Examining Emergent BioSolutions' Failure to Protect Public Health Funds — Hearing Transcript (May 19, 2021)

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U.S. GOVERNMENT PUBLISHING OFFICE
WASHINGTON : 
44–686 PDF 
2021 
EXAMINING EMERGENT BIOSOLUTIONS’ 
FAILURE TO PROTECT PUBLIC HEALTH 
AND PUBLIC FUNDS 
HEARING 
BEFORE THE 
SELECT SUBCOMMITTEE ON THE CORONAVIRUS 
CRISIS 
OF THE 
COMMITTEE ON OVERSIGHT AND 
REFORM 
HOUSE OF REPRESENTATIVES 
ONE HUNDRED SEVENTEENTH CONGRESS 
FIRST SESSION 
MAY 19, 2021 
Serial No. 117–23 
Printed for the use of the Committee on Oversight and Reform 
( 
Available on: govinfo.gov, 
oversight.house.gov or 
docs.house.gov 

(II) 
COMMITTEE ON OVERSIGHT AND REFORM 
CAROLYN B. MALONEY, New York, Chairwoman 
ELEANOR HOLMES NORTON, District of 
Columbia 
STEPHEN F. LYNCH, Massachusetts 
JIM COOPER, Tennessee 
GERALD E. CONNOLLY, Virginia 
RAJA KRISHNAMOORTHI, Illinois 
JAMIE RASKIN, Maryland 
RO KHANNA, California 
KWEISI MFUME, Maryland 
ALEXANDRIA OCASIO-CORTEZ, New York 
RASHIDA TLAIB, Michigan 
KATIE PORTER, California 
CORI BUSH, Missouri 
DANNY K. DAVIS, Illinois 
DEBBIE WASSERMAN SCHULTZ, Florida 
PETER WELCH, Vermont 
HENRY C. ‘‘HANK’’ JOHNSON, JR., Georgia 
JOHN P. SARBANES, Maryland 
JACKIE SPEIER, California 
ROBIN L. KELLY, Illinois 
BRENDA L. LAWRENCE, Michigan 
MARK DESAULNIER, California 
JIMMY GOMEZ, California 
AYANNA PRESSLEY, Massachusetts 
MIKE QUIGLEY, Illinois 
JAMES COMER, Kentucky, Ranking Minority 
Member 
JIM JORDAN, Ohio 
PAUL A. GOSAR, Arizona 
VIRGINIA FOXX, North Carolina 
JODY B. HICE, Georgia 
GLENN GROTHMAN, Wisconsin 
MICHAEL CLOUD, Texas 
BOB GIBBS, Ohio 
CLAY HIGGINS, Louisiana 
RALPH NORMAN, South Carolina 
PETE SESSIONS, Texas 
FRED KELLER, Pennsylvania 
ANDY BIGGS, Arizona 
ANDREW CLYDE, Georgia 
NANCY MACE, South Carolina 
SCOTT FRANKLIN, Florida 
JAKE LATURNER, Kansas 
PAT FALLON, Texas 
YVETTE HERRELL, New Mexico 
BYRON DONALDS, Florida 
DAVID HICKTON, Select Subcommittee Staff Director 
JENNIFER GASPAR, Chief Counsel 
SENAM OKPATTAH, Clerk 
CONTACT NUMBER: 202-225-5051 
MARK MARIN, Minority Staff Director 
SELECT SUBCOMMITTEE ON THE CORONAVIRUS CRISIS 
JAMES E. CLYBURN, South Carolina, Chairman 
MAXINE WATERS, California 
CAROLYN B. MALONEY, New York 
NYDIA M. VELA´ ZQUEZ, New York 
BILL FOSTER, Illinois 
JAMIE RASKIN, Maryland 
RAJA KRISHNAMOORTHI, Illinois 
STEVE SCALISE, Louisiana, Ranking Minority 
Member 
JIM JORDAN, Ohio 
MARK E. GREEN, Tennessee 
NICOLE MALLIOTAKIS, New York 
MARIANNETTE MILLER-MEEKS, Iowa 

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Hearing held on May 19, 2021 ...............................................................................
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WITNESSES 
Mr. Robert G. Kramer, President and Chief Executive Officer, Emergent 
BioSolutions, Inc. 
Oral Statement ........................................................................................................
7 
Mr. Faud El-Hibri, Executive Chairman of the Board of Directors, Emergent 
BioSolutions, Inc. 
Oral Statement ........................................................................................................
9 
Written opening statements and the written statements of the witnesses are 
available on the U.S. House of Representatives Document Repository at: 
docs.house.gov. 
INDEX OF DOCUMENTS 
Documents entered into the record during this hearing are listed below. 
* Article regarding the President’s ban on intellectual property in China; 
submitted by Rep. Scalise. 
Documents are available at: docs.house.gov. 


(1) 
EXAMINING EMERGENT BIOSOLUTIONS’ 
FAILURE TO PROTECT PUBLIC HEALTH 
AND PUBLIC FUNDS 
Wednesday, May 19, 2021 
HOUSE OF REPRESENTATIVES 
COMMITTEE ON OVERSIGHT AND REFORM 
SELECT SUBCOMMITTEE ON THE CORONAVIRUS CRISIS 
Washington, D.C. 
The subcommittee met, pursuant to notice, at 10:40 a.m., 2154 
Rayburn House Office Building, Hon. James E. Clyburn (chairman 
of the subcommittee) presiding. 
Present: Representatives Clyburn, Waters, Maloney, Vela´zquez , 
Foster, 
Raskin, 
Krishnamoorthi, 
Scalise, 
Jordan, 
Green, 
Malliotakis, and Miller-Meeks. 
Chairman CLYBURN. Good morning. 
The committee will come to order. 
Without objection, the chair is authorized to declare a recess of 
the committee at any time. I now recognize myself for an opening 
statement. 
I want to begin by thanking our members and today’s witnesses 
for joining us today. The coronavirus pandemic has brought out the 
best in many of our citizens. We have been inspired by the doctors, 
nurses, and other frontline workers who have put their own lives 
on the line to help others, and by the scientists who created 
coronavirus vaccines in record time. 
At the same time, others have sought to profit from the pan-
demic, put lives at risk, and violate the public trust. That is why 
we are here today. Last year, the Trump administration awarded 
Emergent BioSolutions nearly $650 million in taxpayer funds to 
manufacture coronavirus vaccines that were then being developed 
by companies like Johnson & Johnson and AstraZeneca. But nearly 
a year later, Emergent has destroyed millions of vaccines due to 
contamination, and millions more are being held back for testing, 
to ensure that they can be used, all due to Emergent’s failure to 
properly maintain its facilities, adequately train its staff, and en-
sure that proper protocols were followed. 
I want to be clear. This hearing is not about questioning the safe-
ty or efficacy of vaccines that have been authorized for use. The 
vaccines available to the public are safe and effective, and I encour-
age everyone who has not been vaccinated to do so as soon as you 
can. Emergent’s failures are disappointing precisely because these 
vaccines are so effective. Because the company was unable to de-

2 
liver, the vaccinations to millions of people around the world have 
been delayed, putting their lives at needless risk. 
This morning the Select Subcommittee released its staff memo-
randum detailing several concerning findings from our investiga-
tion into Emergent. The documents released today shed light on 
the multiple warnings Emergent received last year regarding seri-
ous manufacturing problems at its plant, including a new report re-
garding a June 2020 inspection, which found that Emergent had an 
inadequate contamination control strategy at its vaccine production 
facility. The documents also revealed that after failing to heed 
these warnings and contaminating millions of doses of critically 
needed vaccines, Emergent determined that its executives’ perform-
ance merited millions of dollars in bonuses. 
These documents provide insight into the dysfunction at Emer-
gent that caused so many life-saving vaccines to be ruined, but also 
leave us with many questions. We have questions about how these 
vaccines came to be ruined, not just this past February, when 
Emergent destroyed up to 15 million doses of the Johnson & John-
son vaccine, but in at least three other incidents last year. 
We have questions about why Emergent failed to take action to 
fix the manufacturing problems plaguing its plant, even after the 
company was warned that its poor practices led to a very real risk 
of contamination. 
We have questions about why the Trump administration invested 
so much in Emergent in May 2020, particularly when an FDA in-
spection conducted just a month earlier raised serious red flags. 
Former President Trump’s own Assistant Secretary for Prepared-
ness and Response, has admitted that he knew that the decision 
to entrust hundreds of millions of dollars with Emergent was a 
risk. Yet he did so anyway. Documents released today raise new 
questions about what exactly Emergent was being paid to do. 
We have questions about whether Emergent was favored for 
these lucrative Federal contracts because of its close relationship 
with the Trump administration appointee who was responsible for 
them. 
We have questions about how the company’s actions, for several 
years leading up to the pandemic, squeezed budgets and deprived 
our country of critical supplies, inhibiting our ability to respond 
when the virus reached American shores. 
We have questions about the Emergent executives, whether they 
earned the millions of dollars in bonuses they were awarded while 
all of this was happening. 
I look forward to hearing from today’s witnesses so that the 
American people can start to get answers. But today’s hearing is 
only the beginning. The Select Subcommittee, along with the Com-
mittee on Oversight and Reform, has opened an investigation into 
Emergent and its troubling practices. I would like to thank Chair-
woman Maloney for joining me in this important endeavor. 
I now recognize her for a two-minute statement. 
Ms. MALONEY. Thank you, Chairman Clyburn. Thank you for 
calling this important hearing and for partnering with me on this 
joint investigation being conducted by the Oversight Committee 
and Select Subcommittee on Emergent BioSolutions. 

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As we work to end the coronavirus pandemic, it is essential that 
we vaccinate as many people as possible in this country while sup-
porting a global vaccination effort. To do so, we need our con-
tracting partners in the private sector to fulfill their commitments. 
I have concerns, serious concerns that Emergent executives, in-
stead of fulfilling their commitments to the American people, ap-
pear to have wasted taxpayer dollars while lining their own pock-
ets. 
In April 2020, the FDA raised concerns about Emergent’s 
Bayside facility in Baltimore, including problems with quality con-
trol standards, inadequate training, and risk of contamination. Just 
one month later, disregarding all the red flags, Emergent received 
a $628 million contract to produce coronavirus vaccines. That 
means Emergent made a commitment to the government and the 
American people that it could safely manufacture these vaccines, 
despite the recent problems and concerns of the FDA. 
Unfortunately, the company has failed to live up to that commit-
ment. Poor lab practices at Emergent have led to millions of corona 
vaccines being thrown out because of contamination or suspected 
contamination. In other words, the company took taxpayers’ money, 
at least $271 million so far that they have spent, but failed to de-
liver the crucial, life-saving coronavirus vaccines that the country 
needs. 
But at the same time that the company was destroying millions 
of vaccine doses, at the direction of the FDA, its executives were 
cashing out. Last year, CEO Bob Kramer received $5.7 million in 
total compensation, an increase of 51 percent from 2019. He has 
yet to have given this country one vaccine, yet they have taken 
$5.7 million, as payment over 275 in contracts, and Executive 
Chairman Fuad El-Hibri cashed out in stock worth more than $42 
million. So, as they are destroying the vaccines they are cashing 
out, taking stock out of the company. These stock trades raised se-
rious questions about why top executives were selling shares when 
they knew about serious problems at Emergent’s Baltimore plant, 
but the public didn’t know about it, and I repeat, they hadn’t pro-
duced one single vaccine. 
I am glad that Mr. Kramer and Mr. El-Hibri have agreed to ap-
pear today. Thank you very much. I would also like to point out 
that although some of the documents we requested have been pro-
duced, many, many more are outstanding. It is imperative that Mr. 
Kramer and Mr. El-Hibri commit to producing all responsive docu-
ments in a timely manner. I also expect, and I am sure my col-
leagues join me in this request, that both witnesses commit to re-
turn to testify once again that document production is complete 
and our committees have completed our investigation. It is very dif-
ficult to conduct oversight when the documents we request have 
not been received. So again, respectfully I request, for the com-
mittee, for the government, for the taxpayers, that the documents 
we requested are produced. At least produce the documents. 
I thank you very much for being here, I thank the chairman, I 
thank my colleagues. I yield back. 
Chairman CLYBURN. Thank you. I now recognized the distin-
guished ranking member, Mr. Scalise, for his opening remarks, and 

4 
to recognize an additional member of the minority, for a two- 
minute statement. Mr. Scalise. 
Mr. SCALISE. Thank you, Mr. Chairman, and I want to thank you 
for holding today’s hearing. Each of us had felt the renewed free-
dom, and we enjoy seeing the smiles of our friends and neighbors 
again this past week as mask mandates have been dropped. Masks 
are flying off the faces of Americans faster than liberals in Wash-
ington spend a trillion dollars. That is a great thing to see. 
Those of us on the Select Subcommittee on the Coronavirus Cri-
sis have a duty and a responsibility to help educate our colleagues, 
our constituents, the media, and leaders in education and business 
about how we got here. We have had a spirited debate about the 
effectiveness of lockdowns. Let’s set that aside for today, and God 
willing, leave that debate in the rear-view mirror, where history 
will ultimately pass their judgment. 
But every one of us on this subcommittee should look our col-
leagues in the eye and say that there is bipartisan agreement on 
this subcommittee that it was the vaccine that ended this pan-
demic. So,how did we get to this point where America created the 
fastest vaccine in human history and produced, manufactured, and 
distributed enough vaccine to give a shot to every American who 
wants one? 
The story begins over 30 years ago, when the U.S. Trade Rep-
resentative began negotiating international trade agreements in 
earnest. On a bipartisan basis for three decades, USTR made pro-
tections of U.S. intellectual property a cornerstone of those agree-
ments. Trade agreements have proved controversial from time to 
time, but what has never been controversial was that if American 
ingenuity could flourish and is protected, that America can compete 
and win. And over that period, American pharmaceutical compa-
nies led the world in both research and development and the intro-
duction of new, life-saving drugs. 
About 25 years ago, after Republicans took back the majority for 
the first time since 1955, Congress decided to make a major push 
on biomedical research. The Republican Congress worked with then 
President Bill Clinton to double the size of the National Institutes 
of Health. During the administration of George W. Bush, the Re-
publican Congress made yet another major investment in NIH, 
with strong bipartisan support. 
During the Bush Administration, the Federal Government began 
to take seriously the threat of bioterrorism and pandemic response. 
The Executive branch began working with Emergent on producing 
anthrax and smallpox vaccines. It takes time and expertise and 
partnerships to have the infrastructure in place to respond effec-
tively. When H1N1 hit during the Obama-Biden administration, 
America was not ready. White House Chief of Staff Ron Klein actu-
ally acknowledged as much, saying that we just got lucky. Well, 
hoping to get lucky is not a smart strategy. 
But we did keep at it. We invested in BARDA. The Executive 
branch’s relationship with Emergent continued throughout the 
Obama years, and they continued to develop expertise and infra-
structure on some highly sophisticated manufacturing techniques 
and technologies. President Bush launched PEPFAR, a public-pri-
vate partnership to save Africa from the AIDS epidemic. A key pil-

5 
lar in that was working with U.S. pharmaceutical companies on de-
veloping key drugs and protecting their intellectual property. 
And then came Fred Upton and Diana DeGette, and their bipar-
tisan leadership on the 21st Century Cures Act. That was one of 
my proudest efforts during my tenure as majority whip, to see that 
bill signed into law. We doubled NIH yet again, and just as impor-
tantly, we established the Emergency Use Authorization process, 
upon which this vaccine would be approved, a provision that, by 
the way, is saving millions of lives. 
In January 2020, China lied to the world, and the lies of the 
Communist Party of China caused COVID–19 to spread throughout 
the globe, igniting the worst pandemic we have seen in 100 years. 
What we can say now, as far as finding a vaccine and a way out 
of the pandemic, is that America led the world. President Trump’s 
Operation Warp Speed built on 30 years of smart policy. It was fo-
cused on protecting IP, investing in biomedical research, and in-
vesting in public-private partnerships on critical manufacturing in-
frastructure. 
President Trump’s leadership on Operation Warp Speed was crit-
ical. Importantly, OWS leveraged work going back over two admin-
istrations, Republican and Democrat, to partner with companies 
like Emergent to begin the manufacturing process before the vac-
cines were even approved. That decision proved to be a game- 
changer. It is why we could get so many shots in the arms of Amer-
icans so quickly after getting the Emergency Use Authorization. 
Mr. Chairman, President Bush—President Biden, has now put at 
risk a key pillar of this strategy, the protection of United States in-
tellectual property. You have seen President Biden talking about 
actually giving away America’s intellectual property. This is some-
thing that would be a cave into the special interests in Washington, 
some progressives who don’t believe that America should be the 
ones who own our own intellectual property. 
For years Republicans and Democrats alike were criticizing Chi-
na’s theft of American intellectual property. Today you have got the 
Biden administration talking about giving away our intellectual 
property to China, for nothing. How outrageous would that be? 
Imagine where we are because of American ingenuity, which is 
now at risk. Stripping innovators of their constitutionally protected 
patents will undermine that very innovation. It will weaken our 
international competitiveness, and only help Communist China, the 
country that spread this pandemic. It would force the American de-
velopers of COVID–19 vaccines and therapeutics to relinquish their 
intellectual property rights to these medicines. 
But it will likely take manufacturers years to build the facilities. 
If we give this intellectual property away, which we strongly urge 
the Biden administration not to do, but if that were to happen, it 
is not like tomorrow they just start making those vaccines that are 
being made in America. What is being made in America is using 
American infrastructure that was built over years, and, in fact, 
over multiple administrations, Republican and Democrat. That 
ability does not exist today in China. If we give away the tech-
nology, we lose the technology, but China would not be able to safe-
ly and effectively mass produce those drugs for years. So,make no 
mistake. This is not about helping the world get COVID vaccines 

6 
quicker. It is about undermining American ingenuity and intellec-
tual property. 
Today’s hearing underscores that critical point. The Federal Gov-
ernment has worked with Emergent over Democrat and Republican 
administrations on complicated, sensitive biomedical manufac-
turing infrastructure, and yet the majority feels they need to un-
dermine confidence in the drugs that they produce. Does anyone 
believe that handing over U.S. intellectual property to a startup, in 
a far less developed country is going to quickly yield actual safe 
and effective shots in the arm? Of course it will not. 
President Biden is destroying 30 years of successful bipartisan 
policy, and for what? His plan won’t even work. Why don’t we pro-
tect American intellectual property? Contract with U.S. manufac-
turers, and help distribute the vaccine to countries who are in 
need. It is a quicker and a smarter strategy. There would be more 
shots given and we wouldn’t have to kneecap our future pandemic 
responses to do it. Instead of putting shots in arms, the Biden ad-
ministration is putting U.S. IP in China’s hands. That is insane. 
With that, Mr. Chairman, I yield two minutes to the gentlelady 
from Iowa. 
Mrs. MILLER-MEEKS. Mr. Chair, I have a parliamentary inquiry 
first. 
Chairman CLYBURN. The gentlelady is recognized. 
Mrs. MILLER-MEEKS. Thank you. My parliamentary inquiry, Mr. 
Chairman, recent CDC guidelines state, quote, ‘‘Fully vaccinated 
people can resume activities without wearing a mask or physically 
distancing,’’ end quote. It clarifies further fully vaccinated people, 
quote, ‘‘can resume activities they did prior to the pandemic,’’ end 
quote. It says vaccinated people do not need to wear a mask inside. 
This is all regardless of the vaccination status of people around 
you. 
I wholeheartedly agree with the chairman that these vaccines 
are extraordinarily effective, but contrary to the science, the House 
Attending Physician is mandating mask-wearing for vaccinated 
members. 
Mr. Speaker, why isn’t the committee charged with upholding 
public health CDC guidelines on masks? 
Chairman CLYBURN. My understanding is that this committee is 
being governed by the recommendations of the Attending Physi-
cian. Now I don’t believe that that is a valid parliamentary inquiry, 
and I will recognize whoever is to be recognized for their two- 
minute statement. 
Mrs. MILLER-MEEKS. Thank you, Mr. Chair. 
On May 11, committee Republicans sent a letter to the CDC 
about the apparent influence of the American Federation of Teach-
ers on official government documents. We have yet to receive a re-
sponse. The AFT is not a medical group. It is not a scientific group. 
Yet it is providing verbatim edits to scientific and medical guid-
ance, at the CDC’s request. 
Chairman Clyburn and the House Democrats spent the better 
part of a year investigating alleged influence at the CDC, but re-
main silent on these egregious reports. This is influenced by polit-
ical operatives that are both unelected and unaffiliated with the 

7 
Federal Government. As one of the two medical experts on this 
committee, this is appalling. 
President Biden promised his administration would follow 
science and truth. Director Walensky said the guidance was free 
from medical meddling. A paper trail shows this to be patently 
false. Biden’s Secretary of Education said, quote, ‘‘In-person learn-
ing offers our young people the best opportunity,’’ end quote. Why 
not listen to him? 
The Democrats and the teachers’ union kept schools closed, and 
now not only has a generation of young children been robbed of a 
year of education, but mental health problems are up 31 percent, 
drug use and addiction resulting in overdose have exploded, and 
children as young as 9 have committed suicide, all traced back to 
the shuttering of schools. Now we know who is responsible, the 
teachers’ union. Union involvement in the drafting and editing of 
scientific guidance is the very definition of political meddling. It is 
unclear how many children were locked out of school because of the 
union’s selfishness, and even today, summer camps don’t have 
guidance from the CDC on reopening without masks. Do they need 
to hire the AFT? 
The lives of American children must be governed by medical 
science and not political science. 
Thank you, Mr. Chair. I yield my time. 
Chairman CLYBURN. 
[Inaudible] and Chief Executive Officer of Emergent BioSolu-
tions. He joined Emergent in 1999 as Chief Financial Officer, and 
held a variety of executive leadership roles until becoming CEO in 
2019. He is a member of Emergent’s board of directors. 
Mr. Fuad El-Hibri is the Executive Chairman of Emergent’s 
Board of Directors. He founded Emergent in 1998, and served as 
Chief Executive Officer from the company’s founding in 2012. 
Will the witnesses please raise their right hands so I may swear 
them in. Do you affirm or swear that the testimony you are about 
to give is the truth, the whole truth, and nothing but the truth, so 
help you God? 
[Witnesses are sworn.] 
Chairman CLYBURN. Thank you. Let the record show that the 
witnesses answered in the affirmative. 
Without objection, your written statements will be made part of 
the record. Mr. Kramer, you are now recognized for five minutes 
for your opening statement. 
STATEMENT OF ROBERT G. KRAMER, PRESIDENT AND CHIEF 
EXECUTIVE OFFICER, EMERGENT BIOSOLUTIONS, INC. 
Mr. KRAMER. Chairman Clyburn, Chairwoman Maloney, Ranking 
Member Scalise, and members of the subcommittee, my name is 
Bob Kramer. I am the CEO of Emergent BioSolutions. Thank you 
for the opportunity to appear today to discuss Emergent’s role in 
the COVID–19 pandemic response. 
We have worked around the clock at every level in our company 
since we were called upon to be a critical manufacturer of COVID– 
19 vaccine. I can assure you that no one is more disappointed than 
we are that we had to suspend our 24/7 manufacturing of new vac-
cine. As CEO, I take full responsibility for that. 

8 
At Emergent, we focus on public health threats that pose an ex-
traordinary danger to the Nation, such as bioterror weapons. Cur-
rently, our portfolio is comprised of vaccines and therapies for an-
thrax, smallpox, typhoid fever, cholera, and botulism. We are also 
part of the fight against the opioid crisis, with our Narcan nasal 
spray product. 
After the 2009 H1N1 pandemic, BARDA recognized that the 
United States lacked sufficient domestic capability to rapidly man-
ufacture vaccines in quantities necessary to meet the demands of 
a pandemic emergency. This prompted BARDA to fund three Cen-
ters for Innovation in Advanced Development and Manufacturing, 
or CIADM. In 2012, our Bayview operation was selected as one of 
those facilities. However, despite our own investment of more than 
$200 million, the expected pipeline of government task orders to 
utilize the facility persistently fell short of what was needed to 
reach full operating potential. As a result, by the end of 2019, 
Bayview had roughly 100 employees and was less than a year away 
from licensure. 
When the COVID–19 pandemic began, Emergent, the U.S. Gov-
ernment, and our other partners recognized that while Bayview 
was not yet fully staffed or operating at scale, the facility’s unique 
attributes could be used to support the challenge of producing mass 
amounts of vaccine. 
In April 2020, Emergent agreed to manufacture a drug substance 
for the J&J COVID–19 vaccine candidate at Bayview. In late May, 
the government issued a task order, under the CIADM contract, re-
quiring us to reserve additional Bayview capacity, which we were 
later directed to release to AstraZeneca. 
Ramping up production of two novel vaccines on a very large 
scale in the same facility is unprecedented, but the government de-
cided that given the critical need, Emergent should manufacture 
both drug substances simultaneously, and we moved with extraor-
dinary speed to scale up the new technology. We began manufac-
turing of the AZ bulk drug substance in August 2020, and did the 
same for J&J in November. 
However, in March 2021, a single batch of J&J’s COVID–19 vac-
cine candidate failed routine quality control testing. We imme-
diately initiated an investigation which determined that the bio-
reactor material used for the J&J program was in the vicinity of 
material being disposed of from the AstraZeneca suite. Detailed 
testing was also conducted on other batches in process, and the 
presence of AstraZeneca virus was not detected. 
We have implemented an array of corrective steps. Critically, we 
have removed the AstraZeneca vaccine candidate from Bayview, 
which is now dedicated only to the J&J vaccine. J&J has been on-
site with us throughout the pandemic, and they are now providing 
24/7 oversight of all production areas, change control, qualifica-
tions, and process items. 
I understand that we are here today to answer for the contami-
nation incident, and I apologize for the failure of our controls, and 
I give you my personal assurance that I will take every step that 
is needed to resume production safely. 
At the same time, I do want to take this opportunity to let you 
know that many Emergent employees, from frontline workers to 

9 
engineers and managers, have been working around the clock, put-
ting much else in their lives on hold, sometimes at considerable 
personal sacrifice amid the pandemic, as they have sought to en-
sure that we all have access to COVID–19 vaccine. They have been 
the true heroes here, and I am deeply appreciative of their dedica-
tion, their hard work, and their sacrifice. 
Thank you, and I look forward to your questions. 
Chairman CLYBURN. Thank you very much, Mr. Kramer. We will 
now turn to Mr. El-Hibri. You are now recognized, Mr. El-Hibri, for 
five minutes. 
STATEMENT OF FUAD EL-HIBRI, EXECUTIVE CHAIRMAN OF 
THE BOARD OF DIRECTORS, EMERGENT BIOSOLUTIONS, INC. 
Mr. EL-HIBRI. Chairman Clyburn, Chairwoman Maloney, and 
Ranking Member Scalise, and members of the subcommittee, my 
name is Fuad El-Hibri and I am the Executive Chairman of Emer-
gent BioSolutions. Thank you for the opportunity to appear before 
you today and answer questions regarding Emergent’s role in re-
sponding to the COVID–19 pandemic. 
Emergent started in 1998, as a small company that acquired the 
rights to a laboratory and manufacturing facility. The site’s pri-
mary function was to produce anthrax vaccine for the Department 
of Defense. The manufacturing capacity at that time was only a 
fraction of what the U.S. military required. At the time of the ac-
quisition, the facility was subject to an FDA notice of intent to re-
voke its license. 
I served as the President and Chief Executive Officer of Emer-
gent from its inception until 2012. Since that time, I have been Ex-
ecutive Chairman of the board of directors, which means I am re-
sponsible for board leadership, governance-related external out-
reach, and advising the management team on strategic decisions, 
rather than day-to-day management. 
Emergent handles some of the most challenging biological mate-
rials in its manufacturing processes, including anthrax bacteria 
and live virus strains. Since its founding, we have strived to manu-
facture at the highest quality. The board takes that responsibility 
very seriously. On behalf of the board, I would like to assure the 
subcommittee and the American people that we understand the im-
portance of responding to the COVID–19 pandemic. 
As you are aware, we recently had a cross-contamination event 
with one lot of vaccine drug substance at our Bayview facility in 
Baltimore, Maryland. Manufacturing drug substance for two viral 
products in one facility, on a massive scale, while incorporating 
new manufacturing technology into the facility is a challenge at 
any time, even more so in the midst of a public health emergency. 
Let me be clear. The cross-contamination incident is unaccept-
able, period. Mr. Kramer will testify regarding the specific actions 
that the company is taking to remedy the situation. 
At the board level, we have expanded our oversight. In the last 
six weeks, in addition to our regular meetings, the board has met 
six times to oversee management’s progress. At our last board 
meeting, the board authorized the creation of a special committee 
charged with manufacturing and quality oversight. 

10 
In addition, in consultation with the board, Mr. Kramer has re-
cently changed the reporting structure for the quality organization. 
Mr. Kramer has also changed management oversight for the 
Bayview facility. 
I want to assure the subcommittee that Emergent is committed 
to addressing all quality and manufacturing issues at the Bayview 
facility with diligence, thoroughness, and urgency, so that Johnson 
& Johnson can deliver safe and effective vaccines to the American 
people and the world. 
I would also like to address the suggestion that my personal rela-
tionship with Dr. Robert Kadlec influenced the award of govern-
ment contracts to Emergent. This is simply not true. Dr. Kadlec 
has had a distinguished career in the U.S. Government, including 
the Air Force and senior positions in Congress and the Executive 
branch, working on biodefense issues. During his time outside of 
government, he was a valued consultant to our company and oth-
ers. Emergent’s contracts with the U.S. Government have all been 
subject to standard government contracting procedures, overseen 
by independent career government contracting officers. 
To conclude, I would like to emphasize that Emergent takes very 
seriously its role as a reliable supplier of medical countermeasures, 
vaccines, and therapeutics for public health threats to the U.S. 
Government and patients. We remain very focused on addressing 
the manufacturing challenges at the Bayview facility, and the 
board’s top priority is ensuring that management takes all correc-
tive actions required to resume production. 
Thank you for the opportunity to appear today. I look forward to 
answering your questions. 
Chairman CLYBURN. Thank you very much, Mr. El-Hibri. Each 
member will now have five minutes for questions. The chair now 
recognizes himself for five minutes. 
Mr. Kramer, in March, we learned that Emergent’s Baltimore 
plant was forced to destroy millions of coronavirus vaccines over 
the last six months due to suspected contamination. Mr. Kramer, 
exactly how many doses of the Johnson & Johnson vaccine and 
AstraZeneca vaccine were destroyed due to contamination at your 
plant, and how many others have not been shipped because of on-
going safety testing? 
Mr. KRAMER. So, Chairman Clyburn, just to be clear, our work 
for J&J and for AstraZeneca is to manufacture the bulk drug sub-
stance for both of those candidates. I can’t specifically comment on 
the number of doses. What I can comment on is the incident that 
occurred in March resulted in the loss of one batch. It was a viral 
contamination. That was what our root cause investigation deter-
mined. And the equivalent number of doses associated with that 
one batch was about 15 million doses. 
Chairman CLYBURN. So, for both AstraZeneca and Johnson & 
Johnson, the total was 15 million. 
Mr. KRAMER. Chairman Clyburn, I was just speaking the John-
son & Johnson product, not the AstraZeneca product. So, I think 
it is important to understand that when we began this work back 
last year, in April and May, we were challenged, along with our 
network of partners, AstraZeneca, J&J, and the U.S. Government, 
and BARDA, to very quickly tech transfer in these two candidates, 

11 
scale them up, and be in a position to make tens of millions, if not 
hundreds of millions of vaccines. That process typically takes one 
to two years, and we were being asked to do that in a period of 
months. 
The early stages of the manufacturing, particularly of the 
AstraZeneca product, resulted in a number of lost batches, because 
the startup was occurring so very quickly and we were really work-
ing at unprecedented pace. 
Later, in 2020, once the cadence and the process was established 
and locked down and validated, we were operating in areas with 
a much greater success rate. I can’t give you an exact number of 
doses that were lost of the AstraZeneca product. I can simply com-
ment that we did lose a number of production runs early in the 
scaling up of the manufacturing process, because of the pace that 
we 
were 
responding 
to, 
along 
with 
BARDA, 
along 
with 
AstraZeneca, to be in a position to respond to the pandemic very, 
very quickly. 
Chairman CLYBURN. Well, do you think you might be able to get 
that number to us, at a later date? 
Mr. KRAMER. Yes, Mr. Chairman. I would be glad to do that. 
Chairman CLYBURN. Well, thank you very much. Now I want you 
to understand, we are not second-guessing anything here. This 
committee is really trying to find some accountability for what we 
consider to be some egregious failures. So, let me ask this. How 
many doses of each of these have been shipped abroad, and of 
those, how many are currently being held by foreign authorities for 
testing to confirm whether or not they are safe to use? 
Mr. KRAMER. So, Chairman Clyburn, we manufacture the drug 
substance for both AstraZeneca and J&J, and after our production 
is complete we ship that product to AstraZeneca and to J&J. They, 
in turn, do the—or through other contractors of theirs—do the ac-
tual final fill and finish and labeling and packaging, and placing 
of the vaccine in the final vials that you are used to seeing when 
you are immunized. So, I can’t tell you exactly the number of doses 
that are in their possession, because we ship them drug substance 
in large volumes. They, in turn, put it in the final container, and 
they determine where that product is shipped. I can only describe 
to you the number of drug substance batches that we have manu-
factured and supplied to both AstraZeneca and J&J. 
Chairman CLYBURN. So, you can get that number to me also? 
Mr. KRAMER. Yes, sir. 
Chairman CLYBURN. Thank you. I now yield to the ranking mem-
ber for five minutes. 
Mr. SCALISE. Thank you, Mr. Chairman. Mr. Kramer, I first 
want to ask about Operation Warp Speed. What is your view on 
how that worked? Did that work the way it was intended to open 
the door so that we could get multiple vaccinations moved through 
the FDA process quickly, in record time, in a safe and effective 
manner? 
Mr. KRAMER. So, Ranking Member Scalise, I think Operation 
Warp Speed had a lot of very positive attributes and principles, one 
of which clearly is this notion of strong public-private partnerships, 
and second, the idea that in order to quickly develop and scale and 
make available hundreds of millions of vaccine doses, it was really 

12 
important to do, in parallel, things like clinical development and 
manufacturing development. Typically you wouldn’t do those two 
activities at the same time, but in order to ensure that if and when 
any of those vaccine candidates would be showing clinical benefit, 
then we would have a current amount of inventory to be made 
available. 
I think it is important to note that a year ago this time we were 
facing the pandemic without any vaccine available to protect the 
public, and our government and industry partners got together and 
formed an incredibly powerful network of public-private partner-
ships in order to rapidly advance the development and the scale- 
up of multiple vaccine candidates, not knowing which, if any of 
those, would be shown to have clinical benefit yet available today. 
I think it is quite remarkable that a year later we have three vac-
cines that are Emergency Use Authorization approved by the FDA, 
with hundreds of millions of Americans being protected from those 
vaccines. 
Mr. SCALISE. Well, thank you, and clearly President Trump de-
serves credit for getting government red tape out of the way and 
just focusing on letting these great drug companies do the work 
that they do in coming up with cures. I mean, here you had a virus 
that was not even known to the world, and less than a year later 
we have got multiple vaccines that have moved their way through 
the FDA process, and clearly the FDA process is involved in how 
your facility runs. 
How many facilities like yours are there in the United States, 
Mr. Kramer? 
Mr. KRAMER. Ranking Member Scalise, in 2012, BARDA estab-
lished three different CIADM facilities, ours being one of them. 
There is also one associated with Texas A&M University and one 
in North Carolina. To my knowledge, when BARDA made the deci-
sion to kind of tap us on the shoulder and access our facility to sup-
port these two vaccine candidates, the other two may not have been 
ready to do the work that we were asked to do. 
Mr. SCALISE. So, this happened under the Obama-Biden adminis-
tration that you all started getting into this line of business? 
Mr. KRAMER. That is correct. 
Mr. SCALISE. So, the FDA process that we are talking about on 
the cross-contamination, was it you all who identified this? Was it 
the FDA? Were all the FDA processes followed, or has that been 
resolved? 
Mr. KRAMER. So, the contamination event was identified through 
our quality control procedures and checks and balances. When we 
were informed and made aware that the contamination occurred, 
as we always do we opened up an investigation to determine the 
root cause of that contamination event. That information was 
shared with the FDA as soon as the investigational report was 
completed in early April. 
Mr. SCALISE. So, you followed those FDA processes. Did any of 
the contaminated doses get out of your facility? Were any put in 
the arms of people, or was this an internal discovery that stayed 
internal? 
Mr. KRAMER. Importantly, Ranking Member Scalise, our internal 
quality control procedures identified the out of specification and the 

13 
contamination. None of that material left our control. The produc-
tion lot was quarantined, set aside, and never left our facility. 
Mr. SCALISE. And I know we are going to have a second round 
of questions. I do want to get into this, though. I understand there 
are some batches that were made that were not contaminated but 
that the FDA has not released yet. Is that the case, and if so, how 
many doses would that amount to that right now are not available 
to be distributed to Americans and maybe other people around the 
world, that the FDA hasn’t released? 
Mr. KRAMER. Yes, Mr. Scalise. There are a number, a significant 
number of doses that we manufactured. Again, we manufacture the 
bulk drug substance, and it has been reported in a number of the 
news agencies there are probably over 100 million doses of the J&J 
vaccine that we have manufactured that are now being evaluated 
by the FDA for potential release and availability to the public. 
Mr. SCALISE. I am out of time but I want to get into that if there 
is a second round, Mr. Chairman. I yield back. 
Chairman CLYBURN. Thank you very much, Mr. Scalise. I now 
yield to Ms. Waters for five minutes. 
Ms. WATERS. Thank you very much, Mr. Chairman. I am so 
pleased that you are holding this hearing, because information re-
garding Emergent is absolutely concerning. And so I want to two 
representatives who are here today to try and clear up some of this 
information. 
First of all, let me ask Mr. Kramer, or Mr. El-Hibri, how did you 
get this contract? It was a no-bid contract, and you referred to it 
as a relationship, or a joint venture between the government and 
you. How did you get the contract, and how much the government 
contribute to the contract in order for you to be ready and capable 
of delivery, and how much did you contribute? How much did 
Bayview contribute? 
Mr. KRAMER. Congresswoman Waters, are you asking about the 
2012 contract or the 2020 contract, if I could ask, please. 
Ms. WATERS. I am talking about the one where you were award-
ed $27 million per month in order to be involved with production 
of the vaccine. 
Mr. KRAMER. So, Congresswoman Waters, that was the task 
order that was awarded to Emergent by BARDA. In April or May 
2020, they selected our facility because BARDA wanted to have im-
mediate access to manufacturing capacity for COVID–19 vac-
cines—— 
Ms. WATERS. May I stop you for one minute, because I want to 
know what Mr. Robert Kadlec had to do with this contract. Now 
as I understand it, Robert Kadlec was a former consultant to Emer-
gent. Is that right? 
Mr. KRAMER. That is correct. 
Ms. WATERS. And that he had been paid some $360,000 by Emer-
gent before awarding the contract, but he had something to do with 
significant participation in your getting the contract. Is that right? 
Mr. KRAMER. Congresswoman Waters, I am not aware that Dr. 
Kadlec was directly involved in any award of a contract, this con-
tract to Emergent. 
Ms. WATERS. Why are you not aware of it? He worked as a con-
sultant to you. Then he went over to the administration where he 

14 
worked, you know, for the President, and he was involved in deci-
sions about contractors, and yours in particular. Are you telling me 
that you did not know that? 
Mr. KRAMER. Congresswoman Waters, what I am—— 
Ms. WATERS. You are under oath, sir. 
Mr. KRAMER. Yes, ma’am. I know that. What I am—— 
Ms. WATERS. Are you telling me that Robert Kadlec had nothing 
to do with the awarding of the contract to Emergent? 
Mr. KRAMER. I am not aware of his direct involvement, Congress-
woman Waters, and the contract. All of our negotiations and dis-
cussions with the government were with BARDA. BARDA is the 
agency who awarded the contract. 
Ms. WATERS. Thank you. If you are basically saying that you do 
not know, let the record reflect that. Thank you very much. 
Now, getting this $27 million per month, were you ever paid any-
where between $20 and $27 million, even though you were not pro-
ducing? 
Mr. KRAMER. Congresswoman Waters, the nature of the contract 
was to allow the government to have access to our facility, for them 
to direct activity. After awarding the contract they directed us to 
immediately begin work with AstraZeneca to tech transfer in, or to 
transfer their candidate into our facility, scale up the manufac-
turing process, and begin the work. 
Ms. WATERS. Thank you. I understand that. But were you paid 
$27 million per month despite the fact you were not manufacturing 
in some of those months? 
Mr. KRAMER. I believe we were, yes. 
Ms. WATERS. OK. Thank you very much. Now let me also ask 
you about the fact that Emergent had more than once, on several 
occasions, been told that your facility was not safe, that basically 
you had contamination problems. How many times were you 
warned, or told about your contamination problems? 
Chairman CLYBURN. I am going to ask the gentlelady to hold 
that question for the next round, because her time has expired. 
Ms. WATERS. Thank you. Thank you, Mr. Chairman. 
Chairman CLYBURN. The chair now recognizes Mr. Jordan for 
five minutes. 
Mr. JORDAN. Thank you, Mr. Chairman. I will have a question 
in the second round for Mr. Kramer, but first round here I wanted 
to focus on a fundamental question. Why don’t Democrats on this 
committee want to know how the virus started? Seventeen months, 
150 million cases worldwide, 600,000 Americans lost their lives. 
Where did this thing start? Did it jump from an animal to humans, 
or was it a leak from a lab, a lab in Wuhan, China? American peo-
ple would probably like to know. After all, they have had their lib-
erties assaulted for the past year. 
The World Health Organization did a study and issued a report, 
the same World Health Organization that Republicans on this com-
mittee asked to come in front of this committee three separate 
times and the Democrats denied us our request. Their report said 
this, quote, ‘‘It was extremely unlikely that the lab leak was the 
cause.’’ Just one problem with that finding—nobody believes them. 
President Biden’s Director of National Intelligence, Avril Haines, 
said this, ‘‘That is not our assessment.’’ Secretary of State Blinken 

15 
said, ‘‘We have got real concerns about the methodology and proc-
ess that went into the WHO report.’’ Secretary of Health and 
Human Services Becerra, a former colleague of ours, said, quote, 
‘‘We have to understand how COVID surfaced, but the Select Com-
mittee in Congress on COVID doesn’t want to know.’’ 
Journalists want to know. Josh Rogin, in a Washington Post col-
umn two weeks ago, he starts his column off by quoting our col-
league, Congressman Gallagher. ‘‘Understanding the cause of the 
pandemic and ensuring that something like it never happens again 
is the most important question we face.’’ He goes on to say this: 
‘‘The Republicans are taking the first steps in a long-overdue effort, 
but without backing from Democrats who are conspicuously absent 
from these efforts. The investigations will struggle.’’ Very true. The 
Select Committee on the Coronavirus won’t look into how 
coronavirus started. I find that fascinating. I find that amazing. 
Nicholas Wade, former New York Times science writer, said this: 
‘‘When looking at the two scenarios,’’ he says, quote, ‘‘it is a stretch 
to get the pandemic to break out naturally outside of Wuhan, and 
then without leaving a trace to make its first appearance in 
Wuhan.’’ But he says this for the lab escape scenario: ‘‘A Wuhan 
origin for the virus is a no-brainer. Wuhan is home to China’s lead-
ing center for coronavirus research. Researchers were genetically 
engineering bat coronaviruses to attack human cells. They were 
doing so under minimal safety conditions. If the virus with an 
uninspected infectiousness had been generated there, its escape 
would be no surprise.’’ Journalists want to know. 
The Secretary of State wants to know. The Secretary of Health 
and Human Services want to know. Journalists want to know. Re-
publicans want to know. Americans want know. Why don’t Demo-
crats in Congress want to know where this thing started? Is it be-
cause Speaker Pelosi called it a diversion last year, when we were 
raising these questions and asking to have these witnesses brought 
in front of us? 
Or maybe it is because—maybe it is because Dr. Fauci, the all- 
knowing Dr. Fauci, who Mr. Rogin, in his piece, said has, quote, 
‘‘repeatedly thrown cold water on the lab leak theory,’’ maybe Dr. 
Fauci would have to answer some tough questions if we actually 
dug into how this thing started. Remember, Dr. Fauci gave 
EcoHealth $3 million. EcoHealth then gave $600,000 to the Wuhan 
lab. Did Dr. Fauci know about this arrangement when he OKed the 
grant? Did Dr. Fauci know the Wuhan lab did not operate with the 
highest level of safety standards, as reported by our own State De-
partment personnel in China. 
How about the process? There is a review board at HHS for any 
grants that do, quote, ‘‘gain of function research.’’ Now two weeks 
ago, Dr. Fauci told Senator Paul that the grant to Wuhan lab was 
not, quote, ‘‘gain of function research,’’ but several respected doc-
tors disagree, say it was. How does this review board process work? 
Who sits on the board? The truth is, nobody knows. The only thing 
we know about this board is its chairman, and we only know that 
because he disclosed it in January 2020. Report here, ‘‘Chris 
Hassell, the chairman, discloses involvement, January 2020, in a 
talk before the National Science Advisory Board for Biosecurity.’’ 
He said during the talk that the current definition of what comes 

16 
in front of his board is, quote, ‘‘very narrow.’’ Quote, ‘‘I’ll just prob-
ably be more frank than may be appropriate. I think it is too nar-
row.’’ He then went on and suggested that the government could 
be funding gain-of-function research that his committee hasn’t vet-
ted. There are some important questions there for Dr. Fauci. 
How about the fundamental question, the fundamental question: 
Why are we funding research in a lab in Wuhan, China, is the first 
place? Why are we doing that? I think the American people would 
like to know, especially what they went through over the last year. 
And just as important—just as important, Mr. Chairman, why 
won’t this committee, the only committee in the U.S. Congress fo-
cused solely on the coronavirus, why won’t we look into how this 
thing started? I think the American people would like an answer 
to that question. 
I yield back. 
Chairman CLYBURN. Thank you for yielding back. The chair now 
recognizes Mrs. Maloney for five minutes. 
Mrs. MALONEY. Thank you, Mr. Chairman, and I thank our wit-
nesses too. I would like to thank them for appearing today, for pro-
ducing some of the documents that we requested. But I want to 
note that there are many outstanding documents, even though they 
were due two weeks ago. And so, I would first like to ask Mr. Kra-
mer, you have received $628 million in a contract. Will you commit 
to testifying again after we receive these documents and complete 
our investigation? Will you give us that courtesy? Yes or no. 
Mr. KRAMER. Yes, I will, Chairwoman. 
Mrs. MALONEY. Thank you. Mr. El-Hibri, will you commit to tes-
tifying again after we receive the documents? It is our duty to over-
see these documents. It is our charge. We have not received them. 
Would you commit to testifying, Mr. El-Hibri? 
Mr. EL-HIBRI. I do commit, Chairwoman. 
Mrs. MALONEY. Thank you very much. We look forward to get-
ting the documents we requested. 
I just want to go back to the questions about the inspections. 
Were you aware in June 2020 of these inspection findings from 
Johnson & Johnson that there was contamination and there was 
no plan for the deficiencies that they saw? Were you aware, in 
June 2020, of these inspection findings, Mr. Kramer? 
Mr. KRAMER. I was aware of the report, Chairwoman Malo-
ney—— 
Mrs. MALONEY. OK. Thank you. And so, you oversee the business 
operations. In the months after that inspection, what actions did 
you take to correct them? 
Mr. KRAMER. Chairwoman Maloney, our team responded as they 
do with inspections, whether they be from our clients or from regu-
latory—— 
Mrs. MALONEY. I am sure they did—reclaiming my time—but we 
still had to destroy millions of AstraZeneca’s vaccine doses because 
they were contaminated. And just last week, November 3, you en-
tered into an aggressive stock-trading plan to sell over 10 million 
of Emergent stock in January and February 2021. 
So essentially, right after your company was in the process of de-
stroying, or had destroyed, millions of vaccines that we could have 
used to save lives, but before this was made public to the people 

17 
of this country, you entered into a plan to dump over 10 million 
of your own company stock, which you knew were going to go down 
once the problem came to light. So, that makes me think you were 
more interested in enriching yourself than serving the public. If it 
was my company, I would be there trying to get it fixed so that we 
could get the results of the contract. 
So far, we have given your company $628 million. They have 
taken $271 million, and as yet we have not gotten one usable vac-
cine. Is that correct? We haven’t been able to jab one vaccine to 
save one American life. Is that correct? 
Mr. KRAMER. Chairwoman Maloney, there are a number—— 
Mrs. MALONEY. Yes or no. Yes or no. Have we gotten any vac-
cines out of your company that we could use? 
Mr. KRAMER. Chairman Maloney, those—we have tens of mil-
lions of doses—— 
Mrs. MALONEY. Excuse me. Yes or no. Have we been able to use 
the vaccine? Have we been able to save someone’s life, out of 628 
million committed dollars, of which $271 million have been spent, 
have we been able to get one vaccine? Yes or no. 
Mr. KRAMER. None of the vaccines that we have manufactured 
has been made available to the U.S. 
Mrs. MALONEY. OK. We haven’t been able to get one vaccine. 
But you have been able to sell stock. Were you aware of the prob-
lems at the facility when you went out there and sold your stock? 
At the time you made your stock sale, merchant stock prices were 
hovering around $120 a share, but the price has now fallen to 
under $60 a share. Is it true that if you had sold your stocks today 
instead of before the news of Emergent’s contamination, it would 
have been worth about $5 million rather than $10 million? But I 
will answer it. You got the $10 million. And instead of thinking of 
ways to address your company’s contamination, you were thinking 
of ways to enrich yourself. And I am deeply troubled about this. We 
lost so many lives. If we had the vaccines we would have saved 
those lives. And I am concerned how you were able to get a no-bid, 
sole-source contract to prepare a vaccine that you had no experi-
ence in doing, and, in fact, the experiences from your past contract, 
for BioCorp, for anthrax, according to government oversight, was a 
disaster. GAO said that it was not done well, that they couldn’t use 
it, that it is half of the strategic national stockpile, and scientists 
are saying it is not needed, and all these questions about the pro-
duction of bio, and now you get another one. How do you get a con-
tract when your track record was so poor on the first sole-source 
contract? 
Chairman CLYBURN. We are going to hold his answer to that 
question for the next round, Chairman Maloney. 
Mrs. MALONEY. I yield back. 
Chairman CLYBURN. The chair now recognizes Dr. Green for five 
minutes. 
Mr. GREEN. Thank you, Mr. Chairman and Ranking Member 
Scalise, and I want to thank the witnesses for being here today. As 
a physician who researched vaccines, I helped write a protocol on 
a vaccine at USAMRIID when I was there, in my Army days, I 
have followed the development of these vaccines very carefully, es-
pecially as we received real-world data from the widespread vac-

18 
cination population. The three vaccines that are being used in the 
United States are remarkably effective, preventing the infection 
and transmission of COVID–19. Over 150 million people have re-
ceived at least one vaccine dose. More 115 million are fully vac-
cinated, with more being vaccinated every day. 
The results are incredibly clear. The CDC issued guidelines. The 
CDC’s guidelines were that if you are vaccinated you don’t have to 
wear a mask inside a building. 
Dr. Monahan very quickly had a knee-jerk response to that, 
using his medical decisionmaking, and said, ‘‘Yes, you know what? 
You don’t need to wear a mask inside a committee room.’’ Within 
4 days he had reversed his opinion and said, ‘‘Wait a minute. 
Sorry. You can get into an elevator without a mask on, with as 
many people as you want, and not social distance, but you have to 
wear a mask inside a committee room.’’ I want to know, what data 
changed in those four days that his medical decisionmaking 
changed. Or was there influence from people who just want to con-
tinue to exert control. 
I will be having a conversation later with Dr. Monahan to figure 
that out. Obviously, I think that that is an issue, so we will take 
that up with Dr. Monahan. 
I would like to take an issue with at least the implications of 
some of the comments made by my colleagues across the aisle. 
Democrats hate bonuses. They hate them. They hate when innova-
tion is rewarded. They want equity of outcomes. That is the big 
push from progressives. And that is why President Biden is consid-
ering giving away these companies’ intellectual property on mes-
senger RNA technology. You can’t have these American companies 
making billions of dollars off of the technology that they have been 
working on for decades. 
But oh, by the way, it is OK if we give it to China. Let’s let them 
take it and let their pharmaceutical companies make billions of dol-
lars. Let’s let their state enterprises subsidize those companies and 
put American companies out of business. Great idea. Let’s put our 
pharmacologic biomedical research guys out of business by sharing 
the very technology that has made them distinct. Great idea. Not 
a great idea. 
Look at Motorola. They went to do business in China. They were 
forced to share their intellectual property on cell towers with the 
Chinese government. They gave that technology to Huawei. That 
company was worth about $11 billion in 1992, and in 2011, I think, 
2009, they were scrapped for $900 million because Huawei stole 
the technology, and with funding from the Chinese government put 
that American company out of business. Fifty thousand Americans 
lost their jobs. Do you want that happening in our biotech indus-
try? President Biden, do you want that in our biotech industry? 
You would share the intellectual property, the efforts of hundreds 
of American scientists. Just give that away to the Chinese Com-
munist Party. 
And oh, by the way, also very concerning, worse than all of that, 
messenger RNA has a dual-use national security implication. And 
if biology is a war-fighting domain, and the Chinese have said it 
is, giving them, handing them this technology on a silver platter 
is a threat to national security. And yet, here we are, thinking 

19 
about sharing the intellectual property of these companies, inter-
estingly enough, who have gotten assistance from the American 
taxpayer. 
This industry is a proud American innovative industry. It needs 
to be protected. Yes, we need better vaccine distribution globally to 
help people who are hurting. I am the ranking member of Western 
Hemisphere on Foreign Affairs, and we need—China is out there 
giving away its ineffective vaccine, trying to steal relationships, 
compelling Paraguay to deny its relationships with Taiwan so that 
they can get the vaccine. China trading the lives of people for, you 
know, disrespect to Taiwan, their political endeavor. And here we 
are talking about sharing our intellectual property on messenger 
RNA technology with China. Ludicrous. 
I yield. 
Chairman CLYBURN. I thank the gentleman for yielding back. 
The chair now recognizes Ms. Vela´zquez for five minutes. 
Ms. VELA´ ZQUEZ. Thank you, Mr. Chairman. Mr. El-Hibri, in 
2017, former President Trump nominated Dr. Robert Kadlec to 
serve as the Assistant Secretary for Preparedness and Response for 
the Department of Health and Human Services. Mr. El-Hibri, you 
and Dr. Kadlec had a professional relationship for many years be-
fore he was appointed to serve in the Trump administration. Is this 
correct? 
Mr. EL-HIBRI. That is correct. 
Ms. VELA´ ZQUEZ. What kind of relationship was this? Did you 
work together? 
Mr. EL-HIBRI. Yes, we did work together. We worked together 
in—— 
Ms. VELA´ ZQUEZ. OK. No, no, no. This is a yes-or-no answer. 
The Select Committee has received documents showing that 
Emergent paid Dr. Kadlec’s consulting firm an annual retainer of 
$120,000, between 2012 and 2015. Mr. Chairman, I have the exhib-
its here, 23, 22, and 24, and that shows a total of $360,000. Was 
Dr. Kadlec paid $120,000 each year? 
Mr. EL-HIBRI. I trust that your information is correct. 
Ms. VELA´ ZQUEZ. Was Kadlec paid a total of $360,000? 
Mr. EL-HIBRI. Yes. 
Ms. VELA´ ZQUEZ. Did Dr. Kadlec receive payment from Emergent 
outside of his retainer? If so, how much? 
Mr. EL-HIBRI. No, he didn’t. 
Ms. VELA´ ZQUEZ. I remind the witness that you are under oath. 
Mr. EL-HIBRI. I am not aware that he received any other com-
pensation. 
Ms. VELA´ ZQUEZ. Dr. Kadlec ended his consulting practice in 2015 
to go and work for Senator Richard Byrd. But just two years later 
he became the Assistant Secretary for Preparedness and Response, 
where he had great influence over large amounts of taxpayer dol-
lars. 
In 2017, one of Emergent’s business goals was to see that the 
Strategic National Stockpile, then worth $7 billion, was transferred 
from the Centers for Disease Control and Prevention to the Office 
of the Assistant Secretary for Preparedness and Response. 
Mr. El-Hibri, when was the Strategic National Stockpile trans-
ferred to ASPR control? 

20 
Mr. EL-HIBRI. I believe it was in 2018. 
Ms. VELA´ ZQUEZ. OK. This move also played out well for Emer-
gent. In 2019, ASPR awarded Emergent a 10-year, $2 billion con-
tract for smallpox vaccines, and a $261 million order for anthrax 
vaccines. Then, in 2020, ASPR awarded more than $680 millions 
to Emergent. 
Mr. El-Hibri, how often did you speak to your former business 
associate, Dr. Kadlec, when he served as Assistant Secretary? 
Mr. EL-HIBRI. I would say maybe four or five times during a two- 
or three-year period. 
Ms. VELA´ ZQUEZ. And how often do you speak to him when Emer-
gent received contracts for vaccines in 2019 and 2020? 
Mr. EL-HIBRI. When there is an outstanding RFP. 
Ms. VELA´ ZQUEZ. Did you speak often? 
Mr. EL-HIBRI. During an open RFP period, I do not speak with 
him. 
Ms. VELA´ ZQUEZ. How about you, Mr. Kramer? Did you or any 
other Emergent executives speak to or socialize with Dr. Kadlec 
while these contracts were being issued? 
Mr. KRAMER. Congresswoman, I did not have any conversations 
with Dr. Kadlec about this. 
Ms. VELA´ ZQUEZ. It is striking that Emergent profited so much 
after their former consultant received an influential appointment. 
With that I yield back, Mr. Chairman. 
Chairman CLYBURN. Thank you, gentlelady, for yielding back. 
The chair now recognizes, for five minutes, Ms. Malliotakis. 
Ms. MALLIOTAKIS. Thank you, Mr. Chairman and ranking mem-
ber. Everyone, including the President, is talking about bringing 
our supply chain home, particularly when it comes to the pharma-
ceuticals. Everyone is talking about manufacturing in the United 
States. It was something that he made very clear during his state 
of the Union address as well through Executive order. 
But what I don’t understand are the policies that have been com-
ing forward that don’t achieve that goal. President Biden recently 
announced that he was green-lighting sending American vaccine 
intellectual property to foreign countries. This was mentioned by 
some of my colleagues before. This is something that I don’t think 
any American can understand, and it is a plan to cave to progres-
sives, it is a plan to disseminate American innovation, a plan to 
keep the U.S. from responding to future pandemics, and a plan, by 
the way, that has been internationally condemned. A U.S. spokes-
man for the German Chancellor Merkel said, quote, ‘‘The protection 
of intellectual property is a source of innovation. It must remain 
so in the future.’’ The German chancellor is looking out more for 
the American people that our President. 
Without properly protecting American intellectual property, there 
are no future innovations. That is what I hope that my colleagues 
understand, and it is one of the top reasons why we have lost man-
ufacturing jobs to other countries, particularly the Communist 
Party of China. And it is the demonization that we are hearing 
here today of our private partners. It is entering climate agree-
ments that actually give China and India a clear advantage. There 
is no level playing field. And it is proposals like the President’s to 
increase the corporate tax rate so the highest level in the modern-

21 
ized world, that is a reason why we are having difficulty in finding 
a manufacturer to even produce this vaccine. 
So, I would like to just phrase my questions to talk about intel-
lectual property and how that is going to affect future innovation. 
Mr. Kramer, are strong IP protections vital to responding to novel 
emerging diseases? 
Mr. KRAMER. Congresswoman Malliotakis, I think it is important 
that IP protections for manufacturers and for the pharmaceutical 
companies who own these products, that they are protected. At the 
same time, I think it is important to focus on what is the ultimate 
goal. And if the ultimate goal is to make sure that the millions, if 
not billions of individuals around the globe who need access to vac-
cine, I think there are different ways to accomplish that goal. 
Ms. MALLIOTAKIS. OK. And if you would like to share some of 
those with me I would appreciate that. 
Mr. KRAMER. I would simply say, again, IP protection is impor-
tant. Pharmaceutical companies like ours and many of our part-
ners, invest millions, if not billions of dollars in constructing and 
creating that IP, and it is important to respect that. 
Ms. MALLIOTAKIS. Thank you. It is my understanding that the 
Trump administration tried different angles to get this vaccine pro-
duced. They had difficulties finding manufacturers within the 
United States who would be willing to take the risk. Can you talk 
a little bit about the type of risks that companies like yours, who 
make drugs that respond to biothreats, take on? 
Mr. KRAMER. Yes. Thank you. I think it is important to recognize 
that the ultimate goal of any manufacturer of a vaccine, whether 
it is the J&J vaccine, or Pfizer, or Moderna, our collective goal is 
to ensure that there is a consistent manufacturing supply and reli-
able process that meets all of our quality standards to make these 
critically needed vaccines available. 
In order to do that, it is very complex. You need a combination 
of qualified raw materials, a trained work force, dedicated equip-
ment, a properly controlled environment, and all around that you 
need proper quality controls and checks. That process, to get to 
that steady state, often requires years and years of work, and we 
were asked to do that in a matter of months. And I say that not 
to be a prelude to making any excuses for the work that we have 
done, but rather that when the FDA concludes that companies like 
ours have adequately met all those standards, and they put their 
approval on FDA-released material, that should give the public 
comfort and confidence that those products are safe and effective. 
The other thing I would say is once that state of readiness and 
repeatability is achieved, the last thing that you want to do is ei-
ther to change that process or to move that process or, heaven for-
bid, stop that process, because it does call into question the con-
tinuity of that, which is ultimately critically important. 
So, we all strive for getting to that state of control and quality 
operations for our vaccines. 
Chairman CLYBURN. The gentlelady’s time has expired. The chair 
now recognizes Mr. Foster for five minutes. 
Mr. FOSTER. Thank you, Mr. Chair. I would like to start by just 
making a couple of quick points. First, that the origins of SARS- 
CoV–2 will be investigated by the House Science Committee Inves-

22 
tigations and Oversight Committee, and as chair of that committee, 
I can assure you that our hearings will be a rational discussion 
among scientists, rather than a blizzard of semi-informed talking 
points designed for social media. 
Second, the idea of manufacturing vaccines in parallel with their 
test and approval did not originate with Trump’s Operation Warp 
Speed. The Gates Foundation was doing this back in February and 
March, and telling Congress to do likewise. 
Then, in April 2020, in a bipartisan letter led by then Member 
Donna Shalala and I, signed by 35 bipartisan Members of Con-
gress, we told HHS and FTC, quote, ‘‘Congress has given you clear 
direction and funding to invest in multiple routes to mass produc-
tion, for multiple, plausible vaccine candidates in advance of their 
testing and approval, with the acknowledgement that much of that 
capacity will likely go unused when the final set of vaccines is cho-
sen for mass deployment. We re-emphasized that direction from 
Congress, and ask you to inform Congress immediately if it ap-
pears that mass production capabilities, or significantly promising 
vaccine candidates are being delayed for economic reasons.’’ So, we 
gave them money and clear direction in advance of Operation Warp 
Speed’s launch. 
But that is not what we are talking about here. I would like to 
first off re-emphasize that these vaccines are safe and effective and 
critical to the health, not only of the person being vaccinated but 
to their families, friends, and the communities they live in. But 
that only works if the vaccines are properly manufactured. 
Mr. Kramer’s testimony seemed to imply that the contamination 
incident was a sort of unavoidable, one-off, random incident that 
could not have been predicted. But Emergent’s Bayview plant has 
been repeated cited by the FDA, other Federal agencies, and pri-
vate auditors in recent years for having poor manufacturing prac-
tices. 
Mr. Kramer, on a recent call with investors you admitted that, 
quote, ‘‘Cross-contamination is a well-known risk when producing 
drug substance from multiple viral products in a single plant.’’ So, 
Mr. Kramer, is it fair to say that you were aware of this risk before 
your company proceeded to ruin millions of coronavirus vaccines 
through cross-contamination? 
Mr. KRAMER. Congressman Foster, it is a well-known risk that 
if the precautions are not taken there is a likelihood of a cross-con-
tamination. We took that risk seriously, we took all appropriate 
precautions to prevent that from happening, and, unfortunately, 
one incident did result in a cross-contamination. We take that very 
seriously. We have put in place a number of corrective actions since 
that incident occurred, including strengthening our training, 
strengthening our cleaning, and removing, quite frankly, the 
AstraZeneca virus and vaccine from our facility to eliminate that 
risk from happening again. 
Mr. FOSTER. OK. I am also a little bit confused about the state-
ment that you just made under oath, that it was your internal QA 
checks that first caught the contamination. So, where exactly was 
the laboratory which first detected the contaminated batch? 
Mr. KRAMER. Congressman Foster, I think I recognized that our 
quality control systems—— 

23 
Mr. FOSTER. Answer the question. Where was the laboratory that 
caught the contamination? Was it your internal QA laboratory, you 
know, process, or was it that of your customer? 
Mr. KRAMER. The particular assay and the location of the work 
that detected the contamination was the J&J facility in Leiden. 
Mr. FOSTER. In the Netherlands. So, why did you refer to that 
as your internal QA checks that detected the contamination? 
Mr. KRAMER. Part of our robust quality controls and quality sys-
tems include a number of assays that we have done. In this par-
ticular case—— 
Mr. FOSTER. But they did not detect the contamination. Correct? 
It was detected by your customer seeing a defective batch being de-
livered. 
Mr. KRAMER. That assay that was conducted by J&J was part of 
our quality control system. So yes, it was detected by J&J, but that 
test was part of our internal quality control procedures. 
Mr. FOSTER. OK. I am highly confused about how you refer to 
your internal procedures as those of simply your customers making 
sure that you have delivered a product that conforms to specs. 
The record also shows that you should have been on very high 
alert for those sorts of risks. The Select Subcommittee released new 
documents today that add to the mounting pile of evidence showing 
that Emergent had plenty of warnings regarding inadequate condi-
tions at your facilities, yet Emergent failed to act. 
And I will have more questions in my next round of questions. 
I yield back. 
Chairman CLYBURN. Thank you. The chair now recognizes Dr. 
Miller-Meeks for five minutes. 
Mrs. MILLER-MEEKS. Thank you, Mr. Chair. Thank you all for 
coming before the subcommittee today to testify. We have spoken 
extensively about diversified supply chains and bringing especially 
the manufacturing of PPE and pharmaceuticals back to the United 
States. How many facilities, Mr. Kramer, are there in the United 
States that manufacture vaccines? 
Mr. KRAMER. Congresswoman Miller-Meeks, I don’t have that 
number. I don’t know. 
Mrs. MILLER-MEEKS. OK. Mr. Kramer, when, and under what 
Presidential administration did Emergent receive its CIADM con-
tract to begin construction on the Baltimore facility? 
Mr. KRAMER. It was under the Obama Administration. 
Mrs. MILLER-MEEKS. And who was Vice President at that time? 
Mr. KRAMER. I believe Joe Biden. 
Mrs. MILLER-MEEKS. And did the contract state that you were, 
quote, ‘‘Nimble, flexible capacity to produce medical counter-
measures in the face of any attack or threat, known or unknown, 
including a novel, previously unrecognized, naturally occurring, 
emerging infectious disease,’’ end quote? 
Mr. KRAMER. I believe that is correct, yes. 
Mrs. MILLER-MEEKS. And since you are an expert in this area, 
does coronavirus meet those terms? 
Mr. KRAMER. I believe so, yes. 
Mrs. MILLER-MEEKS. So BARDA, not the Trump administration, 
just exercised a task order on that Obama-era contract. Correct? 
Mr. KRAMER. That is correct. 

24 
Mrs. MILLER-MEEKS. When did the FDA initiate an inspection of 
your Baltimore facility? 
Mr. KRAMER. The last FDA inspection was in April of this year. 
Mrs. MILLER-MEEKS. And when did Emergent announce its 
agreement with the FDA to suspend operations? 
Mr. KRAMER. Near the conclusion of that last FDA inspection. 
Mrs. MILLER-MEEKS. And are you currently working with the 
FDA to remediate these issues? 
Mr. KRAMER. We are. Immediately following the last FDA inspec-
tion, which I believe ended on April 20, we began work on our cor-
rective action plan and our response to the 43 observations. We 
submitted that comprehensive plan on April 30, and the FDA is 
currently is under review. 
Mrs. MILLER-MEEKS. In fact, the Biden White House said your 
quality control worked as it should. Did quality control catch these 
issues? 
Mr. KRAMER. Yes, it did. 
Mrs. MILLER-MEEKS. Were any Americans harmed? 
Mr. KRAMER. No, they were not. 
Mrs. MILLER-MEEKS. When you are awarded contracts, do they 
come from nonpartisan career contracting officials? 
Mr. KRAMER. Yes, that is true. 
Mrs. MILLER-MEEKS. So, the Democrats’ claim of a political gift 
is just false. In fact, Biden’s Director of BARDA said he is 100 per-
cent confident that this contract was awarded based on merit and 
science and not undue influence. 
Recently, Dr. Roger Ebright of Rutgers identified a research arti-
cle by the Wuhan Institute of Virology scientist, ‘‘Discovery of a 
rich gene pool of bat SARS-related coronavirus provides new in-
sights into the origin of SARS-Coronavirus, and it qualifies as a 
gain-of-function and was clearly a product of NIH funding.’’ The 
paper, drafted by WIV scientists clearly states that the underlying 
research was funded by, among other entities, the NIH. NIH’s own 
data base of grantees list the research and confirms that over 
$660,000 was spent supporting it. 
Perhaps we should focus more on investigating where this virus 
came from, and if it emanated from a lab which had some funding 
from NIH and Dr. Fauci, rather than trying to make it more dif-
ficult for vaccines to get into the arms of American citizens. 
Thank you. I yield back my time. 
Chairman CLYBURN. I thank the gentlelady for yielding back. 
The chair now recognizes Mr. Raskin for five minutes. 
Mr. RASKIN. Thank you, Mr. Chairman. Mr. Kramer, here is 
what I don’t get. On six different occasions there were inspections 
and audits, in the spring and summer of 2020, that ended with 
warnings to Emergent that you need to take urgent action to im-
prove conditions at the facility, to retrain the staff in order to pre-
vent cross-contamination, and yet still there was cross-contamina-
tion, and millions of vaccine shots ended up being destroyed. Is 
that right? 
Mr. KRAMER. Congressman Raskin, we were aware with the 
number of audits, and we treat all of that audit information seri-
ously. We ways respond with corrective actions to those audits and 
take all possible precautions from it happening again. As we de-

25 
scribed, unfortunately there was the one contamination, the cross- 
contamination issue that occurred earlier this year, and we are 
doing everything we can to remediate and to prevent that from 
happening again. 
Mr. RASKIN. Can you explain in more detail how that happened, 
if you had been responding to these multiple warnings? 
Mr. KRAMER. I am not sure I understand the question. 
Mr. RASKIN. How did the cross-contamination take place? 
Mr. KRAMER. The cross-contamination occurred as a result of ma-
terial that was leaving the AstraZeneca suite following a produc-
tion cycle and production run. And as it was being exited out of our 
facility it came in the general vicinity of some media that was 
being prepared for the initiation of a J&J run. So, we don’t know 
exactly the virus of the AstraZeneca product was transferred into 
the media, but somehow it was. It is our determination, based on 
that root cause investigation, that that is how the virus was in the 
J&J product. 
Mr. RASKIN. But how did Johnson & Johnson first discover it? 
Mr. KRAMER. There are a number of samples, Congressman 
Raskin, that are taken throughout the manufacturing process as 
we monitor the production runs, and as I was describing earlier, 
one of those quality control tests we had asked J&J to perform at 
their facility in Leiden, since they are experts and are much more 
experienced at that test than we are, that was where the first sam-
ple was detected as being out of specification. 
Mr. RASKIN. OK. I want to ask you about the bonuses. Shortly 
before you had to destroy 15 million of the Johnson & Johnson vac-
cine shots the company’s board found that your executive vice 
president responsible for manufacturing, Mr. Kirk, had signifi-
cantly exceeded performance in 2020, that year, right then, and 
awarded him a bonus of over $360,000 on top of his normal salary, 
bringing his total compensation, as I read it, to $1,778,627. How 
did you make the decision to give him a bonus in the middle of this 
cross-contamination event and this debacle in the production proc-
ess? 
Mr. KRAMER. Congressman, throughout 2020, Mr. Kirk played an 
integral role in interfacing with our corporate clients as well as 
with BARDA and HHS Operation Warp Speed. Sean Kirk was 
working literally around the clock, 24 hours a day, for months on 
end in order to supervise and direct all of the work that was being 
done. I think what needs to be underscored is the incredible chal-
lenge and the work that was required to get both of these can-
didates, AZ and J&J, up and running in an incredibly short period 
of time, under—— 
Mr. RASKIN. Well—— 
Mr. KRAMER [continuing]. Extraordinary conditions. 
Mr. RASKIN [continuing]. Forgive me. One of our colleagues said 
that Democrats evidently don’t believe in bonuses. I think we defi-
nitely believe in bonuses for success, but we don’t believe in bo-
nuses for failure. And wouldn’t you agree that this was a cata-
strophic failure in the process, and how can that be rewarded with, 
I think he ended up with $420,000 in a bonus? I mean, what would 
it take for someone not to get a bonus? 

26 
Mr. KRAMER. So, I don’t agree that it was a failure. Our com-
pany’s work, in this case Mr. Kirk’s work, was extraordinary. The 
amount of work that was accomplished, the progress that was 
made to advance these two candidates into manufacturing develop-
ment, and get them in the state of readiness to be prepared to re-
spond to the pandemic was incredible. 
Mr. RASKIN. Weren’t there two separate episodes of contamina-
tion at the Bayview facility, not one, and didn’t it result in the de-
struction of, I think it was 10 million vaccines? 
Mr. KRAMER. I think it is important to note that there was a 
cross-contamination, which I described, with the J&J product. 
There were a number of contaminations while we were starting up 
the AstraZeneca manufacturing process, which you would normally 
find. Again, when you startup a biologic manufacturing process it 
requires an incredible amount of trained work force, manufacturing 
steps in order to get the process right. 
I think what has not been reported accurately is the fact the 
package of IP that we received from AstraZeneca, under normal 
circumstances that would be well defined, you would bring that 
into your manufacturing facility and be able to quickly replicate 
that. That was not the case with the AstraZeneca product. And, in 
fact, we ended up making 80 different process changes alone in the 
first 60 to 90 days of trying to stand that manufacturing process 
up. So, it was very difficult, very complicated, and it did result in 
a number of lost production runs. 
Mr. RASKIN. Thank you for that. Thank you, Mr. Chairman. 
Chairman CLYBURN. The time has expired. The chair now recog-
nizes Mr. Krishnamoorthi. 
Mr. KRISHNAMOORTHI. Thank you, Mr. Chairman. Mr. Kramer, 
in May 2020, Emergent was contracted to receive $628 million to 
reserve and prepare its Bayview facility to produce vaccine. Cor-
rect? 
Mr. KRAMER. That is correct. 
Mr. KRISHNAMOORTHI. And under the terms of that contract, 
Emergent was required to maintain its facility, quote, ‘‘in a state 
of readiness to perform current good manufacturing practices.’’ You 
don’t dispute that, right? 
Mr. KRAMER. That is correct. 
Mr. KRISHNAMOORTHI. And a month after the contract was 
awarded, Janssen Pharmaceuticals performed an audit that found, 
quote/unquote, ‘‘mold issues at the Bayview facility.’’ 
FDA, in April 2021, found that the building used for manufac-
turing vaccine, quote, ‘‘is not maintained in a clean and sanitary 
condition.’’ You don’t dispute that. Correct? 
Mr. KRAMER. I believe that is correct, yes. 
Mr. KRISHNAMOORTHI. And FDA found paint peeling on the floors 
and walls. You don’t dispute that either, right? 
Mr. KRAMER. I believe that is correct, yes. 
Mr. KRISHNAMOORTHI. And you don’t deny that the FDA found 
brown residue and black residue on plant walls. Correct? 
Mr. KRAMER. I am not aware of that particular finding. 
Mr. KRISHNAMOORTHI. Yes. It is on page 3. I have got to tell you, 
Mr. Kramer, my son, my teenage son’s room gives your facility a 
run for its money in terms of its cleanliness. And, you know, on 

27 
page 8 of this FDA report, which I have right here, it says Emer-
gent, quote, ‘‘has failed to adequately train personnel involved in 
manufacturing operations, quality control sampling, and engineer-
ing operations to prevent cross-contamination of both drug sub-
stances.’’ You don’t deny that that FDA found that, right? 
Mr. KRAMER. That is correct. 
Mr. KRISHNAMOORTHI. So, it is no surprise that late last year 
Emergent had to toss out five batches of AstraZeneca vaccine, 
amounting to roughly 10 to 15 million doses of vaccine, and then 
yet again, as you testified this morning, you had to throw out, dis-
card, destroy, bulk drug substance amounting to 15 million doses 
of J&J vaccine. 
Now let me point you to the scorecard for what you folks actually 
achieved. In 2020, you received a contract for about $648 million— 
that is two or three contracts. You personally were paid $5.6 mil-
lion in 2020, and the number of usable doses delivered to the 
American people was a grand total of, you guessed it, zero. Zero. 
A spectacular failure. And yet, in a February 2021 meeting of the 
compensation committee of Emergent’s board of directors, I will 
show you what was presented to them. They said you, quote/un-
quote, ‘‘significantly exceeded expectations for 2020.’’ I have got to 
tell you, Mr. Kramer, if you look at this chart right here, given the 
fact that no usable doses made it into anyone’s arms, you did not 
significantly exceed the American people’s expectations. 
Interestingly, that same presentation recommends that you get a 
bump from $5.6 million in 2020 to $7.8 million in 2021. That is this 
year. You earned $3.7 million in 2019, so you experienced a 51 per-
cent increase in your compensation, amounting to almost a $2 mil-
lion increase. 
Sir, given that you take full responsibility for what happened in 
2020, that you apologized to this committee today, sir, would you 
commit to turning over your $1.9 million bonus to the taxpayers of 
America? 
Mr. KRAMER. Congressman, I will not make that commitment, 
no. 
Mr. KRISHNAMOORTHI. I didn’t think so, sir. In fact, in 2020, you 
were evaluated for 2020, the compensation committee said you, 
quote, ‘‘ensured successful execution of all six corporate goals.’’ Un-
fortunately, none of those six corporate goals related, in any way, 
to the number of vaccines that you put into American arms. 
Now you wrote in an op-ed, in the Baltimore Sun, that, quote, 
‘‘People in our country, or at least some in our media, tend to put 
a target on the backs of people doing good.’’ You don’t think that 
you are testifying before us because we thought you did good in 
2020, do you? 
Mr. KRAMER. Uh—— 
Mr. KRISHNAMOORTHI. I didn’t think so. Thank you. I yield back. 
Chairman CLYBURN. The gentleman’s time has expired. 
We now will take a five-minute break before the second round. 
Thank you. We stand in recess for five minutes. 
[Recess.] 
Chairman CLYBURN. The committee will come to order. We will 
now proceed with our second round of questions. I now recognize 
myself for five minutes. 

28 
Last month, the FDA released an inspection report detailing new 
findings about Emergent’s previous failures, and found that many 
of the company’s manufacturing problems were still unresolved. I 
have a chart here behind me that indicates some findings. The 
FDA found that even after Emergent was made aware of three sep-
arate incidents of vaccine contamination at the Baltimore plant, 
the company failed to, quote, ‘‘conduct thorough investigations.’’ 
Now if you look at these findings here, ‘‘Emergent failed to con-
duct thorough investigations,’’ ‘‘Emergent’s vaccine production facil-
ity is not maintained in a clean and sanitary condition,’’ ‘‘Emer-
gent’s procedures to prevent cross-contamination are not followed,’’ 
‘‘Emergent failed to adequately train personnel to prevent cross- 
contamination of bulk drug substances,’’ Mr. Kramer, is there an 
excuse for this kind of finding? 
Mr. KRAMER. Mr. Chair, we take those findings very seriously. 
It is always disappointing when you have any finding of deficiency. 
I think what is important is that with our response to the FDA on 
those observations that we have put together and submitted to 
them on April 30, included a number of significant and robust re-
mediation plans and corrective actions, including significantly in-
creasing the housekeeping and sanitization process. We made a 
number of improvements to the personnel and material flow and 
the design for that activity throughout the facility. We have also 
undergone a number of training programs for all of the employees 
in Bayview on viral contamination risk and how to avoid it, good 
manufacturing procedures. 
So, we are taking all those actions seriously, including the re-
placement of any floor or surface activity throughout the facility in 
order to be responsive to those observations. We submitted that to 
the FDA on April 30. We look forward to their feedback, and impor-
tantly, we think that those robust corrective actions will put us 
back on track to resume production soon. 
Chairman CLYBURN. Well, may I ask, when do you plan, or what 
are your expectations about resuming production? 
Mr. KRAMER. Sir, as we articulated to the FDA in our response 
to the 483 plan and observations, there were a number of steps 
that we suggested be implemented before we would resume produc-
tion. We have made significant progress against all of those com-
mitments. We are very close to completing them, and I would ex-
pect we will be in a position to resume production within a matter 
of days. 
Chairman CLYBURN. Well, Mr. Kramer, you may recall at the be-
ginning of my opening statement I made it very clear that this was 
the beginning of an investigation, and we have asked for some doc-
umentation, which we have not yet received. Now will you commit 
today to getting those documents to the subcommittee so that our 
investigation can go forward? 
Mr. KRAMER. Absolutely. Yes, sir. 
Chairman CLYBURN. Well, thank you very much, and with that 
I will yield to the ranking member for five minutes. 
Mr. SCALISE. Thank you, Mr. Chairman. I want to get back to 
the question about the 100 million or more doses of the Johnson 
& Johnson vaccine that are in your facility. I don’t know if there 
has been any determination made, but it sounds like the FDA has 

29 
not resolve this issue. Is there any concern that those were con-
taminated, or are these 100 million doses that more than likely are 
safe and need to be adjudicated by the FDA? Can you explain, how 
long has the FDA been sitting on that? 
Mr. KRAMER. The FDA is evaluating, to my understanding, the 
doses that have been manufactured for bulk drug substance that 
most of which has been provided to J&J. As far as I understand, 
there have been requests for some additional testing on all of those 
lots and doses that have been provided by J&J to the FDA, and it 
is under their evaluation right now. 
Mr. SCALISE. How long have they had it? 
Mr. KRAMER. I think they have had some of the data for probably 
a week or two. 
Mr. SCALISE. And, Mr. Chairman, I wish the FDA was here, be-
cause, you know, if there are 100 million doses, I know one of the 
successes of Operation Warp Speed was that President Trump had 
gotten the FDA directly working with the drug companies that 
were developing the vaccine so that any time that there was red 
tape, any time that there was a question about something, they 
could get an answer within a day, not within weeks—it may be al-
most a month in some of these cases—where the FDA was working 
overtime to get these questions addressed. I mean, we are talking 
about 100 million doses of vaccine that could be all completely fine, 
safe, and effective. 
Obviously, that is a determination that the FDA should be work-
ing overtime to do, because again, you have got President Biden 
talking about giving away the intellectual property to China, for 
free, giving it away. And, by the way, China doesn’t have any abil-
ity to start turning around and making that vaccine in a safe and 
effective way. They have got no track record, by the way, of doing 
that, if we give it away to them. And in the meantime you have 
got 100 million doses that FDA should be working overtime to get 
an answer on, because if it turns out that those are safe and effec-
tive, why don’t we allow those to get out and used instead of giving 
the entire intellectual property away? 
Let me ask you this, because you work with a lot of companies, 
not just Johnson & Johnson. AstraZeneca has been mentioned too. 
You have seen this proposal by the Biden administration to give 
away the intellectual property for the vaccine of COVID–19. What 
kind of impact would that have on the ability for companies to 
come up with, or even be willing to invest the billions it takes to 
find a vaccine, if they know that for the next virus that is out there 
that President Biden will give that away too? What kind of impact 
would that have on the willingness of some of these innovators to 
even get involved in this, versus just saying we are not even going 
to try to find a vaccine because if we find it, Biden is just going 
to give it away. 
Mr. KRAMER. Yes, Ranking Member Scalise. I think clearly IP 
protection is critically important to companies like ours, and impor-
tantly to the developers of these critically important products. I 
have not seen the exact proposal by the current administration so 
I cannot comment on that, but fundamentally I think IP protection 
is very important. 

30 
Mr. SCALISE. Well, let me ask, Mr. Chairman, if I can ask unani-
mous consent to get this article included in the record, which talks 
about the President’s plan to give away the intellectual property to 
China, as well as other countries. 
Chairman CLYBURN. Without objection. 
Mr. SCALISE. Thank you. There are other countries, by the way, 
that are watching this. I will give you an example. A spokesman 
for German Chancellor Merkel just said, quote, regarding the giv-
ing away proposal by Biden, to give away the IP, quote, ‘‘The pro-
tection of intellectual property is a source of innovation and must 
remain so in the future,’’ close quote. In fact, Germany is criticizing 
President Biden’s proposal to give away the IP because they know 
what that means and what devastating effect it would have on the 
ability to get future vaccines. 
My God, I mean, isn’t it a sad state of affairs that the German 
chancellor is more concerned about American intellectual property 
than the President of the United States? I would urge President 
Biden to talk to some of our other allies around the world who real-
ize this is a crazy idea, to give away our IP to China, who has no 
track record of even having the ability to make anything safely and 
effective like a vaccine. It might take them years, and in the mean-
time we have given away, as Dr. Green pointed out, not only the 
vaccine but the template for other things that could be used 
against us by China. This is a dangerous idea we should not do. 
Mr. Chairman, I yield back the balance of my time. 
Chairman CLYBURN. Thank you, Mr. Scalise. The chair now rec-
ognizes Ms. Waters for five minutes. 
Ms. WATERS. Thank you very much, Mr. Chairman. As we have 
reviewed information about Emergent today, of course we find that 
there was a no-bid contract and that this contract was participated 
in, in some way, by a former consultant to the tune of $360,000 
paid to Robert Kadlec. We also have found that based on testimony 
today we have learned that Emergent sold stock in what could be 
considered, or appears to be, insider trading. They have been paid 
millions of dollars despite destroying millions of vaccine doses. 
And they can’t be trusted. They have had serious manufacturing 
problems, multiple inspections and audits that were conducted in 
2020, that warned of serious quality control. Evidence recently ob-
tained by the committee shows that Emergent was aware of serious 
control issues at its Bayview facility, but failed to act. In June 
2020, an advisor to Operation Warp Speed identified risks in rely-
ing on Emergent to handle the production of two coronavirus vac-
cines. During a separate audit, Janssen Pharmaceuticals, a sub-
sidiary of Johnson & Johnson, found that the Bayview facility had 
a deficient contamination control strategy. 
On June 17, 2020, Carlo de Notaristefani, the lead manufac-
turing advisor for Operation Warp Speed, issued a private report 
on Emergent. The report identified multiple risks at the Bayview 
facility, including concerns about facility readiness, personnel, and 
compliance. The report stated most of the large-scale, existing 
equipment is not suitable for the new processes and will be either 
removed or mothballed. The supporting infrastructure is very lim-
ited and will need substantial remediation and expansion to allow 
manufacturing to proceed at the planned rate. Personnel risks are 

31 
significant. The stacking plans presented seem inadequate to the 
level of current activities required for all full-scale production of 
the program. 
Let me just say this. The Republicans here today have tried to 
basically make this an argument about intellectual property. Today 
this is really not about intellectual property and whether or not we 
are giving away, or the President is giving away intellectual prop-
erty. This is about the safety of all Americans and other countries 
that hopefully we can be involved with in helping them to get the 
vaccines that they need in order to deal with the problems that 
have occurred, the pandemic, and all of the other countries who are 
looking to us for some assistance. And I am hopeful we will be able 
to do that. But we cannot do that if we are investing in a company 
like Emergent, who is endangering us all. 
And so I would certainly ask this committee not only to continue 
the investigation but please, based on all of the information that 
we have, it can be concluded that Emergent should not be in the 
business of developing vaccines, whether it is trying to work with 
Johnson & Johnson or AstraZeneca or anybody else, because they 
cannot be trusted. 
And so I am hopeful that the moneys that we are paying, the 
moneys that the Federal Government is paying for reservation, 
without getting any result, be directed to another and other compa-
nies that have proven that they can safely produce and manufac-
ture the vaccines that are needed to deal with this pandemic. 
I thank you so very much for holding this hearing today, Mr. 
Clyburn. This is so important. But I think we know enough about 
Emergent not to trust them. Why would we continue to deal with 
a company that has violated the contract in so many ways, who 
have a dirty facility, and have us believe that, oh, there may be a 
contamination because of the way that a vaccines was traveling. 
No. This vaccine may be contaminated because the facility is dirty. 
It is not clean. It is not in shape to do the kind of production that 
they have said they would do, and they are in violation of this con-
tract. As a matter of fact, they should be trying to present them-
selves from being sued, or jailed because of what they have done. 
And this is very serious, and this cannot be swept under the rug. 
This cannot be, oh, we need it so badly, we have just got to con-
tinue with them, despite everything that we know about them, and 
we need to trust them one more time. 
Mr. Chairman, thank you so very much. We should not trust 
them, not another minute, not another day. 
I yield back the balance of my time. 
Chairman CLYBURN. I thank the gentlelady for yielding back. 
The chair now recognizes Mr. Jordan for five minutes. 
Mr. JORDAN. Thank you, Mr. Chairman. Mr. Kramer, the govern-
ment came to you, right? The Obama-Biden government came to 
you and said, ‘‘In the event there is a pandemic, we need to be 
ready. You are one of the places we think can be ready.’’ So, they 
initially came to you. Is that accurate? 
Mr. KRAMER. Yes, that is accurate. 
Mr. JORDAN. And they came to you because you were one of a 
handful of companies who could do this kind of work. I think you 

32 
said in your opening testimony there like two or three of you in the 
whole country. Is that right? 
Mr. KRAMER. That is correct, Congressman Jordan, and, impor-
tantly, we have been doing work in the public health threat area 
for now decades. 
Mr. JORDAN. Yes. Mr. Kramer, the government wasn’t just like— 
they just didn’t pick you out of a hat and say, ‘‘Oh, you are one 
of the three companies, and there are only three.’’ They came to 
you because you have got a proven track record. It is my under-
standing, and Mr. Green served our country in the military, he said 
he has got all kinds of vaccines that you helped manufacture in his 
arms. You helped with the anthrax vaccine, the smallpox vaccine. 
I think you have worked on the Zika virus. You have worked on 
the Narcan treatment that so many communities around our coun-
try have had to have with this opioid crisis. So, you have worked 
on all those issues. Is that accurate? 
Mr. KRAMER. Yes, it is accurate. Thank you. 
Mr. JORDAN. And when government came to you this time, they 
asked you to do something unique. They asked you to ramp up, 
stand up this facility in a record amount of time, because we were 
dealing with the COVID virus that, unfortunately the Democrats 
on this committee don’t want to figure out where it started, but we 
were dealing with a virus we had never really seen, a magnitude 
we had never really seen before. So, they asked you to do it in a 
record amount of time, and they asked you to deal with two vac-
cines at the same time. Is that accurate? 
Mr. KRAMER. Yes, it is. 
Mr. JORDAN. All the other work, you had only dealt with one at 
a time in your facility, one vaccine or one issue you were working 
on, not Johnson & Johnson and AstraZeneca, not Astra Vinegar, as 
the chairwoman from the Financial Services Committee, but John-
son & Johnson and AstraZeneca. Is that right? 
Mr. KRAMER. That is correct, Congressman Jordan. 
Mr. JORDAN. And then you had a cross-contamination that you 
guys found, because of the fact that you had two vaccines you were 
working on at the same time. 
Mr. KRAMER. That is correct. 
Mr. JORDAN. And since that was discovered, as the ranking mem-
ber was just pointing out, you have not been able to use the over 
100 million doses of the J&J vaccine that you currently have at 
your facility. Is that accurate? 
Mr. KRAMER. It is, Congressman. Those doses are actively under 
review by the FDA as we meet today. 
Mr. JORDAN. Has your company or J&J raised any concerns—is 
there anything that tells you those vaccines aren’t good vaccines? 
Mr. KRAMER. Those vaccines have passed all of our internal qual-
ity control measures, and I believe J&J would say the same on 
their part. 
Mr. JORDAN. So, J&J hasn’t raised any concerns, you think they 
are fine vaccines, but they are not being used. 
Mr. KRAMER. That is correct. 
Mr. JORDAN. And instead, the Biden administration is thinking 
about giving over the intellectual property to foreign countries, and 
as we know, we have got some heads of state around the world who 

33 
are saying that is a crazy idea. But they are thinking about doing 
that instead of using the 120 million doses that everyone believes 
are just fine. That is the situation right now. Is that right? 
Mr. KRAMER. I think that is an accurate description, yes. 
Mr. JORDAN. So, giving IP to China, the very country where the 
virus started, that is what the Biden administration is looking at 
doing, instead of using 120 million doses that Johnson & Johnson 
and both you all think are just fine. 
Finally, I just have a few seconds left. The previous member ba-
sically accused you of committing a crime, saying you engaged in 
insider trading. It is my understanding, from public reports, that 
the stock purchase that you exercised were determined long before 
there were any concerns about anything at your facility, and those 
were on schedule to happen, regardless of any decisions that may 
or may not have been made. Is that accurate? 
Mr. KRAMER. It is accurate, Congressman Jordan, and thanks for 
the opportunity to clarify. All of my stock sales were made pursu-
ant to the plan that was approved by the company, and impor-
tantly, was put in place during a quiet period that was also ap-
proved by the company. And most importantly, once that plan was 
filed, and it was a 10b5–1 plan, my participation was completely 
removed from the execution of those trades. 
Mr. JORDAN. Mr. Chairman, I would just—thank you, Mr. Kra-
mer—Mr. Chairman, I would just add, why won’t this committee 
have a hearing on this IP issue, which is of paramount importance, 
and just as importantly, why won’t this committee, the only select 
committee in the U.S. Congress, have a hearing on the origins of 
the very virus that caused all this chaos over the last year, not only 
in America but around the world? 
Chairman CLYBURN. Thank you very much for the questions. I 
think Mr. Foster answered that question earlier. 
Mr. JORDAN. No, he didn’t. He said Science is going to look into 
it at some point. Our charter is very clear, Mr. Chairman. Our 
charter says ‘‘prepare for future pandemics.’’ The best way to pre-
pare for future pandemics is to figure out how this pandemic start-
ed, and the fact that the select committee on the COVID virus 
won’t look at how it started makes absolutely no sense to me. But 
more importantly, it makes absolutely no sense to the American 
people. Journalists want to know. The Secretary of Health and 
Human Services wants to know. The Secretary of State wants to 
know how this started. The only ones who don’t want to know are 
Democrats on the select committee and Democrats in the Congress. 
Chairman CLYBURN. Thank you very much. You wanted to know 
where we have been, I would like to spend some time on where we 
are going. And with that I will yield five minutes to Mrs. Maloney. 
Mrs. MALONEY. Thank you, Mr. Chairman. Thank you, Mr. 
Ranking Member. 
Mr. El-Hibri, if I could ask you a few questions. You testified in 
1999, before the Committee on Government Reform, about your 
company’s failure to fulfill its commitments under a contract to 
produce anthrax vaccine for the U.S. Government. Do you recall 
that hearing? 
Mr. EL-HIBRI. Yes, I do, Congresswoman. 

34 
Mrs. MALONEY. And you testified that your company, Bioport, 
which, as I understand, now is a subsidiary of Emergent, was not 
meeting commitments because of unforeseen delays. Also that year, 
the Government Accountability Office came out with a report that 
said that your company’s inability to achieve its business plan, they 
also said the company could not perform. And it appears that we 
are having a similar situation today. There is a pattern here. Now, 
Emergent, your primary company of which Bio is a subsidiary, has 
been unable to fulfill its commitment to the government. We 
haven’t gotten the vaccines that we ordered. 
But not only does your company have a history of underper-
forming, it has a history of unreasonable price increases. The price 
you charged the government for a dose of anthrax vaccine in-
creased from $3.35 in 1998, to around $30 in 2020. That is an 800 
percent increase. 
So my question is, the cost of producing the anthrax vaccine has 
not increased by 800 percent—I guess the question I want to ask 
is how much does it cost you to produce a dose of anthrax vaccine? 
Has it jumped 800 percent? How much does it cost, either Mr. Kra-
mer or Mr. El-Hibri? Do you have that answer, or can you get it 
to us later? 
Mr. EL-HIBRI. We will get you that information later, Congress-
woman. 
Mrs. MALONEY. I couldn’t hear you. What? 
Mr. EL-HIBRI. I said I will give you that information later, if I 
may. 
Mrs. MALONEY. OK. Great. And what is Emergent’s approxi-
mately profit margin on each dose of anthrax vaccine sold in the 
U.S., and this one, if you could get that to me later, and I will give 
you some other questions. But what percentage of your sales of an-
thrax vaccine are to the U.S. Government? Do you export your vac-
cine to any other country, or do you just sell to America? Do you 
know, Mr. El-Hibri? Do you sell to other countries or only to Amer-
ica? 
Mr. EL-HIBRI. Yes, we do have international sales of anthrax. 
Mrs. MALONEY. Could you get us that report on where you sell 
it over there? 
Mr. EL-HIBRI. I will. 
Mrs. MALONEY. So, what I find sort of disturbing is really a pro-
curement question. Why does the country give a contract to a com-
pany that has a history of not completing the contract, and then 
on top of it, charging huge price increases, 800 percent? And I 
think that is something that the committee needs to look at, be-
cause this is unfair to the American taxpayer, to say the very least. 
When you have a contract, you should produce the product. So far, 
we haven’t even gotten one dose of the product out to the American 
taxpayer, yet you have been able to get bonuses, millions of dollars 
in pay going out to executives, and they have not completed the 
contract. 
So, I am really posing to my colleagues, we should at least write 
procurement laws that if you are not producing the product you 
shouldn’t be paid. You certainly shouldn’t get a bonus, and you 
should not give a contract to a company that does not have a track 
record of completing the task. I, for one, support American manu-

35 
facturing. I come from New York. We couldn’t even get gowns or 
masks. They were walking around in trash bags, going to work in 
them, because we couldn’t produce them. The only time we got 
them is when we, ourselves, seamstresses, businesses converted 
overnight to make the personal protection equipment for our people 
and the vaccines. We did produce vaccines in record time. 
So, I feel very strongly that we should have strong procurement 
laws that gest a good product for the American people. We need to 
produce our personal protection equipment, our vaccines, and ev-
erything else related to a pandemic here in the United States. We 
cannot rely on other countries, and I believe that is something we 
need to look at. 
I, for one, Mr. Chairman, would like to question whoever ap-
proved this contract in the U.S. Government. What were they 
thinking when they said you could allow a company to increase the 
cost 800 percent, and that there was no requirement that you actu-
ally produce the product before you get paid substantially with bo-
nuses and everything else? 
My time has expired. I thank you, Mr. Chairman, for your hard 
work and all of my colleagues. Thank you. I yield back. 
Chairman CLYBURN. Thank you, Mrs. Maloney. The chair recog-
nizes Dr. Green, for five minutes. 
Mr. GREEN. Thank you, Mr. Chairman, and I would like to begin 
my second round of comments just reiterating this issue about the 
origins of the vaccine. There are multiple articles coming out now 
that make all sorts of implications. We need to get to the bottom 
of it. It is a shame this committee has not addressed it. We are the 
Coronavirus Select Committee, and we haven’t even looked at the 
origins of this thing. We haven’t looked at the World Health Orga-
nization and their complicitness with China on messaging. Those 
things have to be looked at. 
I was excited to hear that Representative Foster, a gentleman 
whom I have deep respect for, said that someday that will happen 
in Science and Tech. I certainly want to ask Representative Foster, 
what are you all waiting on? Let’s get going. 
BARDA tasked you guys, talking to our witnesses now, to take 
both vaccines onto your assembly line, J&J and AstraZeneca. I 
think, as I understood from your previous testimony, you did think 
that there was some concern about having both vaccines. Is that 
correct, that there was potential for problem with you have both on 
two assembly lines? Is that correct? 
Mr. KRAMER. I think it was widely acknowledged by Emergent 
as well as our network of partners that there was inherent risk of 
bringing both vaccines into our facility and ramping them up very 
quickly. 
Mr. GREEN. So, that is what I understood to be a risk. And J&J, 
as I understand it, you guys had 16 batches, one of which was 
cross-contaminated, 15 of which were not, or at least are still being 
inspected, and that equals 140 million doses that are waiting to 
make sure that the FDA is checking to make sure they are OK, 
and when that happens they get shipped. Is that correct? 
Mr. KRAMER. Generally, correct. Yes, sir. 
Mr. GREEN. OK. So, these slides that are being shown around 
where money was given and zero vaccine, granted there are 140 

36 
million doses sitting there waiting on FDA approval, that may 
eventually, maybe next week, be sent to people who need it. OK. 
Thank you for that. 
You know, I am a former military officer. I think most people 
know that. I deployed all around the world in combat. I took the 
anthrax vaccine—I think you guys created that—and I really ap-
preciate your work in the biodefense world. You know, even Barack 
Obama recognized you are one of the only companies that can do 
this kind of stuff, and gave you business way back when. 
Botulism toxin, smallpox—I got the smallpox. You know, after 
Sverdlovsk we knew that the Russians were weaponizing smallpox, 
so as we went into Iraq I got another smallpox vaccine, and I really 
appreciate you guys doing that. Typhoid, cholera. You also do a lot 
of treatment drugs. I think as an ER physicians, I have used nasal 
Narcan to save a patient’s life, and I think you guys make that too, 
right? 
Mr. KRAMER. Yes, sir, we do. 
Mr. GREEN. So, the overdose come into the emergency depart-
ment, we spray this nasal Narcan, we save their life. That is your 
company, as I understand it. Correct? 
Mr. KRAMER. Yes, sir. That is right. 
Mr. GREEN. But you have all these products out there. You had 
company goals. You were managed by a board. The board set goals 
for the CEO. Those goals were met—at least that is what the, you 
know, minutes from the meetings have been read earlier—and bo-
nuses were paid. And as I understand it, everybody in the company 
got a bonus. Is that right? I mean, can you elaborate on that for 
just a second? 
Mr. KRAMER. Yes, sir. All of our employees are eligible for a 
bonus based on their individual performance as well as the cor-
porate performance, and separate from that, in 2020, we offered a 
special equity award of roughly $7,500 in our stock to all of our em-
ployees in recognition of the significant—— 
Mr. GREEN. All these other things. All these many other things 
that your company is producing and saving lives all across Amer-
ica. So, you gave your folks a bonus for their incredible work in all 
of these other products. You had one contamination line, 15 other 
batches, 140 million doses that are sitting there that may get ap-
proved and may get sent into arms, and we are here, spending this 
committee’s time, talking about this when we ought to be talking 
about where this virus came from in the first place. 
I cannot believe we are even having this conversation. You are 
a reputable company that has done yeoman’s work to protect this 
Nation in biodefense. You have one contamination, and they want 
to take you to court. Yet China, cooperating with the World Health 
Organization, everybody knows what happened. There is not a 
human on this planet that doesn’t say, ‘‘Hey, China screwed all of 
us,’’ and we suffered more because of it. Yet we can’t get this com-
mittee to say a word about it. But let’s take on this great company 
who did its best to try to get a vaccine out there. Meanwhile, it is 
doing all these other things to save Americans’ lives. 
I yield. 
Chairman CLYBURN. I thank the gentleman for yielding back. 
The chair now recognizes Ms. Vela´zquez for five minutes. 

37 
Ms. VELA´ ZQUEZ. Thank you, Mr. Chairman. Mr. Kramer, Emer-
gent last year was warned multiple times regarding persistent 
staffing problems at its Bayview plant in Baltimore. Specifically, in 
April 2020, the FDA warned in an inspection report, that, and I 
quote, ‘‘Employees are not given training in the particular oper-
ations they perform as part of their function.’’ Exactly a year to 
date later, FDA cited Emergent for exactly the same thing. Is this 
correct, Mr. Kramer? 
Mr. KRAMER. Those observations by the FDA are correct, Con-
gresswoman. We take them very seriously. We have put in place 
a number of corrective actions to increase our training—— 
Ms. VELA´ ZQUEZ. OK. Mr. Kramer, so you are stating that is cor-
rect, that the report was correct. 
Today, the select subcommittee released an audit report drafted 
by the lead manufacturing advisor for the former Operation Warp 
Speed, who found that Emergent had, and I quote, ‘‘significant per-
sonnel risks.’’ He wrote, and I quote, ‘‘The staffing plans presented 
seem inadequate,’’ and also noted the need for extensive training. 
Is that correct? Yes or no. 
Mr. KRAMER. I haven’t seen that report, but I believe that is cor-
rect and accurate. I think what is important to recognize is last 
year at this time, as we started up the process of working with 
both AstraZeneca and J&J, we incurred a significant staffing chal-
lenge, increasing from 100 employees to 400 employees last year. 
That is always a challenge. 
Ms. VELA´ ZQUEZ. Well, Mr. Kramer, I would like to know, and the 
members of the select subcommittee would like to know that under 
your watch, what assessments were in place to guarantee that 
staffing plans were adequate for the unprecedented crisis at hand? 
Mr. KRAMER. I am not sure I understand the question, Congress-
woman. 
Ms. VELA´ ZQUEZ. Well, look. Report after report, audit after audit, 
they found inadequate training. We just want to know that you are 
taking the necessary steps so that whenever we face again another 
unprecedented crisis, that you will have what it requires in terms 
of your personnel and the work force to perform the job at hand. 
Another audit performed by BARDA found that Emergent has 
just one employee coordinating testing to ensure that the materials 
used for the coronavirus vaccines remain stable. BARDA concluded 
that the employee’s heavy workload likely caused a mistake to be 
made. Is that true, Mr. Kramer? 
Mr. KRAMER. I am not aware of that particular finding. 
Ms. VELA´ ZQUEZ. So, I think we all see a pattern here. And ac-
cording to The New York Times, as Emergent scrambled to meet 
the heavy demands of vaccine production, one senior manufac-
turing supervisor responded to reports of quality errors by asking, 
and I quote, ‘‘Do you want me to make drugs or fix issues? I don’t 
have time to do both.’’ 
This is a very concerning pattern with predictable results. I want 
to make it clear, I am certain that the workers at the Bayview 
plant have been working very hard, under difficult circumstances, 
to do their job and manufacture these critically needed vaccines. 
This isn’t about what they are doing. It is about what you haven’t 
done, sir. Why did it take an FDA-imposed shutdown of your plant 

38 
for Emergent to find the time to properly train its employees? 
Shouldn’t these employees have been trained before they mis-
handled coronavirus vaccines? 
Mr. Kramer, Emergent needs to do better. You need to do better. 
You should treat your work force, your employees, with respect, 
and provide the tools they need in order to perform their jobs. 
I yield back. 
Chairman CLYBURN. I thank the gentlelady for yielding back. 
The chair now recognizes Mr. Foster for five minutes. 
Mr. FOSTER. Thank you, Mr. Chairman. Mr. Kramer, you have 
repeatedly emphasized how much you care about employee training 
and quality control. Does your company spend more on quality con-
trol training for employees or on government relations and lob-
bying? 
Mr. KRAMER. I don’t have those exact numbers. I do know, Con-
gressman, that we have a significant number of our employees that 
are dedicated to both quality assurance and quality control, and as 
I commented earlier, we are using this 30-day period from when 
the inspection concluded, roughly 30 days ago, to even today, to 
conduct extensive training for all of our employees in the Bayview 
site so we can get them prepared to resume production soon. 
Mr. FOSTER. Yes. Well, you can generally tell how much an orga-
nization really cares about things by looking at how much they 
spend in different areas. And so if you could get us those numbers 
for the amount you spend on government relations and lobbying, 
as well as quality control training, both currently, after you pre-
sumably upgraded your game in that, as well as historically, after 
the last year. I think that would be very informative. 
Let’s see. Something that is actually more quantifiable or spe-
cific. In June 2020, not the government but your customer vaccine 
manufacturer, J&J, through its subsidiary, Janssen, performed its 
own audit of Emergent’s facilities, and it found that there were, 
quote, ‘‘mold issues associated with the facility shutdown/startup.’’ 
And then 10 months later, when the FDA came in for an inspec-
tion, they found that the building used for manufacture of vaccine, 
quote, ‘‘is not maintained in a clean and sanitary condition,’’ un-
quote, and that there was, quote, ‘‘brown residue was observed on 
the wall.’’ 
So, Mr. Kramer, do you have a knowledge of what this brown 
residue was? 
Mr. KRAMER. I am not aware of the brown residue material. 
Mr. FOSTER. So, you generally don’t read the FDA inspection re-
ports. Is that correct? 
Mr. KRAMER. I do read the majority of the FDA inspection re-
ports. I just don’t recall this particular reference. 
Mr. FOSTER. OK. So, brown residue on the wall is not something 
that caught your attention. OK. 
And so now I guess one of the things our committee is going to 
have to be doing is trying to understand the balance of effort going 
forward in putting our country in a better posture on this. So, do 
you—actually, either of you—have any advice, if you were in our 
shoes, as to how to make sure that when we have standby capacity 
that we have been spending huge amounts of money for, how we 
should properly exercise that, to know that when the emergency 

39 
hits that capability is actually, you know, can be stood up and all 
of the, you know, nuts and bolts, like quality assurance, is in place 
so that we have a well-exercised muscle when we need that ener-
gizing in the future. Yes, any lesson learned that you think you 
would pass to us? 
Mr. EL-HIBRI. May I answer that, Congressman? 
Mr. FOSTER. Yes, please. 
Mr. EL-HIBRI. I think the Obama-Biden administration was on 
the right track to identify manufacturing facilities that are suitable 
to respond to a future pandemic crisis and emergency. So, I think 
that concept is a very good concept. 
Now what happened over an eight-year period, nine-year period, 
is that the task orders, in order to keep the facility up and run-
ning, weren’t adequate over this period of time, so that really the 
facility, even though it was meant to be at a state of readiness, was 
not quite at that level. So, we had maybe 100, and sometimes less 
than 100 employees in any given year, except for those few times 
where we did get a task order for the H1N1 flu vaccine and for 
Ebola and Zika. 
Mr. FOSTER. So, if you could come up with an estimate of what 
the total missing investment was during that period, and also the 
total amount of, you know, high employee bonuses that were 
issued, just to understand sort of the balance of funding during 
that period. 
Mr. EL-HIBRI. Yes. I will be happy to do that and provide that 
for you. 
I just want to make one thing clear, if I may, which is that when 
all these audits were performed by AZ and by Johnson & Johnson 
and by BARDA, this was before they entered into a contract with 
us, not after. So, everyone went into this with their eyes wide open, 
that this is a facility that had never licensed a produce, had manu-
factured a licensed product before, that is a facility that although 
not in perfect condition, far from it, was the facility that had the 
highest level of state of readiness. And it was in partnership with 
Johnson & Johnson and AstraZeneca and BARDA, after they have 
done their audits, that we agreed to work together to manufacture 
vaccine at risk. As you have said, that they sent the congressional 
letter to HHS or to BARDA, saying, ‘‘Hey, listen. We need to take 
risks in an environment where we need to respond rapidly,’’ and 
this is exactly what the government did. So, I am happy to—— 
Mr. FOSTER. Yes, the idea of taking technical risk, I think we are 
all completely on board with. But the idea of just failure to prop-
erly execute on the plan, the admittedly risky plan to try manufac-
turing in several sites, I think that is a different level of question 
and investigation that we are going to be pursuing here. 
Anyway, my time has expired, and I yield back. 
Chairman CLYBURN. Thank you for yield back. The chair now 
recognizes Dr. Miller-Meeks for five minutes. 
Mrs. MILLER-MEEKS. Thank you, Mr. Chair. I find it interesting 
that President Biden stopped construction on the border wall on 
January 20, but those contracts are still being honored and still 
being paid. And I would certainly encourage my colleagues who are 
concerned about taxpayer money being spent when a contract has 

40 
not been fulfilled to have support for construction completion of the 
border wall that has already been paid. 
Earlier this month, President Biden endorsed using intellectual 
property waiver at the World Trade Organization for COVID vac-
cines and therapies. Not only would a waiver of this kind destroy 
billions of dollars in U.S. intellectual property by handing over U.S. 
IP to countries such as Russia and China, but would also set a 
precedent for future pandemics and pharmaceutical investment. As 
a former director of the Iowa Department of Public Health, I know 
first-hand how important it is to have private sector partners work-
ing with us to prepare for future emergencies. 
Mr. Kramer, how many vaccines do you have sitting your facili-
ties which were not contaminated and could be shared with other 
countries or put into the arms of Americans? 
Mr. KRAMER. I don’t have an exact number, and the reason is 
that we, again, make the bulk drug substance and then we typi-
cally ship that to our customers, either J&J or AstraZeneca, and 
from there they are ultimately responsible for doing the filling, fin-
ishing, packaging, and labeling. So, we lose transparency of the 
equivalent number of doses after we ship our product to them. 
Mrs. MILLER-MEEKS. If you were cleared by the FDA today, how 
quickly could you begin manufacturing more J&J vaccines? 
Mr. KRAMER. We would be ready to resume production in the 
next couple of days. 
Mrs. MILLER-MEEKS. And how long does it typically take, in a 
first-world country such as the U.S., to increase manufacturing ca-
pacity and have the infrastructure in place to manufacture vac-
cines, such as the J&J vaccine? 
Mr. KRAMER. It normally would be measured in years, Congress-
woman. 
Mrs. MILLER-MEEKS. So, is it reasonable to assume that it would 
take longer in other countries? 
Mr. KRAMER. It likely would, yes. 
Mrs. MILLER-MEEKS. Well, I think it is interesting that in 2007, 
melamine pet food from China caused dogs to die and had to be re-
moved. In 2008, in July 2008, milk and baby formula was delib-
erately adulterated with melamine in order to pass quality control 
measures. Babies were harmed. In October, similar adulteration to 
eggs; in 2012, sweet potato dog treats from China causing kidney 
failure; and in June 2020, manufacturers in China charged with 
three counts of violating FDCA for misbranded, substandard res-
pirator masks, falsely purported to be N95 standard. The FBI said 
this was a blatant disregard for the safety of American citizens. 
And on March 7 of this year, 2021, The Wall Street Journal, 
‘‘U.S. officials at the State Department indicated Russian intel-
ligence agencies have mounted disinformation campaigns to under-
mine confidence in the Pfizer and other vaccines.’’ 
With both Russia and China seeking to increase the utilization 
of their vaccines abroad, overt efforts to denigrate Pfizer have been 
well documented. So, given these deliberate manufacturing safety 
violations, not an error, that did not harm anybody, given these de-
liberate safety violations when we are not in a pandemic and don’t 
have to ramp up production immediately, can you foresee a medical 

41 
manufacturing or a national interest in waiving intellectual protec-
tion of property for vaccine manufacturers? 
Mr. KRAMER. I am not sure I understand completely your ques-
tion. 
Mrs. MILLER-MEEKS. Do you think it is beneficial to the U.S. to 
waive intellectual property protections for the vaccines to foreign 
countries, given their manufacturing and safety violations? 
Mr. KRAMER. I think there are clearly some risks, as you have 
articulated. 
Mrs. MILLER-MEEKS. And are there other biodefense capabilities 
here in the United States, to whom would we turn that over to if 
it were not companies such as Emergent, who are willing to take 
that risk? 
Mr. KRAMER. I think it has been fairly well documented that 
Emergent is unique in that we have, over the last two decades, fo-
cused on public health threats. We manufacture products that, in 
many cases, are the only products of their nature in the world that 
are approved by the appropriate regulatory authorities. So, I think 
that it would be a significant risk. 
Mrs. MILLER-MEEKS. Well, as a 24-year military veteran, former 
director of the Iowa Department of Public Health, and one who has 
administered vaccines in the 24 counties in their congressional dis-
trict, I thank you for all the work you have done in biodefense ca-
pabilities and helping prepare the United States for this pandemic 
and future pandemics. 
I yield back my time. 
Chairman CLYBURN. I thank the gentlelady for yield back. The 
chair now recognizes Mr. Raskin for five minutes. 
Mr. RASKIN. Thank you, Mr. Chair. Mr. Kramer, the sub-
committee is releasing documents today which show that Emergent 
has been charging the U.S. Government $27 million a month to re-
serve its facilities for use. Can you explain where that provision in 
the contract came from? You get $27 million a month, as I under-
stand it, regardless of whether or not you produce any vaccine. Is 
that right? 
Mr. KRAMER. The nature of the contract with BARDA that we 
signed this time last year was to ensure that the U.S. Government, 
in this case through its agency, BARDA, had immediate access to 
certain areas within a couple of our facilities. They subsequently, 
in the case of the AstraZeneca vaccine, directed us to make certain 
space available in our facility to support the work that we are 
doing with AstraZeneca. 
Mr. RASKIN. OK. And so, did you have any other responsibilities 
for that $27 million a month, other than just to have the space 
available if they needed it? 
Mr. KRAMER. It was primarily an access matter, Congressman 
Raskin. I would say that right before this task order was put in 
place we had been in negotiations with another company to do 
COVID–19 vaccine work in the facility. So, it was not as if that 
space was going to go unutilized. We, quite frankly, had another 
opportunity to do work in that same space. 
Mr. RASKIN. OK. But there was nothing in the contract then, as 
you read it, that required you to bring the facility up to par, so that 
it met standards in the event that it was needed to be used. In 

42 
other words, you had no obligation to do anything that would have 
prevented the problems that you later encountered. 
Mr. KRAMER. The nature of the task order was to make sure that 
the government had access to certain areas of our facility so they 
could direct additional vaccine development and manufacturing 
work, at their priority, to Emergent. 
Mr. RASKIN. OK. And I know that you touted this arrangement 
as one of the primary drivers of your big profits in 2020, on one 
of your earnings calls, so you were obviously aware, this was good 
deal. Where did that $27 million figure come from? Have you ever 
been able to charge that before to a private customer? 
Mr. KRAMER. The dollar figure is really based on different activ-
ity on a per-production-run basis that is market rate. We were in 
lengthy negotiations with another party to utilize that same space 
at essentially that same rate of production suite time. 
Mr. RASKIN. I see. So, they were paying you basically $27 million 
because somebody else was about to pay you $27 million, as a 
monthly fee for the use of the facilities. Is that right? 
Mr. KRAMER. Yes, I think the interest by BARDA and the U.S. 
Government was to ensure that they had availability to much- 
needed capacity to make COVID–19 vaccines. 
Mr. RASKIN. OK. I understand that HHS is deducting some of 
that money, not paying for all of it for the failures in actually being 
able to produce the vaccine. And so, first of all, did you accept that, 
that HHS is withholding some of that money, and what kind of res-
titution do you think is owed the taxpayers for the failure to 
produce any vaccine once that part of the contract was activated? 
Mr. KRAMER. So, I am not aware that there is any reduction in 
the contract value that is being exercised by the government, so I 
am not aware of that. 
Mr. RASKIN. OK. So, you are expecting $628 million for essen-
tially the reservation of this space, regardless of whether or not you 
are able to deliver on the vaccine. 
Mr. KRAMER. The task order that was put in place this time last 
year, in total, was approximately $628 million. It included a por-
tion for what you are referring to, which was the reservation fee. 
There was also roughly $85 million of funding for some additional 
fill finish equipment, and the installation of that, in order to in-
crease drug product or fill finish capability at another one of our 
sites here in Maryland. 
Mr. RASKIN. OK. I got you. Well, Mr. Kramer, thank you for your 
testimony. Mr. Chairman, I just wanted to say, you know, with 
more than a half a billion dollars involved in this project, I hope 
we can get to the bottom of whether this contract and its terms 
were really, in fact, fair terms, and whether that is what the tax-
payers have a right to expect. 
And I turn it back over to you, Mr. Chairman. 
Chairman CLYBURN. I thank the gentleman for yielding back. 
The chair now recognizes the ranking member for any closing 
statement he would like to make. 
Mr. SCALISE. Thank you, Mr. Chairman. I appreciate the hearing 
today, and Mr. Kramer, I appreciate the testimony you gave. 
One of the things that we should be pushing for that comes out 
of this hearing, Mr. Chairman, is that as the testimony revealed 

43 
there may be over 100 million doses of the Johnson & Johnson vac-
cine that could be OKed that are being held right now, help up, 
that could be in the arms of people. The FDA, as we saw with Op-
eration Warp Speed, where the red tape was cut, where we pushed 
Federal agencies to work smarter and faster, turn things around 
quicker, all hands should be on deck to get that answer. And if, as 
both Emergent and potentially Johnson & Johnson’s internal re-
views have said, that those 100-plus million doses are OK, then 
why hold them up? 
I mean, you have got the Biden administration right now talking 
about giving away the intellectual property of this vaccine to 
China, for free, undermining the very protections that our Amer-
ican companies enjoy, that encourages them to go out and create 
new vaccines. If you give that away you will send a chilling effect 
on any company going out there on a limb and saying, ‘‘We are 
going to put up our money to find a vaccine for the next thing,’’ 
whether it is ALS or Alzheimer’s or cancer, or a future virus that 
might be started by China. That would be gone. And instead you 
have got 100 million doses that could be going to put into use, sav-
ing more lives. FDA needs to get us that answer. They need to get 
that issue resolved quickly. 
But it gets to the bigger question. Mr. Chairman, President 
Biden needs to just come out and say he is not going to give away 
our IP. Our friends around the world are saying this would be ri-
diculous to do. When the German Chancellor is saying, ‘‘Don’t do 
it,’’ because they know how dangerous that would be, especially 
giving it to China, who does not have a good record, not only on 
intellectual property—it is bad enough that they steal intellectual 
property all the time, but then to give it away to them, where it 
is a national security threat, potentially. How they could be think-
ing of doing this boggles the mind. 
I will be getting a letter together, with anybody else on the com-
mittee that wants to sign on, please let me know, urging President 
Biden to drop this crazy idea of giving away—giving away—what 
is an American success story. We came up with multiple vaccines 
for a virus that we didn’t even know in less than a year. Revolu-
tionary. Never happened before that quickly, and safe and effective. 
And to give it away to China, it just boggles the mind. 
Which brings me to the final point, Mr. Chairman. We ought to 
have a hearing in this committee on the origins of COVID–19. 
There may be other committees that might look at it, but as Mr. 
Jordan pointed out, this is the Select Subcommittee on the 
Coronavirus. And there are a lot of scientists out there suggesting 
that it may have actually come not from transmission between a 
bat and humans but potentially from the lab in Wuhan. We ought 
to know that. We ought to find out about that. We ought to do ac-
tual investigation and hearing to look into it, because we sure don’t 
want this to happen again, but we also ought to know what really 
got us to this point, a point that caused hundreds of thousands of 
lives in America, millions across the globe. Hardship, heartache. 
You still have millions of kids that aren’t in school, against the 
science. We should have a hearing on that, because every school— 
we should be bringing school systems who are keeping the kids out 
of school right now in front of this committee and have them an-

44 
swer about the science. Dr. Fauci, every doctor has said they 
should be in school, and, in fact, you are doing long-term harm to 
these kids by not having them in school, just to appease some 
union bosses who don’t have the kids’ best interests in mind. We 
will look back on this year later and say it was a national scandal 
that some of these systems kept millions of our young kids out of 
the classroom, and they will never catch up. That is something we 
ought to have a hearing on to. 
But I appreciate the time we have had looking into this. Hope-
fully we can move forward. Mr. Chairman, with that I yield back. 
Chairman CLYBURN. I thank the gentleman for yielding back. Let 
me close today’s hearing by thanking Mr. Kramer and Mr. El-Hibri 
for your testimony and for taking the time to be here with us 
today. 
As the coronavirus pandemic continues, the select subcommittee 
is focused on identifying shortcomings in our response and cor-
recting them to ensure future success. In that spirit, we need you 
to do better. We need you to do a better job cleaning your facilities 
and training your staff. We need you to recognize that inspections 
by the FDA, your partners, and your own auditors are vital to help-
ing Emergent be successful. And we need you to take their rec-
ommendations seriously and fix the problems they identify. 
Accepting public funds requires upholding the public’s trust. 
Emergent has wasted public funds and broken the public’s trust. 
Mr. Kramer and Mr. El-Hibri, to repair this breach of public trust, 
Emergent must consider returning those wasted public funds. That 
includes the amount spent on doses that have been destroyed, on 
testing, and for the time you have wasted while production is put 
on hold, and problems were fixed. The errors that we have heard 
about today must never happen again. We have heard your prom-
ises, but what we need now is performance. 
As I said in my opening statement, the select subcommittee’s in-
vestigation is ongoing. This hearing is just the beginning. With 
Chairwoman Maloney’s partnership, we will pursue this investiga-
tion until we understand why these terrible errors happened, and 
how they can be remedied, and what can be done to make sure 
they never happen again. 
With that, and without objection, all members will have five leg-
islative days within which to submit additional written questions 
for the witnesses to the chair, which will be forwarded to the wit-
nesses for their response. 
This hearing is adjourned. 
[Whereupon, at 1:39 p.m., the subcommittee was adjourned.] 
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