grieving
the lost of their loved ones, and I hope we will continue to
see bipartisan cooperation to marshal all the resources that
are necessary to combat this virus and to do everything
possible to prevent any more loss of life.
With that, let me introduce the witnesses we have today.
Mr. Joel Szabat is the Acting Under Secretary for Policy at
the Department of Transportation. Mr. Szabat has served
extensively across the Department of Transportation since the
early 2000s.
In 2005, he oversaw the U.S. Government's reconstruction of
Iraqi airports, ports and railroads, and served as the
transportation counselor to the U.S. Embassy in Baghdad.
He also previously served as Deputy Assistant Secretary for
Transportation Policy and Deputy Assistant Secretary for
Management and Budget at DOT.
From 2012 to 2018, Mr. Szabat served as the Executive
Director of the Maritime Administration. Most recently, in
January, Mr. Szabat was named to represent the Department of
Transportation in the President's Coronavirus Task Force to
help coordinate strategy to prevent the spread of the outbreak.
He graduated from Georgetown University and Harvard
Business School.
Rear Admiral Steven Redd is the Deputy Director for Public
Health Science and Implementation Science at the Center for
Disease Control and Prevention. In this capacity, Dr. Redd is
responsible for state and local readiness, emergency
operations, select agents and toxins, and the Nation's cache of
emergency medical counter-measures.
Prior to this role, Dr. Redd was the Director of the
Influenza Coordination Unit. He was also the Incident Commander
for the 2009 H1N1 Pandemic Response.
Dr. Redd received his Bachelor's Degree in History from my
alma mater, Princeton University, and his medical degree with
honors at the Emory University School of Medicine.
He trained in medicine at Johns Hopkins Hospital and
completed the two-year Epidemic Intelligence Service Training
Program at the CDC.
Our third witness is Mr. William ``Bill'' Ferrara, who is
the Executive Assistant Commissioner for Operations Support at
U.S. Customs and Border Protection. Mr. Ferrara has served in
numerous roles at CBP.
Previously, Mr. Ferrara served as the Acting Executive
Director of Mission Support in the Office of Field Operations
where he was responsible for managing an operating budget of
$4.1 billion as well as providing asset and logistical support
and customer-focused human resource solutions for nearly 28,000
employees.
From June 2016 to June 2019, Mr. Ferrara also served as the
Director of Field Operations for the Boston Field Office. From
November 2018 to February 2019, he also performed the duties of
the Department of Homeland Security Attache to the United
Kingdom.
He holds an Associate of Arts Degree in Business from the
Community College of Rhode Island and is a graduate of the CBP
Leadership Institute and the University of Chicago Booth School
of Business.
We'll now recognize Mr. Szabat for his testimony.
STATEMENT OF HON. JOEL SZABAT,
ACTING UNDER SECRETARY FOR POLICY,
U.S. DEPARTEMNT OF TRANSPORTATION
Mr. Szabat. Good afternoon, Chairman Cruz, Ranking Member
Sinema, and distinguished Members of the Subcommittee.
Thank you for inviting me to testify on behalf of the
United States Department of Transportation and Secretary Elaine
L. Chao on our efforts to minimize the risk of the spread of
COVID-19 in the United States.
On February 26, President Trump appointed Vice President
Pence to lead the U.S. Government's efforts to combat the
virus. Secretary Azar chairs the White House Task Force and I
have represented the Department of Transportation on the Task
Force since its inception on January 31.
The government's health professionals have the lead in
determining the response to the Coronavirus. DOT, in a
supporting role, has and will continue to coordinate daily with
aviation stakeholders, foreign counterparts, and other Federal
agencies to manage the risk in the United States.
In this capacity, the Department of Transportation
continues to ensure, first, an active air bridge remains in
place for the safe return from affected areas for Americans, in
addition to the thousands who have already safely traveled home
from overseas.
Second, airlines funneling passenger flights to one of 11
designated airports equipped to health screen Americans
returning from the virus-stricken areas.
Third, continued air and sea cargo traffic between the
United States and China and other countries, such as South
Korea and Italy, as the virus spreads.
Fourth, health protocols established to protect the crews
of aircraft continuing to fly between the United States and
foreign locations.
And, finally, dissemination of health messages about the
virus for airlines to use to inform their passengers.
Our travel restrictions have been remarkably effective in
the first layer of health screening of overseas travelers
before they return home. These travel requirements delayed the
spread of the virus from China to the United States, giving the
Nation precious time to prepare further measures and plan for
proper mitigation.
In the first 25 days since the President's proclamation,
only 15 cases were detected within the United States.
Our actions ensured that nearly 200,000 Americans who were
in or had recently left China could return to the United States
through an air bridge home. The number of passengers traveling
from China to the United States has fallen from roughly 15,000
people each day before the virus outbreak to fewer than a
thousand each day now. To date, over 53,000 incoming passengers
have received health screening.
This achievement took the cooperation of nearly 200
commercial airlines, a like number of overseas airports, and
the Civil Aviation Authority of China. The department is also
working closely with our sister Federal agencies under the Task
Force. Their expertise and authorities were all necessary to
accomplish this success.
On January 31, the Administration declared that the virus
presented a public health emergency in the United States. That
same day, a Presidential proclamation established the framework
for our travel restrictions intended to protect the U.S. public
from this communicable disease while allowing American
nationals to travel safely home.
The travel restrictions first applied to China. It has
subsequently been extended to Iran and airport passenger exit
screening has been introduced in Italy and South Korea with the
cooperation of their authorities.
To focus the expertise of the medical professionals
conducting screening, the Secretary of the Department of
Homeland Security directed all flights inbound to the U.S.
carrying persons who have recently been in China to arrive at
one of 11 U.S. airports. Significant consideration,
coordination, and analysis among the Federal agencies occurred
to select those appropriate airports.
Prior to and following the Presidential proclamation, DOT
and interagency partners proactively communicated with air
carriers and others in the aviation industry. DOT hosted
multiple stakeholder calls with over 475 invited industry
participants representing a range of U.S. and foreign carriers,
domestic airports, trade associations, unions, and other valued
partners.
As we plan for community transmission within the United
States, DOT will be coordinating similar efforts with transit
stakeholders as part of the whole of government plan, which
includes the state and local public health agencies that are on
the front line of mitigation efforts.
One of the lessons we learned from SARS is that the public
reconsiders travel in the face of a new communicable disease.
COVID-19 is having that same impact on aviation today.
Industry analysts estimate that the virus will reduce
passenger numbers by some 4.7 to 6 percent worldwide. The
industry is resilient and snaps back quickly. At the peak of
SARS, U.S. travel halved. Within 2 months, it was back to
normal.
The Federal Government and state and local governments are
executing their long-prepared emergency response plans. The
President's Coronavirus Task Force was constructed to
coordinate the whole of government effort to work through the
virus. We will work through it and we will come out on the
other side.
Thank you, and I look forward to your questions.
[The prepared statement of Mr. Szabat follows:]
Prepared Statement of Hon. Joel Szabat, Assistant Secretary for
Aviation and International Affairs, Performing the Duties of the Under
Secretary of Transportation for Policy
Good afternoon Chairman Cruz, Ranking Member Sinema, and
distinguished Members of the Subcommittee. Thank you for inviting me to
testify on behalf of the U.S. Department of Transportation (DOT) and
Secretary Elaine L. Chao on our efforts to minimize the risk of spread
of COVID-19 in the United States. We continue to play an active role in
President Trump's response to the outbreak and the whole-of-government
effort to ensure the welfare of the American people. We are taking
necessary actions and preparations to ensure the continued safety and
efficiency of our Nation's transportation system and minimize
disruption to trade and commerce.
On February 26th, President Trump appointed Vice President Pence to
lead the U.S. Government's effort to combat the virus. Secretary Azar,
who chairs the White House Task Force, remains focused on coordinating
the USG response to the outbreak. I represent the Department of
Transportation on the Task Force. The Task Force, comprised of subject
matter experts from the White House and several U.S. Government
agencies, is charged with leading the Administration's efforts to
contain the spread of the virus, while ensuring that the American
people have the most accurate and up-to-date health and travel
information.
The USG's health professionals have the lead in determining the
response to the COVID-19 outbreak. DOT, in its supporting role, has and
will continue to coordinate daily with aviation stakeholders, foreign
counterparts and other Federal agencies to manage the risk in the
United States. In this capacity, DOT continues to ensure:
1. An active airbridge remains in place for the safe return of
Americans from affected areas;
2. Airlines are funneling passenger flights to one of the eleven
designated U.S. airports equipped to health-screen Americans
returning from affected areas;
3. Continued air and sea cargo traffic between the U.S. and China;
4. Health protocols are established to protect the crews of aircraft
continuing to fly between the U.S. and foreign locations; and,
5. Dissemination of health messages about the virus, for airlines to
use to inform their passengers.
The U.S. Government's travel restrictions and advisories have been
a remarkably effective `first layer' of containment. These travel
requirements delayed the arrival of the virus to the United States,
giving the Nation precious time to prepare further measures, and plan
for mitigation.
This achievement took the cooperation of nearly 200 commercial
airlines, a like number of overseas airports, and the Civil Aviation
Authority of China. The Department, including the Federal Aviation
Administration, is also working closely with our sister Federal
agencies under the Task Force aegis, especially the Centers for Disease
Control and Prevention (CDC), Customs & Border Protection,
Transportation Security Administration, and the U.S. Citizenship and
Immigration Services. Their expertise and authorities, as well as those
of the Departments of State, Homeland Security and Health & Human
Services, were all necessary to accomplish this success.
On January 31, 2020, the Secretary of the Department of Health and
Human Services (HHS) declared that the virus presented a Public Health
Emergency in the United States. That same day, the President exercised
his authority under the Immigration and Nationality Act to issue a
Proclamation suspending the entry into the United States of certain
foreign nationals, to protect persons within the United States from the
threat of this communicable disease. While this Proclamation is in
effect, most foreign nationals who have been in China within the last
14 days prior to their arrival are barred from entering the U.S., with
various exceptions, including lawful permanent residents and most
immediate family members of U.S. citizens and lawful permanent
residents. As the Coronavirus expanded beyond the borders of China, we
gained concurrence with the governments of Italy and South Korea to
institute aggressive containment actions, which include exit
screenings.
Any U.S. citizen returning to the U.S. who has been in China's
Hubei province in the previous 14 days is subject to up to 14 days of
mandatory quarantine. Any returning U.S. citizen who has been in the
rest of mainland China within the previous 14 days undergoes proactive
entry health screening at a designated port of entry, as well as up to
14 days of self-quarantine. To focus the expertise of the medical
professionals conducting screening, the Secretary of the Department of
Homeland Security (DHS) has directed all flights inbound to the U.S.
carrying persons who have recently traveled from, or were otherwise
present within, China to arrive at one of eleven U.S. airports.\1\
Significant consideration, coordination, and analysis occurred to
select the appropriate airports.
---------------------------------------------------------------------------
\1\ Hartsfield-Jackson Atlanta International Airport (ATL),
Georgia; Dallas/Fort Worth International Airport (DFW), Texas; Detroit
Metropolitan Airport (DTW), Michigan; Newark Liberty International
Airport (EWR), New Jersey; Daniel K. Inouye International Airport
(HNL), Hawaii; Washington-Dulles International Airport (IAD), Virginia;
John F. Kennedy International Airport (JFK), New York; Los Angeles
International Airport, (LAX), California; Chicago O'Hare International
Airport (ORD), Illinois; Seattle-Tacoma International Airport (SEA),
Washington; and San Francisco International Airport (SFO), California
---------------------------------------------------------------------------
The U.S. Government has taken steps to ensure that the nearly
200,000 Americans who were in, or had recently left China, could return
to the U.S. through an airbridge home. The number of passengers
traveling from China to the United States has fallen from roughly
15,000 each day before the virus outbreak to fewer than 1,000 each day
now.
The complexity of passenger flows across the globe include not just
nonstop flights between the U.S. and China, but also travelers
connecting through foreign countries. The Department was part of the
Interagency coordination with foreign airports and airlines to
establish a robust initial screening.
The welfare of passengers returning home is among the U.S.
Government's highest priorities. HHS and the CDC developed a script to
provide information on U.S. health screening at designated ports of
entry, which DOT coordinated with governments and airlines for flight
crews to read to passengers ahead of arrival. Today, all four carriers
still providing flights to the U.S. from China are using this script.
Further, DOT helped our Government partners enact workable health
protocols for pilots and crews that continue to fly from China to the
U.S. These protocols differ for China-based and U.S.-based crews, and
allow continued all-cargo operations. U.S. cargo carriers that were
offering scheduled and charter service between China and the United
States before the outbreak continue to serve China.
Prior to and following the first Presidential Proclamation, DOT and
interagency partners proactively communicated with air carriers and
others in the aviation industry. DOT hosted multiple stakeholder calls
with over 475 invited industry participants, representing 44 different
U.S. and foreign air carriers, 26 domestic airports, and many trade
associations, unions, and other valued partners. The Administration
also communicated with foreign governments to maintain awareness of
changes in their travel restrictions and screening and quarantine
policies that could impact Americans traveling to or through those
countries. Open communication is key to implementing practical
solutions for continued operations.
As the President said on February 28th, these containment measures
have been remarkably effective. As we plan for community transmission
in the United States, DOT will be coordinating similar efforts with
transit stakeholders, as part of the whole-of-government plan. The Task
Force and U.S. Government Departments and Agencies continue to
proactively plan for mitigation strategies by working with the State
and local public health agencies that would be on the front line of
``mitigation'' efforts.
Successful containment and mitigation of the virus to keep the
American people safe will depend on the efforts of all levels of
government, the public health system, the transportation industry, and
our communities. The ability to sustain transportation services, move
emergency relief personnel and commodities, and mitigate adverse
economic impacts requires effective transportation policy decisions.
DOT is postured to respond effectively, and we continue to work closely
closely with government and industry to support the USG's response to
the virus.
Thank you and I look forward to your questions.
Senator Cruz. Thank you, Mr. Szabat.
Admiral Redd.
STATEMENT OF DR. STEPHEN REDD, DIRECTOR,
OFFICE OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE,
CENTERS FOR DISEASE CONTROL AND PREVENTION
Dr. Redd. Good afternoon, Chairman Cruz, Ranking Members
Cantwell and Sinema, and Distinguished Members of the
Subcommittee.
My name is Stephen Redd, and I am the Deputy Director for
Public Health Service and Implementation Science. I'm also
serving as the Senior Response Official in CDC's 2019 Novel
Coronavirus Response.
Thank you for the invitation to testify today on behalf of
the U.S. Centers for Disease Control and Prevention (CDC) on
our efforts to protect the health and safety of Americans from
this disease, COVID-19.
Let me begin by acknowledging that this is a new virus and
a new disease. New information and science continue to
accumulate and U.S. Government decisions to respond to this
epidemic will continue to be based on that evolving science.
Our overriding goal is to protect America from the effects
of the virus. We're working to slow its spread into the U.S.
and to minimize the impact.
The U.S. Government's approach to COVID-19 is built on
years and years of preparing and responding to infectious
disease emergencies, such as SARS, MERS, Ebola, and pandemic
influenza.
A key component of our work is to support state, local,
tribal, and territorial public health departments. This system
is the backbone of public health and also of our responses to
public health emergencies.
Up to now, more than 1,500 CDC staff have been involved in
the response, both at headquarters in Atlanta and in the field.
Over the past 2 months, Federal, state, and local governments
have mobilized to protect the American people.
As we've heard, globally we have seen over 90,000 confirmed
cases and those have occurred in 85 international
jurisdictions. As we've discussed, several countries are
currently reporting sustained community spread.
CDC, with our Federal and local partners, have instituted
multilayered aggressive containment and mitigation measures to
slow introduction and spread of the virus into the United
States. These public health interventions include early case
recognition and isolation, identifying and tracking contacts,
and in some instances implementing movement restrictions or
quarantine.
We've posted targeted travel warnings for several countries
and even for cruise ship travel in Asia so Americans can stay
informed on proper precautions to take when, and if, they
travel abroad.
Measures the U.S. Government has taken include denying
entry to the U.S. for certain travelers. This step has reduced
the number of people coming into the United States from China
by over 90 percent.
We've also, as you've heard, funneled travelers from highly
affected countries to 11 airports where we've instituted
screening procedures and, to date, we've screened more than
50,000 travelers.
As of noon today, CDC has reported 120 cases of COVID-19
from 13 states. We expect to continue to find more cases and we
expect these cases will be a mixture of travel-related cases,
of cases related to contact and community spread cases.
It's likely that we'll see some communities more highly
affected while others remain virus-free. I want to recognize
that people are concerned about this situation as are we.
As always, our Number 1 priority is the health and safety
of the American people. We appreciate that Americans are taking
this threat seriously and continuing to seek information about
how to be prepared.
While the immediate risk to the general American public is
low today, U.S. Government is doing everything we can to keep
it low. Risk varies by exposure and some areas of the country
are now experiencing community spread.
I ask you as trusted leaders in your communities to help us
with our mission to provide clear information to you and your
constituents by urging people to get the facts from CDC about
how to best protect themselves and their families.
Thank you.
[The prepared statement of Dr. Redd follows:]
Prepared Statement of Dr. Stephen Redd, Director, Office of Public
Health Preparedness and Response, Centers for Disease Control and
Prevention
Testimony of the Department of Health and Human Services on COVID-19
Since President Trump took office, his work to protect the health
and safety of the American people has included a specific focus on
monitoring, preparing for, and responding to biological threats, such
as infectious disease outbreaks. As soon as the United States became
aware of a novel coronavirus at the end of 2019, the U.S. Government
was tracking its spread and began preparing necessary responses.
Within the first two weeks of China's initial report of the
outbreak in December 2019, China reported 45 pneumonia cases and two
deaths. More recently, there has been an increase in cases outside of
China.
COVID-19 is a new disease, caused by a novel (or new) coronavirus
that has not previously been seen in humans. This new disease,
officially named Coronavirus Disease 2019 (COVID-19) by the World
Health Organization (WHO), is caused by the SARS-COV-2 virus, which is
in the same family of viruses as that cause the common cold, There are
many types of human coronaviruses including some that commonly cause
mild upper-respiratory tract illnesses. Coronaviruses are a large
family of viruses. Some cause illness in people, and others, such as
canine and feline coronaviruses, only infect animals. Rarely, animal
coronaviruses that infect animals have emerged to infect people and can
spread between people. This is suspected to have occurred for the virus
that causes COVID-19. Middle East Respiratory Syndrome (MERS) and
Severe Acute Respiratory Syndrome (SARS) are two other examples of
coronaviruses that originated from animals and then spread to people.
The potential global public health threat posed by this virus is
high, but right now, the immediate risk to most Americans is low. The
greater risk is for people who have recently traveled to an affected
country or been exposed to someone with COVID-19.
On January 29, 2020, President Trump announced the formation of the
President's Task Force on the Novel Coronavirus, which is chaired by
the Secretary for Health and Human Services and coordinated through the
National Security Council. The President's Task Force is composed of
subject matter experts from the White House and several United States
Government agencies, and it includes some of the Nation's foremost
experts on infectious diseases. The Task Force is leading the
Administration's efforts to monitor, contain, and mitigate the spread
of COVID-19 while ensuring that the American people have the most
accurate and up-to-date information to protect themselves and their
families.
The President's top priority is the health and welfare of the
American people, and his Administration has made it a priority to
prepare for infectious disease outbreaks that can cross borders. In
2018, President Trump launched the National Biodefense Strategy, which
lays out a framework for coordination among agencies, with the
Secretary of the U.S. Department of Health and Human Services (HHS) as
Chair of the Biodefense Steering Committee, and helps identify gaps in
preparedness and response. As the situation around the new coronavirus
evolves, the Administration will continue its coordinated response, in
collaboration with state and local governments and the private sector,
and adjust its positioning as needed.
Within HHS, the Centers for Disease Control and Prevention (CDC),
the Assistant Secretary for Preparedness and Response (ASPR), the
National Institute of Allergy and Infectious Diseases (NIAID), and the
Food and Drug Administration (FDA) play critical roles in responding to
COVID-19 by preventing and slowing the spread of the disease, assisting
repatriated Americans, protecting the supply of food, drugs, and
devices, and developing diagnostics, therapeutics, and vaccines.
Centers for Disease Control and Prevention
In late December 2019, Chinese authorities announced a cluster of
pneumonia cases of unknown etiology centered on a local seafood market
in Wuhan, China, with an estimated case onset in early December. CDC
immediately began monitoring the outbreak, and within days--by January
7, 2020--had established a Center-led Incident Management Structure. On
January 21, 2020, CDC transitioned to an Agency-wide response based out
of its Emergency Operations Center. This allows CDC to provide
increased operational support to meet the outbreak's evolving
challenges and provides strengthened functional continuity to meet the
long-term commitment needed to curb the outbreak.
CDC is assisting ministries of health in countries in every region
of the globe with their most urgent and immediate needs to prevent,
detect, and respond to the COVID-19 outbreak.
CDC's most expert and practiced infectious disease and public
health experts are dedicated to this response 24/7 to protect the
American people. CDC is a disease preparedness and response agency, and
this work is fundamental to our mission both domestically and
internationally. The Agency's approach to COVID-19 is built upon
decades of experience with prior infectious disease emergencies
including responses to SARS, MERS, and Ebola, and to pandemic
influenza.
To mitigate the impact of COVID-19 within the United States, CDC is
working alongside Federal, state, local, tribal, and territorial
partners, as well as public health partners. This public health
response is multi-layered and includes aggressive containment and
mitigation activities with an objective to detect and minimize
introductions of this virus in the United States so as to reduce its
spread and impact. It is impossible to catch every single traveler
returning from an affected country with this virus--given the nature of
this virus and how it's spreading. Our goal continues to be slowing the
introduction of the virus into the United States as we work to prepare
our communities for more cases and possible sustained spread.
To accomplish this, CDC is also working with multiple countries, in
collaboration with U.S. Agency for International Development (USAID)
and other Federal agencies and WHO to support ministries of health
around the globe to prepare and respond to the outbreak. For example,
the U.S. Government is helping to support countries to implement
recommendations provided by WHO related to the identification of people
who might have this new infection, diagnosis and care of patients, and
tracking of the outbreak. CDC staff are also starting to work together
with interagency colleagues in those countries to conduct
investigations that will help inform response efforts going forward.
The Agency is using its existing epidemiologic, laboratory, and
clinical expertise to gain a more comprehensive understanding of COVID-
19. CDC is leveraging prior programmatic investments in domestic and
global public health capacity and preparedness to strengthen the
Agency's response to COVID-19. Thus far, this response has been built
largely on the foundation of our seasonal and pandemic influenza
program's infrastructure. The ongoing response to COVID-19 also
demonstrates CDC's continued commitment to strengthen global health
security. CDC has been engaged in global health security work for over
seven decades. Thanks to investments in Global Health Security, the
U.S. Government's work has helped partner countries build and improve
their public health system capacity. This global effort strengthens the
world's ability to prevent, detect, and respond to infectious diseases
like this new coronavirus.
This outbreak also underscores the need for the United States to
continue to play a leadership role on the global stage, and to
strengthen global capacity to stop disease threats at their sources,
before they spread. Furthermore, the outbreak demonstrates the
importance of continued investment in our Nation's public health
infrastructure. Despite years of progress in domestic disease
prevention and response, efforts to help modernize our federal, state,
and local capability and health systems that are crucial to responding
to and understanding unprecedented threats continue.
The U.S. Government has taken unprecedented steps to prevent the
spread of this virus and to protect the American people and the global
community from this new threat and allow State, local, territorial, and
private partners time to prepare for any necessary response and
mitigation activities. Since February 2, 2020, pursuant to arrival
restrictions imposed by the Department of Homeland Security, flights
carrying persons who have recently traveled from or were otherwise
present within mainland China or other affected countries have been
funneled to designated U.S. airports with CDC quarantine stations. At
these airports, passengers are subject to enhanced illness screening
and self-monitoring with public health supervision up to 14 days from
the time the passenger departs the affected country. This enhanced
entry screening serves two critical purposes. The first is to detect
illness and rapidly respond to symptomatic people entering the country.
The second purpose is to educate travelers about the virus and what to
do if they develop symptoms.
These measures are part of a layered approach which includes our
other core public health efforts, including aggressively tracking
COVID-19 around the globe, building laboratory capacity, and preparing
the national healthcare system for community spread. These core
capabilities and expertise are essential to CDC's comprehensive
approach to addressing this outbreak.
While CDC believes that the immediate risk of this new virus to the
American public is low, CDC is preparing the Nation's healthcare system
to respond to identification of individual cases and potential person-
to-person transmission of COVID-19 in the community, at the same time
ensuring the safety of its patients and workers. CDC has developed
guidance on appropriate care and infection control for patients with
COVID-19 and is engaging regularly with clinical and hospital
associations to confirm that its guidance is helpful and responsive to
the needs of the healthcare system.
Furthermore, understanding the current constraints of the global
supply of personal protective equipment (PPE), CDC is working with
industry and the U.S. health system to comprehend possible effects on
facilities' abilities to procure the needed levels of PPE, and to
provide strategies to optimize the supply of PPE.
Effective disease surveillance enables countries to quickly detect
outbreaks and continuously monitor for new and reemerging health
threats. CDC continues to monitor the COVID-19 situation around the
world.
CDC has begun working with domestic public health laboratories that
conduct community-based influenza-like illness surveillance and
leveraging our existing influenza and viral respiratory surveillance
systems so that we may begin testing people with flu-like symptoms for
the SARS-COV-2 virus. HHS is developing plans to expand this effort.
This collaboration with domestic public health labs is another
layer of our response that will help us detect if this virus is
spreading in a community. All of our efforts now are to prevent the
sustained spread of this virus in our communities, but we need to be
prepared for the possibility that it will spread. Results from this
surveillance could necessitate changing our response strategy.
CDC has issued guidance for people at high risk of exposure to the
virus, including flight crews, recent travelers to China, and
healthcare workers. Through its extensive Health Alert Network, CDC
shared guidance for clinical care for healthcare professionals and
state and local health departments. Health departments, in consultation
with healthcare providers, can evaluate patients and determine whether
someone may have the illness and should be subjected to additional
diagnostic testing.
CDC has a demonstrated record of innovative science and evidence-
based decision-making, and an experienced and expert workforce that is
working 24/7 to combat this public health emergency. The COVID-19
outbreak is evolving rapidly, and the U.S. Government is constantly
making adjustments to respond to the changing nature of this public
health emergency. Our goal continues to be slowing the introduction of
the virus into the United States and preparing our communities for more
cases and possible sustained spread. While leaning forward aggressively
with the hope that we will be able to prevent community spread, CDC
remains vigilant in confronting the challenges presented by this new
coronavirus.
Assistant Secretary for Preparedness and Response
Currently, there are no vaccines or therapeutics approved by the
FDA to treat or prevent novel coronavirus infections. The Biomedical
Advanced Research and Development Authority (BARDA), part of ASPR, is
working with counterparts across the government, including within HHS
and with the Department of Defense (DOD). The team is reviewing
potential vaccines, treatments, and diagnostics from across the public
and private sectors to identify promising candidates that could be
developed to detect, protect against, or treat people with coronavirus
infections. BARDA is working closely across the U.S. Government to
assess and identify potential partners and technologies suitable to
address the COVID-19 outbreak--both for prevention and treatment.
This has allowed BARDA to leverage existing partnerships,
accelerating the development of COVID-19 medical countermeasures,
including diagnostics, therapeutics, and vaccines. Established
partners, including Regeneron, Janssen, and Sanofi Pasteur, have shown
success in developing both prophylactic and therapeutic medical
countermeasures for emerging infectious diseases.
BARDA is collaborating with Regeneron to leverage their partnership
agreement to develop multiple monoclonal antibodies that, individually
or in combination, could be used to treat this emerging coronavirus.
Regeneron's monoclonal antibody discovery platform, called VelocImmune,
was used to develop a promising investigational three-antibody
therapeutic which was deployed to treat Ebola in the most recent
outbreak in the Democratic Republic of the Congo, and an
investigational two-antibody therapeutic to treat MERS. The technology
shortened multiple aspects of the product development timeline for
therapeutics to treat MERS and Ebola from years to months. The
technology helped shorten certain stages of drug development, including
the process of antibody discovery and selection, preclinical-scale
manufacturing, and clinical-scale manufacturing. BARDA and Regeneron
are working to utilize these monoclonal antibodies, produced by a
single clone of cells or a cell line with identical antibody molecules,
which will bind to certain proteins of a virus, reducing the ability of
the COVID-19 virus to infect human cells.
BARDA is working with Janssen to leverage their Ebola, Zika, HIV
vaccine platform to expedite development of vaccines that protect
against the SARS-CoV-2 virus. Using existing resources, BARDA will
share research and development costs and expertise with Janssen to help
accelerate Janssen's investigational COVID-19 vaccine into clinical
evaluation. Janssen will also scale-up production and manufacturing
capacities required to manufacture the candidate vaccine. This same
approach was used to develop and manufacture Janssen's investigational
Ebola vaccine with BARDA support; that vaccine is being used in the
Democratic Republic of the Congo as part of the current Ebola outbreak
response. Additionally, BARDA and Janssen are working together to help
develop treatments for coronavirus infections. Janssen will conduct
high throughput screening on thousands of potential antiviral compounds
in order to identify medicines that could safely and effectively be
used to reduce the severity of illness and treat COVID-19 infections,
as well as identify compounds that have antiviral activity against
SARS-CoV-2 as an initial step in developing new treatments. These
products include those in development to treat and prevent MERS or
SARS, which are caused by coronaviruses also related to COVID-19.
Finally, in their work with Sanofi Pasteur, BARDA is able to
leverage a licensed recombinant influenza vaccine platform to produce a
recombinant SARS-CoV-2 vaccine candidate. The technology produces an
exact genetic match to proteins of the virus. DNA encoding the protein
will be combined with DNA from a virus harmless to humans, and used to
rapidly produce large quantities of antigen which stimulate the immune
system to protect against the virus. The antigens will be separated and
collected from these cells and purified to create working stocks of
vaccine for advanced development.
BARDA has initiated early steps of medical countermeasures
development with partners and will continue to work to accelerate this
process. Availability of these medical countermeasures is essential to
save lives and protect Americans against 21st century public health
threats.
Our nation's healthcare system is better prepared than it has ever
been. For example, all 50 states have Pandemic Plans, as a requirement
of CDC's Public Health Emergency Preparedness Program (PHEP) and ASPR's
Hospital Preparedness Program (HPP). HPP was established after the
September 11, 2001, terrorist attacks, with the goal of improving the
capacity of local hospitals across the country to deal with disasters
and a large influx of patients in an emergency. Using HPP funding,
state grantees initially purchased equipment and supplies needed for
emergency medical surge capacity. Over time, the program has
successfully evolved to support local, coordinated healthcare
coalitions, including hospitals, public health facilities, emergency
management agencies, and emergency medical services providers.
Investments administered through PHEP and HPP have improved individual
health care entities' preparedness and have built a system for
coordinated healthcare system readiness. HPP is the only source of
Federal funding to prepare the Nation's mostly private health care
system to respond to emergencies, including COVID-19.
Beginning in 2018, ASPR has been supporting Regional Disaster
Health Response Systems (RDHRS) pilot projects. The RDHRS concept aims
to provide funding directly to hospitals and healthcare systems to
establish multi-state regional partnerships to increase preparedness
and response capability and capacity for hospitals and healthcare
facilities in advance of, during, or immediately following incidents,
including emerging infectious diseases. Two sites were selected in
September 2018 to begin development of RDHRS pilots. In 2019, two
grants were awarded to support new centers of excellence pilots focused
on pediatric disaster care. The RDHRS and Pediatric Disaster Care
Center of Excellence cooperative agreement requirements are
intentionally aligned to ensure synergy between the programs and
collaboration between all sites and facilities. Ultimately, these
efforts inform best practices to help ready healthcare delivery systems
for disasters and emergencies and are critical in aiding response and
limiting the impact of disaster. As you all are aware, the United
States is in the middle of influenza season. Many emergency departments
are at 90 percent capacity. If influenza worsens, or if COVID-19
intensifies domestically, emergency departments would be severely
strained, which is why supporting models such as the Hospital
Preparedness Program healthcare coalition network is so important.
The National Ebola Training and Education Center (NETEC) combines
the resources of healthcare institutions experienced in treating Ebola
to offer training, readiness consultations, and expertise to help
facilities prepare for Ebola and other special pathogens. The regional
Ebola and other special pathogen treatment centers, of which ASPR and
CDC funded 10 across the country, all have respiratory infectious
disease isolation capacity or negative pressure rooms for at least 10
patients, including pediatric patients. The NETEC and the regional
Ebola and other special pathogen treatment centers have been used to
support recent quarantine efforts. Should the coronavirus infections
increase domestically, these centers will become critical in isolating
infected persons and providing adequate treatment.
ASPR and CDC also work to enhance medical surge capacity by
organizing, training, equipping, and deploying Federal public health
and medical personnel, such as National Disaster Medical System (NDMS)
teams, and providing logistical support for Federal responses to public
health emergencies. NDMS was originally created during the Cold War to
take care of military casualties from overseas in U.S. civilian
hospitals. Today, NDMS teams are deployed to strategic locations across
the country, caring for U.S. citizens who may have been exposed to
SARS-CoV-2, effectively providing medical care and limiting the
potential spread of the disease.
Recently, to assist in the repatriation effort, ASPR stood up a
National HHS Incident Management Team (IMT) located in Washington, DC.
The IMT serves as the national command and control element, deploying
Public Health Service Commission Corps Officers and NDMS personnel.
In addition, HHS provided cache equipment, (e.g., medical supplies
and resources) to Travis AFB, Marine Corps Air Station Miramar,
Lackland, Air Force Base, and Camp Ashland to support evacuees
quarantined at these facilities. HHS deployed one Disaster Medical
Assistance Team (DMAT) and one IMT on February 12, 2020, to support
American citizens in Japan on the Diamond Princess cruise ship, as well
as the U.S. Embassy, to provide medical care, prescriptions, and
behavioral health support.
Many active pharmaceutical ingredients and medical supplies,
including auxiliary supplies such as syringes and gloves, come from
China and India. This outbreak demonstrates why ASPR is seeking
innovative solutions and partnerships to better protect national
security. ASPR is working to increase access to personal protective
equipment (PPE) by:
Coordinating with CDC and other Federal agencies to share
information about optimization of PPE, to prevent overbuying
and overuse of existing supplies
Engaging private sector partners who manufacture and
distribute PPE to share information and concerns, and to
explore options to anticipate and meet the needs of the U.S.
healthcare sector more effectively. During recent discussions,
for example, distributors informed us that they have
implemented allocations to help prevent stockpiling at
healthcare facilities. The allocation is a percentage of a
customer's previous orders and is designed to help protect the
healthcare supply chain and ensure the right supplies are
available for those who need it.
We are also partnering with other Federal agencies such as
DHS, DOD and the U.S. Department of Veterans Affairs who are
large buyers of PPE, to develop acquisition strategies that
incentivize industry to expand PPE production while not
exacerbating supply challenges.
The Strategic National Stockpile (SNS) holds thousands of
deployable face masks, N95 respirators, gloves, and surgical gowns that
could be deployed if state and local supplies are diminished due to the
current COVID-19 response and commercial supplies are exhausted. The
SNS is working hand-in-hand with commercial supply chain partners and
other Federal agencies to continue monitoring supply levels and to
prepare for a potential deployment of SNS personal protective gear if
it is needed.
The National Institutes of Health
The National Institutes of Health (NIH) is the HHS agency leading
the research response to the global health emergency of COVID-19.
Within the NIH, the National Institute of Allergy and Infectious
Diseases (NIAID) is responsible for conducting and supporting research
on emerging and re-emerging infectious diseases, including COVID-19.
NIAID is well-positioned to respond rapidly to infectious disease
threats as they emerge by leveraging fundamental basic research
efforts; a domestic and international research infrastructure that can
be quickly mobilized; and collaborative and highly productive
partnerships with industry. NIAID provides preclinical research
resources to scientists in academia and private industry throughout the
world to advance translational research for emerging and re-emerging
infectious diseases. These research resources are designed to bridge
gaps in the product development pipeline, thereby lowering the
scientific, technical, and financial risks incurred by industry and
incentivizing companies to partner in the development of effective
countermeasures including diagnostics, therapeutics, and vaccines.
NIAID also supports the Infectious Diseases Clinical Research
Consortium, which includes a network of Vaccine and Treatment
Evaluation Units (VTEUs). The VTEUs conduct clinical trials to
investigate promising therapeutic and vaccine candidates when public
health needs arise. NIAID collaborates with other Federal agencies,
including through the HHS Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE), to help advance progress against
newly emerging public health threats. In addition, partnerships with
academia, the biotechnology and pharmaceutical industries, domestic and
international researchers, and organizations such as the World Health
Organization (WHO) are integral to these efforts.
NIAID has a longstanding commitment to coronavirus research,
including extensive efforts to combat two other serious diseases caused
by coronaviruses: SARS and MERS. This research has improved our
fundamental understanding of coronaviruses and provides a strong
foundation for our efforts to address the challenge of SARS-CoV-2, the
novel coronavirus that causes COVID-19. NIAID has responded to the
newly emerging COVID-19 outbreak by expanding our portfolio of basic
research on coronaviruses. NIAID scientists have rapidly identified the
human receptor used by SARS-CoV-2 to enter human cells. In addition,
NIAID investigators and their collaborators recently identified the
atomic structure of the spike protein, an important SARS-CoV-2 surface
protein that is a key target for the development of vaccines and
therapeutics. NIAID scientists also are evaluating the stability of
SARS-CoV-2 on various ordinary surfaces and in aerosols to better
understand the potential for viral spread throughout the community.
NIAID-supported researchers are assessing the risk of emergence of
bat coronaviruses in China, including the characterization of bat
viruses and surveys of people who live in high-risk communities for
evidence of bat coronavirus infection. Such research is necessary to
better understand this emerging infection and to investigate optimal
ways to diagnose, treat, and prevent COVID-19.
The NIAID Centers of Excellence for Influenza Research and
Surveillance (CEIRS), which conduct influenza risk assessments in
multiple sites throughout the world particularly in Asia, have
responded rapidly to the COVID-19 outbreak. CEIRS researchers at the
University of Hong Kong are evaluating the epidemiology, transmission
dynamics, and severity of COVID-19. These scientists also have
performed environmental sampling of the Wuhan market where the first
COVID-19 cases were reported.
NIAID is working with CEIRS collaborators and the CDC to obtain
additional virus and biological samples from patients to further
advance research efforts on COVID-19. Recently, the NIAID-funded BEI
Resources Repository made samples of SARS-CoV-2 available for
distribution to domestic and international researchers at Biosafety
Level 3 laboratories. In addition, CEIRS researchers and other NIAID-
supported scientists are developing reagents, assays, and animal models
that can be used to evaluate promising therapeutics and vaccines. These
research resources also will be shared with the domestic and
international scientific community as soon as they become available.
On February 6, 2020, NIAID issued a Notice of Special Interest
regarding the Availability of Urgent Competitive Revisions for Research
on the 2019 Novel Coronavirus. This notice encourages existing NIAID
grantees to apply for supplements for research project grants focused
on the natural history, pathogenicity, and transmission of the virus,
as well as projects to develop medical countermeasures and suitable
animal models for preclinical testing of COVID-19 vaccines and
therapeutics.
NIAID has responded to public health concerns about COVID-19 by
increasing ongoing coronavirus research efforts to accelerate the
development of interventions that could help control current and future
outbreaks of COVID-19. These activities build on prior NIAID research
addressing other coronaviruses, such as those that cause SARS and MERS.
The CDC has developed a real-time Reverse Transcription-Polymerase
Chain Reaction (rRT-PCR) test that can detect COVID-19 using
respiratory samples from clinical specimens. NIAID is accelerating
efforts to develop additional diagnostic tests for COVID-19, and NIAID-
supported investigators are developing PCR-based assays for SARS-CoV-2
to facilitate preclinical studies and aid in the development of medical
countermeasures. NIAID scientists also are developing reagents for an
enzyme-linked immunosorbent assay for SARS-CoV-2. CEIRS researchers at
the University of Hong Kong have developed a separate RT-PCR test and
made their protocol publicly available through the WHO. These NIAID-
supported investigators also have distributed assay reagents to 12
countries to facilitate the diagnosis of COVID-19.
NIAID is pursuing the development of antivirals and monoclonal
antibodies for potential use against SARS-CoV-2. NIAID has launched a
multicenter, randomized controlled clinical trial to evaluate the
safety and efficacy of the antiviral drug remdesivir for the treatment
of COVID-19 in hospitalized adults with laboratory-confirmed SARS-CoV-2
illness. The adaptive design of this trial will enable the evaluation
of additional promising therapies. NIAID plans to assess other existing
antivirals for activity against SARS-CoV-2, and NIAID scientists are
working to identify monoclonal antibodies with therapeutic potential
from COVID-19 patient samples as well as historical SARS patient
samples. NIAID-funded scientists also aim to delineate new viral
targets to facilitate the development of novel therapeutics with broad
activity against coronaviruses. Finally, NIAID is expanding its suite
of preclinical services to add assays that investigators can use to
accelerate research and development of therapeutics for COVID-19.
A safe and effective vaccine for SARS-CoV-2 would be an extremely
valuable tool to stop the spread of infection and prevent future
outbreaks. Public and private entities across the globe have announced
plans to develop SARS-CoV-2 vaccine candidates following the release of
the SARS-CoV-2 genetic sequence. NIAID is supporting development of
several SARS-CoV-2 vaccine candidates, and is utilizing vaccine
platform technologies that have shown promise against the coronaviruses
that cause SARS and MERS.
The NIAID Vaccine Research Center (VRC) is collaborating with the
biotechnology company Moderna, Inc., on the development of a vaccine
candidate using a messenger RNA (mRNA) vaccine platform containing the
gene that expresses the VRC-designed spike protein of SARS-CoV-2. NIAID
anticipates the experimental vaccine will be ready for clinical testing
in the NIAID VTEUs within the next two months and will conduct
preclinical studies as well as a first-in-human study of this COVID-19
vaccine candidate. The Coalition for Epidemic Preparedness Innovations
(CEPI) will fund the manufacture of the first clinical production lot
of this mRNA-based vaccine candidate using the Moderna rapid
manufacturing facility.
NIAID Rocky Mountain Laboratories (RML) scientists are
collaborating with Oxford University investigators to develop a
chimpanzee adenovirus-vectored vaccine candidate against SARS-CoV-2; in
addition, they have partnered with CureVac on an mRNA vaccine
candidate. RML investigators also have launched a collaboration with
the University of Washington and have begun early-stage testing of an
RNA vaccine candidate against SARS-CoV-2. In addition, NIAID-supported
scientists at Baylor College of Medicine and their collaborators are
evaluating an experimental SARS-CoV recombinant protein vaccine to
determine if it also provides protection against SARS-CoV-2. NIAID is
exploring additional collaborations with extramural research and
industry partners on other vaccine concepts. NIAID also is supporting
the development of standardized assays and animal models that will be
utilized to evaluate vaccine candidates.
With all these efforts, NIAID is coordinating closely with
colleagues at the CDC, BARDA, FDA, DOD, and other Federal and
international partners.
To achieve the ultimate goal of having a SARS-CoV-2 vaccine
available to the public, it is important that NIAID and the entire
biomedical research community pursue a range of vaccine strategies in
order to be better positioned to overcome the scientific or technical
challenges associated with any particular vaccine approach. In this
regard, NIAID has dedicated resources toward preclinical research to
advance a robust pipeline of vaccine candidates into Phase 1 clinical
evaluation. Further vaccine research, including Phase 2 clinical
trials, will then be required. Additional research also is needed to
better understand the fundamental biology of coronaviruses and to
facilitate the design of vaccines that elicit optimal immune responses
and protect against infection.
While ongoing SARS-CoV-2 vaccine research efforts are promising, it
is important to realize that the development of investigational
vaccines and the clinical testing to establish their safety and
efficacy take time. Although we plan to begin early-stage clinical
testing of an NIAID-supported vaccine candidate in the next few months,
a safe and effective, fully licensed SARS-CoV-2 vaccine will likely not
be available for some time. Currently, the COVID-19 outbreak response
in the United States remains focused on the proven public health
practices of containment--identifying cases, isolating patients, and
tracing contacts.
NIH is committed to continued collaboration with other HHS agencies
and additional partners across the U.S. Government and international
community to advance research to address COVID-19. As part of its
mission to respond rapidly to emerging and re-emerging infectious
diseases throughout the world, NIAID is expanding our efforts to
elucidate the biology of SARS-CoV-2 and employ this knowledge to
develop the tools needed to diagnose, treat, and prevent disease caused
by this virus. NIAID is particularly focused on developing safe and
effective COVID-19 vaccines. These efforts also help to expand our
knowledge base and improve our continued preparedness for the next
inevitable emerging disease outbreak.
Food and Drug Administration
The FDA plays a critical role in overseeing our Nation's FDA-
regulated products as part of our vital mission to protect and promote
public health, including during public health emergencies. Our work
primarily focuses on four key areas: first, actively facilitating
efforts to diagnose, treat, and prevent the disease; second,
surveilling product supply chains for potential shortages or
disruptions and helping to mitigate such impacts, as necessary; third,
conducting inspections and monitoring compliance, including of
facilities that manufacture FDA-regulated products overseas; fourth,
helping to ensure the safety of consumer products.s
A key focus area for the FDA is helping to expedite the development
and availability of medical products needed to diagnose, treat, and
prevent this disease. We're committed to helping foster the development
of critical medical countermeasures as quickly as possible to protect
public health. We provide regulatory advice, guidance, and technical
assistance to sponsors in order to advance the development and
availability of vaccines, therapies, and diagnostic tests for this
novel virus.
On February 4, 2020, the FDA issued an emergency use authorization
(EUA) to enable immediate use of a diagnostic test developed by the
CDC, facilitating the ability for this test to be used in CDC-qualified
laboratories.\1\ The FDA is dedicated to actively working with other
COVID-19 diagnostic developers to help accelerate development programs
and requests for EUAs. We have developed an EUA review template for
tests to detect the virus, which outlines the data requirements for a
Pre-EUA package that is available to developers upon request. To date,
we have shared the EUA review template with more than 100 developers
who have expressed interest in developing diagnostics for this virus.
---------------------------------------------------------------------------
\1\ FDA. 2019 Novel Coronavirus Emergency Use Authorization.
February 4, 2020. https://www
.fda.gov/medical-devices/emergency-situations-medical-devices/
emergency-use-authorizations#co
ronavirus2019. FDA. FDA Takes Significant Step in Coronavirus Response
Efforts, Issues Emergency Use Authorization for the First 2019 Novel
Coronavirus Diagnostic: Critical Milestone Reached in Response to this
Outbreak. https://www.fda.gov/news-events/press-announcements/fda-
takes-significant-step-coronavirus-response-efforts-issues-emergency-
use-authorization-first.
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The medical product supply chain is always potentially vulnerable
to disruption, which makes our surveillance work and collaboration with
industry critical and why the Agency takes a proactive stance on any
potential impact or disruption to the supply chain. An outbreak of this
global scale has an impact on the medical product supply chains,
including potential disruptions to supply or shortages of critical
medical products in the United States. We are in contact with
manufacturers; global regulators, like the European Medicines Agency;
health care delivery organizations; and other participants in the
medical product supply chains to quickly identify and address any
supply concerns that come from issues related to China and other
locations in Southeast Asia sourcing raw materials for manufacturing
drugs.
We are also tracking reports of increased ordering of some
essential medical devices through distributors, such as personal
protective equipment (PPE) (e.g., respirators and surgical gowns,
gloves and masks). FDA is working proactively to stay ahead of
potential shortages or disruptions of medical products. The agency will
use all available authorities to react swiftly and mitigate the impact
to U.S. patients and health care professionals as these threats arise.
Monitoring the safety of FDA-regulated product supply chains is one
of the FDA's highest priorities. The FDA utilizes risk-based models to
identify firms for inspection and prioritizes inspections based on
specific criteria. Because of travel restrictions to China, the Agency
has postponed planned inspection activities in China. However, we are
currently continuing inspection and enforcement activities as normal
for the rest of our operations. Inspections of facilities in China
remain prioritized in our site selection model and, when travel
restrictions are lifted, inspections of facilities in China will
resume. Any travel to China that is deemed to be mission-critical is
being assessed on a case-by-case basis in close coordination with other
HHS components and with the Department of State. FDA is committed to
maintaining its scheduled inspections around the globe to the extent
possible, while maintaining the safety of the staff involved. We will
revisit this approach and adjust as necessary as this outbreak
continues to unfold. In the meantime, FDA is working with our partner
government agency, U.S. Customs and Border Protection (CBP), to
evaluate and adjust our risk-based targeting strategy to ensure FDA-
regulated products are safe when entering the United States.
While the outbreak is impacting our ability to conduct inspections
in China, it's important to underscore that the FDA's regular risk-
based process of surveillance testing of imported products, including
those from China, continues.
Inspections are one of many tools that the Agency uses to inform
its risk strategy for imported FDA-regulated products and to help
prevent products that do not meet the FDA's standards from entering the
U.S. market. Other tools include: import alerts, increased import
sampling, and screening. Inspections are also part of, among other
things, the new and generic drug approval process. While such pre-
approval inspections are on hold in China, we are working to mitigate
the impact on new and generic drug approval decisions by requesting
records that may be used in lieu of an inspection, depending on the
circumstances. Based on our evaluation of previous FDA inspection
history, a firm's previous compliance history and information from
foreign health authorities with which we have mutual recognition
agreements, we determine if the totality of the information would
suffice in lieu of such a pre-approval inspection.
All products offered for entry into the United States, including
items for personal use, are subject to the regulatory requirements of
CBP. Imported shipments of FDA-regulated products referred by CBP,
including those from China, are then reviewed by the FDA and must
comply with the same standards as domestic products. At this time, we
want to reassure the public that there is no evidence to support
transmission of COVID-19 associated with imported goods, including food
and drugs for people or pets, and there have not been any cases of
COVID-19 in the U.S. associated with imported goods.
We established a cross-agency task force to closely monitor for
fraudulent FDA-regulated products and false product claims related to
COVID-19 and we have already reached out to major retailers to ask for
their help in monitoring their online marketplaces for fraudulent
products with coronavirus and other pathogen claims.
FDA is utilizing all our existing authorities to address COVID-19
and we welcome the opportunity to work with Congress to strengthen our
response capabilities. There are four specific proposals included in
the President's Budget that would better equip the Agency to prevent or
mitigate medical product shortages.
(1) Lengthen Expiration Dates to Mitigate Critical Drug Shortages
Shortages of critical drugs can be exacerbated when drugs must be
discarded because they exceed a labeled shelf-life due to
unnecessarily short expiration dates. By expanding FDA's
authority to require, when likely to help prevent or mitigate a
shortage, that an applicant evaluate, submit studies to FDA,
and label a product with the longest possible expiration date
that FDA agrees is scientifically justified, there could be
more supply available to alleviate the drug shortage or the
severity of a shortage.
(2) Improving Critical Infrastructure by Requiring Risk Management
Plans
Enabling FDA to require application holders of certain drugs to
conduct periodic risk assessments to identify the
vulnerabilities in their manufacturing supply chain (inclusive
of contract manufacturing facilities) and develop plans to
mitigate the risks associated with the identified
vulnerabilities would enable the Agency to strengthen the
supply chain by integrating contingencies for emergency
situations. Currently, many applicants lack plans to assess and
address vulnerabilities in their manufacturing supply chain,
putting them, and American patients, at risk for drug supply
disruptions following disasters (e.g., hurricanes) or in other
circumstances.
(3) Improving Critical Infrastructure Through Improved Data Sharing:
Requiring More Accurate Supply Chain Information
Empowering FDA to require information to assess critical
infrastructure, as well as manufacturing quality and capacity,
would facilitate more accurate and timely supply chain
monitoring and improve our ability to recognize shortage
signals.
(4) Device Shortages
FDA does not have the same authorities for medical device
shortages as it does for drugs and biological products. For
instance, medical device manufacturers are not required to
notify FDA when they become aware of a circumstance that could
lead to a device shortage or meaningful disruption in the
supply of that device in the United States, nor are they
required to respond to inquiries from FDA about the
availability of devices. Enabling FDA to have timely and
accurate information about likely or confirmed national
shortages of essential devices would allow the Agency to take
steps to promote the continued availability of devices of
public health importance. Among other things, FDA proposes to
require that firms notify the agency of an anticipated
meaningful interruption in the supply of an essential device;
require all manufacturers of devices determined to be essential
to periodically provide FDA with information about the
manufacturing capacity of the essential device(s) they
manufacture; and authorize the temporary importation of certain
devices where the benefits of the device in mitigating a
shortage outweigh the risks presented by the device that could
otherwise result in denial of importation of the device into
the United States.
Senator Cruz. Thank you, Dr. Redd.
Mr. Ferrara.
STATEMENT OF WILLIAM FERRARA, EXECUTIVE ASSISTANT COMMISSIONER
FOR OPERATIONS SUPPORT, U.S. CUSTOMS AND BORDER PROTECTION
Mr. Ferrara. Good afternoon, Chairman Cruz, Ranking Members
Sinema and Cantwell, and Members of the Subcommittee.
Thank you for the opportunity to testify today on CBP's
response to the Coronavirus or COVID-19.
U.S. Customs and Border Protection is an integral part of
the U.S. Government's response to the virus as our men and
women serve as the frontline of defense at and between U.S.
ports of entry, whether they be land, air, or sea.
CBP has been working closely with the Department of
Homeland Security, the Centers for Disease Control and
Prevention, and other interagency partners since cases of the
virus in China began to increase.
CBP and its Federal partners have taken decisive proactive
and preemptive actions to mitigate the threat, minimize risk,
and slow the spread of the virus. With limited exceptions, all
foreign nationals who have traveled to China or Iran within 14
days are ineligible to enter the United States at this time.
DHS, including CBP, continues to work very closely with our
partners at the CDC to route all persons who have been in
Mainland China or Iran in the last 14 days to one of 11
designated ports of entry where the Federal Government has
focused public health resources.
All flights coming from Mainland China are funneled to one
of the 11 designated POEs. There are no flights from Iran.
However, all passengers coming from Iran are also funneled to
one of the 11 POEs.
For passengers traveling to the United States by air, we
also work in collaboration with the air carriers and foreign
partners to deny the boarding of individuals that would be
found inadmissible upon their arrival to the United States.
CBP continues to facilitate CDC's enhanced health screening
of travelers entering the United States. These screening
measures are a critical part of the U.S. Government's strategy
to slow the spread of the virus and protect the American
people.
All travelers who have been in Mainland China and Iran
within the past 14 days or who exhibit symptoms consistent with
COVID-19 are sent to CDC staff or DHS Countering Weapons of
Mass Destruction, CWMD, contract personnel for medical
evaluation.
Travelers identified by CBP officers doing their primary
inspection are referred to a secondary screening area. In the
secondary screening area, DHS, CWMD contract personnel take the
following actions in support of CDC.
They verify if the CDC enhanced screening is required,
collect contact information for travelers requiring enhanced
health screening, ask travelers about health status, for
example, if they have a fever, cough, or difficulty breathing,
and take and record the traveler's temperature.
CWMD is currently supporting CDC's enhanced health
screening efforts through agreements with state or local EMS,
public health and first responders in an overtime capacity.
CWMD established this capacity in response to the Ebola virus
threat. These actions ensured a trained, vetted, and badged
workforce was ready to rapidly deploy to support the CDC. DHS
was able to use this established capability to quickly address
the threat of COVID-19.
At and in between all ports of entry, CBP officers and
agents continue to remain alert and notify CDC and other public
health officials when encountering travelers exhibiting signs
of overt illness.
Officers and agents are well-trained and use a combination
of travel history records, questioning, observation, and self-
declarations to identify those requiring additional health
screening.
CBP also closely works with the U.S. Coast Guard to ensure
that ships and crews with nexus to China or Iran are
appropriately identified and screened prior to coming into
port.
At CBP, our employees are our greatest asset. We are taking
every precaution to keep our workforce safe, especially those
who may regularly encounter potential disease carriers.
All of the CBP's operational offices have a 30-day supply
of personal protective equipment or PPE, including gloves,
masks, coveralls, and hand sanitizer. These are located locally
across all field offices, sectors, and air branches.
CBP continues to work with DHS and the interagency to
monitor the global supply chain impacts and project critical
PPE needs for the CBP workforce.
On February 5, 2020, CBP issued an updated job hazard
analysis to all employees that outlines the current
comprehensive PPE guidance, which includes guidance about
wearing masks under the appropriate circumstances.
CBP continues to share information with our workforce on an
ongoing basis. We are committed to doing all that we can to
keep our workforce safe as they work to ensure the safety of
our Nation.
Thank you for the opportunity to appear today, and I look
forward to your questions.
[The prepared statement of Mr. Ferrara follows:]
Prepared Statement of William Ferrara, Executive Assistant Commissioner
for Operations Support, U.S. Customs and Border Protection
Good afternoon Chairman Cruz, Ranking Member Sinema, and Members of
the Subcommittee. Thank you for the opportunity to testify today on
CBP's response to the coronavirus, or COVID-19.
U.S. Customs and Border Protection (CBP) is an integral part of the
U.S. Government's response to the virus, as our men and women serve as
the first line of defense at--and between--all U.S. ports of entry,
whether land, air, or sea.
CBP has been engaged and working closely with the Department of
Homeland Security (DHS), the Centers for Disease Control and Prevention
(CDC), and other interagency partners since cases of the virus in China
began to increase. CBP and its Federal partners have taken decisive,
proactive, and preemptive action to mitigate the threat, minimize risk,
and slow the spread of the virus.
With limited exceptions, all foreign nationals who have traveled to
China or Iran within 14 days are ineligible to enter the United States
at this time. DHS, including CBP, continues to work very closely with
our partners at the CDC to route all admissible persons who have been
in mainland China or Iran in the last 14 days to one of 11 designated
ports of entry--or POEs--where the Federal Government has focused
public health resources.
All flights coming from mainland China are funneled to one of the
11 designated POEs. There are no direct flights from Iran; however, all
passengers coming from Iran are also funneled to one of the 11 POEs.
For passengers traveling to the U.S. by air, we also work in
collaboration with air carriers and foreign partners to deny the
boarding of individuals that would be found inadmissible upon arrival
in the U.S.
CBP continues to facilitate CDC's enhanced health screening of
travelers entering the United States. These screening measures are a
critical part of the U.S. government strategy to slow the spread of the
virus and protect the American people.
All travelers who have been in People's Republic of China,
excluding the Special Administrative Regions of Hong Kong and Macau,
and Islamic Republic of Iran within the past 14 days or who exhibit
symptoms consistent with COVID-19 are sent to CDC staff or DHS
Countering Weapons of Mass Destruction (CWMD) contract personnel for a
medical evaluation.
Travelers identified by CBP officers during their primary
inspection are referred to a secondary screening area. In the secondary
screening area, DHS CWMD contract personnel are taking the following
actions in support of CDC: verifying enhanced screening is required,
collecting contact information for travelers requiring enhanced health
screening, asking travelers about health status (fever, cough, or
difficulty breathing), and taking and recording traveler temperatures.
CWMD is currently supporting CDC's enhanced health screening
efforts through agreements with state or local EMS, public health, and
first responders in an overtime capacity. CWMD established this
capability in response to the Ebola virus threat. These actions ensured
a trained, vetted, and badged workforce was ready to rapidly deploy to
support the CDC. DHS was able to use this established capability to
quickly address the threat of COVID-19.
At and between all ports of entry, CBP officers and agents continue
to remain alert and notify CDC and other public health officials when
encountering travelers exhibiting signs of overt illness. Officers and
agents are well trained, and use a combination of traveler history
records, questioning and observation, and self-declarations to identify
those requiring additional health screening. CBP also works closely
with the U.S. Coast Guard to ensure all cargo ships and crew with a
nexus to China and Iran are appropriately identified and screened prior
to coming into port.
At CBP, our employees are our greatest asset. We are taking every
precaution to keep our workforce safe, especially those who may
regularly encounter potential disease carriers. All of CBP's
operational offices have a 30 day supply of personal protective
equipment or PPE including gloves, masks, Tyvek coveralls, and hand
sanitizer; these are located locally across all Field Offices, Sectors,
and Air Branches. CBP continues to work with DHS and the CDC to monitor
global supply chain impacts and project critical PPE needs for the CBP
workforce.
On February 5, 2020, CBP issued an updated Job Hazard Analysis to
all employees that outlines the current comprehensive PPE guidance,
which includes guidance about wearing masks under the appropriate
circumstances. CBP continues to share information with its workforce on
an ongoing basis. We are committed to doing all that we can to keep our
workforce safe, as they work to ensure the safety of our Nation.
Thank you for the opportunity to appear today, and I look forward
to your questions.
Senator Cruz. Thank you very much to each of the witnesses.
Before I begin my questioning, I want to submit three
letters for the record. Without objection.
The first is a letter from Commissioner John Hellerstedt of
the Texas Department of State Health Services that is sent to
Secretary Azar of the U.S. Department of Health and Human
Services and others. That letter requested that the CDC submit
a written rationale for releasing patients from quarantine at
Lackland Air Force Base in Texas.
The second letter is a response from Director Redfield of
the CDC to Commissioner Hellerstedt outlining the procedures
for discharging patients.
And then the third letter is a letter that I sent along
with Senators Cornyn and McSally to CBP regarding the possible
spread of Coronavirus across our border.
[The letters referred to were unavailable at time of
printing.]
Senator Cruz. I want to start my questions with that third
letter.
Mr. Ferrara, would you please explain how the screening
process at the border currently works and how people coming
through the 29 land ports of entry in Texas are screened?
Mr. Ferrara. Thank you, sir. At all of our ports of entry,
our officers and agents are trained to look for folks that may
exhibit signs of illness. So that's something that happens
every day of the week in our operations.
With particular note of Coronavirus, COVID-19, we have
issued guidance to our officers to ask certain questions about
travels, particularly folks who are coming from China, now Iran
is included in that, and we do question. We check travel
documentations and other information to try to see if in fact
that person has traveled to those two areas.
If they in fact have, if CDC is available at the area, we
work directly with them. If not, we have our reach-back and we
use our public health officials, local public health officials
that we have relationships with to come to the proper
conclusion.
Senator Cruz. So does CBP plan to work with CDC medical
staff in the future to heighten the level of screening
performed at those points of entry?
Mr. Ferrara. We currently work now with CDC and we follow
the guidance, the medical guidance that CDC provides, so that
interaction is continually happening, sir.
Senator Cruz. Dr. Redd, let me ask some specifics about
what we know of this virus.
Right now, what is the overall case fatality ratio for
COVID-19?
Dr. Redd. There's a number that I can give you, but I'd
like to say that as more cases occur and we gain more
experience, that number's likely to change. There has been a
lot of questions both about the detection of the numerator, the
cases that have died, and also whether all of the cases that
have infection with this disease have been identified. That's
particularly true in China where the case fatality rates have
been in general a little bit higher than they've been seen in
the rest of the world.
So I would encourage us to answer that question to look for
cases that have been imported in other countries and their
spread and there's really kind of a cleaner set of information.
Senator Cruz. With the understanding that information is
still growing and there's a great deal unknown, what is CDC's
best estimate of the fatality rate?
Dr. Redd. It's probably somewhere between--you know, today,
I would say somewhere between half a percent and 1 percent and
just to give you a frame of reference, seasonal influenza is
about one in a thousand. So all of those estimates are higher
than seasonal influenza today.
Senator Cruz. OK. Now that number differs from the estimate
from the World Health Organization. What explains that?
Dr. Redd. I think that number probably includes information
from China where there's a question of whether all of the less
severe cases have been counted. I think this is something that
as more cases occur in China, we're likely to see that number,
that percentage decline, but I think it's really stay tuned,
but what we know now is it's substantially more severe than
seasonal influenza.
Senator Cruz. How contagious is COVID-19 and in particular
what's the predicted R naught and if you would explain----
Dr. Redd. Sure.
Senator Cruz.--what that means, as well?
Dr. Redd. Sure. The way that we assess transmissibility is
how many cases occur from one case, how many additional cases
can be sort of the downstream cases.
Seasonal influenza usually somewhere between a little bit
more than one and one and a half new cases is generated from a
single case.
For the information that we have right now for the novel
Coronavirus, it's probably between two and three or two and a
half and three and a half. That number is largely based on the
experience in China.
The elements of that, sort of what determines what the R
naught is, that number of new cases, has to do with the virus.
It has to do with susceptibility of people who might be exposed
to the virus and then it has to do with the context.
So situations where there's a lot of crowding might expect
to see a higher R naught than in a place that had less
crowding. So I think this is a number also we're going to be
following.
I would say there has been a little bit less variability in
that particular number than there has been in the mortality.
Senator Cruz. Now reports are coming from China that have
indicated the incubation period can be up to 24 days. That
differs from my understanding of the 14-day protocol for
releasing patients from quarantine. Can you speak to the
accuracy of that report?
Dr. Redd. Well, that's one report and I think that is a key
question. What we're doing--I think that it's just going to be
important to monitor that.
We have not seen secondary cases after people have gone
through that 14-day incubation period. I think our preliminary
indication was that actually the incubation period of this
virus was a little bit shorter on average than MERS or SARS to
other Coronaviruses that can cause severe disease in humans.
So I think that this is something that provides some margin
of safety between the average. I think it's something we're
going to have to continue to follow and we'll adjust as new
information becomes available.
Senator Cruz. So, Dr Redd, are there common sense and
reasonable precautions that Americans at home should be taking
now if you're concerned about your health and safety and your
family's health and safety?
Dr. Redd. Absolutely. And I think this is an opportunity,
as I close my statement, if you can help us with this, that
would be terrific, but there are really things that we do to
protect, prevent respiratory infections in general, hand
washing, covering coughs. If you're sick with a respiratory
illness, stay home. That can be a hard thing to do.
I think in this circumstance, it's even more important than
it is in a usual basis, and, last, it's really important for
people to stay informed, that information is changing so
quickly that if you know something at the beginning of the
week, it could be different at the end of the week, and I think
particularly areas where the disease has been identified as
something that has been changing quite rapidly.
Senator Cruz. Thank you.
Senator Sinema.
Senator Sinema. Thank you, Mr. Chairman.
My first question is to Mr. Ferrara and to Acting Under
Secretary Szabat.
It's my understanding that it can be difficult for airlines
to comply with passenger data requirements if travelers choose
not to provide complete data or in the case of booking through
third party sites.
I'd like to ask unanimous consent to enter into the record
a letter from Airlines for America that has been sent to the
Department of Health and Human Services outlining some
suggestions to overcome this gap by having the Federal agencies
set up a single online web form for all inbound international
passengers. That would be by sea, land, or air.
Mr. Chairman, if there's no objection, I'd like to ask that
that be entered into the record.
[The information referred to was unavailable at time of
printing.]
Senator Sinema. A single online web form would allow the
CDC to directly collect information from passengers and provide
for a more complete, accurate, and timely collection of data.
My question to you two gentlemen is what discussions, if
any, have there been between the Department of Transportation,
U.S. Customs and Border Protection, and the CDC with the
concerns these airlines have raised along with their proposed
suggestions? From a public health perspective, would compliance
be improved if all travelers were directed to some sort of
single portal, and, if so, what kind of funding or additional
authority would be needed from Congress to create such a system
rapidly?
Mr. Szabat. Senator, thank you for the question and your
interest in this area.
Like you, I just want to tip my hat to those in the
aviation industry and the association that have really stepped
forward to try to offer common sense solutions to this
challenge that we have.
As you mentioned, you know, this is a real need that we
have within the Federal Government. As travelers are coming to
the United States, we want to be able to contact trace them so
that if it turns out that somebody who comes in is ill, we can
reach back and find out who else they've been in contact with.
Previously, the information that has been gathered that we
can collect directly from the industry only has about 20-25
percent accuracy. In part, you've alluded to the fact that much
of this information comes through travel agents which are not
directly affected by the information that is provided by the
air carriers themselves.
So we have been working, I would say, multiple times daily
communications among the agencies and also with the association
trying to work through the technological difficulties of
getting to the ultimate goal of this rule that has been put out
which the carriers have said will take six to 12 months to
fully comply with and so we don't want to wait 6 to 12 months
to get that data.
So we have an interim system. The carriers have been kind
enough to work with us right now, paperwork-based, on the
travelers that are coming in. That works well, given the small
number of passengers we have arriving right now. We're down to
fewer than a thousand a day are coming in mostly from China.
With that, the system we have now covers that, but it's not
scalable as we add--you know, the concerns of adding more
countries to the travel.
So we think that the proposal that the carriers have put
forward is definitely worth looking at and the challenge that
we're going to have is a technical one of how well we work it
within the various IT data bases of the Federal Government
agencies.
Mr. Ferrara. We provide all the information that we have in
our systems to CDC via the airlines and as the Under Secretary
mentioned, it's not complete for the CDC purposes.
What we've done is a stopgap working with CWMD, the
contractors who are manually inputting those into CDC computers
directly at those 11 airports.
To the first part of your question, we have participated.
It's an all of government effort to speak with the airline
industry and this data exchange is a constant conversation, not
just for this particular issue. So there are a lot of the right
people working and getting through but there are some
challenges.
Senator Sinema. If you'd like to respond, as well?
Dr. Redd. Well, I think that at the moment, we're trying to
make the system that we have work, but it's clear that we need
a better system.
Just as a small example of how we're working together, when
the Customs and Border Protection people didn't have computers
to enter the data, we were able to provide those from CDC so
that we could facilitate that entry.
Senator Sinema. Yesterday I had the opportunity to see Vice
President Pence and as I mentioned in my opening statement
followed up with a letter to him this morning.
My understanding is that there's a web developer who has
the technology available to develop an app. similar to the
mobile passport app that could be done as quickly as two to
four weeks. Of course, the technical challenge is how do we get
that across all of our institutions and deploy it, but I
believe that that provides a real opportunity for us to address
this contact tracing issue in a matter of several weeks rather
than six to 12 months. So that's something I hope that we can
work together on and consider how to implement that quickly.
Like the question that I asked earlier, the collaboration
between the transportation industry and the government is
incredibly important, but pharmaceutical manufacturers are also
currently leading the way in developing both a vaccine and
developing a plasma-based treatment.
Companies, like Johnson & Johnson, Gilead Merck, Sanofi,
and many others are providing their expertise in dealing with
previous pandemics and collaborating through the Biomedical
Advance Research and Development Authority as well as other
public health entities.
There has been conflicting information coming from
different parts of the Administration on the timeline for not
just the development but the implementation of a vaccine for
ordinary Americans to access and that that is unacceptable.
So my question for you, Dr. Redd, is, is the CDC engaged
with these biomedical and pharmaceutical companies both in the
development of a vaccine and in development of treatment of
those experiencing the illness? When one has been approved for
use for either vaccine or treatment, how will the CDC work with
others to deploy it amongst our transportation, border, and
health personnel who, of course, are at increased risk for
exposure because of the roles in keeping the broader public
safe?
Dr. Redd. Thank you, Senator. I appreciate the last part of
your question because I think that's where I can speak most
directly.
The NIH and the Biomedical Advance Research and Development
Authority are the main parts of the department that are working
on the basic development and then the advanced development to
get a product that could be approved.
I think that the example of the work that we did in H1N1
influenza, that would be what I would foresee. It's going to be
awhile before we have a vaccine and probably a treatment, as
well.
In H1N1, the government procured the vaccine, its
distribution, and it was essentially a government-run program,
quite similar and actually built on the vaccines for children's
backbone for a product that wasn't licensed at the time.
We didn't procure it but we managed the distribution of a
drug called Paramivir which is used to treat influenza.
I would envision that kind of a system. I think right now,
the first part of your question is really the key one, is to
get a product that is safe and effective.
Senator Sinema. Thank you. Thank you, Mr. Chairman.
Senator Cruz. Thank you. And just to underscore Senator
Sinema's first question, my understanding is that the airlines
have offered to contract with a third party vendor and to cover
the cost themselves to stand up a website and/or a secure
mobile app that they believe could be stood up within 2 weeks
to gather the information that, as I understand it, CDC is
requesting.
Do each of the three of you think that is a good idea?
Mr. Szabat. Short answer, Senator, yes, it's a good idea.
We welcome the fact they've reached out. They've made this
proposal.
Our challenge at this end, and we're working this as hard
and as fast as we can, is, is it technologically feasible to be
implemented? That's the one challenge we have. If we can,
that's a great solution that gets us from the temporary
solution we're working with now and not having to wait six to
12 months for permanent solution.
Dr. Redd. The way the system is devised right now, CDC
receives the information from Customs and Border Protection. I
think, however, that information, if it's of high quality and
complete, would be great.
Mr. Ferrara. It's technologically possible and it meets all
the privacy rules and all of the different standards, security
standards, I think it would be a great opportunity to look into
for sure.
Senator Cruz. Thank you.
Senator Gardner.
STATEMENT OF HON. CORY GARDNER,
U.S. SENATOR FROM COLORADO
Senator Gardner. Thank you, Mr. Chairman. Thank you all for
your work on this obviously very critical.
I want to thank public health officials in Colorado for the
work that they have been doing and the Governor of Colorado for
the work that he has been doing to make sure that we have a 50-
state approach that protects our people, as I know you are
fighting each and every day for. So thank you.
What steps has the CDC taken to coordinate with foreign
governments to verify that their screenings and public health
protocols abide by U.S. standards specifically with regard to
travel from hot spots, like South Korea and Italy?
Dr. Redd. So we are in very close contact, particularly
with the State Department and Department of Defense, in Korea.
My understanding is that both Korea and Italy have instituted
exit screening to identify persons who might be ill with the
Coronavirus.
I think this is really an ongoing global effort. We're also
working with the World Health Organization. Our work, really
there's sort of two parts to that. One is in places where we
have staff, we're able to directly interface. That's true in
Korea, not true in Italy. It's true in China, not in Iran.
Senator Gardner. Does it make sense to test everyone who
comes in from countries of higher concern, hundred percent
testing?
Dr. Redd. I think the problem with that would be similar to
the symptoms screening, that a person could be incubating the
disease, be----
Senator Gardner. Test negative.
Dr. Redd.--tested and then later they develop symptoms or
maybe not develop symptoms and actually have the virus.
Senator Gardner. OK. When airlines or other transportation
providers have questions regarding how to abide by the CDC IFR
and best protect their passengers' and employees' health and
prevent potential further spread of COVID-19, does the CDC have
a person, a single individual prepared to serve as a point of
contact for those questions?
Dr. Redd. What we've done, and this is part of the
rulemaking process, is that that rule is out for comment, there
is a way to provide comments to that rule. We're examining it--
--
Senator Gardner. So we have no sort of expedited procedure
to appoint one person who can answer these questions?
Dr. Redd. There actually are multiple people that are
reviewing that. So I think we're probably getting----
Senator Gardner. Reviewing the rule or reviewing whether or
not we can appoint one person to answer questions?
Dr. Redd. Well, reviewing the comments that are being
submitted.
Senator Gardner. OK. So right now, if United Airlines
needed to call somebody, there is no one person point of
contact?
Dr. Redd. There is not. There is a joint----
Senator Gardner. That's a problem.
Dr. Redd.--e-mail address that actually--well, it actually
gets better coverage than a single person would provide. So
that there is, I think, in effect, there is a place that--it
depends also on what the issue is. If it's about the interim
final rule, that really needs to----
Senator Gardner. So how long does this interim final rule
take?
Dr. Redd. I think there is--that interim final rule will
be--it will be continued until the public health emergency is
over or until there's resolution----
Senator Gardner. And that's in effect now or we're waiting
for public comment?
Dr. Redd. The rule is open for public comment now.
Senator Gardner. OK. So when does it go into effect?
Dr. Redd. The interim final rule is--the part that makes it
interim has gone into effect already. So that's this process
of----
Senator Gardner. Right. OK.
Dr. Redd.--getting data from----
Senator Gardner. So you're able to operate under this as it
is. So thank you.
Dr. Redd. Correct.
Senator Gardner. Thank you. Has the CDC provided updated
guidance to states on when to test for COVID-19 in light of
community spread?
Dr. Redd. Yes, sir. In fact, when we were coming over here
in the taxi, there was a news report that that's been released
essentially giving broader discretion to clinicians caring for
patients to get testing done rapidly. So that was put in effect
today.
Senator Gardner. And do you have national or international
standards that govern airline precautions, disinfection
protocols, passenger coordination should an airline employee
test positive for COVID-19?
Dr. Redd. We have guidance. I think the rules about that--I
might defer to my colleague about the standards. We do have
guidance that's posted specifically for COVID-19 on aircraft
equipment issues, but there are also international regulations
which I might turn to my colleague.
Mr. Szabat. And, Senator, are you asking about the
standards that we have for, you know, how we disinfect the
aircraft or about health standards, PPE, for the crews?
Senator Gardner. Both. I mean, how we make sure the
airplane itself is safe and how we make sure the crew is safe,
as well.
Mr. Szabat. OK. So several different measures. Because we
made a conscious decision, we issued the 212F, the travel
restrictions with China, not to take down all flights that we
still continue to have, passenger flights taking Americans back
from China, we also wanted to put into place vigorous crew
health protocols for both the passenger and the cargo planes
that are flying back and those differ in terms of the
requirements for whether they can leave the aircraft or airport
facility and their contact with other people and the amount of
everything from washing their hands to the types of protective
gear that they wear.
Depending on whether or not they are China-based, in other
words, they're living in China and flying out of China to the
U.S., or they're coming from the U.S., staying briefly in China
and then turning around and coming back.
Senator Gardner. Let me just ask one more question because
I'm out of time, and I think it follows up on what Senator
Sinema had said.
So we have no way right now to a hundred percent or near
one hundred percent contact every passenger on a plane who may
be flying with an individual who tests positive for
Coronavirus?
Mr. Szabat. Half true. Before we put in these interim
measures, our contact tracing was about 20-25 percent. With the
interim measures we have in place now at the F11 airports that
Mr. Ferrara was referring to, right now, according to DHS,
they're at 94 to 96 percent accuracy with that contact tracing
information.
Senator Gardner. If I may, Mr. Chairman?
Dr. Redd. I'd like to actually amend my answer. The
guidance for cleaning, we're expecting to be cleared today or
very shortly. So we actually don't have guidance of today. So
let me correct what I told you earlier.
Senator Gardner. Well, I hope that gets approved
immediately. Thank you.
Senator Cruz. Thank you, Senator Gardner, and I'll note for
the record that while after this hearing commenced, the news
broke that we now have the 11th fatality in the United States
from California, so the first that has occurred outside of
Washington State.
Senator Cantwell.
Senator Cantwell. Thank you, Mr. Chairman.
Rear Admiral Redd, I'd like to cover a couple of things.
One, you know we're trying to do a supplemental to get more
funds out to the states for public health. I think hopefully
we'll vote on this before the end of this week, $7.8 billion. I
think there's $11.5 million that would be a grant to Washington
State for public health.
Do you think some of that money could be used to better
direct the public toward the testing regime? Right now we're
being very broad. We're saying if you suspect something, yes,
call these various entities and then people are calling their
doctors and they're saying we don't have that and you have to
go over here. Then they call them and they're like no.
So can we use some of the dollars that you're going to get
to be crisper about how to go about the testing? If you want a
protocol that says you have to call your physician first, let's
clearly state that and then let's be clear about how many tests
a day that we're able to do and how we create a system for
that. Does that make sense?
Dr. Redd. It does make sense. I think that some of that
money certainly will be used for communication activities, and
I think that guidance, clarifying that guidance on who should
be tested and can be tested will be an important part of that.
It's also likely to change over time as has already occurred.
Senator Cantwell. That's why I think if you create this
site and create accurate information for people, then you won't
have the anxieties of people saying I feel sick, I have this
going on, and I can't get a test, and so we want to alleviate
that and so I hope that some of those dollars can be used for
that.
Another thing that I would hope that you would advocate for
is so Seattle Flu Study was a research institution, everybody
working collaboratively to study and analyze flu results.
Obviously you had to consent to be in that. That is how we
caught the one student. The individual student thought they
were sick with the flu and then 3 days, 4 days later, when we
finally changed the protocol for who could get tested, they
tested positive.
So I think now the University of Washington has changed
that so that it also covers COVID-19. Every city in America
should be doing this. Everybody should have a flu COVID-19 IRB.
That's a research analysis, and the reason why it's important
is so that we can see this interplay between those who think
they just have the flu and so we can track the genetics of
where this is going because now we find that it's all related
to the Washington One case and this is finding out how
community spread works.
So can we also do that?
Dr. Redd. Yes, ma'am. Actually, we are--I believe today,
there will be the collection of specimens in several
jurisdictions with additional jurisdictions through the week
with the plan to build out a system that would be much broader
really to all the reasons that you said.
Senator Cantwell. But every city in America could start
this now. They'd have it in place and then they have to get the
agreement and they have to get the information so they can just
put flu information in this.
Dr. Redd. Yes, ma'am. I think using the flu system, this is
really being built on flu surveillance to add novel Coronavirus
so that communities will know if the virus is in their
community and----
Senator Cantwell. Yes.
Dr. Redd.--would be able to have an estimate of if it's not
there, what's the certainty that it isn't there.
Senator Cantwell. I think it will help. I'm glad the
University of Washington got this done.
So now for the airplane, which our colleagues were just
asking about, how long can the virus material last on a
surface?
Dr. Redd. The virus can last hours to a day. That has been
the estimate. It's similar to other Coronaviruses.
Senator Cantwell. Up to a whole day?
Dr. Redd. Yes, ma'am.
Senator Cantwell. Up to a whole day. OK. I've not heard
that before, but I'm glad you're clarifying that.
Dr. Redd. Different surfaces have different----
Senator Cantwell. We've heard the generalization before and
I think that's what is sometimes confusing. So up to a day and
so now what do we need to do for our airplanes, given that?
Dr. Redd. That's going to be in the guidance that we hope
is released very shortly of what--there's really the health
side of that guidance which will be released and then the issue
that we addressed in the earlier question.
Senator Cantwell. Mr. Szabat, do you want to comment on
this? I think people are concerned about the obvious
individuals and being able to contact them, but then people
want to understand what is our plan? What is the Department of
Transportation's plan to communicate if the virus can be alive
on a surface for a whole day? What kind of precautions do we
need to take on our air surfaces?
Mr. Szabat. Thank you, Senator, for the question. This is a
whole of government effort because the Department of
Transportation's authorities, when you look at the safety side,
are related to the safety of flight, which is to say, we are in
consultation with CDC, with the other agencies, and especially,
I think, OSHA and NIOSH, which develop what are the standards
for individuals on the airplanes.
Our focus is to ensure that the mix of chemicals and other
treatments do not actually harm the aircraft itself.
Senator Cantwell. Are you saying you don't have the
authority to set the standard?
Mr. Szabat. So we're saying that health standard is by
design not our authority because it's a health authority for
individuals.
Senator Cantwell. OK. Whose authority is it? Is it CDC's or
is it----
Dr. Redd. The information that we would have would be
guidance. It wouldn't have statutory authority is my
understanding.
Mr. Szabat. And my understanding, and again I'm not the
medical person on this panel, but much of the authority runs
with OSHA, which is not on the panel here, and we are in
current discussions with OSHA on developing these standards.
Senator Cantwell. OK. I thank you for having the hearing,
Mr. Chairman. I think this is something we need to tackle right
away. We need to understand what we are saying to the flying
public about what the airlines should be doing, what we should
be doing to create the best and most positive environment for
air transportation to continue.
As you said, Mr. Szabat, we're going to want air
transportation and we want it to be done. So let's get this
protocol clearly established. Let's work together, get it
established.
Thank you, Mr. Chairman.
Senator Cruz. Thank you, and to underscore Senator
Cantwell's point, if there are authorities that are needed to
keep the flying public safe, let Congress know immediately and
we will create whatever authorities are needed because the
priority needs to be public safety.
Senator Lee.
STATEMENT OF HON. MIKE LEE,
U.S. SENATOR FROM UTAH
Senator Lee. Thank you, Mr. Chairman. Thanks to all of you
for being here, for the insight that you've provided.
As you know, Congress is preparing to consider supplemental
funding to several agencies to respond to the Coronavirus
outbreak.
Two weeks ago, the Trump Administration requested $1.25
billion in new funding from Congress for various response
efforts.
I'd like to ask each of you to just respond briefly to
share how your agency would plan to use supplemental funding
and also to respond to a related question regarding, you know,
assuming the Administration's request reflected the needs of
agencies to respond, if Congress gives you substantially more
than what the Administration asked for or what you asked for,
do you have a plan to responsibly spend all of it and what
would that look like?
We'll start with you, Mr. Ferrara, and then just go down.
Mr. Ferrara. Thank you, sir. Currently, based on the
current projected threat, CBP has what we need to do our job.
Should things change working with the interagency and that
threat would change, we would certainly inform on our resource
needs.
Senator Lee. But you've got what you need right now without
a supplemental, is that what you mean?
Mr. Ferrara. Yes, sir.
Senator Lee. OK. Mr. Redd. Dr. Redd.
Dr. Redd. Yes, we would use the funds, substantial amount
of those funds would go to state and local health departments
to do the work that is being done right now on identifying
cases, testing those cases in their laboratories, identifying
contacts. This is very labor-intensive work.
So laboratory testing would be an element of that at the
state and local level, communication, surveillance, some of the
things that we talked about with the effort to test specimens
that are collected for other respiratory specimens. So there'd
be a suite of activities that state and local governments would
do.
At the Federal level, we would be able to use those funds
for many of the same things but laboratory support,
surveillance work, communication, the things that we do, we do
in emergencies, so that I think we would not have a problem
spending all the money.
Senator Lee. OK. And with regard to the part of the
question dealing with the $1.25 billion, I assume that included
whatever supplemental sum you thought you might need.
So if we were to authorize more than that, tell me how that
fits in.
Dr. Redd. Well, I think it might be better to see where we
are with the bill that's going through. I think that there is a
scalability to the amount. You know, a smaller amount of money
would last a shorter period of time. A larger amount would last
a longer period.
Senator Lee. Mr. Szabat.
Mr. Szabat. Thank you, Senator, for the question. Under the
game plan, sort of emergency response planning, this whole of
government effort is led by the health communities,
specifically the Secretary of HHS. So the vast majority of the
money requested, and I believe the money that's under
discussion right now by Congress, is for the CDC and the other
health agencies.
Much of that money or some of that money would flow through
them to address some of the needs, such as Senator Cantwell
mentioned about what we're trying to do with health guidance
and protocols for airlines, but that money is going through
HHS.
So at the moment, there is no money requested specifically
for the Department of Transportation.
Senator Lee. OK. Thank you. Dr. Redd, reports indicate that
the South Korean Government has been trying to get a handle on
who's coming into the country by having air carriers try to
assess passengers as they're boarding the planes going into
Korea to figure out whether they are suffering from the virus
prior to boarding.
Have you provided any guidance to air carriers in the
United States dealing with how we would assess this issue with
inbound passengers?
Dr. Redd. So I'm not familiar with--if I'm understanding
the question with South Korea, we have provided guidance for
screening that would be in passengers coming to the United
States, but if there's something else, if we are working on
that, I'm not familiar with it.
I think that the value of that screening, a lot of that
work is to figure out--collect some of the information that
we've been talking about. That's the way we've done it in the
past, to collect contact information so that those individuals
can be tracked. It's very laborious and that's really the
reason for this interim final rule is to do more to automate
that system.
Senator Lee. To automate the system whereby you collect
data on each passenger----
Dr. Redd. Correct.
Senator Lee.--with an eye toward hopefully excluding those
who might bear symptoms or show some indication that they carry
the virus?
Dr. Redd. Well, largely we can screen for symptoms, but
it's that question from earlier. If a person is incubating the
disease, being able to track them through that incubation
period or at least informing them that if they have symptoms,
here's what you should do.
So I think we wouldn't be able to identify people who are
incubating disease from the contact information, but we could
use that information to follow them.
Senator Lee. OK. Thank you. Thank you, Mr. Chairman.
Senator Cruz. Thank you.
Senator Schatz.
STATEMENT OF HON. BRIAN SCHATZ,
U.S. SENATOR FROM HAWAII
Senator Schatz. Thank you, Chairman Cruz. Thank you to all
of the testifiers.
Dr. Redd, I'm trying to get a handle on what our national
strategy is in terms of containment versus mitigation, and it
seems to me that containment is something you do in the first
phase of something that's a potential pandemic and that we are
rapidly entering a phase of this during which there's
sufficient community spread where the containment strategy has
sort of vanishingly smaller and smaller returns, and I want to
make sure I'm getting that right and then ask a follow-up
question.
Dr. Redd. That is correct. I think one sort of nuance to
that is that there are likely to be parts of the country where
mitigation is the right posture. At the same time, there could
be other parts of the country where----
Senator Schatz. You can still use containment?
Dr. Redd.--containment--right, exactly.
Senator Schatz. OK. So that was--so my next question was if
we're into mostly a mitigation strategy phase, then why
restrict air travel at all? In other words, if we're talking
about restricting air travel from Korea but it seems to me that
with the exception of the episode in that religious
organization in the southern part of South Korea, that what's
actually happened in South Korea is they just tested more and
got very aggressive about it. So their data is in, our data is
not in.
It's not clear to me that their 6 or 7,000 cases, that
their numerator and denominator's going to end up any higher
than ours will end up by the time we do all of our testing and
so then it gets a little silly if we're not allowing people to
travel when one place is not any less or more safe than the
other.
Dr. Redd. So I think I agree with your general point. I
could give the example of H1N1 influenza where for a short
period of time we had a travel advisory to Mexico. That didn't
last very long because you'd be more likely to get H1N1 in the
United States than you would if you were returning from Mexico.
So that would be a situation where we wouldn't--that would
basically be--a scenario like that wouldn't make sense to do
this really intensive effort to track people that are entering
the country.
Senator Schatz. OK. And just a new question. Your website
right now says there are 80 total cases. That's not true, is
it?
Dr. Redd. We update that on a daily basis and as cases are
reported from states, they do that on their own schedule. So
ours is kind of a once-a-day----
Senator Schatz. Right. But it's sort of garbage in/garbage
out. We just don't know yet. It's not that it's 80. It's that
you've confirmed 80.
Dr. Redd. That's correct.
Senator Schatz. OK. So I would just recommend that you
figure out a better way to reflect, and I understand the
uncertainty here, but what's going to happen, I'm afraid, is
that right now people are, I think, unreasonably reassured by
this low total case count and unreasonably fearful of other
places that are actually--really what's happened is they've
deployed tests more efficiently and effectively than the United
States has and so what's going to happen is we're going to be
calm until the tests get deployed and then those numbers are
going to spike like crazy and we're going to have a panic as a
result of that.
So I think you've really got to figure out on the
communications side how to reflect that uncertainty and prepare
the public for the very high likelihood that the number of
cases that we have confirmed is going to skyrocket not because
epidemiologically anything changed but because we finally
deployed the kits.
Dr. Redd. Yes, sir. I think we'll know. The study that
Senator Cantwell described to us will help address that issue.
If we do more testing and we don?t find--that is possible. I
think that----
Senator Schatz. I'm talking about in the next couple of
weeks as the testing goes right up.
Dr. Redd. No. Right.
Senator Schatz. So final question for you. This is so
constructive and so bipartisan, I thank the Chairman for
convening this hearing and the Ranking Member.
Can you ask the folks at the CDC if they would commit to a
daily briefing on camera, no politicians involved? It doesn't
have to be inflammatory. It doesn't have to be alarmist, but
just a daily here's what's going on because that's what happens
in a natural disaster context. That?s what happens when you
have sort of a civil defense issue.
We just need to hear from a singular authoritative informed
voice and on a daily basis so that we're not all catch-as-
catch-can trying to figure out where the data is and where this
thing is going.
Mr. Szabat, am I pronouncing your name correctly?
Mr. Szabat. Yes, Senator.
Senator Schatz. Oh, good. My understanding is the FAA has
the authority to implement an emergency order so that those--as
you were talking to Senator Cantwell about this, that right now
there are guidelines and then I understand that under normal
circumstances, you're talking about the whether or not the
airplane can fly safely, but these are emergency circumstances
and I don't want to spend another two or three weeks figuring
out whose authority is necessary to sort of--you know, and get
a bunch of lawyers involved trying to figure out where you
derive the authority.
In an emergency situation, you are certainly authorized to
change those voluntary guidelines that the airlines, some are
abiding by and some not, and just change that into an emergency
order, and I'd like you to look at that, please.
Mr. Szabat. Senator, we will, and we will look at it as a
whole of government effort. One of the reasons for the Task
Force is to see if there's something that has to be done and it
legally falls through the cracks of the authority of one
agency, we borrow the authority of other agencies in order to
get it done.
Senator Schatz. Thank you.
Senator Cruz. Dr. Redd, Senator Schatz asked about testing.
From my conversation yesterday with Vice President Pence and
Secretary Azar, my understanding is that testing kits are going
out. What was told to me is by the end of next week, the
capability will be there for 1.25 million tests, is that
accurate?
Dr. Redd. That is a combination of numbers from the public
health tests that CDC is deploying that are done in public
health departments and what could be done by private companies
applying through the FDA process to use a test that would be a
commercial test, but that number is in the range that I've
heard, as well.
Very small portion of those would be the public health
tests. The majority would be company-developed.
Senator Cruz. So one of the great frustrations is the lack
of testing. You're telling the subcommittee that the tests are
on the--the kits are on their way and testing that will be
remedied shortly, is that correct?
Dr. Redd. For the public health testing, we will have the
capacity to do 75,000 tests by the end of this week.
Senator Cruz. OK. Senator Sullivan.
STATEMENT OF HON. DAN SULLIVAN,
U.S. SENATOR FROM ALASKA
Senator Sullivan. Thank you, Mr. Chairman, and thank you to
the panelists for this very important briefing.
Secretary Szabat, I want to follow up on our earlier phone
call, my discussion with you today, and see if there's any more
progress.
You know, the broader discussion for the other witnesses is
we've closed down the passenger travel from China and other
areas where there has been a risk, big risk on the issue of
mitigation of the spread for air travel.
However, there is a loophole and I think everybody I've
raised this--I've been raising this issue now going on 4 weeks
with senior Administration officials. The loophole is cargo air
travel. Cargo is very important for the whole country, for the
whole world. We want to be able to have the supplies to address
and be ready for, you know, what could be a significant
challenge for our country, but the pilots on these cargo
flights in some ways are a loophole.
You have Chinese-based crews that get off in the United
States, big cargo hubs, whether Anchorage or Seattle or L.A.,
Memphis, and they spend the night, you know, and they're in the
population.
There's nobody I've spoken to, and I've spoken to
everybody, including Secretary Chao and others, that doesn't
recognize this loophole, but the agencies seem to be ping-
ponging back and forth on how to address it.
One suggestion that I have made is to essentially do a
turn-and-burn. You have cargo passenger airplanes come, say, to
Anchorage. They have two sets of pilots. They land. They get
rid of their cargo and then they get the other pilots to fly it
back.
There was some concern they might retaliate against our
cargo airlines. However, some of the senior officials I've
spoken to don't seem to think that would be a problem.
So can you, Mr. Secretary, I'm hoping you can have a little
more definitive answer than our discussion this morning, can
you tell this committee what we're doing to address this issue
because here's the real problem.
If somehow there's a spread in another city, say Anchorage,
and it's traced back to, you know, a pilot on a cargo crew, the
likelihood of us then wanting to react to shut down the whole
system is going to be strong. So we're trying to preempt this
with some good ideas. These are decent ideas. They're workable.
Nobody's really complained about them. But the authorities seem
to be ping-ponging back and forth.
What are we doing to address this overseas-based crew
loophole that everybody acknowledges we have?
Mr. Szabat. Senator, thank you for the question and thank
you for the courtesy of flagging this for me earlier today.
I regret I do not have a more definitive answer for you now
than I had this morning, except to say we're working this hard.
We'll have a definite answer to you as quickly as possible this
week.
Senator Sullivan. When? When will that be? I've been
literally raising this for almost a month, a month.
Mr. Szabat. OK. So today is Wednesday. I will have it to
you by close of business Friday and hopefully before.
Senator Sullivan. And will that be cleared by everybody, no
ping-ponging in terms of FAA doesn't have authority?
There is this issue that some people are viewing the crew
rest doesn't count if you're sleeping on a plane. Again, we're
kind of dealing with an emergency here. I'm sure the pilots who
are resting on the plane as they're sleeping to come over are
rested enough to fly it back. OK? They're all capable, I mean,
and so again if that's a reg or an authority that you need help
on, let us know, but don't use that as--four weeks now since
I've been raising this with people and so far so good. We
haven't had a spread from a cargo pilot, but I think we're
dodging bullets here and we need to address it.
Mr. Szabat. I?ll have a whole of government answer back to
you by close of business Friday, Senator.
Senator Sullivan. Thank you. Admiral, I want to ask and
highlight another issue that's a little bit more particular to
my state, the great state of Alaska, where one concern I have
is our Alaskan Native populations where, you know, there are
over 200 communities in my state that are not connected by
roads. So they're very isolated in very, very remote parts of
America, the most remote parts of the whole country. They don't
have hospitals. They barely have clinics. Some of these
communities don't even have flush toilets and clean water,
which is a tragedy for the whole nation in my view.
But as you likely know, the 1918 Spanish influenza
decimated these communities in Alaska, decimated them. So
they're vulnerable and what I'm concerned about is if there's
enough focus from CDC, we do have a CDC office in Anchorage, in
part because of our high rates of infectious diseases, what is
the CDC doing to make sure that these extremely vulnerable
populations, if you ever get an outbreak in one of them, where
we're ready to address these situations so we don't have a
situation that happened a hundred years ago which was in some
ways still an impact on my state?
Dr. Redd. Yes, sir. I think this is an important issue. I
know that you know that Dr. Jay Butler, who had served as the
state health officer in Alaska, is now in Atlanta at CDC.
Senator Sullivan. He's outstanding.
Dr. Redd. So I think we have that local knowledge of Alaska
now in Atlanta and I think that will help to make sure that we
don't forget about remote population. I think it's a real
challenge, though.
Senator Sullivan. Can I get your commitment to have
something a little bit more definitive that recognizes the
vulnerabilities of certain communities like this that are very
remote? In some ways, you might not get--the remoteness helps
with the spread, but if it does get out there and there's
really no very--there are no hospitals, there's very doctors.
Can I get your commitment to have a more definitive plan to
help address these kind of----
Dr. Redd. Let me commit to get back to you with what our
proposal would be and we can have a dialogue about that.
Senator Sullivan. Great. And you might want to work with
the CDC office in Anchorage, which also----
Dr. Redd. Yes, sir.
Senator Sullivan.--does coordination with our Native Health
System. Thank you.
Thank you, Mr. Chairman.
Senator Cruz. Thank you.
Senator Tester.
STATEMENT OF HON. JON TESTER,
U.S. SENATOR FROM MONTANA
Senator Tester. I appreciate that, Mr. Chairman. Now you
beat me. I appreciate you all being here, and I want to thank
you for the work that you've already done on this critically
important issue, and I think it is critically important and I
hope it doesn't turn out anything like I have imagining
potentially in my head.
So I just want to give you my circumstance and that is I
fly four legs a week. I have town hall meetings. I meet with
people all the time, probably meet with 70-80 people today
alone.
The question is, is that if anybody's going to get this,
it's going to be people serving in the U.S. Senate because we
all do that. Senator Cruz flies home. He takes a different
airline than I do, flies a different leg, exposed to a
different population, and we come back and have a Commerce
Committee hearing together. OK.
So the question that I have for you is I got the washing
the hands and getting the flu vaccine. Is there anything we can
do to protect ourselves--I don't care who answers it--that you
would recommend or do we just have to do it and hope you don't
have something else wrong with you and so that you can get
through it and survive it and move on?
Dr. Redd. So let me give a broad answer to that. I think
hand washing is a critical element in protecting yourself and
for all of us protecting ourselves. There is kind of the other
side of it, which is things that we want other people to do who
might contract this disease and give it to us, and that would
be covering coughs, really, really important to stay home when
sick, and I think that is probably something that we're going
to have to just continue to stress and that doesn't protect the
person who's staying home but it does protect everyone else.
I think----
Senator Tester. And so I hear all those things. So what is
the incubation period on this stuff, do you know?
Dr. Redd. Well, on average, five to six days with a range
of shorter, couple of days to maybe up to two weeks, as we've
heard.
Senator Tester. So I've got a few achy bones today. I mean,
I stay home?
Dr. Redd. I think I would not stay home or use that as a
reason for Coronavirus. I think fever and respiratory symptoms
would be where----
Senator Tester. So by the time you stay home, you've
already been infected for five or six days is what you're
saying?
Dr. Redd. Well, you've been incubating. I think this is one
of the issues.
Senator Tester. OK. So do we know--and you can say no, we
don't know, if we don't know, but during that incubation
period, can I spread it to the good Senator from Illinois?
Dr. Redd. So I don't think that you're going to like my
answer.
Senator Tester. I did wash my hands. OK. Go ahead.
Dr. Redd. It's not possible to give a definitive answer on
that. I'd say that there is a much stronger suspicion that with
very mild symptoms or right before you develop symptoms, that
there is, in a lot of cases, the chance of spreading the
disease, which is different from the other Coronaviruses,
different from most viruses where the viral load increases the
sicker that you get.
This may be a case where viral load can be high even in
that very early--just almost like the symptoms that you
described. I wish it weren't true.
Senator Tester. No. Look. I got it. So how long do you
think it's going to take for this to run its course in our
population?
Dr. Redd. I don't think that it's possible to speculate.
Senator Tester. Nobody knows.
Dr. Redd. There are a lot of factors that could go into
that. So it really isn't possible to say.
Senator Tester. OK. So there has been a lot of talk--the
good Senator Jacky Rosen just told me that Italy just shut down
some of their schools. I think there has been talk about
shutting this place down. There's talk about shutting all sorts
of stuff down. I'm going to tell you I personally think that's
a mistake because I'm not sure it's going to matter, to be
honest with you, and I think it would contribute--the paralysis
here is bad enough without really creating the paralysis and so
what would be your recommendations on all that stuff because
it's like you've got a person with Coronavirus in an airplane.
They come in and they clean the airplane and somebody else gets
on with the Coronavirus. You really haven't done a damn thing.
Dr. Redd. So that's a very difficult question. I think it's
one of the reasons that the President has set up the system
that he has with the Vice President in charge, that those
different sectors are able to communicate more effectively so
that we can talk about what health benefits might be, but the
adverse consequences, we're not really expert in those.
So I think this is something that we'll facilitate the
appropriate decisions being made as quickly as they're needed
to be made.
Senator Tester. Good. This is a question for Mr. Szabat. Do
you believe that there are going to be flight restrictions
placed if this thing plays out as potential?
Mr. Szabat. Well, the easy answer to that, Senator, is we
already have flight restrictions in place.
Senator Tester. I know, but I'm talking about domestic
flights.
Mr. Szabat. I don't know. We're outside the playbook, you
know. The original playbook did not envision travel
restrictions, you know. Health officials have historically said
in the case of, you know, widespread flu or similar contagious
diseases, we don't do travel restrictions.
We went outside the playbook on this one and I would
contend that the travel restrictions that we and some other
countries did were very effective. In some cases, they weren't.
Italy, for example, did even more of a prohibition than we did
but they waited till after we did and it did not turn out to be
effective. So there's going to be a lot of lessons learned from
that.
But to your question, it's now in the playbook, something
to think about, but I can't tell you under what circumstances
we might consider pulling that trigger.
Senator Tester. OK. Well, I just want to thank you all for
your good work. I can't thank you enough. I have been
frustrated with the President and his reaction to all this from
the get-go, but you guys are pros, and I want to thank you.
Senator Cruz. Senator Capito.
STATEMENT OF HON. SHELLEY MOORE CAPITO,
U.S. SENATOR FROM WEST VIRGINIA
Senator Capito. Thank you, Mr. Chairman. I want to thank
the three gentlemen here today.
I want to just ask just a general question of Mr. Szabat.
You may not have these statistics, but as of now, do you see
domestic travel on the decline because of this and people
canceling flights, less people traveling? What are you all
seeing?
Mr. Szabat. Senator, thank you for the question, and you're
better served asking that question from the industry and
industry analysts who have like specific numbers, but
certainly, you know, we are in daily contact with the industry
and they are looking at a decline in bookings going forward.
Having said that, so far the biggest hit for the airline
industry has been on Asian travel. For the U.S. industry,
that's the smallest part of both of their revenues and
especially of their margins.
This only becomes a major hit for the U.S.-flagged airlines
if the Coronavirus spreads or concern of the virus spreads and
passengers decide not to travel largely domestically and,
secondarily, between the United States and Europe.
Senator Capito. Thank you. Mr. Ferrara, thank you for your
work at CBP and we had the TSA Administrator in front of our
Subcommittee which is Homeland Security and Appropriations the
other day and was talking about the protocols that have been
put in place that you all are coordinating with.
Let me just say when somebody comes in and is at the 11
airports, those are the citizens coming in into the 11
airports, you do a prescreening. You do that in coordination
with CDC.
What if somebody like exhibits the symptoms? Then are they
tested immediately or how is that rolling out?
Mr. Ferrara. Thank you, ma'am. As you said, once they come
in to one of the 11 airports, our officers identify them as
potentially being ill or at least coming from either Iran or
China. We refer them over to CDC or CWMD who's there. That's a
medical determination. So they would determine if a test is
required or not. As to our law enforcement, our priority is the
law enforcement piece of it, making sure they get there, yes,
ma'am.
Senator Capito. Get where they need to go.
Mr. Ferrara. Yes, ma'am.
Senator Capito. It was brought to my attention that there
was an article in the Wall Street Journal this morning, the
title of which is ``Hackers Target Companies with Coronavirus
Scams.'' I mean, it's pretty shameful that people would try to
capitalize on what we see as some growing fears and anxieties
about what's going on.
I don't know if this is a Homeland Security question. I
know absolutely you all have cybersecurity capabilities within
your agencies. Is this something that you all are made aware of
that there are people that are impersonating the World Health
Organization? Obviously this is a money-making kind of scam.
Dr. Redd, do you know anything about this?
Dr. Redd. I was not familiar with that article. I think
that the general issues of cybersecurity are ones that we need
to take very seriously and I think this would be an example of
if those measures aren't in place, how that can lead to
trouble.
Senator Capito. Well, you can imagine a scenario of a
hacker contacting somebody and saying you want to buy 25 masks
or some preventive or a vaccine or expedited travel or whatever
you would be offering would really make a lot of the population
very vulnerable to this kind of attack.
So I would suggest that all of you in your respective
departments take this back with you as a red flag.
Mr. Ferrara, did you want to say something?
Mr. Ferrara. Yes, ma'am. That is a Department of Homeland
Security. That's one of the functions----
Senator Capito. Right.
Mr. Ferrara.--that we do have. So I will certainly bring
that back and provide that information to the department.
Senator Capito. Let me ask you, too, again. We've talked a
lot about aviation. We obviously know about the cruise ship
situation that occurred. We also have a lot of cargo going back
and forth all around the world but certainly to the Far East
and coming back in.
I think initially when I raised this question, Homeland
Security said, well, the incubation period is so much so that
if you're on a ship for 14 days getting back and forth, it's
really not going to be an issue, but we see that it really is
an issue because it could be passed from time to time to time.
So are you working with the Coast Guard on this to make
sure that wherever those ships are coming in from that you have
some kind of capabilities there?
Mr. Ferrara. Yes, ma'am. In conjunction with the Coast
Guard, we again target people from either China or Iran who are
traveling on those cargo ships and we make sure, working with
our medical partners, to keep those folks out of the port until
we get the all-clear from the medical folks.
Senator Capito. Just as a regular course of everyday
living, today I find I challenged myself to try to see how many
things I could not touch that I know had been touched by
numerous people before me. What a challenge and so I think if
everybody would try the exercise around the country, you would
realize how not just susceptible you are but how careful you
need to be when you know you've been in some kind of contact or
direct contact or you yourself maybe have a cold or are
beginning to not feel well.
So that was pretty staggering, starting with the elevator,
the doors, the restroom. I mean, we could go on and on,
constituents coming to visit and all those things.
Thank you very much, Mr. Chairman.
Senator Cruz. Thank you.
Senator Duckworth.
STATEMENT OF HON. TAMMY DUCKWORTH,
U.S. SENATOR FROM ILLINOIS
Senator Duckworth. Thank you, Mr. Chairman. I want to thank
you and the Ranking Member for having this hearing.
As of yesterday, Illinois, my home state, has had four
individuals test positive. I wish them and everyone else who
has been infected a speedy recovery, and I want to credit all
of the staff at the state and local levels for the work that
they've done.
But I have to share my frustration here because I can't
believe that we're having some of the conversations we're
having now after having faced other global outbreaks, such as
H1N1 and SARS.
Did we not learn anything about the processes and
procedures from those previous diseases?
You know, Americans have been flying commercially for more
than a century, yet today on the cusp of a global pandemic, the
inability of the Federal agencies to collect and share critical
data effectively with U.S. airlines and state and local
partners is really hindering our ability to stop the spread and
to fight this disease, and so, you know, my last job in the
Army when I was finishing out my last tour was working at the
Pentagon in the DSCA Ops, which is the Defense Support of
Civilian Authorities, and the last thing I did was give a
briefing on global pandemics and what we would do in a
particular office.
Dr. Redd, you worked on H1N1, right? You alluded to it
earlier.
Dr. Redd. Yes, ma'am.
Senator Duckworth. OK. That was in 2009. So how the heck
has the CDC, the CBP, and DOT, how come we are still trying to
figure out how to deal with these issues? How is it that our
CBP don't have computers? How come we don't have a way that
we're talking to airlines? How did we get here after we've seen
Ebola, we've seen H1N1, we've seen SARS, and what are we going
to do in this instance but then also looking forward to the
next pandemic that hits and there will be another one that
we're ready for and we're not caught flatfooted the way we are
right now?
Dr. Redd. I think that we have improved since--really my
own history begins with the mid-2000s and I think we're far
ahead of where we were at that point in time through a lot of
hard work and attention from the members here, Congress and the
Administration.
I think that you're pointing out some things that need to
change and I think that there will be both in the very near
term work to make sure that we're operating as effectively as
we can now and that there will be after action review items
that will come out, many of which you're listing.
Senator Duckworth. So how long, for you and Mr. Ferrara,
given the data-sharing challenges with airlines, how long does
it take for state emergency management agencies and public
health departments to receive flight information about
potentially infected travelers? How long does it take the State
Department? I mean, I have one of the busiest airports in the
world in Chicago. How long does it take IDPH, Illinois
Department of Public Health, or the local officials to receive
information about a flight that's coming in that potentially
has an infected patient onboard?
Mr. Ferrara. Yes. CBP transmits the information from these
flights within an hour over to CDC. I don't know the process
from CDC to the states.
Senator Duckworth. OK.
Mr. Ferrara. But the information that we do have, we
transmit within an hour.
Senator Duckworth. OK. Dr. Redd, how long does my state--
does it take before my IDPH gets it?
Dr. Redd. Well, I think the problem is that the information
is often incomplete and that is really what the interim final
rule is trying to correct, is that if we have a name, that's
not very helpful. If we have a name and an address, that's
somewhat helpful. If we have a name, address, phone number, e-
mail address, we can find people, and that information at the
health department would basically be the ability to do complete
follow up if those data elements are available.
Senator Duckworth. So you don't have a time-frame for me
right now and we don't know when we're going to have the
capability to rapidly let local public health people know?
Dr. Redd. Well, I think for what we have, it's a very short
period of time, but the real question is getting complete
information and doing that in a timely fashion.
Mr. Szabat. And, Senator, if I may just add to that,
because this has been discussed at the task force level, the
goal of CDC, the health officials, has been to collect the
information so that CDC has it by the time the plane arrives
and is already providing it to the local officials.
The challenge that we have to the public health officials
to where those passengers are actually going because, of
course, they come to one of 11 airports for initial screening
but that's not where they're ending up.
So if someone's flying into Chicago who's going on to
Massachusetts, CDC wants to gather the information and extend
it to the public health officials for wherever in Massachusetts
they're going to.
The system that we have right now is an interim system
which is working very well, but it is paperwork and personnel
intensive and so it works for the passenger load we have coming
in now from China. We could not scale it up to be more broad
and that's the challenge we're talking about about having a
better nationwide system.
Having said that, the system we have now is immeasurably
better than anything we've had before, whether it was with H1N1
or with SARS. So each time we have one of these, we learn and,
as Dr. Redd said, we'll do a hot wash after this. We will learn
from what we've done here and we'll do better next time.
Senator Duckworth. Well, I think we need to do a lot more
than better next time and I would ask our Chairman to maybe
consider holding a hearing after the epidemic and see and learn
about lessons learned and what they plan on doing next time.
I do want to add one more loophole to what my good friend,
the Senator from Alaska, mentioned with the cargo.
Dr. Szabat, Dr. Redd, are passengers aboard charter and
private flights from areas of concern receiving the same
scrutiny as passengers aboard commercial flights because I
think, in addition to the cargo aircraft, private aircraft are
another loophole that's in the system, and I'm out of time.
Senator Cruz. Please answer that question. It's a good
question.
Mr. Szabat. Senator, I'll answer the question. We'll get
back to you with a full answer for the record, but I know I can
speak personally. For example, for charter aircraft, we apply
exactly the same rules to them as we do to any commercial
aircraft. So if you're coming, for example, from China or now
from Iran, we don't have direct flights from Iran, but if
you're coming from China, you would have to land at one of the
F11 airports.
Senator Duckworth. But what about private?
Mr. Szabat. I'll get you an answer for the record on that.
Senator Duckworth. OK. Thank you, Mr. Chairman.
Senator Cruz. Thank you.
Senator Rosen.
STATEMENT OF HON. JACKY ROSEN,
U.S. SENATOR FROM NEVADA
Senator Rosen. Thank you, Mr. Chairman, for having this
very important hearing. Thank you for the work that you're
doing. I know your staff. You're just working around the clock
to try to figure out how to get ahead of this, be proactive,
protect our Nation. So I just want to share my appreciation and
that of all Nevadans with you.
But since the Coronavirus is changing so rapidly, it is
critical that our public health officials doing the work on the
ground, as Senator Duckworth says, have all the information
they need to do contact tracing and the monitoring of travelers
when warranted.
So I just would like to understand what the threshold
metric being used to determine when air travelers must fill out
that Government Public Health Locator Form. Can you explain
that to us? People are not having to do that? What is the
threshold? Is it just people from China, just people from
Italy? Please explain that.
Dr. Redd. OK. So the way for the current rule, it is
travelers--in for final rule applies to travelers from China.
Senator Rosen. Only. So we're not doing it for anybody
outside of China. So should we expand that?
Mr. Szabat. With your permission, Senator, I'll take that
on.
We have two countries now that are covered by the so-called
212F process which are travelers from China, travelers from
Iran. We have no direct flights from Iran. Very few Americans
will be coming back from Iran in a 14-day window. So for the
most part, the IFR rules apply to those travelers.
But we're looking at a model that can be scalable and
expandable. So, for example, right now we just introduced new
types of restrictions for travelers coming from Italy and South
Korea where they're getting exit screening coming out of those
countries but they're not being required to do the same kind of
data collection that we're doing----
Senator Rosen. Who's doing the exit screening? What
qualifications and training are you providing for that?
Mr. Szabat. OK. So it's a careful answer to that question,
Senator. These exit screens are being done by the authorities
in South Korea and in Italy. So these----
Senator Rosen. Before they come here?
Mr. Szabat. Exactly. Yes, yes. Exiting from there when they
come here. That's correct.
Senator Rosen. OK. So you're thinking about expanding it
and you'll obviously keep us apprised of that and
considerations for that.
I also want to build upon that a little bit because
obviously we're talking about air travel and we have all of our
wonderful flight crew, the pilots, the attendants, people who
clean the cabins, but really the flight crew health, given the
direct interaction and contact that the flight crew has with
hundreds of passengers, I'd like to hear a little bit more
about the recommendations for ensuring that their health is
protected and what requirements does the DOT have for personal
protective gear for flight staff, such as masks and gloves, if
those become recommended by public health officials?
Mr. Szabat. So I'm going to start with answering this
question, Senator, and I'll put Dr. Redd on notice that it'll
get passed on to him.
Department of Transportation, we, of course, work closely
with the industry and we hear from both the representatives of
the pilots and the flight attendants, but our role on the PPE
side is that we pass on either the guidance or the requirements
of--and it can be OSHA, NIOSH, or other health agencies.
So we are in a sense from the Department of Transportation
perspective, we're a pass-through. Given my position on the
task force, the role of the task force is to ensure that that
guidance is put out and if I may just put a plug in, because,
as you point out, you know, we give a lot of praise often for
first responders but first responders are responding to
something.
Our flight crews right now, they are on the cutting edge.
They are the ones right now dealing with these risks every day
and we do owe it to them to make sure that they have the very
best equipment and the very best knowledge of how to perform
self-safety practices.
Senator Rosen. Well, so you talked about you're the pass-
through. So how are we going to compel the airline industry to
be sure that the health of these workers are protected as
they--look. All of us fly every week multiple legs on many
different airlines.
Mr. Szabat. Right. So at the moment, the requirements that
we have are the airlines agree to meet these voluntary
standards.
Now if they refuse to meet them or fail to meet them, you
know, we can consider other measures, but right now, it's
clearly in the economic interests of the airlines and certainly
in the personal interests of their pilots and crew to follow
these measures.
Senator Rosen. And I just have a quick second, so I want to
make this very short. Are we providing or are you helping the
airlines to provide training, additional training to those
flight crews for looking for signs of illness so that they may
help when people are on the plane or when they're getting off
the ground and assisting in any of those reporting issues
there?
Dr. Redd. There's a lot of interaction with the airline
industry in that domain. I'm not familiar if we're actually
doing something very specific to Coronavirus, but there's been
a longstanding collaboration in that kind of work. Let me
follow up specifically on that question.
We do have guidance for protecting crews. Again, it's this
question of voluntary guidance and kind of what you should do
versus having the rule or the authority to do that which
resides with OSHA.
Senator Rosen. It's not just a question of the flight
crew's health but then they become carriers in and of
themselves and so that's the spread, the public spread can be
great.
So thank you. I appreciate it. My time is up.
Senator Cruz. Thank you.
Senator Thune.
STATEMENT OF HON. JOHN THUNE,
U.S. SENATOR FROM SOUTH DAKOTA
Senator Thune. Thank you, Mr. Chairman. Thanks for this
hearing and thank you to all of you for everything that you're
doing, continue to do to address the crisis.
Dr. Redd, first of all, I appreciate the CDC's work in
continuing to spread the Coronavirus and I want to thank you
especially for being here today, and I want to just follow up
on some questions I think that have already been asked.
But my understanding is that CDC has issued guidance to air
carriers to ensure that they're taking the precautions
necessary to contain or respond to potential Coronavirus cases
on international flights so the public is aware.
Could you just kind of again perhaps talk about some of
what those steps are, what the airlines are following?
Dr. Redd. I think the main thing is identifying patients
who have respiratory illness and taking action to really
notify. There's a system of communicating with the ground if
something like that were to occur and it's really, I think,
standard guidance but just putting a little sharper edge on it
because of the situation that we're in with the novel
Coronavirus.
Senator Thune. Are there instances of domestic community
spread that you've seen so far and does the CDC anticipate the
need to provide similar guidance to air carriers for domestic
flights similar to what you've done with international?
Dr. Redd. So there are locations in the country which have
cases that have been acquired within the United States,
specifically in Washington State and in California, and I think
it would not be surprising that other locations would see cases
like that.
The guidance for identifying people who are ill is not
limited to international carriers. So it wouldn't be only
international carriers that get that kind of guidance.
Senator Thune. Mr. Szabat, I understand and agree with the
current focus on major international airports in large cities
and efforts to contain Coronavirus, but it is important to
ensure that smaller airports and public health authorities in
rural areas are also prepared when confronted with a potential
case.
Has the department conducted outreach or provided guidance
to smaller airports on containing the spread of the
Coronavirus?
Mr. Szabat. Senator, thank you for the question and for the
concern. We share the concern for the health of the entire
traveling public and of which smaller airports are an important
part of that web within the United States.
So we're working through again what is called the whole of
government effort. When it comes to delivering health,
preventive measures to these airports, to any one of our
private sector stakeholders within the playbook, the emergency
response planning that falls under Health and Human Services,
and in Homeland Security.
So our job is to ensure that those communication channels
are open and are flowing. We have had just in the last 2 weeks
two major conference calls, including aviation organizations
and individual airports, for exactly this reason, to connect
them with--their first line is their own public health
authorities and then through that is the CDC for health
guidance.
Senator Thune. Dr. Redd, what resources is the CDC
providing airports across the country, including smaller
airports, to ensure that they can properly respond to a
potential outbreak?
Dr. Redd. I think in general, the quickest line of where to
get help would be the local health department. We are certainly
available to communicate but we would have guidance and we
would work that through the state and local health departments.
So that's going to be kind of the first line of defense in the
public health system--the local health departments and the
state health departments.
Senator Thune. OK. Mr. Ferrara, it's my understanding that
CBP has enhanced screening measures at major airports across
the country to increase the chances that infected passengers
are quarantined or denied entry into the United States.
Could you elaborate on the information that CBP collects on
each passenger entering the United States during normal
operations and how that has changed for points of entry where
screening has been enhanced?
Mr. Ferrara. Thank you, sir. The information that we're
collecting for contact tracing comes through the traditional
CBP airline systems and that's passed on to CDC. I think that's
the only difference with the process is that it's passed on to
CDC as a rule if these folks are coming in from those countries
of Iran and China.
Senator Thune. Mr. Szabat, does the department have an
initial estimate for Coronavirus' effect on global air travel
to and from the U.S.?
Mr. Szabat. Senator, the department does not. However,
we're closely following what the industry analysts are saying
and so currently, the current projection seems to be in the
range of 4.7 to 6 percent decline in global travel over the
course of the year.
Senator Thune. And does the department believe that the
reduction in international travel will potentially lead to
supply chain constraints for certain medical supplies?
Mr. Szabat. As the department does not have a position on
that, but I can certainly say as a member of the task force, we
see that there are disruptions in certain parts of the supply
chain. We would take as a lesson learned going forward and this
is both through for our private sector counterpart as well as
ourselves, I think there are a lot of lessons to be drawn here
about having over-reliance on a single source of supplies.
Senator Thune. Thank you. Thank you, Mr. Chairman.
Senator Cruz. Thank you.
Senator Markey.
STATEMENT OF HON. EDWARD MARKEY,
U.S. SENATOR FROM MASSACHUSETTS
Senator Markey. Thank you, Mr. Chairman.
Admiral Redd, good to see you, sir. Thank you for your
service. My wife is a retired Rear Admiral in the Public Health
Service. So I know your core, your work and what you're
dedicated to.
So if you could perhaps discreetly just describe to us what
it means when the President starts to call the Coronavirus a
hoax or puts out information which is medically inaccurate?
What from your perspective is necessary in order for you to be
able to do your job and for the public to be able to respond to
the message which you are sending which is medically accurate
in terms of the disease itself and then what the response
should be from the public?
Dr. Redd. I think that in the last several weeks, there has
been a focus on making sure that we are in alignment as a whole
of government approach. I think that that has been very helpful
with Vice President Pence in charge. I think that that will
help make sure that when a decision needs to be made that there
will be communication across departments so that really all the
experts are able to work more closely together and I think
that's going to be very helpful as we move forward here.
Senator Markey. Well, thank you, but just know that we
respect you and we respect science. We respect your conclusions
and we really don't want this to be politicized at all. That
will interfere with our ability to implement the plan that is
effective as soon as possible. I think we've already seen too
much delay in not responding correctly and doing so soon.
I'd like to come to you, Mr. Szabat. It's on the question
of airline fees. We have a pandemic which is going to hit the
United States in much larger measure over the next weeks and
months, according to the experts.
We have airlines that actually have taken charge fees,
change fees, and they've made a whole industry out of it in
terms of the amount of money which they can in fact charge.
The DOT is the only consumer protection agency overseeing
air travel and you are statutorily charged to stop unfair
practices in aviation. Allowing any airline to charge these
excessive fees during the Coronavirus outbreak is beyond
unfair.
So I urge the Department of Transportation to take action
immediately and prohibit all cancellation and charge fees
during this emergency. Anything less is a failure to fulfill
your duty and that's why I plan to send a letter to Secretary
Chao later this afternoon formally asking her to suspend these
change and cancellation fees in the face of this public health
crisis. The time for DOT to act is now. We don't want citizens
deciding they have to fly, you know, just because the
cancellation fee would be too large if in fact from their
perspective given their own health or their other family
members' health that it might be a danger to them if they came
into contact.
Would you commit to ensuring that the DOT, which is the
consumer protection agency, ensures that change in cancelation
fees are suspended during this crisis?
Mr. Szabat. Your concern and your request is noted,
Senator, and you have my commitment that we'll get on that
right away. As you say, this is an emergency response
situation. We're not looking to spend months or years
developing a rule. So we'll get you an answer back very
quickly.
Senator Markey. Yes. I think that's not an incidental issue
for many families. I can see more and more people--I've flown
like seven times in the last 10 days. More and more people on
each flight have a mask on. So for every one of those people is
somebody else that's very concerned and didn't want to cancel
the flight because they had to travel, but they might have if
they didn't have the additional fee.
Mr. Szabat. You're not the only one who's noticed that.
I've noticed it. Several of the carriers in the industry have
already decided to say that, you know, they will withdraw some
of those fees.
Senator Markey. Yes. Well, I'd just recommend to you that
it become an industry-wide practice through your insistence. I
think it will be great.
If I may, Admiral, the highest fatalities from the
Coronavirus have been in areas where the health care system has
been overwhelmed. CDC must take steps to prepare hospitals for
surges of Coronavirus cases that could stress health care
systems capacity to care for those patients, especially those
who may need hospitalization in airborne infection isolation
rooms.
CDC's current guidance, which hasn't been updated since
February 11, nearly a month ago, is for facilities lacking
airborne infection isolation rooms to transfer patients to
facilities with available rooms, but we know this option may
not be available if there is a surge of cases in a particular
region.
Dr. Redd, can you commit to provide hospitals and other
health care providers clear and specific guidance on how to
safely care for a surge of patients without airborne infection
isolation rooms?
Dr. Redd. Let me look into that and get back with you. I
think that you're bringing up a very important point in that if
the number of patients exceeds the number of beds, there's
going to have to be guidance for that situation.
Senator Markey. Yes. So you will provide clear guidance to
those hospitals?
Dr. Redd. Yes, sir.
Senator Markey. Is that what you're saying?
Dr. Redd. Let me get back to you with that, but, yes, we
will do that.
Senator Markey. Yes. I think you will get back to me or----
Dr. Redd. Yes.
Senator Markey.--you will provide the guidance?
Dr. Redd. First get back to you and then provide the
guidance.
Senator Markey. I think they need guidance. I think that
many places in this country need it right now. They need to
know what to do. So I would honestly put a crash team together
to try to figure it out tonight, put them in a room and send it
out to these hospitals. They're out there waiting for you,
you're the expert, to tell them what their----
Dr. Redd. Yes, sir.
Senator Markey.--plan should be. So I honestly believe that
it could hit a region within the next couple of days and they'd
be without any real instruction, and I think that would be
providing a disservice to those people.
So thank you, Mr. Chairman.
Senator Cruz. Thank you, Senator Markey.
I think it is important to correct the record, that I do
not believe it is accurate that the President has said the
Coronavirus is a hoax, and in fact I think that's quite
contrary to what he has in fact said and in fact done. The
President can obviously speak for himself, but my understanding
is what the President referred to as a hoax was the partisan
claim that some are advancing for partisan advantage that the
Administration is not treating this public health crisis
seriously and is not marshaling the resources to keep Americans
safe, and I will say in my observation, having yesterday met
with the Vice President of the United States, with the
Secretary of HHS, with the Commissioner of the FDA, with the
Head of the CDC, that the resources being marshaled are
significant.
Admiral Redd, I want to ask you in your opinion as a health
professional and as a lifelong expert in communicable diseases,
how significant was the step that the President and the
Administration took early on to halt air travel in and out of
China and to quarantine Americans returning to China? How
significant was that?
Dr. Redd. I think it was a very important decision to make
and I think that there was a prolonged period of time when we
had a very small number of cases. So I think that was the right
decision at the right time.
I think we'll be in a better position to evaluate that more
fully as time goes on, but at the present time, it was an
important decision.
Senator Cruz. In your medical judgment, had travel
proceeded unimpeded, would we be facing in all likelihood a
substantially worse outbreak in the United States?
Dr. Redd. We would have more cases, I think we can say for
sure, if those measures had not been put in place.
Senator Cruz. And, Mr. Szabat, from the perspective of the
Department of Transportation, how unusual is it for an
administration to take the steps this Administration took right
at the outset of this outbreak?
Mr. Szabat. Senator, those steps were beyond unusual. They
were unprecedented.
Senator Cruz. I can tell you I spoke personally with the
President I think two days after air travel was halted to China
and the President asked me directly, said, ``Ted, what do you
think?'' I told him, ``Mr. President, you made exactly the
right decision.'' I recognized the real economic consequences
to halting air travel but at the end of the day, the first
priority has to be protecting health and safety, has to be
protecting lives until we understand the scope of this
outbreak, until we understand what is happening with this
virus. We need to do everything that is possible to prevent
this outbreak from becoming a pandemic and so I am grateful
that the Administration acted.
That doesn't mean every step the Administration has taken
has been exactly right. Dealing with any crisis, there are
going to be challenges. There are going to be mistakes. But I
think we have seen a serious focus on this public health crisis
and that's the right thing, and I would note one of the
mistakes was releasing an individual from Lackland who
subsequently tested positive and that's a mistake that I
addressed at the beginning of this hearing.
I want to ask a couple more questions. Then we're going to
wrap up shortly.
It has been reported, my understanding is, the CDC has
asked commercial airlines in affected regions to take the
temperature of passengers boarding planes and that commercial
airline gate agents are understandably feeling not prepared to
do so, not trained to do so. They're not medical professionals.
Is that understanding correct and is it right to be asking
the gate agent to be taking someone's temperature rather than a
medical professional with the training to do that?
Dr. Redd. I will have to check on that. I'm not familiar
with that process. I know that in Korea and in Italy, the
governments are doing the exit screening, but let me get back
to you on confirming that my lack of knowing about that is that
it's not happening.
Senator Cruz. Mr. Szabat.
Mr. Szabat. Just an update because, you know, our
information flow among the agencies here is good but it's not
immediate. So from the Task Force level, you know, we've
learned while these measures have been put in place by the
respective governments of Italy and Korea in consultation with
our agencies, they've chosen how to implement it and so, for
example, in Korea, there are three levels of screening, thermal
temperature screening. Two of them are walk-through. You walk
past devices, one as you enter the airport, one as you go
through security, but the third is they are asking all
airlines, both Korean and that are flying to the U.S., to use
one of those handheld temperature devices to check the
temperatures of people who are going into the United States.
So, yes, that is a request that the governments have made
of the U.S. carriers as well as the foreign carriers to do that
testing.
Senator Cruz. So is it your testimony, just so I can
understand, that it's the Government of Korea that is asking
them to do it, not the U.S. Government?
Mr. Szabat. So the U.S. Government is saying to the
Government of Korea if we want to continue to have flights from
Korea to the United States, you have to do health screening.
Come back and tell us how you intend to do it and this is how
they've come back and told us they intend to do it.
Senator Cruz. Well, let me suggest and listen, I think
health screening makes an awful lot of sense from everything
I've heard, but the concern from airline gate agents that they
are not trained and they don't have the background to be doing
that screening, that seems a very reasonable concern and it
seems to me it ought to be health professionals that are doing
public health screening.
Let me shift to another issue on the CDC. Last month, the
CDC received reports that some of the testing kits were faulty
and experienced inaccuracies in their testing.
Were there cases in which the CDC released patients after
they had been tested with faulty kits, and, if so, in what
circumstances?
Dr. Redd. Let me go through the details of the Lackland
case and I think that is one instance where that occurred and
that was not a faulty test. It was a process of communication.
Actually, the thing that you talked about in your opening
statement is what happened.
There was an individual who was ill, who had recovered from
that illness, and the protocol at that point and still is the
case is that two specimens that are negative more than 24 hours
apart is a requirement to release an individual.
This person had one test that was negative, had a second
test that was indeterminate and then had a third specimen
obtained that was negative but that knowledge of that negative
test didn't occur until after--let me get the sequence right.
So there's a negative test. It was unknown to the people that
did the third test. A fourth test was obtained by a different
group.
According to the protocol, there was the negative test, the
indeterminate test, and a negative test. So that met the
criteria. Unfortunately, that fourth test was not known by the
people making the decision to release the person and turned out
to be a positive test.
I think the real issue was the communication there. No one
should be released with a pending test. That's one just obvious
thing that is really about the internal communication.
I think that the meaning of that test and whether there was
some issue with the test or with a person having a very low
level of virus, I think that's something that we don't know
right now. I don't think it was related to the other issue of
the quality control work that was done on the original test.
Senator Cruz. Is CDC examining why someone who tested
positive had two negative tests? That certainly raises
questions.
Dr. Redd. Yes, sir. Yes, sir, I think one of the questions
will be--I mean, this is really--it's a new infection. It's a
new virus and, for example, in the Ebola response in West
Africa, the role of sexual transmission wasn't something that
was recognized before an outbreak of that size occurred. During
that outbreak, it was learned that that can be an important
cause of really outbreaks or infections.
I'm not suggesting that that's the case here but just
there's more that the scientific community is going to learn
about this disease. I think it may shed some light on how an
outcome like that could occur.
Senator Cruz. Is the current protocol for releasing someone
from quarantine three consecutive negative tests with no
intervening tests?
Dr. Redd. It's two negative tests separated by more than 24
hours. So that has not changed. I think that your suggestion
that this is something that really needs a hard examination is
completely correct.
I think the real issue here was that there was a test that
was out there that wasn't--that the existence of that test
pending should have been something that would have kept the
person from being released at the first place and then with the
positive test, we wouldn't have had the--it would still be the
question of how do you get that kind of sequence but we
wouldn't have had the situation where a person with a positive
test was released.
Senator Cruz. So with respect, Dr. Redd, I think it's
important to frame the problem. The problem wasn't the fourth
test that happened. We're grateful that it did because it
actually caught someone who was still positive. The concern is
why, assuming someone who started out as positive and ended up
as positive, why were there two tests in the middle that were
negative and why was there an inconclusive test? Like that
raises----
Dr. Redd. Right.
Senator Cruz.--real questions about the accuracy of the
testing and I understand this is not an easy thing to do, but--
--
Dr. Redd. I can give you some possibilities, but I think I
can't tell you for sure why that circumstance occurred.
Senator Cruz.--I would welcome those possibilities.
Dr. Redd. One would be that there were a small amount of
viral particles existing at that fourth test that were
detected. It was a correct test, but the other negatives were
also true. So you're right at the limit of detection that there
wasn't actually live virus available, just kind of the remnants
of the nucleic acid of the virus still existed, even though
there wasn't a live virus and it was there in low amounts. So I
think that would be one explanation.
Another would be that, I think this is kind of getting
progressively less likely, but that there was some source of
that virus that emerged, similar to AIDS or the Ebola virus,
where a person can test negative over a long period of time but
still have the virus in semen. So maybe there's some protected
site that we don't know about.
I don't think that's very likely, but, you know, I do think
it's a question that really demands scientific scrutiny.
Senator Cruz. Let me also raise another question about the
protocol. So in the letter from CDC Director Robert Redfield to
Commissioner John Hellerstedt of the Texas Department of State
Health Services, Director Redfield stated that ``the 11
individuals who had been passengers aboard the Diamond
Princess, that 11 individuals had been offered voluntary
testing for the Coronavirus and were asymptomatic for the
entirety of the 14-day quarantine period.''
Is the reason the testing was only voluntary because they
were asymptomatic and does that make sense for lifting a
quarantine if we know someone has been in an environment where
they've been exposed?
Dr. Redd. I think this is a balance of individual liberty
and protecting the health of the public and I think that the
experience has been that staying asymptomatic for that period
of time, that those people would not have had a positive test,
but I think it really is kind of the civil liberties versus
protecting the public balance.
Senator Cruz. So are the current protocols that someone
will be released from quarantine if they're asymptomatic for 14
days whether or not they've been tested?
Dr. Redd. That's correct.
Senator Cruz. And those are the protocols, even though we
had this exchange in our first Q&A----
Dr. Redd. Let me check. Let me check back with you. Let me
verify that before I say something that's incorrect.
Senator Cruz. I mean, there is that study from China
indicating a 24-day incubation period. That may not be accurate
but if our current protocol is to release someone after 14 days
without testing them, if there is an incubation period longer
than 14 days, that could presumably contribute to the spread of
the virus, is that right?
Dr. Redd. If those two circumstances were true, yes, it
would.
Senator Cruz. OK. I want to thank all of the witnesses for
your testimony and I want to echo--you've heard Senators from
both sides of the aisle thank the professionals and I know you
guys are not getting a lot of sleep right now. You are working
hard and this is a serious challenge. This is not easy. There
are a lot of unknowns and I believe we need to follow the
science, we need to follow the medicine, but we need to also be
proactive protecting the American public, and so I thank each
of you for doing so.
I also want to underscore a point that was made from
multiple Senators, which is, if there are legal authorities
that any of your agencies need right now to protect public
health and safety and prevent the spread of this virus, tell us
and tell us quickly. I think you will find a bipartisan
eagerness to ensure we have the tools to prevent this outbreak
from growing, to prevent further deaths, but we cannot address
legal impediments if your agencies don't draw them specifically
to our attention.
I would note we have a funding bill that is moving rapidly
and it is possible even as quickly as that funding bill
attaching a provision to that if it proved necessary to
addressing this challenge.
With that, I want to thank all of the witnesses for their
testimony.
The hearing record will remain open for two weeks. During
that time, Senators are asked to submit any questions for the
record and upon receipt, the witnesses are requested to submit
their written answers to the Committee as soon as possible.
And with that, this hearing is now adjourned.
[Whereupon, at 4:47 p.m., the hearing was adjourned.]
A P P E N D I X
Prepared Statement of Nancy Messonnier, M.D., Director, Centers for
Disease Control and Prevention's (CDC) National Center for Immunization
and Respiratory Diseases
Good afternoon, Chairman Cruz, Ranking Member Sinema, and members
of the Subcommittee. I am Dr. Nancy Messonnier, Director of the Centers
for Disease Control and Prevention's (CDC) National Center for
Immunization and Respiratory Diseases. Thank you for the opportunity to
testify before you, and for your commitment to supporting CDC's work in
protecting public health.
Since President Trump took office, his work to protect the health
and safety of the American people has included a specific focus on
monitoring, preparing for, and responding to biological threats, such
as infectious disease outbreaks. As soon as the United States became
aware of a novel coronavirus at the end of 2019, the U.S. Government
was tracking its spread and began preparing necessary responses.
Within the first two weeks of China's initial report of the
outbreak in December 2019, China reported 45 pneumonia cases and two
deaths. The outbreak has since expanded to over 80,026 cases and over
2,912 deaths in China, with the majority of cases still centered in
Hubei Province, where the outbreak originated. Globally, 68 countries
have reported a total of 88,992 cases and 3,042 deaths. More recently,
there has been an increase in cases outside of China.
COVID-19 is a new disease, caused by a novel (or new) coronavirus
that has not previously been seen in humans. This new disease,
officially named Coronavirus Disease 2019 (COVID-19) by the World
Health Organization (WHO), is caused by the SARS-COV-2 virus, which is
in the same family of viruses as that cause the common cold, There are
many types of human coronaviruses including some that commonly cause
mild upper-respiratory tract illnesses. Coronaviruses are a large
family of viruses. Some cause illness in people, and others, such as
canine and feline coronaviruses, only infect animals. Rarely, animal
coronaviruses that infect animals have emerged to infect people and can
spread between people. This is suspected to have occurred for the virus
that causes COVID-19. Middle East Respiratory Syndrome (MERS) and
Severe Acute Respiratory Syndrome (SARS) are two other examples of
coronaviruses that originated from animals and then spread to people.
As of March 2, 2020, 91 cases have been reported across 10states, and
45 cases have been detected among people repatriated from Hubei, China
and the Diamond Princess We expect to see additional imported cases and
limited person-to-person spread. While community-wide transmission has
not been documented yet in the United States, it is expected, and we
are aggressively preparing for it.
Most cases of COVID-19 in the United States have been associated
with travel from China, but some person-to-person spread among close
contacts of travelers has been seen. It's important to note that this
virus is not spreading within American communities at this time. The
potential global public health threat posed by this virus is high, but
right now, the immediate risk to most Americans is low. The greater
risk is for people who have recently traveled to China or been exposed
to someone with COVID-19.
On January 29, 2020, President Trump announced the formation of the
President's Task Force on the Novel Coronavirus, which is chaired by
the Secretary for Health and Human Services and coordinated through the
National Security Council. The President's Task Force is composed of
subject matter experts from the White House and several United States
Government agencies, and it includes some of the Nation's foremost
experts on infectious diseases. The Task Force is leading the
Administration's efforts to monitor, contain, and mitigate the spread
of COVID-19 while ensuring that the American people have the most
accurate and up-to-date information to protect themselves and their
families.
The President's top priority is the health and welfare of the
American people, and his Administration has made it a priority to
prepare for infectious disease outbreaks that can cross borders. In
2018, President Trump launched the National Biodefense Strategy, which
lays out a framework for coordination among agencies, with the
Secretary of the U.S. Department of Health and Human Services (HHS) as
Chair of the Biodefense Steering Committee and helps identify gaps in
preparedness and response. As the situation around the new coronavirus
evolves, the Administration will continue its coordinated response, in
collaboration with state and local governments and the private sector
and adjust its positioning as needed.
Within HHS, the Centers for Disease Control and Prevention (CDC),
the Assistant Secretary for Preparedness and Response (ASPR), the
National Institute of Allergy and Infectious Diseases (NIAID), and the
Food and Drug Administration (FDA) play critical roles in responding to
COVID-19 by preventing and slowing the spread of the disease, assisting
repatriated Americans, protecting the supply of food, drugs, and
devices, and developing diagnostics, therapeutics, and vaccines.
Centers for Disease Control and Prevention
In late December 2019, Chinese authorities announced a cluster of
pneumonia cases of unknown etiology centered on a local seafood market
in Wuhan, China, with an estimated case onset in early December. CDC
immediately began monitoring the outbreak, and within days--by January
7, 2020--had established a Center-led Incident Management Structure. On
January 21, 2020, CDC transitioned to an Agency-wide response based out
of its Emergency Operations Center. This allows CDC to provide
increased operational support to meet the outbreak's evolving
challenges and provides strengthened functional continuity to meet the
long-term commitment needed to curb the outbreak.
As of March 2, 2020, CDC has deployed over 1,500staff to work full
time on the COVID-19 response, including those working on the response
from CDC headquarters, overseas offices, and field deployments. This
includes CDC staff supporting China through the CDC country office in
Beijing, China; that office has a 30-year history of collaboration with
the China National Health Commission and China Center for Disease
Control on emerging threats and respiratory illness. Beyond China, CDC
is assisting ministries of health in countries in every region of the
globe with their most urgent and immediate needs to prevent, detect,
and respond to the COVID-19 outbreak.
CDC's most expert and practiced infectious disease and public
health experts are dedicated to this response 24/7 to protect the
American people. CDC is a disease preparedness and response agency, and
this work is fundamental to our mission both domestically and
internationally. The Agency's approach to COVID-19 is built upon
decades of experience with prior infectious disease emergencies
including responses to SARS, MERS, and Ebola, and to pandemic
influenza.
To mitigate the impact of COVID-19 within the United States, CDC is
working alongside Federal, state, local, tribal, and territorial
partners, as well as public health partners. This public health
response is multi-layered and includes aggressive containment and
mitigation activities with an objective to detect and minimize
introductions of this virus in the United States so as to reduce its
the spread and impact. It is impossible to catch every single traveler
returning from China with this virus--given the nature of this virus
and how it's spreading. Our goal continues to be slowing the
introduction of the virus into the United States as we work to prepare
our communities for more cases and possible sustained spread.
To accomplish this, CDC is also working with multiple countries, in
collaboration with U.S. Agency for International Development (USAID)
and other Federal agencies and WHO to support ministries of health
around the globe to prepare and respond to the outbreak. For example,
the U.S. Government is helping to support countries to implement
recommendations provided by WHO related to the identification of people
who might have this new infection, diagnosis and care of patients, and
tracking of the outbreak. CDC staff are also starting to work together
with interagency colleagues in those countries to conduct
investigations that will help inform response efforts going forward.
The Agency is using its existing epidemiologic, laboratory, and
clinical expertise to gain a more comprehensive understanding of COVID-
19. CDC is leveraging prior programmatic investments in domestic and
global public health capacity and preparedness to strengthen the
Agency's response to COVID-19. Thus far, this response has been built
largely on the foundation of our seasonal and pandemic influenza
program's infrastructure. The ongoing response to COVID-19 also
demonstrates CDC's continued commitment to strengthen global health
security. CDC has been engaged in global health security work for over
seven decades. Thanks to investments in Global Health Security, the
U.S. Government's work has helped partner countries build and improve
their public health system capacity. This global effort strengthens the
world's ability to prevent, detect, and respond to infectious diseases
like this new coronavirus.
This outbreak also underscores the need for the United States to
continue to play a leadership role on the global stage, and to
strengthen global capacity to stop disease threats at their sources,
before they spread. Furthermore, the outbreak demonstrates the
importance of continued investment in our Nation's public health
infrastructure. Despite years of progress in domestic disease
prevention and response, efforts to help modernize our federal, state,
and local capability and health systems that are crucial to responding
to and understanding unprecedented threats continue.
Within a week of China posting a genetic sequence online, CDC had
developed a real time Reverse Transcription-Polymerase Chain Reaction
(rRT-PCR) test that can diagnose COVID-19 in respiratory samples from
clinical specimens. On Monday, February 3, 2020, CDC submitted an
Emergency Use Authorization (EUA) package to the FDA in order to
expedite FDA permitted use of the CDC-developed laboratory test kit,
called the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The next
day, FDA approved the EUA and the test kit began shipping on February
5, 2020 to select, qualified U.S. and international laboratories. As
states began validating the kit in their laboratories, an issue with
one of the testing components was discovered. This issue was
immediately reported to CDC and no further domestic or international
kits were shipped. In addition, in response to this issue, CDC has
significantly increased its test throughput in Atlanta allowing for
continued monitoring of the outbreak without disruption. CDC is working
on remanufacturing the test kit, which will help improve the global
capacity to detect and respond to the 2019 novel coronavirus.
In addition to the development of a diagnostic test, CDC has
publicly posted the assay protocol for this test. Availability of this
resource is a starting place for greater commercial availability of
these tests. CDC continues to upload the entire genome of the viruses
from all reported cases in the United States to GenBank as sequencing
was completed. CDC has also grown the COVID-19 virus in cell culture,
which is necessary for further studies, including for additional
genetic characterization. The cell-grown virus was sent to the National
Institutes of Health's Biodefense and Emerging Infections Research
Resources Repository for use by the domestic and international
scientific community.
The U.S. Government has taken unprecedented steps to prevent the
spread of this virus and to protect the American people and the global
community from this new threat and allow State, local, territorial, and
private partners time to prepare for any necessary response and
mitigation activities. Since February 2, 2020, pursuant to arrival
restrictions imposed by the Department of Homeland Security, flights
carrying persons who have recently traveled from or were otherwise
present within mainland China, not including Hong Kong, Macau, or the
Island of Taiwan) have been funneled to designated U.S. airports with
CDC quarantine stations. At these airports, passengers are subject to
enhanced illness screening and self-monitoring with public health
supervision up to 14 days from the time the passenger departs China. As
of March 2, 2020, CDC, with assistance from the U.S. Department of
Homeland Security, has conducted 49,827passenger screenings at
airports. This enhanced entry screening serves two critical purposes.
The first is to detect illness and rapidly respond to symptomatic
people entering the country. The second purpose is to educate travelers
about the virus and what to do if they develop symptoms. Travelers who
have been in Hubei Province in the past 14 days are either taken to a
medical facility for treatment if symptomatic, or, if asymptomatic, are
placed under a Federal, state, or local quarantine order for a 14-day
period. For travelers from other parts of China, outside of Hubei
Province, asymptomatic travelers are asked to monitor their health for
a period of 14 days at their final destination, in coordination with
their local health departments.
Furthermore, in an effort to slow the spread of COVID-19 in the
United States, CDC issued its highest level of travel guidance for
China, Level 3, recommending that travelers avoid all nonessential
travel to the country. CDC has supported the Department of State in the
safe and expeditious departure of U.S. citizens and other exempted
persons.
As of February 26, 2020, this includes 7 chartered flights that
returned passengers from Wuhan City, China and most recently,
passengers from a cruise ship docked in Japan. These measures are part
of a layered approach which includes our other core public health
efforts, including aggressively tracking COVID-19 around the globe,
building laboratory capacity, and preparing the national healthcare
system for community spread. These core capabilities and expertise are
essential to CDC's comprehensive approach to addressing this outbreak.
While CDC believes that the immediate risk of this new virus to the
American public is low, CDC is preparing the Nation's healthcare system
to respond to identification of individual cases and potential person-
to-person transmission of COVID-19 in the community, at the same time
ensuring the safety of its patients and workers. CDC has developed
guidance on appropriate care and infection control for patients with
COVID-19 and is engaging regularly with clinical and hospital
associations to confirm that its guidance is helpful and responsive to
the needs of the healthcare system.
Furthermore, understanding the current constraints of the global
supply of personal protective equipment (PPE), CDC is working with
industry and the U.S. health system to comprehend possible effects on
facilities' abilities to procure the needed levels of PPE, and to
provide strategies to optimize the supply of PPE.
Effective disease surveillance enables countries to quickly detect
outbreaks and continuously monitor for new and reemerging health
threats. CDC continues to monitor the COVID-19 situation around the
world.
CDC has begun working with domestic public health laboratories that
conduct community-based influenza-like illness surveillance and
leveraging our existing influenza and viral respiratory surveillance
systems so that we may begin testing people with flu-like symptoms for
the SARS-COV-2 virus. HHS is developing plans to expand this effort.
This collaboration with domestic public health labs is another
layer of our response that will help us detect if this virus is
spreading in a community. All of our efforts now are to prevent the
sustained spread of this virus in our communities, but we need to be
prepared for the possibility that it will spread. Results from this
surveillance could necessitate changing our response strategy.
CDC has issued guidance for people at high risk of exposure to the
virus, including flight crews, recent travelers to China, and
healthcare workers. Through its extensive Health Alert Network, CDC
shared guidance for clinical care for healthcare professionals and
state and local health departments. Health departments, in consultation
with healthcare providers, can evaluate patients and determine whether
someone may have the illness and should be subjected to additional
diagnostic testing.
The current outbreak meets two criteria for a pandemic. It is a new
virus, and it is capable of person-to-person spread. If sustained
person-to-person spread in the community takes hold outside China, this
will increase the likelihood that the WHO will deem it a global
pandemic. Extensive work has been done over the past 15 years in the
United States to prepare for an influenza pandemic. Influenza pandemic
preparedness platforms and plans are appropriate in the event that the
current COVID-19 outbreak becomes a pandemic. Public health partners
have been encouraged to review their pandemic preparedness plans and
begin planning for community spread.
CDC has a demonstrated record of innovative science and evidence-
based decision-making, and an experienced and expert workforce that is
working 24/7 to combat this public health emergency. The COVID-19
outbreak is evolving rapidly, and the U.S. Government is constantly
making adjustments to respond to the changing nature of this public
health emergency. Our goal continues to be slowing the introduction of
the virus into the United States and preparing our communities for more
cases and possible sustained spread. While leaning forward aggressively
with the hope that we will be able to prevent community spread, CDC
remains vigilant in confronting the challenges presented by this new
coronavirus.
Assistant Secretary for Preparedness and Response
Currently, there are no vaccines or therapeutics approved by the
FDA to treat or prevent novel coronavirus infections. The Biomedical
Advanced Research and Development Authority (BARDA), part of ASPR, is
working with counterparts across the government, including within HHS
and with the Department of Defense (DOD). The team is reviewing
potential vaccines, treatments, and diagnostics from across the public
and private sectors to identify promising candidates that could be
developed to detect, protect against, or treat people with coronavirus
infections. BARDA is working closely across the U.S. Government to
assess and identify potential partners and technologies suitable to
address the COVID-19 outbreak--both for prevention and treatment.
This has allowed BARDA to leverage existing partnerships,
accelerating the development of COVID-19 medical countermeasures,
including diagnostics, therapeutics, and vaccines. Established
partners, including Regeneron, Janssen, and Sanofi Pasteur, have shown
success in developing both prophylactic and therapeutic medical
countermeasures for emerging infectious diseases.
BARDA is collaborating with Regeneron to leverage their partnership
agreement to develop multiple monoclonal antibodies that, individually
or in combination, could be used to treat this emerging coronavirus.
Regeneron's monoclonal antibody discovery platform, called VelocImmune,
was used to develop a promising investigational three-antibody
therapeutic which was deployed to treat Ebola in the most recent
outbreak in the Democratic Republic of the Congo, and an
investigational two-antibody therapeutic to treat MERS. The technology
shortened multiple aspects of the product development timeline for
therapeutics to treat MERS and Ebola from years to months. The
technology helped shorten certain stages of drug development, including
the process of antibody discovery and selection, preclinical-scale
manufacturing, and clinical-scale manufacturing. BARDA and Regeneron
are working to utilize these monoclonal antibodies, produced by a
single clone of cells or a cell line with identical antibody molecules,
which will bind to certain proteins of a virus, reducing the ability of
the COVID-19 virus to infect human cells.
BARDA is working with Janssen to leverage their Ebola, Zika, HIV
vaccine platform to expedite development of vaccines that protect
against the SARS-CoV-2 virus. Using existing resources, BARDA will
share research and development costs and expertise with Janssen to help
accelerate Janssen's investigational COVID-19 vaccine into clinical
evaluation. Janssen will also scale-up production and manufacturing
capacities required to manufacture the candidate vaccine. This same
approach was used to develop and manufacture Janssen's investigational
Ebola vaccine with BARDA support; that vaccine is being used in the
Democratic Republic of the Congo as part of the current Ebola outbreak
response. Additionally, BARDA and Janssen are working together to help
develop treatments for coronavirus infections. Janssen will conduct
high throughput screening on thousands of potential antiviral compounds
in order to identify medicines that could safely and effectively be
used to reduce the severity of illness and treat COVID-19 infections,
as well as identify compounds that have antiviral activity against
SARS-CoV-2 as an initial step in developing new treatments. These
products include those in development to treat and prevent MERS or
SARS, which are caused by coronaviruses also related to COVID-19.
Finally, in their work with Sanofi Pasteur, BARDA is able to
leverage a licensed recombinant influenza vaccine platform to produce a
recombinant SARS-CoV-2 vaccine candidate. The technology produces an
exact genetic match to proteins of the virus. DNA encoding the protein
will be combined with DNA from a virus harmless to humans, and used to
rapidly produce large quantities of antigen which stimulate the immune
system to protect against the virus. The antigens will be separated and
collected from these cells and purified to create working stocks of
vaccine for advanced development.
BARDA has initiated early steps of medical countermeasures
development with partners and will continue to work to accelerate this
process. Availability of these medical countermeasures is essential to
save lives and protect Americans against 21st century public health
threats.
Our nation's healthcare system is better prepared than it has ever
been. For example, all 50 states have Pandemic Plans, as a requirement
of CDC's Public Health Emergency Preparedness Program (PHEP) and ASPR's
Hospital Preparedness Program (HPP). HPP was established after the
September 11, 2001, terrorist attacks, with the goal of improving the
capacity of local hospitals across the country to deal with disasters
and a large influx of patients in an emergency. Using HPP funding,
state grantees initially purchased equipment and supplies needed for
emergency medical surge capacity. Over time, the program has
successfully evolved to support local, coordinated healthcare
coalitions, including hospitals, public health facilities, emergency
management agencies, and emergency medical services providers.
Investments administered through PHEP and HPP have improved individual
health care entities' preparedness and have built a system for
coordinated healthcare system readiness. HPP is the only source of
Federal funding to prepare the Nation's mostly private health care
system to respond to emergencies, including COVID-19.
Beginning in 2018, ASPR has been supporting Regional Disaster
Health Response Systems (RDHRS) pilot projects. The RDHRS concept aims
to provide funding directly to hospitals and healthcare systems to
establish multi-state regional partnerships to increase preparedness
and response capability and capacity for hospitals and healthcare
facilities in advance of, during, or immediately following incidents,
including emerging infectious diseases. Two sites were selected in
September 2018 to begin development of RDHRS pilots. In 2019, two
grants were awarded to support new centers of excellence pilots focused
on pediatric disaster care. The RDHRS and Pediatric Disaster Care
Center of Excellence cooperative agreement requirements are
intentionally aligned to ensure synergy between the programs and
collaboration between all sites and facilities. Ultimately, these
efforts inform best practices to help ready healthcare delivery systems
for disasters and emergencies and are critical in aiding response and
limiting the impact of disaster. As you all are aware, the United
States is in the middle of influenza season. Many emergency departments
are at 90 percent capacity. If influenza worsens, or if COVID-19
intensifies domestically, emergency departments would be severely
strained, which is why supporting models such as the Hospital
Preparedness Program healthcare coalition network is so important.
The National Ebola Training and Education Center (NETEC) combines
the resources of healthcare institutions experienced in treating Ebola
to offer training, readiness consultations, and expertise to help
facilities prepare for Ebola and other special pathogens. The regional
Ebola and other special pathogen treatment centers, of which ASPR and
CDC funded 10 across the country, all have respiratory infectious
disease isolation capacity or negative pressure rooms for at least 10
patients, including pediatric patients. The NETEC and the regional
Ebola and other special pathogen treatment centers are being used to
support the ongoing quarantine effort. Should the coronavirus
infections increase domestically, these centers will become critical in
isolating infected persons and providing adequate treatment.
ASPR and CDC also work to enhance medical surge capacity by
organizing, training, equipping, and deploying Federal public health
and medical personnel, such as National Disaster Medical System (NDMS)
teams, and providing logistical support for Federal responses to public
health emergencies. NDMS was originally created during the Cold War to
take care of military casualties from overseas in U.S. civilian
hospitals. Today, NDMS teams are deployed to strategic locations across
the country, caring for U.S. citizens evacuated from China who may have
been exposed to SARS-CoV-2, effectively providing medical care and
limiting the potential spread of the disease.
Currently, to assist in the repatriation effort, ASPR has stood up
a National HHS Incident Management Team (IMT) located in Washington,
DC. The IMT serves as the national command and control element.
Currently, HHS has deployed 606 Public Health Service Commission Corps
Officers and NDMS personnel:
March Air Reserve Base (in Riverside County, California): 39
personnel onsite
Travis Air Force Base (in Solano County, California): 214
personnel onsite
Marine Corps Air Station Miramar (in San Diego, California):
127 personnel onsite
Lackland Air Force Base (in San Antonio, Texas): 150
personnel on site
Camp Ashland (in Omaha, Nebraska): 76 personnel onsite
In addition, HHS is providing cache equipment, (e.g., medical
supplies and resources) to Travis AFB, Marine Corps Air Station
Miramar, Lackland, Air Force Base, and Camp Ashland. HHS deployed one
Disaster Medical Assistance Team (DMAT) and one IMT on February 12,
2020 to support American citizens in Japan on the Diamond Princess
cruise ship, as well as the U.S. Embassy, to provide medical care,
prescriptions, and behavioral health support. Regarding the cruise
ship, the Department of State facilitated voluntary repatriation of
over 300 U.S. citizens and family members who were passengers. During
the evacuation process, after passengers had disembarked the ship and
initiated transport to the airport, U.S. officials received notice that
14 passengers, who had been tested 2-3 days earlier, had tested
positive for COVID-19. For the flight, these passengers were kept in a
specialized containment area on the evacuation aircraft to isolate them
in accordance with standard protocols. After consultation with HHS
officials, including experts from ASPR, Department of State allowed the
14 individuals, who were in isolation, separated from other passengers
and continued to be asymptomatic, to remain on the aircraft to complete
the evacuation process. All passengers were closely monitored by
medical professionals throughout the flight, and any who became
symptomatic were moved to the specialized containment area. Upon
landing in the United States, passengers deplaned at either Travis AFB
or Joint Base San Antonio and will remain under quarantine for 14 days.
The 14 individuals who had tested positive for COVID-19 continued to
the University of Nebraska Medical Center in Omaha, Nebraska. Every
precaution to ensure proper isolation and community protection measures
are being taken, driven by the most up-to-date risk assessments by U.S.
health authorities.
Many active pharmaceutical ingredients and medical supplies,
including auxiliary supplies such as syringes and gloves, come from
China and India. This outbreak demonstrates why ASPR is seeking
innovative solutions and partnerships to better protect national
security. ASPR is working to increase access to personal protective
equipment (PPE) by:
Coordinating with CDC and other Federal agencies to share
information about optimization of PPE, to prevent overbuying
and overuse of existing supplies
Engaging private sector partners who manufacture and
distribute PPE to share information and concerns, and to
explore options to anticipate and meet the needs of the U.S.
healthcare sector more effectively. During recent discussions,
for example, distributors informed us that they have
implemented allocations to help prevent stockpiling at
healthcare facilities. The allocation is a percentage of a
customer's previous orders and is designed to help protect the
healthcare supply chain and ensure the right supplies are
available for those who need it.
We are also partnering with other Federal agencies such as
DHS, DOD and the U.S. Department of Veterans Affairs who are
large buyers of PPE, to develop acquisition strategies that
incentivize industry to expand PPE production while not
exacerbating supply challenges.
The Strategic National Stockpile (SNS) holds thousands of
deployable face masks, N95 respirators, gloves, and surgical gowns that
could be deployed if state and local supplies are diminished due to the
current COVID-19 response and commercial supplies are exhausted. The
SNS is working hand-in-hand with commercial supply chain partners and
other Federal agencies to continue monitoring supply levels and to
prepare for a potential deployment of SNS personal protective gear if
it is needed.
The National Institutes of Health
The National Institutes of Health (NIH) is the HHS agency leading
the research response to the global health emergency of COVID-19.
Within the NIH, the National Institute of Allergy and Infectious
Diseases (NIAID) is responsible for conducting and supporting research
on emerging and re-emerging infectious diseases, including COVID-19.
NIAID is well-positioned to respond rapidly to infectious disease
threats as they emerge by leveraging fundamental basic research
efforts; a domestic and international research infrastructure that can
be quickly mobilized; and collaborative and highly productive
partnerships with industry. NIAID provides preclinical research
resources to scientists in academia and private industry throughout the
world to advance translational research for emerging and re-emerging
infectious diseases. These research resources are designed to bridge
gaps in the product development pipeline, thereby lowering the
scientific, technical, and financial risks incurred by industry and
incentivizing companies to partner in the development of effective
countermeasures including diagnostics, therapeutics, and vaccines.
NIAID also supports the Infectious Diseases Clinical Research
Consortium, which includes a network of Vaccine and Treatment
Evaluation Units (VTEUs). The VTEUs conduct clinical trials to
investigate promising therapeutic and vaccine candidates when public
health needs arise. NIAID collaborates with other Federal agencies,
including through the HHS Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE), to help advance progress against
newly emerging public health threats. In addition, partnerships with
academia, the biotechnology and pharmaceutical industries, domestic and
international researchers, and organizations such as the World Health
Organization (WHO) are integral to these efforts.
NIAID has a longstanding commitment to coronavirus research,
including extensive efforts to combat two other serious diseases caused
by coronaviruses: SARS and MERS. This research has improved our
fundamental understanding of coronaviruses and provides a strong
foundation for our efforts to address the challenge of SARS-CoV-2, the
novel coronavirus that causes COVID-19. NIAID has responded to the
newly emerging COVID-19 outbreak by expanding our portfolio of basic
research on coronaviruses. NIAID scientists have rapidly identified the
human receptor used by SARS-CoV-2 to enter human cells. In addition,
NIAID investigators and their collaborators recently identified the
atomic structure of the spike protein, an important SARS-CoV-2 surface
protein that is a key target for the development of vaccines and
therapeutics. NIAID scientists also are evaluating the stability of
SARS-CoV-2 on various ordinary surfaces and in aerosols to better
understand the potential for viral spread throughout the community.
NIAID-supported researchers are assessing the risk of emergence of
bat coronaviruses in China, including the characterization of bat
viruses and surveys of people who live in high-risk communities for
evidence of bat coronavirus infection. Such research is necessary to
better understand this emerging infection and to investigate optimal
ways to diagnose, treat, and prevent COVID-19.
The NIAID Centers of Excellence for Influenza Research and
Surveillance (CEIRS), which conduct influenza risk assessments in
multiple sites throughout the world particularly in Asia, have
responded rapidly to the COVID-19 outbreak. CEIRS researchers at the
University of Hong Kong are evaluating the epidemiology, transmission
dynamics, and severity of COVID-19. These scientists also have
performed environmental sampling of the Wuhan market where the first
COVID-19 cases were reported.
NIAID is working with CEIRS collaborators and the CDC to obtain
additional virus and biological samples from patients to further
advance research efforts on COVID-19. Recently, the NIAID-funded BEI
Resources Repository made samples of SARS-CoV-2 available for
distribution to domestic and international researchers at Biosafety
Level 3 laboratories. In addition, CEIRS researchers and other NIAID-
supported scientists are developing reagents, assays, and animal models
that can be used to evaluate promising therapeutics and vaccines. These
research resources also will be shared with the domestic and
international scientific community as soon as they become available.
On February 6, 2020, NIAID issued a Notice of Special Interest
regarding the Availability of Urgent Competitive Revisions for Research
on the 2019 Novel Coronavirus. This notice encourages existing NIAID
grantees to apply for supplements for research project grants focused
on the natural history, pathogenicity, and transmission of the virus,
as well as projects to develop medical countermeasures and suitable
animal models for preclinical testing of COVID-19 vaccines and
therapeutics.
NIAID has responded to public health concerns about COVID-19 by
increasing ongoing coronavirus research efforts to accelerate the
development of interventions that could help control current and future
outbreaks of COVID-19. These activities build on prior NIAID research
addressing other coronaviruses, such as those that cause SARS and MERS.
The CDC has developed a real-time Reverse Transcription-Polymerase
Chain Reaction (rRT-PCR) test that can detect COVID-19 using
respiratory samples from clinical specimens. NIAID is accelerating
efforts to develop additional diagnostic tests for COVID-19, and NIAID-
supported investigators are developing PCR-based assays for SARS-CoV-2
to facilitate preclinical studies and aid in the development of medical
countermeasures. NIAID scientists also are developing reagents for an
enzyme-linked immunosorbent assay for SARS-CoV-2. CEIRS researchers at
the University of Hong Kong have developed a separate RT-PCR test and
made their protocol publicly available through the WHO. These NIAID-
supported investigators also have distributed assay reagents to 12
countries to facilitate the diagnosis of COVID-19.
NIAID is pursuing the development of antivirals and monoclonal
antibodies for potential use against SARS-CoV-2. NIAID has launched a
multicenter, randomized controlled clinical trial to evaluate the
safety and efficacy of the antiviral drug remdesivir for the treatment
of COVID-19 in hospitalized adults with laboratory-confirmed SARS-CoV-2
illness. The adaptive design of this trial will enable the evaluation
of additional promising therapies. NIAID plans to assess other existing
antivirals for activity against SARS-CoV-2, and NIAID scientists are
working to identify monoclonal antibodies with therapeutic potential
from COVID-19 patient samples as well as historical SARS patient
samples. NIAID-funded scientists also aim to delineate new viral
targets to facilitate the development of novel therapeutics with broad
activity against coronaviruses. Finally, NIAID is expanding its suite
of preclinical services to add assays that investigators can use to
accelerate research and development of therapeutics for COVID-19.
A safe and effective vaccine for SARS-CoV-2 would be an extremely
valuable tool to stop the spread of infection and prevent future
outbreaks. Public and private entities across the globe have announced
plans to develop SARS-CoV-2 vaccine candidates following the release of
the SARS-CoV-2 genetic sequence. NIAID is supporting development of
several SARS-CoV-2 vaccine candidates, and is utilizing vaccine
platform technologies that have shown promise against the coronaviruses
that cause SARS and MERS.
The NIAID Vaccine Research Center (VRC) is collaborating with the
biotechnology company Moderna, Inc., on the development of a vaccine
candidate using a messenger RNA (mRNA) vaccine platform containing the
gene that expresses the VRC-designed spike protein of SARS-CoV-2. NIAID
anticipates the experimental vaccine will be ready for clinical testing
in the NIAID VTEUs within the next two months and will conduct
preclinical studies as well as a first-in-human study of this COVID-19
vaccine candidate. The Coalition for Epidemic Preparedness Innovations
(CEPI) will fund the manufacture of the first clinical production lot
of this mRNA-based vaccine candidate using the Moderna rapid
manufacturing facility.
NIAID Rocky Mountain Laboratories (RML) scientists are
collaborating with Oxford University investigators to develop a
chimpanzee adenovirus-vectored vaccine candidate against SARS-CoV-2; in
addition, they have partnered with CureVac on an mRNA vaccine
candidate. RML investigators also have launched a collaboration with
the University of Washington and have begun early-stage testing of an
RNA vaccine candidate against SARS-CoV-2. In addition, NIAID-supported
scientists at Baylor College of Medicine and their collaborators are
evaluating an experimental SARS-CoV recombinant protein vaccine to
determine if it also provides protection against SARS-CoV-2. NIAID is
exploring additional collaborations with extramural research and
industry partners on other vaccine concepts. NIAID also is supporting
the development of standardized assays and animal models that will be
utilized to evaluate vaccine candidates.
With all these efforts, NIAID is coordinating closely with
colleagues at the CDC, BARDA, FDA, DOD, and other Federal and
international partners.
To achieve the ultimate goal of having a SARS-CoV-2 vaccine
available to the public, it is important that NIAID and the entire
biomedical research community pursue a range of vaccine strategies in
order to be better positioned to overcome the scientific or technical
challenges associated with any particular vaccine approach. In this
regard, NIAID has dedicated resources toward preclinical research to
advance a robust pipeline of vaccine candidates into Phase 1 clinical
evaluation. Further vaccine research, including Phase 2 clinical
trials, will then be required. Additional research also is needed to
better understand the fundamental biology of coronaviruses and to
facilitate the design of vaccines that elicit optimal immune responses
and protect against infection.
While ongoing SARS-CoV-2 vaccine research efforts are promising, it
is important to realize that the development of investigational
vaccines and the clinical testing to establish their safety and
efficacy take time. Although we plan to begin early-stage clinical
testing of an NIAID-supported vaccine candidate in the next few months,
a safe and effective, fully licensed SARS-CoV-2 vaccine will likely not
be available for some time. Currently, the COVID-19 outbreak response
in the United States remains focused on the proven public health
practices of containment--identifying cases, isolating patients, and
tracing contacts.
NIH is committed to continued collaboration with other HHS agencies
and additional partners across the U.S. government and international
community to advance research to address COVID-19. As part of its
mission to respond rapidly to emerging and re-emerging infectious
diseases throughout the world, NIAID is expanding our efforts to
elucidate the biology of SARS-CoV-2 and employ this knowledge to
develop the tools needed to diagnose, treat, and prevent disease caused
by this virus. NIAID is particularly focused on developing safe and
effective COVID-19 vaccines. These efforts also help to expand our
knowledge base and improve our continued preparedness for the next
inevitable emerging disease outbreak.
Food and Drug Administration
The FDA plays a critical role in overseeing our Nation's FDA-
regulated products as part of our vital mission to protect and promote
public health, including during public health emergencies. Our work
primarily focuses on four key areas: first, actively facilitating
efforts to diagnose, treat, and prevent the disease; second,
surveilling product supply chains for potential shortages or
disruptions and helping to mitigate such impacts, as necessary; third,
conducting inspections and monitoring compliance, including of
facilities that manufacture FDA-regulated products overseas; fourth,
helping to ensure the safety of consumer products. I will be providing
an update of our ongoing work as well as tools that could help enhance
the FDA's response capabilities.
A key focus area for the FDA is helping to expedite the development
and availability of medical products needed to diagnose, treat, and
prevent this disease. We're committed to helping foster the development
of critical medical countermeasures as quickly as possible to protect
public health. We provide regulatory advice, guidance, and technical
assistance to sponsors in order to advance the development and
availability of vaccines, therapies, and diagnostic tests for this
novel virus.
On February 4, 2020, the FDA issued an emergency use authorization
(EUA) to enable immediate use of a diagnostic test developed by the
CDC, facilitating the ability for this test to be used in CDC-qualified
laboratories. \1\ The FDA is dedicated to actively
working with other COVID-19 diagnostic developers to help accelerate
development programs and requests for EUAs. We have developed an EUA
review template for tests to detect the virus, which outlines the data
requirements for a Pre-EUA package that is available to developers upon
request. To date, we have shared the EUA review template with more than
65 developers who have expressed interest in developing diagnostics for
this virus.
---------------------------------------------------------------------------
\1\ FDA. 2019 Novel Coronavirus Emergency Use Authorization.
February 4, 2020. https://www
.fda.gov/medical-devices/emergency-situations-medical-devices/
emergency-use-authorizations#co
ronavirus2019. FDA. FDA Takes Significant Step in Coronavirus Response
Efforts, Issues Emergency Use Authorization for the First 2019 Novel
Coronavirus Diagnostic: Critical Milestone Reached in Response to this
Outbreak. https://www.fda.gov/news-events/press-announcements/fda-
takes-significant-step-coronavirus-response-efforts-issues-emergency-
use-authorization-first.
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The medical product supply chain is always potentially vulnerable
to disruption, which makes our surveillance work and collaboration with
industry critical and why the Agency takes a proactive stance on any
potential impact or disruption to the supply chain. An outbreak of this
global scale has an impact on the medical product supply chains,
including potential disruptions to supply or shortages of critical
medical products in the United States. We are in contact with
manufacturers; global regulators, like the European Medicines Agency;
health care delivery organizations; and other participants in the
medical product supply chains to quickly identify and address any
supply concerns that come from issues related to China and other
locations in Southeast Asia sourcing raw materials for manufacturing
drugs.
We are also tracking reports of increased ordering of some
essential medical devices through distributors, such as personal
protective equipment (PPE) (e.g., respirators and surgical gowns,
gloves and masks). FDA is working proactively to stay ahead of
potential shortages or disruptions of medical products. The agency will
use all available authorities to react swiftly and mitigate the impact
to U.S. patients and health care professionals as these threats arise.
Monitoring the safety of FDA-regulated product supply chains is one
of the FDA's highest priorities. The FDA utilizes risk-based models to
identify firms for inspection and prioritizes inspections based on
specific criteria. Because of travel restrictions to China, the Agency
has postponed planned inspection activities in China. However, we are
currently continuing inspection and enforcement activities as normal
for the rest of our operations. Inspections of facilities in China
remain prioritized in our site selection model and, when travel
restrictions are lifted, inspections of facilities in China will
resume. Any travel to China that is deemed to be mission-critical is
being assessed on a case-by-case basis in close coordination with other
HHS components and with the Department of State. FDA is committed to
maintaining its scheduled inspections around the globe to the extent
possible, while maintaining the safety of the staff involved. We will
revisit this approach and adjust as necessary as this outbreak
continues to unfold. In the meantime, FDA is working with our partner
government agency, U.S. Customs and Border Protection (CBP), to
evaluate and adjust our risk-based targeting strategy to ensure FDA-
regulated products are safe when entering the United States.
While the outbreak is impacting our ability to conduct inspections
in China, it's important to underscore that the FDA's regular risk-
based process of surveillance testing of imported products, including
those from China, continues.
Inspections are one of many tools that the Agency uses to inform
its risk strategy for imported FDA-regulated products and to help
prevent products that do not meet the FDA's standards from entering the
U.S. market. Other tools include: import alerts, increased import
sampling, and screening. Inspections are also part of, among other
things, the new and generic drug approval process. While such pre-
approval inspections are on hold in China, we are working to mitigate
the impact on new and generic drug approval decisions by requesting
records that may be used in lieu of an inspection, depending on the
circumstances. Based on our evaluation of previous FDA inspection
history, a firm's previous compliance history and information from
foreign health authorities with which we have mutual recognition
agreements, we determine if the totality of the information would
suffice in lieu of such a pre-approval inspection.
All products offered for entry into the United States, including
items for personal use, are subject to the regulatory requirements of
CBP. Imported shipments of FDA-regulated products referred by CBP,
including those from China, are then reviewed by the FDA and must
comply with the same standards as domestic products. At this time, we
want to reassure the public that there is no evidence to support
transmission of COVID-19 associated with imported goods, including food
and drugs for people or pets, and there have not been any cases of
COVID-19 in the U.S. associated with imported goods.
We established a cross-agency task force to closely monitor for
fraudulent FDA-regulated products and false product claims related to
COVID-19 and we have already reached out to major retailers to ask for
their help in monitoring their online marketplaces for fraudulent
products with coronavirus and other pathogen claims.
FDA is utilizing all our existing authorities to address COVID-19
and we welcome the opportunity to work with Congress to strengthen our
response capabilities. There are four specific proposals included in
the President's Budget that would better equip the Agency to prevent or
mitigate medical product shortages.
(1) Lengthen Expiration Dates to Mitigate Critical Drug Shortages
Shortages of critical drugs can be exacerbated when drugs must be
discarded because they exceed a labeled shelf-life due to
unnecessarily short expiration dates. By expanding FDA's
authority to require, when likely to help prevent or mitigate a
shortage, that an applicant evaluate, submit studies to FDA,
and label a product with the longest possible expiration date
that FDA agrees is scientifically justified, there could be
more supply available to alleviate the drug shortage or the
severity of a shortage.
(2) Improving Critical Infrastructure by Requiring Risk Management
Plans
Enabling FDA to require application holders of certain drugs to
conduct periodic risk assessments to identify the
vulnerabilities in their manufacturing supply chain (inclusive
of contract manufacturing facilities) and develop plans to
mitigate the risks associated with the identified
vulnerabilities would enable the Agency to strengthen the
supply chain by integrating contingencies for emergency
situations. Currently, many applicants lack plans to assess and
address vulnerabilities in their manufacturing supply chain,
putting them, and American patients, at risk for drug supply
disruptions following disasters (e.g., hurricanes) or in other
circumstances.
(3) Improving Critical Infrastructure Through Improved Data Sharing:
Requiring More Accurate Supply Chain Information
Empowering FDA to require information to assess critical
infrastructure, as well as manufacturing quality and capacity,
would facilitate more accurate and timely supply chain
monitoring and improve our ability to recognize shortage
signals.
(4) Device Shortages
FDA does not have the same authorities for medical device
shortages as it does for drugs and biological products. For
instance, medical device manufacturers are not required to
notify FDA when they become aware of a circumstance that could
lead to a device shortage or meaningful disruption in the
supply of that device in the United States, nor are they
required to respond to inquiries from FDA about the
availability of devices. Enabling FDA to have timely and
accurate information about likely or confirmed national
shortages of essential devices would allow the Agency to take
steps to promote the continued availability of devices of
public health importance. Among other things, FDA proposes to
require that firms notify the agency of an anticipated
meaningful interruption in the supply of an essential device;
require all manufacturers of devices determined to be essential
to periodically provide FDA with information about the
manufacturing capacity of the essential device(s) they
manufacture; and authorize the temporary importation of certain
devices where the benefits of the device in mitigating a
shortage outweigh the risks presented by the device that could
otherwise result in denial of importation of the device into
the United States.
______
Response to Written Questions Submitted by Hon. Marsha Blackburn to
Dr. Stephen Redd
Question 1. Why were two passengers, who tested positive for COVID-
19, flown back to the United States on the same plane as passengers who
tested negative? Given our prior experience with a similar situation
during the SARS outbreak in 2003, shouldn't we have been prepared for
this?
Did the Department of State override the CDC's decision to not let
those passengers come back to the U.S. If yes, who made this decision?
Answer. As a preliminary matter, the U.S. Government's operations
overseas related to this coronavirus outbreak represent the culmination
of years of collaborative work between the Departments of State (DOS),
Health and Human Services (HHS), Defense, Homeland Security (DHS),
Transportation, and others. During complex operations, such as the
evacuation of U.S. citizens out of Wuhan, China or from the Diamond
Princess cruise ship, there will be situations that merit interagency
discussion and rapid decisionmaking. In the case of the Diamond
Princess evacuation, HHS had staff on the ground in Yokohama, in
Washington state, and staff to receive evacuees in California, Texas,
and Nebraska HHS worked closely with the Department of State in
bringing those U.S. citizens home.
As a general practice, HHS provides DOS public health guidance from
the Centers for Disease Control and Prevention (CDC) and preparedness
policy and operational support through the Assistant Secretary for
Preparedness and Response (ASPR). Regarding the Diamond Princess cruise
ship, CDC supported the DOS-led mission to repatriate U.S. citizens
returning to the United States from Japan who were aboard the Diamond
Princess cruise ship. Due to the dynamic nature of the ongoing
outbreak, the U.S. Government recommended that U.S. citizens disembark
and return to the United States. As DOS and HHS describe in their joint
media statement from February 17, 2020 (https://www.state.gov/joint-
statement-by-u-s-department-of-state-and-u-s-department-of-health-and-
human-services-on-repatriation-of-american-passengers-from-the-diamond-
princess-cruise-ship/), during the evacuation process, after passengers
had disembarked the ship and initiated transport to the airport, U.S.
officials received notice that 14 passengers, who had been tested 2-3
days earlier, had tested positive for COVID-19. After consultation with
HHS officials, including experts from HHS ASPR, and the State
Department made the decision to allow the 14 individuals, who were in
isolation, separated from other passengers, and continued to be
asymptomatic, to remain on the aircraft to complete the evacuation
process.
On February 16, 2020, 329 American citizens returned to the United
States by flights chartered by DOS. The planes were met by a team of
U.S. Government personnel deployed at the bases to assess the health of
the passengers. The passengers were screened before leaving the Diamond
Princess and were monitored and evaluated by medical and public health
personnel during the trip, after arrival, and throughout the 14-day
quarantine period. All of these individuals completed their quarantine.
The President's Coronavirus Task Force is positioned to arbitrate
disagreements on matters of interagency response policy and allow for
healthy resolution where Department-level Principals hold differing
opinions. The Task Force brings each Department's authorities and
expertise to bear on current problems of unprecedented complexity. Such
an arbitration and decision has thus far not been required, as each
Department works with their partners to find the best way forward.
Question 2. Are there plans in place if a passenger or crewmember,
becomes symptomatic while on board the aircraft? Have DOT and the
airlines worked with public health officials to determine whether these
precautions create an appropriate level of separation to main safety
until the aircraft lands?
Answer. CDC has recommended actions should a passenger or
crewmember become ill during their international arrival flight to the
United States. In the case of COVID-19, this includes individuals who
exhibit symptoms like fever, difficulty breathing, and persistent
cough. Once a symptomatic individual has been identified, CDC
recommends several infection control measures which include, among
others:
Minimizing contact between passengers and cabin crew and the
sick person. If possible, separate the sick person from others
(ideally by a distance of 2 meters or 6 feet) and designate one
crew member to serve the sick person and keep interactions as
brief as possible
Offering a facemask, if available and if the sick person can
tolerate it. If a facemask is not available or cannot be
tolerated, ask the sick person to cover their mouth and nose
with tissues when coughing or sneezing.
Encouraging sick travelers to wash their hands or use
alcohol-based hand sanitizer, if available.
In addition, the Federal Aviation Administration (FAA) published a
Safety Alert For Operators (SAFO) 20009, dated 4/17/20, which has since
been updated as of
5/11/2020, which pointed to CDC guidance. Further, this aligns with
International Civil Aviation Organization (ICAO) recommendations and
Collaborative Arrangement for the Prevention and Management of Public
Health Events in Civil Aviation (CAPSCA).
ICAO, based on research from CAPSCA, published an Electronic
Bulletin, EB 2020/30, ``Implementing a Public Health Corridor to
Protect Flight Crew During the COVID-19 Pandemic (Cargo Operations),''
to introduce the concept of ``public health corridor.'' This concept
uses a risk-based approach, taking into account safety management
principles, with the key elements being the use of ``clean'' \1\ crew,
aircraft, airport facilities and transporting ``clean'' passengers.
---------------------------------------------------------------------------
\1\ ``Clean'' in this context refers to implementing measures to
ensure as far as possible a ``COVID-19 free'' status within the
aviation transport sector, per EB 2020/30 dated May 11, 2020. (https://
www.capsca.org/Documentation/CoronaVirus/eb030e.pdf)
---------------------------------------------------------------------------
Please see the following resources for more detail:
Guidance for Airlines on Reporting Onboard Deaths or
Illnesses to CDC: https://www.cdc.gov/quarantine/air/reporting-
deaths-illness/guidance-reporting-onboard-deaths-illnesses.html
Updated Interim Guidance for Airlines and Airline Crew:
Coronavirus Disease 2019 (COVID-19): https://www.cdc.gov/
quarantine/air/managing-sick-trave
lers/ncov-airlines.html
Preventing Spread of Disease on Commercial Aircraft:
Guidance for Cabin Crew: https://www.cdc.gov/quarantine/air/
managing-sick-travelers/commercial-aircraft/infection-control-
cabin-crew.html
CDC continues to work closely with the Department of Transportation
and airlines to assess the existing precautions to help keep travelers
safe. In addition, the DOT/FAA is in constant communication with ICAO
and civil aviation authorities worldwide to accept relief to ensure
transparency and consistency around the world.
Question 3. Regarding the passenger who flew out of John F. Kennedy
International Airport to Rochester, NY, over the weekend had
coronavirus and was contagious. How was this individual allowed to fly?
Was this passenger's temperature checked before departure and after
landing?
Answer. CDC only screens international travelers arriving from
countries with restricted or limited entry. This screening includes
temperature checks, questions, and a visual observation for signs and
symptoms.
Question 3a. How many health screenings are sufficient to asses a
person's well-being to fly?
Answer. CDC's guidance has always been that individuals who are ill
should not fly and not put their fellow travelers and receiving
communities at risk. If CDC is notified of an ill traveler as part of
the reporting requirements under 42 CFR 70.11 and 71.21, then CDC works
with state and local health departments to implement a public health
response.
Question 3b. What cleaning techniques are absolutely necessary to
ensure future passengers of that specific jet won't contract the virus?
Answer. CDC has published guidance for disinfecting an aircraft if
an ill passenger has been identified as follows (https://www.cdc.gov/
quarantine/air/managing-sick-travelers/ncov-airlines.html):
Clean porous (soft) surfaces (e.g., cloth seats, cloth seat
belts) at the seat of the symptomatic passenger(s) and within 6
feet (2 meters) of the symptomatic passenger(s) in all
directions.
Clean porous (soft) surfaces (e.g., seat covers and carpet)
by removing visible contamination if present and using
appropriate cleaners that are compatible with aircraft surfaces
and components in accordance with the manufacturer's
instructions. For items that can be laundered, use the warm
setting and dry items completely on high heat.
Clean non-porous (hard) surfaces (e.g., leather or vinyl
seats) at the seat of the symptomatic passenger(s) and within 6
feet (2 meters) of the symptomatic passenger(s) in all
directions, including: armrests, plastic and metal parts of the
seats and seatbacks, tray tables, seat belt latches, light and
air controls, cabin crew call button, overhead compartment
handles, adjacent walls, bulkheads, windows and window shades,
and individual video monitors.
Clean non-porous (hard) surfaces with disinfectant products
with EPA-approved emerging viral pathogens claims that are
expected to be effective against the virus that causes COVID-19
(SARS-CoV-2) and ensure these products are compatible with
aircraft surfaces and components. All products should be used
according to label instructions (e.g., concentration,
application method and contact time, PPE).
Clean lavatories used by the symptomatic passenger(s),
including: door handle, locking device, toilet seat, faucet,
washbasin, adjacent walls, and counter.
Properly dispose of any items that cannot be cleaned (e.g.,
pillows, passenger safety placards, and other similar items).
Question 4. Earlier this week, a TSA officer at Orlando
International Airport tested positive for COVID-19. TSA officials said
they coordinated with the Greater Orlando Aviation Authority and
performed enhanced cleaning where the individual worked. Officials told
other TSA officers who were in close contact with the impacted officer
to stay home and self-observe for the next 14 days.
Is the Department working closely with the Orlando Airport on this
critical finding? Have you notified passengers who have also come in
close contact with the employee?
Answer. CDC's Quarantine Stations were not engaged in the case of a
TSA Officer at Orlando International Airport who tested positive for
COVID-19. CDC defers to other Federal agencies' internal occupational
health protocols for their employees but shares guidance and CDC's
internal practices when requested.
______
Response to Written Questions Submitted by Hon. Amy Klobuchar to
Dr. Stephen Redd
Coronavirus (COVID-19) has now infected people in states across the
country including Minnesota. On Thursday, I voted to secure $7.8
billion in emergency funding to help states, local governments, and
tribes prepare to confront the virus and to aid in the rapid
development of a vaccine, and this critical legislation was signed into
law on Friday.
Question 1. Can you describe the CDC's process for the development
and distribution of clinical care guidance for health care
professionals, as well as state and local health departments?
Answer. CDC's evidence-based guidance to address coronavirus
disease 2019 (COVID-19) is designed to protect patients and healthcare
personnel, encourage safe practices, improve health outcomes, and save
lives (searchable guidance website here: https://www.cdc.gov/
coronavirus/2019-ncov/index.html). Guidelines are based on systematic
evidence reviews that balance considerations of:
Efficacy and real-world usefulness,
Feedback and input from public health partners to refine and
improve guidance, and
The urgency of information needed by healthcare
professionals and health departments across the country.
Working with state and local health departments, CDC has also
provided interim guidance for healthcare professionals on steps to
prevent the spread of SARS-CoV-2, the virus that causes COVID-19,
infections in healthcare facilities and improve patient outcomes,
including steps to improve infection control, provide testing and
treatment for COVID-19, and protect patients and workers (available
here: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html). CDC is
adjusting its response and guidance as conditions change and as more is
learned about this emerging infectious disease.
CDC works with key partners in the clinical and public health
sectors to quickly, directly, and widely disseminate guidance to
improve health outcomes for workers in these fields. This includes, but
is not limited to, the engagements below:
Weekly calls with state health departments, the Council for
State and Territory Epidemiologists, National Association of
Community Healthcare Workers, National Association of City and
County Health Officials, and the Association of Public Health
Laboratories to provide both updates on new guidance and
surveillance analysis, as well as an opportunity for these
partners to ask questions of CDC experts and leadership.
Weekly/Biweekly calls with the American Academy of
Pediatrics, American Nurses Association, American Medical
Association, American College of Emergency Physicians, and the
Society for Healthcare Epidemiology of America to both provide
updates on CDC's guidance regarding the clinical care and case
management of persons with COVID-19 and venue to answer
questions directly from key front line healthcare workers.
Clinician Outreach Communication Activity (COCA) calls, a
webinar-format outreach activity hosted by CDC, which typically
reach hundreds of care providers to dive into specific updates
to CDC's guidance for infectious disease outbreaks, which
currently focus on COVID. These meetings are recorded and saved
for reference on the CDC's website.
CDC is working with the Infectious Diseases Society of
America to build connections across health care disciplines and
to provide access to the latest information on fighting the
disease that has ended the lives of more than 120,000 Americans
and affected even more (press release available here: https://
www.idsociety.org/news--publications-new/articles/2020/idsa-
awarded-cdc-grant-for-covid-19-support-for-health-care-workers/
)
A New York Times article reported that an employee at Dartmouth-
Hitchcock Medical Center who went to the doctor with a fever and
respiratory symptoms ignored his doctor's advice to self-quarantine.
Three days later, he was tested for COVID-19 and confirmed to have the
virus. One of his close contacts has since also tested positive.
Question 2. What is the CDC doing to ensure that Americans are
informed about the virus and to prevent those who may have symptoms of
COVID-19, but have not yet been tested, from spreading it?
Answer. CDC provides critical information to the states and the
American public about community-based interventions for COVID-19
mitigation through webinars, trainings, focused calls, and online
postings. Community-based interventions can be grouped into three
categories:
Personal protective measures (e.g., voluntary home isolation
of ill persons, voluntary home quarantine of exposed household
members, respiratory and cough etiquette, using cloth face
coverings in community settings, practicing hand hygiene)
Community measures aimed at increasing social distancing
(e.g., temporary school dismissals, social distancing in
workplaces (like working remotely), postponing or cancelling
mass gatherings)
Environmental measures (e.g., routine cleaning of frequently
touched objects or surfaces)
In addition, CDC continues to release new resources on its website
to help communities adjust community mitigation strategies. Guidance
released in the past few weeks has included decision tools, suggestions
and consideration documents, and other resources for various sectors
including K-12 schools, camps, restaurants and bars, and faith-based
communities, among others. These are intended to help inform decisions
about the most appropriate actions to meet the needs of local
communities.
CDC provides technical assistance to states by disseminating new
guidance, considerations, tools, and suggestions as they are released
through outreach to key partners in relevant sectors (e.g., health and
education agencies, national professional organizations) as well as
through web content.
In addition to direct dissemination efforts, CDC has made a set of
communication resources available on its website (https://www.cdc.gov/
coronavirus/2019-ncov/communication/index.html) and has provided an
easily accessible repository of guidelines, tools, and resources from
CDC and others for states, tribes, localities, and territories (https:/
/www.cdc.gov/coronavirus/2019-ncov/php/index.html). CDC also routinely
provide technical assistance on COVID-19-related considerations through
e-mails and calls with health departments, education agencies, and the
general public.
Question 3. Can you speak to the challenges that the CDC and state
and local health departments are facing in attempting to contain the
virus?
Answer. The Coronavirus Disease 2019 (COVID-19) pandemic is the
most significant public health challenge to face our Nation in more
than a century. This is a rapidly evolving pandemic in which approaches
must change to keep pace with the needs of the state, territorial, and
tribal jurisdictions. Some key challenges CDC, alongside our state,
tribal, local, and territorial partners, has worked to address include,
but are not limited to:
Data Modernization: At the heart of any public health response is
the critical need for accurate information and data. This crisis has
highlighted the ongoing challenges presented by the Nation's fragmented
and outdated public health data infrastructure--a condition that
predates the pandemic--but it has also helped illuminate the way
forward. Congress has provided critical investments in CDC's data
modernization initiative, including $50 million in CDC's Fiscal Year
2020 appropriation and $500 million in the CARES Act. These investments
will help CDC enhance the capabilities of state and local health
departments so they can marshal fast, targeted responses to disease
outbreaks; enhance syndromic surveillance to serve as a national early
warning system of emerging health threats; and build out Laboratory
Data Exchange to enhance rapid and accurate transmission of critical
laboratory information, among other improvements.
Health Disparities: This pandemic has also highlighted the
persistent disparities in our Nation and the challenges we face to
overcome them. Existing health disparities, housing patterns, work
circumstances, and other factors might make members of many demographic
groups especially vulnerable in public health emergencies such as
outbreaks of COVID-19. CDC recognizes that responding to the needs of
all communities is a priority in this response, and we strive to
continuously identify needs and improve our outreach. Please see this
information on our website, www.cdc.gov/coronavirus/2019-ncov/need-
extra-precautions/racial-ethnic-minorities.html. To accelerate progress
toward reducing COVID-19 health disparities and achieve health equity,
CDC established in the COVID-19 Incident Management Structure, a Chief
Health Equity Officer whose focus is to ensure an all-of-response
approach to identifying and addressing health disparities. To address
these disparities, CDC crafted a strategy to ensure that key data are
available and that high impact programs and initiatives--that are
culturally and linguistically responsive and tailored to address the
unique circumstances of groups at increased risk for COVID-19, are
implemented. The health equity strategy prioritizes:
Expanding the evidence base to increase our understanding of
the impact and factors that lead to the disproportionate burden
of COVID-19 in communities at highest risk.
Expanding testing, contact tracing, isolation options, and
preventive care and disease management in populations at
increased risk for COVID-19.
Expanding programs and practice activities to support
essential and frontline workers to prevent the spread of COVID-
19.
Increasing cultural responsiveness and application of health
equity principles among an increasingly diverse COVID-19
responder workforce.
Frontline Public Health Capacity: Additionally, enhancing frontline
public health capacity in state, local, tribal, and territorial (STLT)
health departments to intensify the coordinated response to COVID-19 is
critical to containing and mitigating the virus. Staffing challenges
have been at the forefront of STLT health departments. These challenges
include finding qualified staff (e.g., laboratorians) and STLT specific
hiring constraints such as overall economic shortfalls and furloughs,
competing demands, and fiscal/administrative hurdles to rapid hiring.
Specific to workforce challenges, CDC is using a multi-pronged approach
to identify and support innovative hiring mechanisms designed to
address the surge staffing needs of health departments. This CDC
initiative will help provide STLT health departments access to a
variety of staffing mechanisms to complement local efforts to increase
capacity, such as:
Realigning existing CDC field staff embedded in health
departments.
Providing flexibilities to applicants and recipients of
Federal financial assistance affected by COVID-19 to redirect
funds for temporary reassignment of personnel.
Deploying CDC teams to address outbreaks in special
settings.
Partnering with CDC Foundation and other organizations to
place surge staff for STLT health departments across the
Nation.
Partnering with other Federal agencies (e.g., AmeriCorps) to
offer staffing options with states.
Facilitating access to a variety of contact tracing and case
investigation training products and tools for a diverse and
evolving public health workforce.
CDC is also providing programmatic guidance, technical assistance,
and resources related to hiring and training new and existing staff.
CDC has developed a range of guidance documents and is facilitating
access to a variety of training products and tools for a diverse and
evolving public health workforce. These products and tools are
available through Get and Keep America Open (www.cdc.gov/coronavirus/
2019-ncov/php/index.html). Additionally, CDC COVID-19 supplemental
appropriations contribute to epidemiology, laboratory capacity
expansion, contact tracing, surveillance and analytics infrastructure
modernization; disseminating information about testing; and workforce
support necessary to mitigate COVID-19. Specifically, in the Paycheck
Protection Program and Health Care Enhancement Act, the Department of
Health & Human Services was provided $11 billion for states,
localities, and territories, tribes, tribal organizations, and urban
Indian organizations to develop, purchase, administer, process, and
analyze COVID-19 tests, conduct surveillance, trace contacts, and
support related activities. CDC utilized the existing Epidemiology and
Laboratory Capacity (ELC) grant to award $10.25 billion to 64 state,
territorial, and local jurisdictions and $750 million was allocated for
tribes, tribal organizations, and urban Indian organizations through
the Indian Health Service.
One specific staffing challenge has been around contact tracing.
Depending upon the level of SARS-CoV-2 spread, communities may choose
to scale up and train a larger case investigation and contact tracing
workforce and work collaboratively across public and private agencies
in order to stop the transmission of COVID-19. Prior to COVID-19, there
were about 2,000 fully trained contact tracers in the US. Various
studies estimate that about 100,000 fully trained contact tracers may
be needed for COVID-19 \1\. CDC's primary role regarding contact
tracing is to provide guidance and support to STLT health departments
in the development and implementation of effective contact tracing
programs. CDC published sample contact tracing training materials
online that are available for local and state public health agencies to
utilize in scaling up training efforts. Those training materials are
available online at https://www.cdc.gov/coronavirus/2019-ncov/php/
contact-tracing/index.html. The goal is for STLT jurisdictions to have
robust public health systems, which may include a fully developed
contact tracing infrastructure. In support of this goal, CDC
communicates daily with our STLT partners to share resources, guidance,
training, and technical assistance that assist in their development of
plans for expanded contact tracing.
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\1\ https://www.centerforhealthsecurity.org/our-work/pubs_archive/
pubs-pdfs/2020/200410-national-plan-to-contact-tracing.pdf
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