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Report (2021-10-22)

Issuer
Government Accountability Office
Document type
Report
Date
2021-10-22

Summary

A Government Accountability Office report to congressional committees, GAO-22-104457, dated November 2021 with a letter dated November 4, 2021, on HHS agencies' planned reviews of COVID-19 vaccine distribution and communication efforts. Prepared under a CARES Act provision, it examines stakeholder perspectives on four federal vaccine distribution programs, efforts to inform health officials, providers and the public about vaccination, and actions HHS agencies are taking to evaluate their vaccine implementation efforts. GAO reports that state and local health officials said the programs helped higher-risk populations gain access but cited coordination challenges. The report states that CDC and HRSA intend to conduct after action reviews but have not finalized plans, and makes four recommendations, with which HHS concurred.

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Full text

United States Government Accountability Office

Report to Congressional Committees

November 2021

COVID-19
HHS Agencies’
Planned Reviews of
Vaccine Distribution
and Communication
Efforts Should Include
Stakeholder
Perspectives

GAO-22-104457


November 2021

COVID-19

Highlights of GAO-22-104457, a report to
congressional committees

HHS Agencies’ Planned Reviews of Vaccine
Distribution and Communication Efforts Should
Include Stakeholder Perspectives

Why GAO Did This Study

What GAO Found

Vaccination remains critical in the
federal response to the COVID-19
pandemic. Vaccine implementation—
prioritizing, allocating, distributing, and
administering doses—requires
coordination among federal, state, and
local levels and other stakeholders.
HHS agencies—including CDC and
HRSA—set up federal vaccine
distribution programs, such as CDC’s
retail pharmacy program that sends
doses directly to pharmacies. The
federal government also sends vaccine
doses to states for further distribution.

In late 2020 and early 2021, agencies within the Department of Health and
Human Services (HHS) set up federal programs for vaccine distribution and
administration. State and local health officials and other stakeholders GAO
interviewed said these programs helped higher-risk populations access COVID19 vaccination. For example, the Health Resources and Services
Administration’s (HRSA) health center program provided vaccinations in
medically underserved areas. However, these stakeholders also cited
challenges, such as initially having limited or no information on the doses federal
programs were sending to pharmacies and health centers in their communities.
They said this made it difficult to decide which sites, including pharmacies and
health centers, to send their own allocated doses when supply was limited.

The CARES Act includes a provision
for GAO to report on its ongoing
monitoring and oversight efforts related
to the COVID-19 pandemic. This report
examines (1) stakeholder perspectives
on federal programs to distribute and
administer COVID-19 vaccines, (2)
efforts to inform health officials,
providers, and the public about
vaccination, and (3) actions HHS
agencies are taking to evaluate their
vaccine implementation efforts.

Stakeholders told GAO the Centers for Disease Control and Prevention’s (CDC)
education materials, such as provider toolkits, were useful to address the public’s
concerns about the safety of COVID-19 vaccines, but providers would have liked
them sooner to be able start promoting vaccination earlier. These stakeholders,
including health officials, said they had difficulty managing public expectations
and responding to questions about vaccine availability when they did not receive
advance notice about changes in federal priority groups for vaccination.
Individual Being Vaccinated as Part of a Federal Program

GAO reviewed data and documents
from HHS, CDC, and HRSA, and
reviewed information from and
interviewed state and local health
officials in four states and one city
selected, in part, for geographic
variation. GAO also interviewed other
stakeholders, including 12 national
associations representing health care
providers and others.

What GAO Recommends
GAO is making four recommendations,
including that CDC and HRSA obtain
input from and share lessons learned
with key stakeholders as they conduct
their future reviews. HHS concurred
with GAO’s recommendations.
View GAO-22-104457. For more information,
contact Alyssa M. Hundrup at 202-512-7114
or hundrupa@gao.gov

Officials from HHS agencies—CDC and HRSA—stated they intend to conduct
after action reviews to identify lessons learned from their COVID-19 vaccine
distribution and communication efforts. However, officials said they have not
finalized their plans for conducting such reviews, nor do they plan to do so while
they continue to respond to the pandemic and have ongoing programs. Thus, it is
uncertain whether they will gather input, including on an ongoing basis, from key
stakeholders instrumental in vaccine distribution and communication efforts, such
as state and local health officials, or whether the results will be shared with those
stakeholders. Doing so will help ensure CDC and HRSA learn what worked well
and identify areas for improvement to inform future vaccination efforts.
United States Government Accountability Office


Contents

Letter

1
Background
State and Local Health Officials and Others Said Federal
Programs Helped Higher-Risk Populations Gain Access to
COVID-19 Vaccination, but Cited Coordination Challenges
Health Officials and Others Said Federal Efforts to Inform about
Vaccination Were Helpful, but Cited Challenges Implementing
Recommendations on Priority Groups
HHS Agencies Intend to Complete After Action Reviews to Identify
Lessons Learned, but Are Uncertain about Plans to Incorporate
Information from, and Share Results with, Stakeholders
Conclusions
Recommendations for Executive Action
Agency Comments

37
39
40
41

COVID-19 Vaccines Authorized in the United States, as of
October 22, 2021

45

Timeline of Key Events Related to COVID-19 Vaccine
Implementation through October 21, 2021

49

Vaccine Finder and the Vaccine Administration
Management System

56

Appendix IV

Comments from the Department of Health & Human Services

57

Appendix V

GAO Contact and Staff Acknowledgments

61

Appendix I

Appendix II

Appendix III

Related GAO Products

7
18
29

62

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GAO-22-104457 COVID-19 Vaccine Distribution and Communication


Tables
Table 1: COVID-19 Vaccination Toolkits Published by CDC,
November 2020 to October 2021
Table 2: Examples of Changes in Information from the Federal
Government on Prioritizing and Targeting COVID-19
Vaccines between December 2020 and March 2021
Table 3: COVID-19 Vaccines FDA Authorized for Emergency Use,
as of October 22, 2021
Table 4: Timeline of Key Events Related to COVID-19
Vaccine Implementation, November 25, 2020 through
October 21, 2021

30
35
46
49

Figures
Figure 1: Percentage of Those Fully Vaccinated in the United
States, by Age Group, as of October 8, 2021
Figure 2: Number of COVID-19 Vaccine Doses Administered and
Reported COVID-19 Cases per Day in the United States,
December 14, 2020 to October 8, 2021
Figure 3: Percentage of COVID-19 Vaccine Doses Distributed
through Four Federal Vaccine Distribution Programs
Compared to the Percentage Distributed through
Jurisdictions, as of August 19, 2021
Figure 4: Four Federal Distribution Programs for COVID-19
Vaccination
Figure 5: FEMA Vaccination Center Pilot Program Sites
Figure 6: DOD and National Guard Personnel Provide Assistance
at FEMA Vaccination Sites
Figure 7: Examples of Federal Education Materials about COVID19 Vaccines in Multiple Languages

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9
10

16
19
22
25
32

GAO-22-104457 COVID-19 Vaccine Distribution and Communication


Abbreviations
ACIP
CDC
COVID-19
DOD
EUA
FDA
FEMA
health center
vaccine program
HHS
HRSA
LTC pharmacy
program
retail pharmacy
program
vaccination center
pilot program
VAMS

Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
Coronavirus Disease 2019
Department of Defense
emergency use authorization
Food and Drug Administration
Federal Emergency Management Agency
Health Center COVID-19 Vaccine Program
Department of Health and Human Services
Health Resources and Services Administration
Pharmacy Partnership for Long-Term Care
Program
Federal Retail Pharmacy Program for COVID-19
Vaccination
Community Vaccination Center Pilot
Site and Mobile Vaccination Program
Vaccine Administration Management System

This is a work of the U.S. government and is not subject to copyright protection in the
United States. The published product may be reproduced and distributed in its entirety
without further permission from GAO. However, because this work may contain
copyrighted images or other material, permission from the copyright holder may be
necessary if you wish to reproduce this material separately.

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GAO-22-104457 COVID-19 Vaccine Distribution and Communication


Letter

441 G St. N.W.
Washington, DC 20548

November 4, 2021
Congressional Committees:
More than a year and a half after the United States declared the
Coronavirus Disease 2019 (COVID-19) pandemic a public health
emergency, the nation continues to grapple with and respond to the
pandemic. After an overall decline in the numbers of COVID-19 cases,
hospitalizations, and deaths from their peaks in early 2021, cases began
to surge again in the summer of 2021 as a new variant of the virus
emerged. 1 Hospitalization and deaths attributed to COVID-19 also
increased, primarily among those unvaccinated, according to federal
health officials. 2 Increasing COVID-19 vaccination coverage among the
public remains a critical priority for the federal government. As of October
8, 2021, about 66 percent of the U.S. population aged 12 years and older
(about 187 million individuals) had been fully vaccinated, according to
data from the Centers for Disease Control and Prevention (CDC). 3
COVID-19 vaccine implementation—which includes prioritizing,
allocating, distributing, and administering vaccine doses—is a highly
complex undertaking, requiring coordination among multiple federal
agencies, the private sector, jurisdictions, tribal officials, and health care

1According to the Centers for Disease Control and Prevention (CDC), viruses, such as

COVID-19, constantly change through mutation, and new variants are expected to occur.
Sometimes new variants emerge and disappear, while at other times, new variants
persist. The Delta variant (which, as of this report, is the dominant strain) spreads much
faster than previous variants and may cause more severe cases of illness than other
variants.

2For example, one study published by CDC showed new COVID-19 hospitalization rates

in New York between May and July 2021 were considerably higher among unvaccinated
adults than fully vaccinated adults. See Department of Health and Human Services,
Centers for Disease Control and Prevention, “New COVID-19 Cases and Hospitalizations
among Adults by Vaccination Status—New York, May 3–July 25, 2021,” Morbidity and
Mortality Weekly Report, vol. 70, no. 34 (Atlanta, Ga.: Aug. 27, 2021).

3As of October 22, 2021, three COVID-19 vaccines were available in the United States but

none of them was available for children under 12 years. Two of the three COVID-19
vaccines available for use were two-dose vaccine regimens and the third one was a
single-dose vaccine. According to CDC, the count of fully vaccinated individuals
represents the number of people who have received the second dose of a two-dose
COVID-19 vaccine regimen and those who received one dose of the single-dose COVID19 vaccine.

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providers. 4 At the federal level, the Department of Health and Human
Services (HHS), along with its component agencies, has been a key
department responsible for vaccine implementation efforts. For example,
HHS, in partnership with the Department of Defense (DOD), has
supported the development, manufacturing, allocation, and distribution of
COVID-19 vaccine doses to states and other jurisdictions and to other
federal vaccine distribution programs.
Since June 2020, we have cited the critical importance of planning for the
development, manufacturing, distribution, and administration of COVID19 vaccines. 5 In September 2020, we recommended that the Secretary of
Health and Human Services, with support from the Secretary of Defense,
develop a national plan for distributing and administering COVID-19
vaccines that outlines an approach for how efforts would be coordinated
across federal agencies and nonfederal entities. 6 CDC issued initial
planning documents in September and October 2020, and in January
2021, the White House issued a national COVID-19 response strategy
that broadly outlined various programs for vaccine distribution. These
documents contain general information on federally supported vaccine
distribution activities, but do not provide details related to how the federal
government is coordinating its efforts or information on the specific roles
of the federal agencies and non-federal entities.
When COVID-19 vaccination began in December 2020, the federal
government provided the majority of the limited supply of vaccine doses
to the 50 states and other jurisdictions to further distribute to health care
providers located in their jurisdictions. In December 2020, the federal
government also began a vaccine distribution program targeting residents
and staff in long-term care facilities. Then, in February 2021, it began
three additional vaccine distribution programs focused on providing
COVID-19 vaccine doses to pharmacies, federally supported health
centers, and mass vaccination sites for administration.

4Jurisdictions include all 50 states, the District of Columbia, eight U.S. territories, and a

small number of major cities.

5GAO, COVID-19: Opportunities to Improve Federal Response and Recovery Efforts,

GAO-20-625 (Washington, D.C.: June 25, 2020).

6The Secretary neither agreed nor disagreed with our recommendation. See GAO,

COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions,
GAO-20-701 (Washington, D.C.: Sept. 21, 2020).

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For COVID-19, CDC has played a key role in informing health care
providers and the public about COVID-19 vaccination. A key component
of any successful vaccination effort is timely, clear, and consistent
communication to stakeholders like state, territorial, and local health
officials and health care providers, as well as to the public about vaccine
availability, effectiveness, and safety. Communication that is responsive
to the public’s questions and concerns can help increase public
confidence and trust in vaccines and in vaccination.
Additionally, in our 2011 review of the federal response to the H1N1
influenza pandemic, we raised the importance of capturing lessons
learned from the federal government’s response. We reported on the
importance of identifying response actions that worked well and those
that could be improved, so the nation could be better prepared when the
next pandemic occurred. 7
The CARES Act includes a provision for GAO to report on its ongoing
monitoring and oversight efforts related to the COVID-19 pandemic. 8 This
report is part of our body of work in response to the CARES Act and
focuses on the federal government’s efforts related to the distribution and
administration of and communication about COVID-19 vaccines. 9 In this
report, we
1. describe state and local health officials’ and other stakeholders’
perspectives on federal efforts to distribute and administer COVID-19
vaccines, including four federal vaccine distribution programs;
2. describe state and local health officials’ and other stakeholders’
perspectives on federal efforts, including CDC’s efforts, to inform
health officials, health care providers, and the public about COVID-19
vaccination; and

7GAO, Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated

into Future Planning, GAO-11-632 (Washington, D.C.: June 27, 2011).

8Pub. L. No. 116-136, § 19010, 134 Stat. 281, 579-81 (2020).
9We have regularly issued government-wide reports on the federal response to COVID-

19. For the latest report, see GAO, COVID-19: Additional Actions Needed to Improve
Accountability and Program Effectiveness of Federal Response, GAO-22-105051
(Washington, D.C.: Oct. 27, 2021). Our next government-wide report will be issued in
January 2022 and will be available on GAO’s website at https://www.gao.gov/coronavirus.
Also, see the GAO Related Products section at the end of this report for additional work
we have done on COVID-19 vaccines.

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3. examine actions HHS agencies are taking to evaluate their efforts to
distribute and administer COVID-19 vaccines and to communicate
about COVID-19 vaccination.
To address the first objective, we reviewed information from and
interviewed selected state and local health officials and other
stakeholders about federal efforts to distribute and administer COVID-19
vaccines, generally covering the period of December 2020 through May
2021. We focused our review on the four federal vaccine distribution
programs that together distributed the most vaccine doses to the public,
outside of vaccine doses distributed through states and other
jurisdictions. These four programs included
•

CDC’s Pharmacy Partnership for Long-Term Care Program (LTC
pharmacy program),

•

CDC’s Federal Retail Pharmacy Program for COVID-19 Vaccination
(retail pharmacy program),

•

the Health Resources and Services Administration’s (HRSA) Health
Center COVID-19 Vaccine Program (health center vaccine
program), 10 and

•

the Federal Emergency Management Agency’s (FEMA) Community
Vaccination Center Pilot Site and Mobile Vaccination Program
(vaccination center pilot program). 11

We also obtained stakeholder perspectives on federal efforts to support
the administration of COVID-19 vaccines, including the use of DOD and
National Guard personnel, and additional categories of individuals
qualified to administer vaccines with liability protections, such as dentists
and veterinarians. The selected state and local health officials and other
stakeholders we spoke to are described below; the perspectives of these
officials and other stakeholders are not generalizable but provided
valuable insight on these issues.

10CDC coordinated with HRSA on the health center vaccine program, but for the purposes
of this report, we refer to this program as a HRSA-operated vaccine distribution program
since HRSA was the primary agency responsible for implementing the program.
11CDC coordinated with FEMA on the vaccination center pilot program, but for the

purposes of this report, we refer to this program as a FEMA-operated vaccine distribution
program since FEMA was the primary agency responsible for implementing the program.

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•

Selected state and local health officials. We reviewed information
from and interviewed or obtained written responses from health
officials from five selected jurisdictions—four states (Connecticut,
Georgia, Minnesota, and Washington) and one city (Philadelphia). 12
Within each of the four states, we also interviewed health officials
from one local health department that had one or more vaccination
site receiving vaccine doses through one of the four federal vaccine
distribution programs we examined. We conducted these interviews
between late March and early May 2021.

•

Other stakeholders. Within each of the four selected states noted
above, we also interviewed representatives from the state’s medical
association and hospital association to obtain the perspectives of
health care providers. In addition, we reviewed information from and
interviewed or obtained written responses from representatives from
12 national associations who represented different stakeholder
groups, including state and local health officials, tribal health
organizations, health care providers involved in vaccine
administration, and others. 13 We conducted these interviews between
April and May 2021.

To address the second objective, we obtained information from CDC’s
website and from written responses on the agency’s efforts to inform
health officials, health care providers, and the public about COVID-19
vaccination, generally covering the period of November 2020 to August
2021. We also conducted interviews with the selected state and local
health officials and other stakeholders described above to get their
perspectives on CDC’s efforts and about recommendations from CDC’s

12We selected jurisdictions to reflect variation in geographic location and the degree to
which state public health infrastructures were centralized or decentralized. We also
selected one major city that received vaccine allocations directly from the federal
government and is considered a jurisdiction.
13We interviewed officials or obtained written responses from: American Hospital

Association, American Medical Association, Association of Immunization Managers,
Association of State and Territorial Health Officials, National Association of Community
Health Centers, National Association of Chain Drug Stores, National Association of
County and City Health Officials, National Community Pharmacists Association, National
Council of Urban Indian Health, National Governors Association, National Indian Health
Board, and National Rural Health Association.

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Advisory Committee on Immunization Practices (ACIP) on which groups
to initially prioritize and target when vaccine supply was limited. 14
For both the first and second objectives, we also reviewed documentation
from and interviewed officials from federal agencies involved in federal
COVID-19 vaccine distribution, administration, or communication efforts.
These agencies included CDC, FEMA, HRSA, and the HHS-DOD
partnership tasked with supporting COVID-19 vaccine development,
manufacturing, and distribution to states and other jurisdictions and
selected federal entities. 15
To address the third objective, we interviewed officials from HHS,
including CDC and HRSA, and reviewed written responses from CDC and
HRSA about their plans for conducting and sharing the results of after
action reviews of federal COVID-19 vaccine implementation efforts. We
compared CDC’s and HRSA’s plans for after action reviews to federal
internal control standards regarding information and communication, and
the underlying principle that management should externally communicate
the necessary quality information to achieve the entity’s objectives. 16 We
also compared the agencies’ plans with the Project Management
Institute’s program management standards, which similarly call for
program managers to engage with key stakeholders. 17 Finally, we
compared the agencies’ plans to prior GAO work on lessons learned from
and after action reports on the federal response to prior emergencies,
including the 2009 H1N1 pandemic. 18
Finally, we analyzed data from CDC’s COVID-19 Data Tracker on the
number of COVID-19 vaccine doses delivered, by distribution channel, as
of August 19, 2021, and on doses administered and new cases of
COVID-19 (the 7-day average of the new cases each day) as of October
14ACIP is comprised of medical and public health experts who make recommendations on

the use of vaccines in the civilian population of the United States.

15This partnership was initially known as Operation Warp Speed, but since May 2021, is

named the HHS-DOD COVID-19 Countermeasures Acceleration Group.

16GAO, Standards for Internal Control in the Federal Government, GAO-14-704G

(Washington, D.C.: Sept. 10, 2014).

17Project Management Institute, Inc., The Standard for Program Management, Fourth

Edition, 2017.

18GAO, Disaster Response: HHS Should Address Deficiencies Highlighted by Recent

Hurricanes in the U.S. Virgin Islands and Puerto Rico, GAO-19-592 (Washington, D.C.:
Sept. 20, 2019) and GAO-11-632.

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8, 2021. We interviewed agency officials about the data on vaccine doses
distributed and administered, and reviewed available documentation on
these sources and on COVID-19 case rate data. We determined these
data were sufficiently reliable for the purpose of providing context on
COVID-19 vaccinations.
We conducted this performance audit from July 2020 to November 2021
in accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.

Background

As of October 22, 2021, three COVID-19 vaccines were available in the
United States. One vaccine was licensed by the Food and Drug
Administration (FDA) for individuals aged 16 years and older and was
also available for individuals aged 12 to 15 years under an emergency
use authorization (EUA), which allows for the temporary use of vaccines
without FDA licensure, provided certain statutory criteria are met. 19 Two
additional vaccines were authorized for emergency use for individuals

19Typically, FDA must license a vaccine before it can be marketed in the United States.
See 42 U.S.C. § 262. On August 23, 2021, FDA licensed the COVID-19 vaccine
developed by Pfizer and BioNTech (marketed as Comirnaty) for the prevention of COVID19 disease. For the purposes of this report, we refer to the COVID-19 vaccine that Pfizer
and BioNTech developed together as the Pfizer vaccine.

The Secretary of Health and Human Services may declare that circumstances, prescribed
by statute, exist justifying the emergency use of certain medical products, such as
vaccines. Once a declaration of an emergency has been made, FDA may temporarily
allow use of unlicensed vaccines through an EUA. For FDA to issue an EUA for a vaccine,
it must be reasonable to believe that the vaccine may be effective and that the known and
potential benefits of the vaccine outweigh the known and potential risks, among other
statutory criteria. See 21 U.S.C. § 360bbb-3. FDA has indicated that issuance of an EUA
for a COVID-19 vaccine for which there is adequate manufacturing information would
require a determination by FDA that the vaccine’s benefits outweigh its risks based on
data from at least one well-designed phase 3 clinical trial that demonstrates the vaccine’s
safety and efficacy in a clear and compelling manner.
Any COVID-19 vaccine that initially receives an EUA from FDA is expected to work toward
submission of a biologics license application, according to FDA guidance. See
Department of Health and Human Services, Food and Drug Administration, Emergency
Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry, (Silver
Spring, Md.: May 2021).

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aged 18 years and older. 20 (See app. I for more information on COVID-19
vaccines available in the United States.) As of October 22, 2021, no
vaccines had been authorized or licensed for children under 12 years, but
one vaccine company (Pfizer) had requested that FDA authorize its
COVID-19 vaccine for children aged 5 years to 11 years. 21
As of October 8, 2021, about 66 percent of the U.S. population eligible for
vaccination (i.e., those aged 12 years and older) was fully vaccinated—
that is, they had received the second dose of a two-dose COVID-19
vaccine or had received the single-dose COVID-19 vaccine—but
vaccination rates varied among different population groups. For example,
more than 80 percent of those aged 65 years and older were fully
vaccinated, compared with less than 60 percent of individuals under 40
years of age, according to CDC data. (See fig. 1.)

20On June 10, 2021, one vaccine company, Moderna, requested FDA amend the EUA for

its COVID-19 vaccine for use in adolescents aged 12 years to 17 years; as of October 22,
2021, FDA had not issued a decision in response. The other authorized COVID-19
vaccine was by Janssen Pharmaceutical Companies, which is part of Johnson & Johnson.
Additional or booster doses have also been authorized and recommended for fully
vaccinated individuals. In August 2021, FDA authorized, and CDC recommended, the use
of an additional dose of the Pfizer and Moderna COVID-19 vaccines in certain
immunocompromised individuals. In September and October 2021, FDA authorized and
CDC recommended that certain populations receive a booster dose of either the Pfizer,
Moderna, or Janssen vaccine. In October 2021, FDA also authorized “mix and match” for
the booster dose—that is, authorizing the use any available COVID-19 vaccine for use as
a booster dose regardless of which COVID-19 vaccine was used as the primary series or
single-dose primary series. According to CDC, an additional dose is administered when
the initial immune response following a primary vaccine series is likely to be insufficient
and a booster dose is administered when the initial sufficient immune response to a
primary vaccine series is likely to have waned over time.
21As of October 22, 2021, FDA’s Vaccines and Related Biological Products Advisory

Committee was scheduled to meet on October 26, 2021, to discuss a request for
authorization of Pfizer’s COVID-19 vaccine for children aged 5 through 11 years.

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Figure 1: Percentage of Those Fully Vaccinated in the United States, by Age Group,
as of October 8, 2021

Notes: The figure does not include data for Texas or for individuals under age 18 years from Idaho,
due to limitations in these states’ reporting of demographic data to CDC. As of October 8, 2021, three
COVID-19 vaccines were available in the United States. One vaccine was authorized for emergency
use in individuals aged 12 years to 15 years on May 10, 2021, and was licensed for individuals aged
16 years and older. The two remaining vaccines were authorized for emergency use for individuals
aged 18 years and older. As of October 8, 2021, there were no vaccines authorized or licensed for
children under 12 years. In this figure, fully vaccinated refers to those individuals who have received
the second dose in a two-dose COVID-19 vaccine regimen and those who received one dose of the
single-dose COVID-19 vaccine.

Over time, as the number of COVID-19 vaccine doses administered
increased, COVID-19 case rates fell steadily through mid-June 2021.
(See fig. 2.) In late June, however, the average number of cases per day
began to increase as the more transmissible Delta variant was circulating.
After September 2021, the average number of cases per day generally
declined; as of October 8, 2021, the average number of cases per day
was 93,437.

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Figure 2: Number of COVID-19 Vaccine Doses Administered and Reported COVID19 Cases per Day in the United States, December 14, 2020 to October 8, 2021

Notes: Data begin on December 14, 2020, when the first dose of COVID-19 vaccine was
administered in the United States. Data on the number of COVID-19 vaccine doses administered
reflect the cumulative number of doses administered as reported to CDC by state, local, and territorial
immunization information systems and other sources. Data on COVID-19 case rates reflect the 7-day
moving average for the number of new cases reported per day and are based on aggregate case
reporting to CDC on probable and confirmed cases by states and jurisdictions. According to CDC, the
actual number of COVID-19 cases is unknown for a variety of reasons, including that people who
have been infected may not have been tested, or may not have sought medical care.

The pace of COVID-19 vaccinations in the United States has fluctuated
over time. In the first 4 months after vaccination began, as vaccine supply
increased, the average number of doses administered daily climbed
steadily, peaking in April 2021. In the following months, the average
number of doses administered daily declined steeply and then in July
2021, began to increase once more, after COVID-19 cases had begun to
surge again. As of October 8, 2021, about 34 percent of the U.S.
population aged 12 years and older was not fully vaccinated.

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Those unvaccinated may include people who desire to be vaccinated but
face access barriers, such as lacking transportation to a vaccination site
or not having the ability to take time off from work to get vaccinated.
Others may be uncertain or reluctant to be vaccinated (sometimes
referred to as vaccine hesitancy) for different reasons, such as having
concerns about the safety of COVID-19 vaccines or believing vaccination
is unnecessary because COVID-19 is not a serious threat to their
health. 22

Federal Efforts to Allocate
and Distribute COVID-19
Vaccines

COVID-19 vaccine implementation—that is, prioritizing, allocating,
distributing, and administering vaccine doses—has been a key
component in mitigating the disease’s effect on the public’s health,
societal functioning, and the economy. (See text box below.) The federal
government began distributing COVID-19 vaccine doses on December
12, 2020, and 2 days later, the first dose of vaccine was administered. 23

22While different models exist for categorizing attitudes toward vaccination, a common

conception is that these attitudes run along a continuum that ranges from full acceptance
of vaccines on one end to full opposition to vaccines on the other. The term “vaccine
hesitancy” has been used to refer to a delay in acceptance of vaccines, including the
COVID-19 vaccine, despite the availability of vaccination services. An individual’s level of
vaccine hesitancy can vary by vaccine and over time. See National Academies of
Sciences, Engineering, and Medicine, The Critical Public Health Value of Vaccines:
Tackling Issues of Access and Hesitancy: Proceedings of a Workshop (Washington, D.C.:
2021).
23See app. II for a timeline of these efforts and other key events related to COVID-19
vaccine implementation.

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COVID-19 Vaccine Implementation
COVID-19 vaccine implementation includes the prioritization, allocation, distribution, and administration of
vaccine doses and relies on communication and coordination between the federal government and
stakeholders, including states and other jurisdictions, local health departments, the private sector, and health
care providers.
Prioritization refers to the identification of groups prioritized for vaccination when vaccine supply is limited.
Within priority groups are separate target groups, which are added as vaccine supply increases. CDC’s
Advisory Committee on Immunization Practices issued its recommendations for priority groups and target
groups for COVID-19 vaccination in December 2020.
Allocation refers to the number of vaccine doses the federal government made available through different
vaccine distribution programs, such as to states and other jurisdictions. States and other jurisdictions used
part of their allocations of vaccine doses from the federal government for CDC’s Pharmacy Partnership for
Long-Term Care Program; the other doses were directed to health care providers within their jurisdictions. In
contrast, three additional federal vaccine distribution programs—(1) CDC’s Federal Retail Pharmacy
Program for COVID-19 Vaccination, (2) the Health Resources and Services Administration’s (HRSA) Health
Center COVID-19 Vaccine Program, and (3) the Federal Emergency Management Agency’s (FEMA)
Community Vaccination Center Pilot Site and Mobile Vaccination Program—were implemented as separate
distribution programs, and each program received a direct allocation of vaccine doses from the federal
government.
Distribution refers to the delivery of COVID-19 vaccine doses to health care providers, as directed by states
and other jurisdictions; federal entities, such as FEMA and HRSA; and other entities that have partnered with
the federal government, such as pharmacies.
Administration refers to the administering of COVID-19 vaccine doses at various sites, including long-term
care facilities, pharmacies, health centers, mass vaccination sites, and physician offices, by authorized
health care providers.
Source: GAO summary of information from the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services, and the Department of Defense. | GAO-22-104457

When COVID-19 vaccine implementation began in December 2020, the
federal government allocated and distributed nearly all available vaccine

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doses to the 50 states and other jurisdictions. 24 Jurisdictions then decided
how to further distribute their allocated vaccine doses to authorized health
care providers within their boundaries, including to pharmacies, health
centers, local health departments, mass vaccination sites, hospitals,
physician offices, and others. 25 Initially, the vaccine supply was limited
and not all health care providers that wanted to administer COVID-19
vaccines received doses, and people who wanted to be vaccinated
experienced challenges doing so, according to multiple stakeholders. We
previously reported that state, territorial, and local health officials and
health care providers experienced multiple challenges when distribution
of COVID-19 vaccines first began in mid-December 2020. 26 For example,
health officials and health care providers said they lacked information on
vaccine shipments, such as the number of doses being delivered, which
was needed to assist their on-the-ground planning for vaccine
administration.
In December 2020, the federal government initiated CDC’s LTC
pharmacy program. Under this program, CDC worked with selected
pharmacy partners to vaccinate residents and staff at participating
nursing homes and other long-term care facilities. 27 To implement this
24In December 2020, the federal government began providing allocations of COVID-19
vaccine doses to 62 jurisdictions, including all 50 states, the District of Columbia, three
major cities (Chicago, New York City, and Philadelphia), and eight territories (American
Samoa, the Federated States of Micronesia, Guam, the Marshall Islands, the Northern
Mariana Islands, Palau, Puerto Rico, and the U.S. Virgin Islands), generally on a weekly
basis. A jurisdiction could then order vaccine doses from the federal government to be
distributed to authorized health care providers for administration, up to the allocated
number of doses (order cap). Although there are 64 jurisdictions implementing COVID-19
vaccination and receiving federal funding for these efforts, allocations of vaccine doses
were made to 62 jurisdictions because two major cities considered jurisdictions—Houston
and San Antonio—had their allocations consolidated with Texas. On June 24, 2021, the
federal government stopped allocating COVID-19 vaccine doses to jurisdictions and
federal vaccine distribution programs because vaccine supply had increased to sufficient
levels to meet the needs of jurisdictions and other federal programs, according to federal
officials.
25As of October 22, 2021, all COVID-19 vaccines in the United States have been

purchased by the U.S. Government for administration exclusively by authorized health
care providers enrolled in CDC’s COVID-19 Vaccination Program. Only health care
providers enrolled as vaccination providers can legally store, handle, and administer
COVID-19 vaccines in the United States.

26GAO, COVID-19: Efforts to Increase Vaccine Availability and Perspectives on Initial

Implementation, GAO-21-443 (Washington, D.C., Apr. 14, 2021).

27For the LTC pharmacy program, CDC worked with CVS, Walgreens, and Managed
Health Care Associates, Inc., as pharmacy partners.

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program, pharmacies used vaccine doses from states’ and other
jurisdictions’ allocations to conduct three on-site vaccination clinics at
each participating facility.
In February 2021, as the vaccine supply began increasing, the federal
government implemented three additional vaccine distribution programs. 28
These three federal programs were outlined in the White House’s national
strategy for the COVID-19 response and received their own allocations of
vaccine doses from the federal government. 29 According to federal
officials, the number of vaccine doses the federal government allocated to
CDC’s retail pharmacy program, HRSA’s health center vaccine program,
and FEMA’s vaccination center pilot program were determined by the
White House COVID-19 Response Team. 30 The programs were
•

CDC’s retail pharmacy program, which distributed vaccine doses
directly to national pharmacy partners and independent pharmacy
networks,

28In addition to allocations of vaccine doses made to states and other jurisdictions and
these three federal programs, the federal government allocated and distributed vaccine
doses to five federal entities (the Bureau of Prisons, DOD, Department of State, Indian
Health Service, and the Veterans Health Administration). The federal government also
allocated vaccine doses to HHS/National Institutes of Health for a small program
managing doses allocated to federal departments and agencies for administration to
critical infrastructure personnel and made a one-time allocation of 751,140 vaccine doses
to the Federal Dialysis Center Program to distribute to participating dialysis centers to
administer vaccines to patients and health care personnel.
29The National Strategy for the COVID-19 Response and Pandemic Preparedness

includes a goal of mounting a safe, effective, and comprehensive vaccination campaign.
See White House, National Strategy for the COVID-19 Response and Pandemic
Preparedness (Washington, D.C.: Jan. 21, 2021). Earlier planning documents, including
CDC’s COVID-19 interim guidance for states and other jurisdictions, identified the LTC
pharmacy partnership and outlined plans for direct partners such as retail pharmacy
chains that would enroll directly with CDC to order and receive COVID-19 vaccines. See
Department of Health and Human Services, Centers for Disease Control and Prevention,
COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, version 2.0
(Atlanta, Ga: Oct. 29, 2020).

30Since January 2021, the White House COVID-19 Response Team has been responsible

for coordinating across the federal government on the COVID-19 response, including
COVID-19 vaccine implementation, and for communicating to the public, state, and local
public health officials and other stakeholders about these efforts through regular public
briefings.

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•

HRSA’s health center vaccine program, which distributed vaccine
doses to federally supported health centers, 31 and

•

FEMA’s vaccination center pilot program, which distributed
vaccine doses to federally operated community vaccination centers
and to mobile vaccination units. 32

The federal government initiated these four federal vaccine distribution
programs, in part, to focus on vaccinating higher-risk populations who
might experience worse health outcomes associated with COVID-19. The
programs were put in place to supplement states’ and jurisdictions’
vaccination efforts, according to federal officials. When the federal
programs were initiated, some pharmacies and health centers were
already receiving vaccine doses from the states or other jurisdictions in
which they were located, as jurisdictions distributed their allocated
vaccine doses to health care providers in their communities. Thus, some
pharmacies and health centers could receive vaccine doses from both
their jurisdiction and a federal vaccine distribution program.
As of August 19, 2021, the federal government had distributed over onethird of all COVID-19 vaccine doses through the four federal vaccine
distribution programs, with most doses going to pharmacies (through
CDC’s LTC pharmacy program and its retail pharmacy program). (See fig.
3.)

31Federally supported health centers generally receive Health Center Program grants from

HRSA under section 330 of the Public Health Service Act (42 U.S.C. § 254b) and provide
primary care services in medically underserved communities. Some organizations meet all
Health Center Program requirements but do not receive federal grant funding through the
section 330 program. However, these centers, which are known as “look-alikes,” receive
other benefits, such as higher reimbursement rates from the Medicare and Medicaid
programs and may receive grants through other federal programs. We use the term
“federally supported health centers” to refer to both “look-alikes” and those health centers
that receive grants under section 330 of the Public Health Service Act.
32On June 20, 2021, the last mass vaccination site under FEMA’s vaccination center pilot
program closed, according to federal officials. However, after that date, agency officials
reported that they continued to support mobile vaccination units and community
vaccination centers managed and operated by states and other jurisdictions (using doses
allocated to the jurisdictions) by providing federal personnel, funding, and material, such
as medical equipment and supplies.

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Figure 3: Percentage of COVID-19 Vaccine Doses Distributed through Four Federal Vaccine Distribution Programs Compared
to the Percentage Distributed through Jurisdictions, as of August 19, 2021

Notes: Figure shows cumulative number and percentage of COVID-19 vaccine doses distributed
through four federal and other vaccine distribution programs from the time vaccine doses were first
distributed in December 2020 to August 19, 2021.
a
A total of 62 jurisdictions—including all 50 states, the District of Columbia, three major cities
(Chicago, New York City, and Philadelphia), and eight territories (American Samoa, the Federated
States of Micronesia, Guam, the Marshall Islands, the Northern Mariana Islands, Palau, Puerto Rico,
and the U.S. Virgin Islands)—received allocations of COVID-19 vaccine doses, generally on a weekly
basis. Although there are 64 jurisdictions implementing COVID-19 vaccination and receiving federal
funding for these efforts, allocations of vaccine doses were made to 62 jurisdictions because two
major cities considered jurisdictions—Houston and San Antonio—had their allocations consolidated
with Texas.
b
Other includes other federal vaccine distribution programs that received direct allocations from the
federal government—(1) four federal entities (the Bureau of Prisons, Department of Defense, Indian
Health Service, and the Veterans Health Administration); (2) Department of Health and Human
Services/National Institutes of Health for a small program managing doses allocated to federal
departments and agencies for administration to critical infrastructure personnel; and (3) a one-time
allocation of vaccine doses to the Federal Dialysis Center Program to distribute to participating
dialysis centers to administer vaccines to patients and health care personnel. Although the
Department of State received allocations of vaccine doses from the federal government, data for this
department are not included in CDC’s data on distribution.
c
CDC coordinated with the Federal Emergency Management Agency (FEMA) on the Community
Vaccination Center Pilot Site and Mobile Vaccination Program (vaccination center pilot program); for
the purposes of this report, we refer to this program as a FEMA-operated vaccine distribution
program. On June 20, 2021, the last mass vaccination site under this program closed, according to
agency officials.
d
CDC coordinated with the Health Resources and Services Administration (HRSA) on the Health
Center COVID-19 Vaccine Program (health center vaccine program); for the purposes of this report,
we refer to this program as a HRSA-operated vaccine distribution program.
e
The number of doses attributed to CDC’s Federal Retail Pharmacy Program for COVID-19
Vaccination (retail pharmacy program) includes doses distributed through its Pharmacy Partnership
for Long-Term Care Program (LTC pharmacy program). The LTC pharmacy program ended on April
23, 2021.

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Although the federal government distributed the majority of vaccine doses
through states and other jurisdictions when COVID-19 vaccine
implementation began, this changed over time. For example, between
April and July 2021, the proportion of vaccine doses distributed through
states and other jurisdictions decreased from 62 percent in early April
2021, to 6 percent in mid-July 2021. During that same time, the proportion
of vaccine doses distributed through CDC’s retail pharmacy program
increased from 29 percent to 92 percent, according to our analysis. 33

CDC’s Efforts to Inform
Health Officials, Health
Care Providers, and the
Public about COVID-19
Vaccination

Before COVID-19 vaccine implementation began, CDC took steps to
inform jurisdictional health officials, health care providers, and the public
about COVID-19 vaccines. For example, CDC created its first COVID-19
Vaccine Toolkit in November 2020. 34 The agency created several other
Toolkits targeted to various audiences, such as health care providers,
health centers, pharmacies, and schools, which included materials for
communicating about the potential and known benefits, safety, side
effects, and effectiveness of COVID-19 vaccines. In addition, CDC
partnered with the Ad Council to create public service announcements to
encourage vaccination. 35 Providing information on safety and efficacy is
important to help inform the public about COVID-19 vaccines and to
address any concerns about vaccination. 36

33Our analysis compared the proportion of vaccine doses CDC reported as distributed
through the different federal vaccine distribution programs between April 1–18, 2021, and
July 8–23, 2021. Our analysis began in April 2021, because this is when CDC began
making data on COVID-19 vaccine doses distributed through the different federal vaccine
distribution programs publicly available. Our analysis ended in July 2021, because these
were the most recent data available at the time of our analysis.
34CDC also developed tools to help the public locate where COVID-19 vaccines were
available and to schedule a vaccination appointment—VaccineFinder and the Vaccine
Administration Management System (VAMS). See app. III for more information on these
tools.
35The Ad Council is a nonprofit and nonpartisan organization that uses advertising, media,
technology, and marketing to develop public service campaigns to raise awareness and to
solve social issues on a national scale.
36For example, one survey conducted between March and May 2021 found that most
people aged 18 to 39 years who responded that they probably or definitely would not get
vaccinated said it was because they did not trust COVID-19 vaccines or were concerned
about possible side effects. Brittney N. Baack et al., “COVID-19 Vaccination Coverage
and Intent among Adults Aged 18–39 Years—United States, March–May 2021,” Morbidity
and Mortality Weekly Report, vol. 70, no. 25 (2021).

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CDC also provided guidance on which segments of the population should
be prioritized for vaccination when initial vaccine supply was limited, when
the agency adopted ACIP’s recommendations. In December 2020, ACIP
recommended that COVID-19 vaccines be allocated through a phased
approach and identified broad priority groups that should be offered
COVID-19 vaccines first while vaccine supply was limited. 37 ACIP
recommendations generally serve as public guidance for safe use of
vaccines and states and other jurisdictions may adopt different
approaches.

State and Local
Health Officials and
Others Said Federal
Programs Helped
Higher-Risk
Populations Gain
Access to COVID-19
Vaccination, but Cited
Coordination
Challenges
Federal Programs Helped
Higher-Risk Populations
Gain Access to
Vaccination, according to
Selected Health Officials
and Other Stakeholders

The four federal distribution programs helped higher-risk populations gain
access to vaccinations and assisted with logistical aspects of
administering COVID-19 vaccines, according to selected state and local
health officials and other stakeholders we interviewed between late March
and early May 2021. (See fig. 4 for descriptions of the four programs.)

37ACIP is comprised of medical and public health experts who make recommendations on

the use of vaccines in the civilian population of the United States. To inform its policy
options, the committee established a COVID-19 Vaccines Work Group in April 2020,
comprised of experts in infectious diseases, vaccinology, vaccine safety, public health,
and ethics. The Work Group has held numerous meetings to review data regarding
vaccine candidates, COVID-19 surveillance, modeling of allocation scenarios, and vaccine
implementation issues.

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Figure 4: Four Federal Distribution Programs for COVID-19 Vaccination

Notes: This figure provides information on four federal vaccine distribution programs: (1) CDC’s
Pharmacy Partnership for Long-Term Care Program (LTC pharmacy program), (2) CDC’s Federal
Retail Pharmacy Program for COVID-19 Vaccination (retail pharmacy program), (3) HRSA’s Health

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Center COVID-19 Vaccine Program (health center vaccine program), and (4) FEMA’s Community
Vaccination Center Pilot Site and Mobile Vaccination Program (vaccination center pilot program).
CDC coordinated with HRSA on the health center vaccine program and with FEMA on the vaccination
center pilot program, but for the purposes of this report, we refer to these programs as HRSA- and
FEMA-operated vaccine distribution programs since these agencies were the primary agencies
responsible for implementing these programs.
In addition, the federal government allocated and distributed vaccine doses to five federal entities (the
Bureau of Prisons, Department of Defense, Department of State, Indian Health Service, and the
Veterans Health Administration). The federal government also allocated vaccine doses to the
Department of Health and Human Services/National Institutes of Health for a small program
managing doses allocated to federal departments and agencies for administration to critical
infrastructure personnel and made a one-time allocation of vaccine doses to the Federal Dialysis
Center Program to distribute to participating dialysis centers to administer vaccines to patients and
health care personnel.
a
A total of 62 jurisdictions—including all 50 states, the District of Columbia, three major cities
(Chicago, New York City, and Philadelphia), and eight territories (American Samoa, the Federated
States of Micronesia, Guam, the Marshall Islands, the Northern Mariana Islands, Palau, Puerto Rico,
and the U.S. Virgin Islands)—received allocations of COVID-19 vaccine doses, generally on a weekly
basis. Although there are 64 jurisdictions implementing COVID-19 vaccination and receiving federal
funding for these efforts, allocations of vaccine doses were made to 62 jurisdictions because two
major cities considered jurisdictions—Houston and San Antonio—had their allocations consolidated
with Texas.
b
According to CDC, social vulnerability refers to the potential negative effects on communities caused
by external stresses on human health, such as natural or human-caused disasters or disease
outbreaks.
c
Federally supported health centers generally receive Health Center Program grants from HRSA
under section 330 of the Public Health Service Act (42 U.S.C. § 254b) and provide primary care
services in medically underserved areas. Some organizations meet all Health Center Program
requirements but do not receive federal grant funding through the section 330 program. However,
these centers, which are known as “look-alikes,” receive other benefits, such as higher
reimbursement rates from the Medicare and Medicaid programs and may receive grants through
other federal programs. We use the term “federally supported health centers” to refer to both “lookalikes” and those health centers that receive grants under section 330 of the Public Health Service
Act.
d
On June 20, 2021, the last mass vaccination site under FEMA’s vaccination center pilot program
closed. However, after that date, the agency continued to support mobile vaccination units and
community vaccination centers managed and operated by states and other jurisdictions (using doses
allocated to the jurisdictions) by providing federal personnel, funding, and material, such as medical
equipment and supplies, according to agency officials.

•

Helped higher-risk populations gain access to vaccinations. The
four federal vaccine programs did well in distributing vaccine doses to
sites aimed at reaching populations at higher-risk for COVID-19,
according to selected state and local health officials. For example,
•

Page 20

CDC’s LTC pharmacy program helped state health departments
by facilitating the vaccination of higher-risk residents and staff of
long-term care facilities, according to some state and local health
officials. Some health officials said CDC’s LTC pharmacy program
made health care providers available to vaccinate residents and

GAO-22-104457 COVID-19 Vaccine Distribution and Communication


staff in long-term care facilities in their jurisdictions. 38 A few of
these officials said vaccinating these higher-risk residents and
staff would have otherwise been a large undertaking.
•

CDC’s retail pharmacy program and FEMA’s vaccination center
pilot program used CDC’s social vulnerability index, which
measures the relative vulnerability of the populations in every
Census tract. CDC’s retail pharmacy program used this index
when initially deciding which pharmacies to add, and FEMA’s
vaccination center pilot program used the index, in part, to select
mass vaccination sites. 39

•

Additionally, some stakeholders, including state and local health
officials, noted that federally supported health centers—which
provide primary care services in medically underserved areas—
added vaccination access points for populations at higher risk for
COVID-19 because they have limited access to care.

•

HRSA’s health center vaccine program and FEMA’s vaccination
center pilot program had flexibilities to provide more equitable
access to vaccination sites. For example, HRSA’s health center
vaccine program was helpful because participating health centers
in their area could schedule vaccination appointment times on
weekends or evenings, according to health officials from one local
health department. Officials from another local health department
told us FEMA officials worked with them to extend operating hours
to include early mornings, evenings, and Saturdays. These local
health officials said the extended hours allowed them to
administer up to 8,000 vaccinations a day at the FEMA site
instead of the up to 6,000 vaccinations a day typically
administered at this type of mass vaccination site. 40 (See fig. 5 for
photos of FEMA mass vaccination sites.) Additionally, health

38More than 62,000 long-term care facilities participated in CDC’s LTC pharmacy

program, according to CDC.

39CDC’s social vulnerability index further groups the 15 social factors into four related

themes: socioeconomic status, household composition and disability, race and ethnicity
and language, and housing type and transportation. Each Census tract receives a ranking
for each Census variable and for each of the four themes as well as an overall ranking.
Census tracts are subdivisions of counties for which the Census collects statistical data.
40Under FEMA’s vaccination center pilot program, vaccination centers were available in
five different types, generally depending on the approximate number of vaccinations that
could be administered each day. These included type 1 (approximately 6,000 vaccinations
per day), type 2 (approximately 3,000 vaccinations per day), type 3 (approximately 1,000
vaccinations per day), type 4 (approximately 250 vaccinations per day), and type 5
(approximately 250 vaccinations per day via mobile clinic).

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officials from two states we interviewed told us they used FEMA’s
mobile vaccination units, which provided access to vaccinations
by meeting individuals where they were located.
Figure 5: FEMA Vaccination Center Pilot Program Sites

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Note: On June 20, 2021, the last mass vaccination site under FEMA’s Community Vaccination Center
Pilot Site and Mobile Vaccination Program (vaccination center pilot program) closed. However, after
that date, the agency continued to support mobile vaccination units and community vaccination
centers managed and operated by states and other jurisdictions (using doses allocated to the
jurisdictions) by providing federal personnel, funding, and material, such as medical equipment and
supplies, according to agency officials

•

Assisted with logistical aspects of COVID-19 vaccinations. Some
of the federal programs supported COVID-19 vaccinations by helping
jurisdictions with administrative and logistical aspects of administering
vaccines, according to state and local health officials we interviewed.
For example,
•

CDC’s retail pharmacy program helped state health departments
by allowing the federal government to enroll pharmacies as
COVID-19 vaccine providers, selected state health officials told
us. 41 For example, officials from one jurisdiction said CDC’s retail
pharmacy program enrolled as vaccine providers all 77
pharmacies located in the jurisdiction that belonged to one
pharmacy partner. Thus, officials from most state health
departments we interviewed said they did not have to enroll those
pharmacies as individual vaccine providers, easing an
administrative burden on state health departments.

•

DOD and National Guard personnel provided critical assistance
and efficient administration of vaccines for FEMA’s vaccination
center pilot program, according to selected state health officials
and other stakeholders. For example, such personnel provided
traffic control and security, and helped to set up mass vaccination
sites, including for FEMA’s vaccination center pilot program. (See
fig. 6.) Because mass vaccination sites require a large number of
staff to operate, the availability of DOD and National Guard
personnel was critical to their operation, according to two state
health officials. According to DOD, at the highest point of support
by DOD active-duty personnel in the week of April 23–30, 2021,
4,731 active-duty personnel were supporting vaccination sites in
over 25 states and territories. DOD reported that by June 22,
2021, active-duty personnel had administered about 5 million
vaccinations.

41Health care providers who want to administer COVID-19 vaccines have to enroll either

through their jurisdictional immunization program (as part of CDC’s COVID-19 Vaccination
Program) or through the federal program in which they are participating. To enroll in these
programs, providers have to, among other things, sign the respective program’s provider
agreement.

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In addition, health officials from most of the states in our review reported
that the National Guard supported vaccine distribution and administration
efforts. Additionally, two stakeholders representing health care providers
said these personnel helped to efficiently administer vaccines at FEMA
sites when demand for vaccinations was high. 42 As of July 22, 2021, over
21,000 National Guard personnel had assisted with vaccine-related
activities, such as distributing vaccines, providing transportation support,
and administering vaccines at 721 vaccination sites, according to DOD.

42Before vaccine distribution began, stakeholders representing state and local health
officials noted the importance of considering if uniformed military vaccinators would
improve or undermine confidence in a COVID-19 vaccine, particularly among certain racial
and ethnic groups and underserved communities where trust in government is strained.
However, some stakeholders we interviewed said this concern was important to note, but
did not use or experience issues with using military personnel.

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Figure 6: DOD and National Guard Personnel Provide Assistance at FEMA Vaccination Sites

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In addition, the federal government’s expansion of liability protections to
additional categories of personnel for administering COVID-19 vaccines
was helpful, according to some local health officials and representatives
of health care providers we interviewed. 43 Specifically, in March 2021,
HHS authorized additional categories of personnel to dispense and
administer COVID-19 vaccines, with liability protections under the Public
Readiness and Emergency Preparedness Act, including dentists,
emergency medical technicians, optometrists, and others. 44
Representatives of health care providers in one state told us that it was a
burden for facilities to pull nurses out of direct patient care to administer
vaccines and that having the flexibility on who could provide vaccinations
was important to make sure their facilities could vaccinate as many
people as possible and remain in operation.

Stakeholders Identified
Challenges Coordinating
with Federal Vaccine
Distribution Programs that
Eased as Vaccine Supply
Increased and as States
and CDC Made
Adjustments

Initially when vaccine supply was limited, state and local health officials
faced challenges coordinating their vaccine-related efforts with the four
federal vaccine programs, according to state and local health officials and
other stakeholders we interviewed. Selected state and local health
officials said they had to spend time and resources answering questions
from the public and program participants about some of the federal
programs, which officials from one state said further burdened their
already limited staff and resources. However, as these vaccine
distribution programs continued operating and vaccine supply increased
in the spring of 2021, these coordination challenges eased. State and
local health officials, representatives of health care providers, and other
stakeholders we interviewed reported the following examples of the
challenges they experienced coordinating with the federal programs:
•

Limited initial information on where vaccine doses were
allocated and amounts allocated. State and local health officials,
health care providers, and other stakeholders said they had limited or
no information about where vaccine doses were going or the amounts
of doses allocated through CDC’s retail pharmacy program and

43Some stakeholders we interviewed said additional health care providers available to
administer vaccines did not address the vaccination challenge of a limited vaccine supply.
44Under this act, licensed health professionals and other individuals authorized to
administer a countermeasure under state law are protected from liability under federal and
state law for administering covered countermeasures against COVID-19, including the
COVID-19 vaccines. HHS may identify additional categories of persons, known as
“qualified persons”, to be afforded such protections. See Pub. L. No. 109-148, div. C, 119
Stat. 2680, 2818 (2005) (codified as amended at 42 U.S.C. §§ 247d-6d et seq.). See
HRSA Notice, 86 Fed. Reg. 14462 (Mar. 16, 2021).

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HRSA’s health center vaccine program when these programs were
initiated. Some of these officials told us the limited information on
where vaccine doses were going made it difficult for states to
optimally and equitably allocate and distribute their own limited supply
of vaccine doses. 45 In some cases, a state’s distribution of doses to a
HRSA-supported health center was already high and additional
federal doses provided under HRSA’s health center vaccine program
resulted in more doses being distributed than the health center could
administer in a timely manner, according to most state health officials
we interviewed.
For CDC’s retail pharmacy program, most state health officials we
spoke with reported experiencing challenges with determining which
pharmacy sites would receive vaccine doses from the program’s
pharmacy partners (i.e., the 21 national pharmacy partners and
independent pharmacy networks). For example, pharmacy partners in
one state chose to distribute vaccine doses to pharmacy sites the
state had not identified as priorities because they were located in
areas with a sufficient number of existing vaccine providers. Health
officials in the state said they had to negotiate with pharmacy partners
participating in CDC’s retail pharmacy program to send vaccine doses
to pharmacy sites in higher-need areas of their state.
Additionally, representatives of health care providers said their
members often did not know which pharmacies had received vaccine
doses when CDC’s retail pharmacy program was initiated, so health
care providers were unable to refer their patients to pharmacies with
available vaccine doses. As vaccine supply increased and there were
enough vaccine doses available for all of the federal vaccine
distribution programs, information on where vaccine doses were
allocated and the amounts allocated became less important. On June
24, 2021, the federal government stopped its weekly allocation of
COVID-19 vaccine doses to jurisdictions and federal vaccine
distribution programs, including CDC’s retail pharmacy program and
HRSA’s health center vaccine program, because vaccine supply had
increased to sufficient levels to meet the needs of jurisdictions and
other federal programs, according to federal officials.
•

Higher than needed vaccine allocation for LTC pharmacy
program. CDC overestimated the number of vaccine doses needed
for CDC’s LTC pharmacy program when vaccine supply was limited in

45As we reported in April 2021, this information was critical for vaccination planning,

especially when states were determining where to send their own allocated doses when
supply was limited and demand for vaccinations was high. See GAO-21-443.

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early 2021, according to state health officials we interviewed. For
example, health officials from one state said CDC set aside about
40,000 doses a week from their state’s overall allocation to be
allocated to the LTC pharmacy program. However, not all of the doses
were used by the LTC pharmacy program because the number of
residents and staff at long-term care facilities being vaccinated was
not as high as CDC had expected. These officials said the inability to
use those doses elsewhere affected their ability to vaccinate other
residents in their state in a timely manner. According to health officials
from another state, the higher-than-needed allocation of vaccine
doses to the LTC pharmacy program delayed other vaccination
efforts. These officials said their jurisdiction could not use the extra
doses until state health officials negotiated with pharmacy partners to
make the extra doses available for use by the jurisdiction instead of
the LTC pharmacy program. These negotiations affected the timely
availability of those vaccine doses when vaccine supply was limited.
Once states recognized the LTC pharmacy program had excess
vaccine doses, some state health officials we interviewed said they
worked with CDC to determine how to make available the extra
vaccine doses to other populations in their areas.
•

Lack of initial planning for continuing vaccinations at long-term
care facilities. Initially, CDC did not have a plan in place to vaccinate
new staff and residents of long-term care facilities who arrived after
the pharmacy partners had completed their three required clinics in
CDC’s LTC pharmacy program, according to selected stakeholders,
including jurisdictional and local health officials. Some of these
stakeholders said this was a challenge because of the frequent
turnover of patients and staff in long-term care facilities. For example,
local health officials from one health department said there were
outbreaks of COVID-19 in long-term care facilities after the LTC
pharmacy program had concluded, when new patients who were not
vaccinated were admitted to the facilities. In mid-March 2021, CDC
began working with four pharmacy partners to provide a direct
allocation of vaccine doses to long-term care pharmacies participating
in CDC’s retail pharmacy program.

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Health Officials and
Others Said Federal
Efforts to Inform
about Vaccination
Were Helpful, but
Cited Challenges
Implementing
Recommendations on
Priority Groups
State and Local Health
Officials and Other
Stakeholders Said CDC’s
Education Materials about
Vaccination Were Useful,
but Would Have Liked the
Information Sooner

CDC’s education materials were useful in informing health officials, health
care providers, and the public about COVID-19 vaccination, according to
selected state and local health officials and other stakeholders. CDC’s
education materials included its COVID-19 Vaccine Toolkits, public
service announcements, print advertisements, and other online resources
that the agency released starting in late-November 2020.
State and local health officials and other stakeholders we interviewed
reported the following benefits of CDC’s education materials:
•

CDC’s online, education materials, including its Toolkits,
addressed COVID-19 vaccine safety concerns. CDC’s online,
educational materials helped state and local health officials and health
care providers address the public’s concerns about the safety of
COVID-19 vaccines, according to selected health officials and other
stakeholders. For example, to inform health care providers and the
public about vaccination, CDC produced several COVID-19 Vaccine
Toolkits. (See table 1.) These Toolkits were useful for health care
providers to discuss COVID-19 vaccines with patients, according to
representatives of providers from selected state hospital and medical
associations we interviewed.

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Table 1: COVID-19 Vaccination Toolkits Published by CDC, November 2020 to October 2021
Toolkit title
Target audience and purpose

Initial publication date

Recipient Education Toolkit
For health care providers and workers to educate people getting vaccinated about the importance of
COVID-19 vaccination

November 25, 2020

Vaccination Communication Toolkit
For health centers, pharmacies, and health care providers to build confidence in COVID-19 vaccination
among health care staff

December 9, 2020

Long-Term Care Facility Vaccination Toolkit
For the leadership and administrators of long-term care facilities to inform staff, residents and their families
about COVID-19 vaccinations in long-term care facilities

December 30, 2020

Essential Worker Vaccination Toolkit
For employers of essential workers to help plan for and inform employees about COVID-19 vaccination

January 15, 2021

Community-Based Organization Vaccination Toolkit
For staff of organizations serving communities to educate communities about COVID-19 vaccination and
address common questions and concerns

January 15, 2021

School Settings and Childcare Programs Toolkit
For education and childcare professionals to provide information about COVID-19 vaccines and increase
confidence in vaccines among education and childcare staff

March 8, 2021

Health Departments and Public Health Partner Vaccination Toolkit
For health departments and public health officials to educate and inform communities about COVID-19
vaccination

April 2, 2021a

Source: GAO summary of the Centers for Disease Control and Prevention (CDC) information. | GAO-22-104457
a
As of October 22, 2021, this Toolkit was the most recent one specific to COVID-19 vaccination
published by CDC on the agency’s website.

CDC also produced other materials, such as online resources, about
COVID-19 vaccines’ safety and effectiveness and the potential for allergic
reactions, which multiple stakeholders used to inform the public about
vaccination. For example, officials from one local health department said
this information was helpful when answering questions from the public
about health and safety concerns about receiving a vaccine while
pregnant. 46 CDC also created materials to help address misinformation,
which included information on how to find credible resources about

46On August 11, 2021, CDC recommended COVID-19 vaccination for people who are
pregnant, breastfeeding, trying to become pregnant, or might become pregnant in the
future. See Department of Health and Human Services, Centers for Disease Control and
Prevention, “COVID-19 Vaccines While Pregnant or Breastfeeding,” (Atlanta, Ga.: Aug.
11, 2021), accessed Aug. 19, 2021,
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html.

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COVID-19 Vaccination Public Service
Announcements
In November 2020, CDC, the Department of
Health and Human Services, and other
stakeholders partnered with the Ad Council to
inform the public about COVID-19 vaccination
by providing information about available
vaccines and the benefits of vaccination. The
partnership used research about the public’s
intentions to be vaccinated to guide its
messaging, among other considerations. The
public service announcements were released
to the public starting in February 2021. Many
announcements were available in Spanish
and English to reach greater proportions of
the public and were released as video ads,
radio ads, print, and on other mediums.

COVID-19 vaccines. 47 Multiple stakeholders reported using such
materials to inform hard-to-reach populations about the safety of available
COVID-19 vaccines.
•

Public service announcements promoted COVID-19 vaccination.
The public service announcements created by CDC and the Ad
Council were helpful in informing the public about COVID-19
vaccination, according to state and local health officials we
interviewed. (See side bar.) These announcements were particularly
helpful because local governments did not always have the resources
to create such messages to inform the public about vaccination,
according to selected state and local health officials. These
announcements targeted specific groups and provided information on
the different reasons for getting vaccinated. For example, one
announcement targeted those who might not consider getting
vaccinated against COVID-19 as important for themselves by
encouraging them to get vaccinated for others, such as their family
members. Another announcement featured country music stars
talking about the importance of vaccination and was directed at those
who admire such celebrities.

•

CDC’s materials could be tailored to reach specific communities.
CDC’s education materials have been useful because they could be
easily modified to meet the needs of particular communities,
according to state and local health officials and other stakeholders we
interviewed. For example, officials from a national association
representing American Indian and Alaska Native populations reported
using CDC education materials to develop culturally appropriate
messages for their communities. State and local health officials we
interviewed similarly reported modifying federal education materials to
disseminate specific messages to encourage vaccination among
specific communities in their respective areas. CDC also provided
translations of various federal education materials, such as
information about the different COVID-19 vaccines available and
frequently asked questions, which were helpful, according to health
officials from one state. (See fig. 7.) Health officials said these

Examples included:
Well-known children’s television characters
discussing the benefits of vaccination.
The experience of hugging loved ones again
after vaccination.
Former U.S. presidents discussing their
motivations to get vaccinated.
Information about how vaccines provide
protection against COVID-19.

Screenshot of a televised video that are part of CDC and the
Ad Council’s COVID-19 vaccine education campaign.
Source: GAO summary of information from the Centers for
Disease Control and Prevention (CDC) and the Ad Council. |
GAO-22-104457

47CDC defines misinformation as false information shared by people not intending to
mislead others, and disinformation as false information shared by people with the intent to
mislead others. See Department of Health and Human Services, Centers for Disease
Control and Prevention, “How to Address COVID-19 Vaccine Misinformation,” accessed
August 19, 2021,
https://www.cdc.gov/vaccines/covid-19/health-departments/addressing-vaccine-misinform
ation.html.

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materials allowed their staff to provide information about COVID-19
vaccination to greater proportions of the public, including higher-risk
populations. 48
Figure 7: Examples of Federal Education Materials about COVID-19 Vaccines in Multiple Languages

48In our work examining the federal response to the H1N1 influenza pandemic, we found
that education materials and other vaccination information were more effective when
available in multiple languages in order to reach some non-English speaking populations.
See GAO-11-632.

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Vaccinate with Confidence Strategic
Framework
In 2019, CDC developed its Vaccinate with
Confidence strategic framework to help build
confidence in vaccines generally and help
prevent outbreaks of vaccine-preventable
diseases in the United States. CDC explained
that this was a new approach with three key
priorities to increase confidence in vaccines:
•

protecting at-risk communities,

•

empowering families with information
about vaccines, and

•

stopping myths about vaccines.

According to CDC, vaccine confidence is the
trust that patients, their families, and health
care providers have in recommended
vaccines, providers who administer vaccines,
and the processes and policies that lead to
vaccine development, licensure or
authorization, manufacturing, and
recommendations for use.
In late 2020, CDC tailored its Vaccinate with
Confidence strategic framework to provide
specific information about COVID-19
vaccines to health care providers and the
public. In this specific framework, CDC
prioritized
•

building trust in the vaccine, health care
providers, and public health officials;

•

promoting confidence in the vaccine
among health care personnel; and

•

engaging communities and individuals in
equitable and inclusive ways.

Source: GAO summary of Centers for Disease Control and
Prevention (CDC) information | GAO-22-104457

•

CDC’s strategic framework and consultations informed state
communication strategies about COVID-19 vaccination. Selected
state health officials also reported using CDC’s Vaccinate with
Confidence strategic framework and consultations in developing
community-specific messaging strategies to inform health care
providers and the public about vaccination. (See sidebar.) As of July
2021, CDC provided 23 states with a “Confidence Consult” at the
request of those states to identify potential strategies to improve
vaccine confidence in their states. 49 For example, health officials from
one state said they used the results from a CDC consultation to
address communities’ concerns about COVID-19 vaccination. These
officials organized smaller community- and faith-based vaccination
events after learning this was an effective way of communicating. The
public tends to trust information about vaccines from local leaders and
community members, according to state and local health officials we
interviewed. 50

However, state and local health officials and other stakeholders indicated
that CDC’s education materials were not always available when it would
have been most helpful. CDC began releasing its COVID-19 Vaccine
Toolkits in late November 2020. These Toolkits would have been more
useful if CDC had released them earlier so health officials and health care
providers could have used them to discuss COVID-19 vaccines with the
public earlier, according to selected health officials and other
stakeholders. For example, health officials from one state health
department said it would have been helpful for providers to have some
materials in early fall 2020 to provide information about vaccination to
their patients before COVID-19 vaccine distribution and administration
began in December 2020. Having information about COVID-19 vaccines
earlier, such as information on the development and authorization
process, might have made some health care providers more comfortable
promoting vaccinations and might have increased some individuals’
49If requested, CDC will provide state and local health departments with Confidence
Consults in which the agency examines and develops solutions to increase confidence in
COVID-19 vaccine. As of July 2, 2021, CDC reported it had completed 23 Confidence
Consults. CDC may offer state and local health departments additional support through
rapid community assessments and Vaccine Confidence Bootcamps, both of which aim to
create specific strategies to increase confidence and COVID-19 vaccinations.
50Experts have also suggested that some individuals may be more likely to get vaccinated
if recommended by a trusted figure. See, for example, National Academies of Sciences,
Engineering, and Medicine, Strategies for Building Confidence in the COVID-19 Vaccines,
(Washington, D.C.: Feb. 3, 2021) and Scott Ratzan et al., “Missing the Point—How
Primary Care Can Overcome Covid-19 Vaccine Hesitancy,” The New England Journal of
Medicine, vol. 384, no. 100 (2021).

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comfort with the vaccines when they became available, according to
some stakeholders.
According to CDC, the agency timed the release of education materials to
coordinate with ACIP’s December 2020 release of recommendations for
priority groups and target groups and based on the vaccination rates of
specific communities. For example, CDC reported it released the Toolkit
for long-term care facility workers in late December 2020 because ACIP’s
recommendations prioritized these workers for early vaccination efforts
around that time.

Health Officials and Others
Reported Challenges
Implementing Federal
Recommendations on
Vaccine Priority Groups

In December 2020, as vaccines were first becoming available, CDC
adopted ACIP’s recommendations on whom state and local health
officials should prioritize and target with initial doses when vaccine supply
was limited. 51 According to CDC, the ACIP recommendations were
designed to be fluid and to allow states and local health departments to
adapt the recommendations to meet their specific needs.
Selected state and local health officials told us that health care providers
and the public were confused about when and where to get vaccinated in
part because of federal changes regarding ACIP’s recommended priority
groups and differences among states and other jurisdictions on who
should be prioritized and targeted for vaccination. In particular,
•

States and localities were not given advanced notice about
federal changes regarding priority groups. Selected stakeholders,
including state and local health officials, reported they were not given
advanced notice when the federal government made changes on
prioritizing and targeting COVID-19 vaccines. (See table 2.) Having
advanced notice of federal changes would have given them time to
better adjust their vaccination plans and to prepare how to answer
questions from health care providers and the public. For example,
officials from a state association representing health care providers
reported their members did not always know whom to prioritize for
vaccination after federal changes were made. Health officials from
one jurisdiction stated that while they understood why eligibility
changes were recommended, they would have appreciated having
this information before the public was told in order to explain how
these changes affected vaccine availability in their communities. For

51ACIP recommendations for COVID-19 vaccines were reviewed by the CDC Director and

were published as official HHS/CDC recommendations in the Morbidity and Mortality
Weekly Report.

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example, not having this information sooner made it challenging for
health officials and health care providers to manage the public’s
expectations about when individuals could get vaccinated while
information from the federal government about who should be eligible
kept changing, according to selected stakeholders we interviewed.
Table 2: Examples of Changes in Information from the Federal Government on Prioritizing and Targeting COVID-19 Vaccines
between December 2020 and March 2021
Date

Event

December 1, 2020

CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that for the initial phase of
vaccine implementation (phase 1a) when vaccine supply was limited, vaccines be offered to those at risk
of contracting COVID-19, which included (1) health care personnel and (2) residents of long-term care
facilities.a

December 20, 2020

CDC’s ACIP recommended that after phase 1a, vaccines should be offered in phase 1b to: (1) persons
aged 75 years and older and (2) frontline essential workers (non-health care) and in phase 1c to: (1)
persons aged 65-74 years, (2) persons aged 16-64 years with high-risk medical conditions, and (3) other
essential workers.b For phase 2, ACIP prioritized all people at least 16 years of age not yet recommended
for vaccination in phase 1.

January 12, 2021

The Secretary of Health and Human Services announced at a press briefing that jurisdictions should open
vaccination to all persons age 65 and older and all people under age 65 with a documented co-morbidity.

January 21, 2021

The White House released a national strategy for the COVID-19 response that encouraged states and
other jurisdictions to open vaccination to persons age 65 years and older and essential workers.c

March 2, 2021

The President directed states to prioritize educators for vaccination with a goal of every educator, school
staff member, and childcare worker receiving at least one shot by the end of March, using CDC’s Federal
Retail Pharmacy Program for COVID-19 Vaccination.

March 11, 2021

The White House announced in a press release that it was directing states, tribes, and territories to make
all adults (those aged 18 years and older) in the United States eligible to receive a COVID-19 vaccine by
May 1, 2021.

Source: GAO analysis of Centers for Disease Control and Prevention (CDC) information and press releases by the White House and Department of Health and Human Services. | GAO-22-104457
a
ACIP defines health care personnel as paid and unpaid persons serving in health care settings who
have the potential for direct or indirect exposure to patients or infectious materials. Long-term care
facility residents are defined as adults who reside in facilities that provide a range of services,
including medical and personal care, to persons who are unable to live independently. See Kathleen
Dooling et al., “The Advisory Committee on Immunization Practices’ Interim Recommendation for
Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020,” Morbidity and Mortality
Weekly Report, vol. 69, no. 49 (2020).

For the purposes of ACIP’s recommendations, non-health care frontline essential workers include
firefighters, police officers, corrections officers, food and agricultural workers, U.S. Postal Service
workers, manufacturing workers, grocery story workers, public transit workers, those who are in the
education sector (teachers and support staff) as well as daycare workers. According to CDC, about
49 million persons, including non-health care frontline essential workers and individuals aged 75
years and older were recommended for vaccination in phase 1b, and an additional 129 million
persons were recommended for vaccination in phase 1c (including about 28 million individuals aged
65 through 74 years). See Kathleen Dooling et al., “The Advisory Committee on Immunization
Practices’ Updated Interim Recommendation for Allocation of COVID-19 Vaccine—United States,
December 2020, “ Morbidity and Mortality Weekly Report, vol. 69, no. 51-52 (2021).

b

c
White House, National Strategy for the COVID-19 Response and Pandemic Preparedness
(Washington, D.C.: Jan. 21, 2021).

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•

Health care providers were uncertain whom to vaccinate because
states and jurisdictions differed in their implementation of
federal recommendations for vaccine priority groups. Health care
providers and the public were confused about who was eligible to be
vaccinated, especially when vaccine supply was limited, according to
selected health officials and other stakeholders. For example,
stakeholders representing health care providers reported their
members received conflicting information about who was eligible for
vaccination, which affected their ability to vaccinate particular groups
because they did not always know whom to vaccinate. Further,
variation among states’ target groups affected the public’s confidence
in COVID-19 vaccination because they received inconsistent
information about when they were eligible for vaccination, according
to one stakeholder we interviewed.
We previously reported similar issues regarding variation among
states and who they prioritized for vaccination during the 2009 H1N1
pandemic. 52 At that time, we noted that state and local health officials
appreciated the flexibility in being able to modify ACIP
recommendations to meet state and local needs, but that the variation
also caused confusion. Similarly, state and local health officials from
one state noted their appreciation for ACIP’s COVID-19 vaccine
recommendations. For example, these state health officials said the
recommendations were useful to communicate with the public about
prioritization for vaccines. However, officials from a state association
representing health care providers said there was more confusion
regarding eligibility for COVID-19 vaccination because they were
trying to vaccinate more people for COVID-19 and the risk for not
doing so was greater compared to the 2009 H1N1 pandemic.

52See GAO-11-632.

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HHS Agencies Intend
to Complete After
Action Reviews to
Identify Lessons
Learned, but Are
Uncertain about
Plans to Incorporate
Information from, and
Share Results with,
Stakeholders

Two HHS component agencies involved in COVID-19 vaccine
implementation—CDC and HRSA—told us that they intend to conduct
after action reviews to identify lessons learned from their COVID-19
vaccine distribution and communication efforts. Specifically,
•

CDC noted that its Center for Preparedness and Response’s Division
of Emergency Operations, in collaboration with CDC subject matter
experts, plans to develop an agency-wide COVID-19 after action
review. Historically, such reviews have included lessons learned and
recommendations for making improvements within its areas of
responsibility, according to CDC. CDC indicated that its review will
entail gathering information from CDC responders that participated
throughout the duration of the response as well as collaborating with
interagency partners, such as FEMA and the HHS/DOD partnership
(formerly known as Operation Warp Speed).
However, as of August 2021, CDC had not identified the specific
topics related to vaccine distribution and communication that it intends
to include in its review, or to what extent, if any, it plans to gather
feedback or perspectives from external stakeholders, such as state
and local health officials and providers. CDC explained that typically,
its reviews are primarily focused on internal response operations and
that coordinating with other departments and agencies may occur
once topics are finalized. Additionally, CDC indicated that its review
would result in a final report that would be vetted through leadership,
but it would be for internal use only; the agency did not indicate plans
to share the final report with key stakeholders outside CDC.

•

HRSA stated that it plans to conduct an after action review and
develop a final report documenting successful strategies, challenges,
recommendations and considerations for future public health
emergencies. HRSA noted that since the inception of its health center
vaccine program, it has regularly used available data, including
program survey data; vaccine allocation, distribution, and
administration data; and stakeholder feedback to assess and
continuously improve the program’s operations in real time. In
conducting an after action review, HRSA stated that it anticipates that
any findings would be informed by and shared as appropriate with the
CDC and health center programs as well as key rural health and other
stakeholders. However, as of August 2021, the agency did not specify
whether state and local health officials would be included as
stakeholders in this effort, how it was maintaining such feedback for
the purposes of an after action review, or what specific topics would
be covered related to vaccine distribution and communication.

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CDC and HRSA did not provide additional details on their forthcoming
after action reviews because, according to agency officials, they have yet
to finalize their plans for conducting such reviews. Officials from both
agencies explained that they have yet to do so, because they are still
involved in the pandemic response. The agencies indicated they would
initiate their reviews once the public health emergency ends or, in the
case of HRSA, when the health center vaccine program and rural health
clinic vaccine program end, if that occurs before the end of the public
health emergency.
Federal internal control standards state that management should
externally communicate the necessary quality information to achieve an
entity’s objectives, such as by obtaining quality information from external
parties so those external parties can help the entity achieve its objectives
and address related risks. 53 Additionally, as we have previously reported,
The Standard for Program Management, produced by the Project
Management Institute, Inc., states that program managers should actively
engage key stakeholders throughout the life cycle of a program, which
would include evaluation activities, such as completing after action
reviews. 54 State and local health officials were key stakeholders in
COVID-19 vaccine distribution and communication efforts as they were
responsible for critical tasks, such as receiving vaccine allocations from
the federal government; identifying the providers in their communities to
receive and administer available doses; and communicating with health
care providers and the public about vaccination.
Given the challenges state and local health officials and other
stakeholders have faced throughout COVID-19 vaccine implementation,
and especially early on when vaccine supply was limited, obtaining
stakeholder perspectives to inform the after action review process would
provide valuable information to CDC and HRSA. For example, as
previously noted, when supply was limited, state and local health officials
often were not aware of the number of vaccine doses being allocated to
vaccination sites within their jurisdictions through federal programs, which
affected the officials’ ability to plan where to send their own allocated
doses. Gathering perspectives from key stakeholders on challenges such
53GAO-14-704G.
54See GAO, Disaster Response: HHS Should Address Deficiencies Highlighted by Recent
Hurricanes in the U.S. Virgin Islands and Puerto Rico, GAO-19-592 (Washington, D.C.:
Sept. 20, 2019). Project Management Institute, Inc., The Standard for Program
Management, Fourth Edition, 2017.

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as these—encompassing federal distribution and administration activities
as well as efforts to inform the public about COVID-19 vaccination
throughout the life cycle of the response—would provide CDC and HRSA
with a more comprehensive understanding of what worked well and areas
for improvement to inform future efforts. Gathering this information as the
pandemic response is ongoing is particularly important because these
stakeholder perspectives could be lost or forgotten over time as vaccine
implementation continues.
Moreover, given the highly complex undertaking involved with vaccine
implementation spanning multiple federal agencies and key stakeholders
across state and local governments and the private sector, sharing the
results of after action reviews and lessons learned with stakeholders is
equally imperative. 55 Any lessons learned or recommendations that CDC
and HRSA identify through their reviews may also be more broadly
relevant or applicable to other key stakeholders, such as state and local
governments, which were also instrumental in vaccine distribution and
communication activities. By sharing such information, stakeholders may
also be able to learn from and adjust their related efforts, critical to
ensuring an effective response for any additional vaccine efforts that may
be needed related to COVID-19 or in future pandemics.

Conclusions

The administration of COVID-19 vaccines across the nation has played a
vital role in the U.S. response to the pandemic. With the pandemic now
well into its second year, vaccination efforts remain critically important,
especially as the Delta variant has emerged and vaccines are anticipated
to be made available for children. Federal agencies, including CDC and
HRSA, have provided higher-risk populations access to vaccines through
the implementation of several federal programs. But, state and local
health officials and other stakeholders cited challenges, such as the
ability to consider federal efforts when making decisions for their own
vaccination programs, particularly when supply was limited.
CDC and HRSA plan to conduct after action reviews of their vaccine
distribution and communication efforts, which could provide valuable
information on any benefits, challenges, and lessons learned. However,
the agencies indicated they do not plan to undertake such reviews until
the end of the public health emergency or, in the case of HRSA, when
their vaccine distribution programs end, and it is uncertain whether their
55We previously reported on the importance of sharing the relevant findings of after action
reports with key stakeholders, such as state and local governments. GAO-11-632.

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plans will include gathering input from key stakeholders, such as state
and local health officials, or whether the results will be shared with such
stakeholders. By gathering perspectives throughout the life cycle of the
response from key stakeholders—including state and local health
officials—and incorporating their feedback as part of these reviews, CDC
and HRSA will help ensure they obtain a more comprehensive
understanding of what worked well and areas for improvement to inform
future efforts.
It is particularly important to gather stakeholder perspectives on an
ongoing basis, given the critical need to continue vaccination efforts,
including to address threats of any new variants or to vaccinate children if
those vaccines become available. Since agencies do not plan to complete
after action reviews until their federal response efforts or programs end,
obtaining key stakeholder perspective on an ongoing basis will help
ensure those perspectives will not be lost or forgotten by the time the
agencies conduct their reviews.
Moreover, by sharing the results of their reviews with such stakeholders,
CDC and HRSA will help ensure a successful and effective response
across federal, state, and local levels for any additional vaccine efforts
that may be needed in the future.

Recommendations for
Executive Action

We are making a total of four recommendations, including two to CDC
and two to HRSA:
•

As CDC finalizes its plans for an after action review related to its
COVID-19 vaccine distribution and communication efforts, the
Director of the Centers for Disease Control and Prevention should
ensure the agency obtains feedback during the life cycle of the
response from key stakeholders, including state and local health
officials, and incorporates their perspectives as it conducts its review.
(Recommendation 1)

•

The Director of the Centers for Disease Control and Prevention
should share relevant findings of its after action review related to
vaccine distribution and communication with key stakeholders, such
as state and local health officials, and other federal agencies, as
appropriate. (Recommendation 2)

•

As HRSA finalizes its plans for an after action review related to its
COVID-19 vaccine distribution and communication efforts, the
Administrator of the Health Resources and Services Administration
should ensure the agency obtains feedback during the life cycle of the

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response from key stakeholders, including state and local health
officials, and incorporates their perspectives as it conducts its review.
(Recommendation 3)
•

Agency Comments

The Administrator of the Health Resources and Services
Administration should share relevant findings of its after action review
related to vaccine distribution and communication with key
stakeholders, such as state and local health officials.
(Recommendation 4)

We provided a draft of this report to DOD, FEMA, and HHS for review and
comment. In written comments provided by CDC and HRSA through HHS
(reproduced in appendix IV), CDC and HRSA concurred with our
recommendations. In its written comments, HHS stated that the GAO
study provided valuable feedback on the implementation of CDC’s and
HRSA’s programs and that the agencies are committed to the continuous
improvement of their vaccine programs. CDC stated a timeline for an after
action review had not been established as it remains involved in the
COVID-19 response, and agreed the agency should share relevant
findings with key stakeholders, as appropriate, from its after action review
once it is completed. CDC also stated that in the meantime, it continues
to incorporate continuous feedback from stakeholders. HRSA stated that
it plans to incorporate feedback from key stakeholders in its after action
review and anticipates sharing results as appropriate with key
stakeholders, such as state and local health officials. HRSA also provided
technical comments, which we incorporated as appropriate. FEMA and
DOD stated they had no comments on the draft report.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Defense, the Administrator of FEMA, the
Secretary of Health and Human Services, and other interested parties. In
addition, the report is available at no charge on the GAO website at
http://www.gao.gov.

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If you or your staff have any questions about this report, please contact
Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov. Contact
points for our Offices of Congressional Relations and Public Affairs may
be found on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix V.

Alyssa M. Hundrup
Director, Health Care

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List of Addressees
The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate
The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate
The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate
The Honorable Gary C. Peters
Chairman
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate
The Honorable Rosa L. DeLauro
Chairwoman
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives

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The Honorable Frank Pallone, Jr.
Chair
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives
The Honorable Bennie G. Thompson
Chairman
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives
The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives
The Honorable Richard E. Neal
Chairman
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives

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Appendix I: COVID-19 Vaccines Authorized
in the United States, as of October 22, 2021
Appendix I: COVID-19 Vaccines Authorized in
the United States, as of October 22, 2021

As of October 22, 2021, three COVID-19 vaccines were available in the
United States. One vaccine was licensed by the Food and Drug
Administration (FDA) for individuals aged 16 years and older and was
also available to individuals aged 12 through 15 years under an
emergency use authorization (EUA). 1 An EUA allows for the temporary
use of vaccines without FDA licensure, provided certain statutory criteria
are met. 2 Two additional vaccines were authorized for emergency use for
individuals aged 18 years and older. 3 As of October 22, 2021, no
vaccines had been authorized or licensed for children under 12 years, but
one vaccine company (Pfizer) had requested that FDA authorize its
COVID-19 vaccine for children aged 5 years to 11 years. 4
On August 12, 2021, FDA amended the EUAs for two COVID-19
vaccines to allow for the use of an additional dose in certain
immunocompromised individuals, specifically in solid organ transplant
recipients or those who are diagnosed with conditions that are considered
1Typically, FDA must license a vaccine before it can be marketed in the United States.

See 42 U.S.C. § 262. On August 23, 2021, FDA licensed the COVID-19 vaccine
developed by Pfizer and BioNTech (marketed as Comirnaty) for the prevention of COVID19 disease. For the purposes of this report, we refer to the COVID-19 vaccine that Pfizer
and BioNTech developed together as the Pfizer vaccine.

2The Secretary of Health and Human Services may declare that circumstances,

prescribed by statute, exist justifying the emergency use of certain medical products, such
as vaccines. Once a declaration of an emergency has been made, FDA may temporarily
allow use of unlicensed vaccines through an EUA. For FDA to issue an EUA for a vaccine,
it must be reasonable to believe that the vaccine may be effective and that the known and
potential benefits of the vaccine outweigh the known and potential risks, among other
statutory criteria. See 21 U.S.C. § 360bbb-3. FDA has indicated that issuance of an EUA
for a COVID-19 vaccine for which there is adequate manufacturing information would
require a determination by FDA that the vaccine’s benefits outweigh its risks based on
data from at least one well-designed phase 3 clinical trial that demonstrates the vaccine’s
safety and efficacy in a clear and compelling manner.
Any COVID-19 vaccine that initially receives an EUA from FDA is expected to work toward
submission of a biologics license application, according to FDA guidance. See FDA,
Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry,
(Silver Spring, Md.: May 2021).

3On June 10, 2021, one vaccine company, Moderna, requested that FDA amend the EUA

for its COVID-19 vaccine for use in adolescents aged 12 years to 17 years; as of October
22, 2021, FDA had not issued a decision in response. The other authorized COVID-19
vaccine was developed by Janssen Pharmaceutical Companies, which is part of Johnson
& Johnson.

4As of October 22, 2021, FDA’s Vaccines and Related Biological Products Advisory

Committee was scheduled to meet on October 26, 2021, to discuss a request for
authorization of Pfizer’s COVID-19 vaccine for children aged 5 through 11 years.

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Appendix I: COVID-19 Vaccines Authorized in
the United States, as of October 22, 2021

to have an equivalent level of immunocompromise. 5 In September and
October 2021, FDA authorized a booster dose of either the Pfizer,
Moderna, or Janssen vaccine for certain populations. 6 In October 2021,
FDA also authorized “mix and match” for the booster dose—that is,
authorizing the use of any available COVID-19 vaccine for use as a
booster regardless of which COVID-19 vaccine was used as the primary
series or single-dose primary series.
The three available COVID-19 vaccines have varying storage
requirements that may affect the setting where each vaccine can be
administered. For example, some vaccine administration settings may not
have equipment, such as freezers, to store vaccine doses at ultra-cold
temperatures, the recommended storage method for the Pfizer vaccine. 7
Table 3 shows the age groups authorized for each of the three COVID-19
vaccines, as well as each vaccine’s dosing schedules, and storage and
handling requirements.
Table 3: COVID-19 Vaccines FDA Authorized for Emergency Use, as of October 22, 2021
Vaccine
company

Date FDA initially Individuals for whom
issued or
vaccine is permitted
amended EUAa
for emergency use

Storage requirements
Dosing and schedule (doses per vial and minimum lot size)

Pfizerb

12/11/2020

12 through 15 yearsc

2 doses, 3 weeks apart Stored frozen at ultra-cold temperaturesd

8/12/21

Certain
immunocompromised
individuals aged
12 years and oldere

1 dose, at least
28 days after the initial
2-dose regimenf

9/22/21

65 years and older; 18
through 64 years at high
risk of severe COVID19; 18 through 64 years
with frequent
institutional or
occupational exposure
to the virus that causes
COVID-19g

1 dose (booster) at
least 6 months after
the initial 2-dose
regimenh

Once thawed and diluted, must be used within
6 hours.
(6 doses per vial, minimum lot size 450 doses)

5According to CDC, an additional dose is administered when the initial immune response

following a primary vaccine series is likely to be insufficient.

6According to CDC, a booster dose is administered when the initial sufficient immune

response to a primary vaccine series is likely to have waned over time.

7Alternatively, Pfizer vaccine vials may be stored frozen at a slightly higher temperatures

of -13 to 5 degrees Fahrenheit for up to 2 weeks.

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Appendix I: COVID-19 Vaccines Authorized in
the United States, as of October 22, 2021

Moderna

Janssenj

12/18/2020

18 years and olderi

2 doses, 1 month apart Stored frozen, but may be refrigerated for up to 30
days once thawed.

8/12/21

Certain
immunocompromised
individuals aged
18 years and oldere

1 dose, at least
28 days after the initial
2-dose regimenf

10/20/21

65 years and older; 18
through 64 years at high
risk of severe COVID19; 18 through 64 years
with frequent
institutional or
occupational exposure
to the virus that causes
COVID-19

1 dose (booster) at
least 6 months after
the initial 2-dose
regimenh

2/27/2021k

18 years and older

1 dose

10/20/21

18 years and older

1 dose (booster) at
least 2 months after
completion of the
single-dose primary
regimenh

Once first dose is withdrawn from vial, other doses
must be used within 12 hours.
(2 vial sizes: maximum 11 doses per vial (range
10-11) or 15 doses per vial (range 13-15),
minimum lot size 10-multi-dose vials)

Refrigerated, but may be stored at room
temperature for up to 12 hours.
Once first dose is withdrawn from vial, other doses
may be stored at 36 to 46 degrees Fahrenheit for
up to 6 hours or at room temperature for up to
2 hours.
(5 doses per vial, minimum lot size 100 doses)

Source: GAO analysis of vaccine company and Food and Drug Administration (FDA) information. | GAO-22-104457
a
Typically, FDA must license a vaccine before it can be marketed in the United States. See 42 U.S.C.
§ 262. The Secretary of Health and Human Services may declare that circumstances, prescribed by
statute, exist justifying the emergency use of certain medical products, such as vaccines. Once a
declaration of an emergency has been made, FDA may temporarily allow use of unlicensed vaccines
through an emergency use authorization (EUA). For FDA to issue an EUA for a vaccine, it must be
reasonable to believe that the vaccine may be effective and that the known and potential benefits of
the vaccine outweigh the known and potential risks, among other statutory criteria. See 21 U.S.C. §
360bbb-3. FDA has indicated that issuance of an EUA for a COVID-19 vaccine for which there is
adequate manufacturing information would require a determination by FDA that the vaccine’s benefits
outweigh its risks based on data from at least one well-designed phase 3 clinical trial that
demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.

Any COVID-19 vaccine that initially receives an EUA from FDA is expected to work toward a
submission of a biologics license application, according to FDA guidance. See Department of Health
and Human Services, Food and Drug Administration, Emergency Use Authorization for Vaccines to
Prevent COVID-19: Guidance for Industry, (Silver Spring, Md.: May 2021). On August 25, 2021,
Moderna announced completion of its submission of a biologics license application to FDA. As part of
the application, Moderna requested the application be given priority review.
b
Pfizer and BioNTech developed this COVID-19 vaccine together, which for the purposes of this
report we refer to as the Pfizer vaccine. On August 23, 2021, FDA licensed the two-dose Pfizer
vaccine for those aged 16 years and older; this vaccine had been available for emergency use since
December 11, 2020. FDA licensed the Pfizer vaccine (marketed as Comirnaty) for the prevention of
COVID-19 disease. Under the authorization in effect at the time of licensure, the vaccine remains
available for adolescents aged 12 through 15 years.
c
On December 11, 2020, FDA authorized the Pfizer vaccine for emergency use in individuals aged 16
years and older, and on May 10, 2021, FDA amended the EUA to include adolescents aged 12-15
years.
d
Alternatively, Pfizer vaccine vials may be stored frozen at a slightly higher temperatures of -13 to 5
degrees Fahrenheit for up to 2 weeks. On May 19, 2021, FDA authorized an increased storage time
for thawed vials of Pfizer’s COVID-19 vaccine prior to dilution. Thawed, undiluted vials can be stored
in the refrigerator at 35 to 46 degrees Fahrenheit for up to 1 month. Previously, thawed, undiluted
vaccine vials could be stored in the refrigerator for up to 5 days.

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Appendix I: COVID-19 Vaccines Authorized in
the United States, as of October 22, 2021

e
According to FDA, immunocompromised individuals refers to solid organ transplant recipients or
those who are diagnosed with conditions that are considered to have an equivalent level of
immunocompromise.

According to CDC, an additional dose is administered when the initial immune response following a
primary vaccine series is likely to be insufficient.

f

g
FDA’s initial authorization included individuals18 through 64 years of age whose frequent institutional
or occupational exposure to the virus that causes COVID-19 put them at high risk of serious
complications, including severe COVID-19. On October 20, 2021, FDA amended the Pfizer EUA to
clarify that individuals aged 18 through 64 years with frequent institutional or occupational exposure
to the virus that causes COVID-19 were eligible for a booster dose, without reference to whether that
exposure put them at high risk of severe COVID-19.
h
According to CDC, a booster dose is a dose of vaccine administered when the initial sufficient
immune response to a primary vaccine series is likely to have waned over time. On October 20, 2021,
FDA amended the EUAs for COVID-19 vaccines to allow each of the available COVID-19 vaccines to
be used “mix and match” for the booster dose—that is, authorizing the use of any available COVID-19
vaccine for use as a booster dose regardless of which COVID-19 vaccine was used as the primary
series or single-dose primary series.

On June 10, 2021, Moderna requested that FDA amend the EUA for its vaccine to include
adolescents aged 12-17 years. As of October 22, 2021, FDA had not issued a decision in response.

i

j

Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

On April 13, 2021, the Centers for Disease Control and Prevention (CDC) and FDA recommended a
pause in the use of the Janssen vaccine so the agencies could review data involving six reported
U.S. cases of a rare and severe type of blood clot in individuals after receiving this vaccine. CDC and
FDA lifted the pause on April 23, 2021, following a safety review, and revised the Janssen vaccine
fact sheets for health care providers and recipients and caregivers to include information about the
risk.

k

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Appendix II: Timeline of Key Events Related
to COVID-19 Vaccine Implementation
through October 21, 2021
Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

Table 4: Timeline of Key Events Related to COVID-19 Vaccine Implementation, November 25, 2020 through October 21, 2021
Date

Event

November 25, 2020

CDC published its first COVID-19 Vaccination Toolkit for health care providers and workers on vaccine
recipient education. The Toolkit included quick references for COVID-19 vaccinators to share with those
being vaccinated, including information on the mRNA COVID-19 vaccines.

December 1, 2020

CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that for the initial phase of
vaccine implementation (phase 1a) when vaccine supply was limited, vaccines be offered to those at risk of
contracting COVID-19, which included (1) health care personnel and (2) residents of long-term care
facilities.a

December 2, 2020

CDC Director adopted ACIP’s recommendation for priority groups for the initial phase of the COVID-19
vaccine implementation.

December 10, 2020

FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss emergency use
authorization request for Pfizer vaccine. Committee voted to recommend the vaccine for emergency use.

December 11, 2020

Pfizer vaccine authorized for emergency use in individuals aged 16 years and older.b

December 12, 2020

Initial doses of Pfizer vaccine shipped to health care providers, as directed by states and other jurisdictions
and five federal entities (the Bureau of Prisons, Department of Defense, Department of State, Indian Health
Service, and the Veterans Health Administration).

December 14, 2020

First dose of COVID-19 vaccine administered; vaccine administration begins.

December 17, 2020

FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss emergency use
authorization request for the Moderna vaccine. Committee voted to recommend the vaccine for emergency
use.

December 18, 2020

Moderna vaccine authorized for emergency use in individuals aged 18 years and older.

December 20, 2020

CDC’s ACIP recommended that after phase 1a, vaccines should be offered in phase 1b to: (1) persons
aged 75 years and older and (2) frontline essential workers (non-health care) and in phase 1c to: (1)
persons aged 65-74 years, (2) persons aged 16-64 years with high-risk medical conditions, and (3) other
essential workers.c For phase 2, ACIP prioritized all people at least 16 years of age not yet recommended
for vaccination in phase 1.

December 21, 2020

CDC Director adopted ACIP’s updated recommendation for priority groups for the initial phase of the
COVID-19 vaccine implementation.

Week of December 21,
2020

Vaccine doses first distributed through CDC’s Pharmacy Partnership for Long-Term Care Program began.

January 11, 2021

CDC published an annex to its interim playbook for jurisdictions that provided new guidance and
considerations to jurisdictions regarding when and how to transition from vaccinating initial populations of
focus to increasing vaccinations among additional priority populations. It also included a framework for
balancing equitable access, service delivery, and vaccine demand; tools for engaging priority populations
and increasing vaccine confidence; and strategies for leveraging private-public partnerships.d

January 12, 2021

The Secretary of Health and Human Services announced at a press briefing that jurisdictions should open
vaccination to all persons age 65 and older and all people under age 65 with a documented co-morbidity.

January 21, 2021

The White House released a national strategy for the COVID-19 response that encouraged states and other
jurisdictions to open vaccination to persons age 65 years and older and essential workers.e

February 4, 2021

FEMA published the agency’s initial guidance on community vaccination centers.f

February 9, 2021

Vaccine doses first distributed through CDC’s Federal Retail Pharmacy Program for COVID-19 Vaccination.

February 12, 2021

DOD’s announced deploying first team of 222 personnel to support FEMA’s Community Vaccination
Centers Pilot Site and Mobile Vaccination Program.

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Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

Date

Event

February 15, 2021

First FEMA Community Vaccination Centers Pilot Site and Mobile Vaccination Program sites established in
Oakland and Los Angeles, California.

Week of February 22,
2021

Vaccine doses first distributed through HRSA’s Health Center COVID-19 Vaccine Program.g

February 27, 2021

Janssen vaccine authorized for emergency use in individuals aged 18 years and older.h

March 2, 2021

The President directed states to prioritize educators for vaccination with a goal of every educator, school
staff member, and childcare worker receiving at least one shot by the end of March, using CDC’s Federal
Retail Pharmacy Program for COVID-19 Vaccination.

March 11, 2021

The White House announced in a press release that it was directing states, tribes, and territories to make all
adults (those aged 18 years and older) in the United States eligible to receive a COVID-19 vaccine by May
1, 2021.

March 12, 2021

HHS authorized additional categories of personnel to dispense and administer COVID-19 vaccines,
including dentists, emergency medical technicians, optometrists, and others.i

March 29, 2021

The White House announced in a press release that (1) 90 percent of adults should be eligible for
vaccination by April 19, 2021 and (2) 90 percent of adults should have a vaccination site within 5 miles of
where they live.

April 9, 2021

Pfizer requested that FDA amend the EUA for its vaccine to include adolescents aged 12-15 years.

April 13, 2021

CDC and FDA recommended a pause in the use of Janssen vaccine so the agencies could review data
involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving this
vaccine.

April 23, 2021

CDC and FDA lifted the pause in the use of Janssen vaccine following a safety review, and revised the
Janssen vaccine fact sheets for health care providers and recipients and caregivers to include information
about the risk.

April 23, 2021

CDC’s Pharmacy Partnership for Long-Term Care Program ended.

May 1, 2021

CDC launched a national hotline (1-800-232-0233) to assist with scheduling appointments.

May 4, 2021

The White House announced efforts to make appointments for COVID-19 vaccinations more accessible. For
example, the President encouraged pharmacies participating in CDC’s retail pharmacy program to begin
offering walk-in appointments and redirected FEMA resources to support smaller vaccination sites and more
mobile clinics to meet people where they are instead of requiring them to come to a designated site to be
vaccinated.
The White House also announced the Vaccines.gov website to assist the public in finding vaccination
appointments.

May 7, 2021

Pfizer submitted a biologics license application with FDA for its COVID-19 vaccine for those 16 years and
older.

May 10, 2021

Pfizer vaccine authorized for emergency use for adolescents aged 12-15 years.

Week of May 17, 2021

HRSA’s Rural Health Clinic COVID-19 Program began (vaccine doses first distributed for this program).j

June 1, 2021

Moderna submitted a biologics license application for its COVID-19 vaccine for those 18 years and older.

June 2, 2021

The White House announced that June 2021 would be a “National Month of Action,” which included a
variety of events surrounding COVID-19 vaccinations. For example, the federal government entered into
partnerships with the private sector to facilitate vaccination, such as with Major League Baseball, which
offered on-site vaccinations at games and gave free tickets to those who were vaccinated.

June 10, 2021

Moderna requested that FDA amend the EUA for its vaccine to include adolescents aged 12-17 years.

June 20, 2021

FEMA’s Community Vaccination Centers Pilot Site and Mobile Vaccination Program ended.k

June 22, 2021

DOD halted deployment of active-duty servicemembers to support federal vaccination efforts.

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Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

Date

Event

July 1, 2021

HRSA’s Rural Health Clinic Vaccine Confidence Program began supporting vaccine outreach in rural
communities. Funding could be used for a variety of activities including conducting educational and
outreach efforts on the benefits and safety of vaccines, providing information to rural residents about how
and where to get vaccinated, and coordinating with existing vaccination sites and public health partners to
identify isolated populations.

July 6, 2021

The White House announced plans to mobilize COVID-19 surge response teams, federal personnel focused
on increasing vaccination rates in communities with low rates, by, for example, filling in gaps in staffing.

July 15, 2021

U.S. Surgeon General issued advisory warning about the threat of health misinformation to the U.S.
response to COVID-19, including preventing people from getting vaccinated.

July 16, 2021

FDA accepted Pfizer’s application requesting licensure for its COVID-19 vaccine and granted the application
priority review (meaning that FDA will aim to make a decision on the application within 6 months, compared
to the 10 months for standard review).

August 11, 2021

CDC recommended COVID-19 vaccination for people who are pregnant, breastfeeding, trying to become
pregnant, or might become pregnant in the future. CDC stated that there was no evidence that COVID-19
vaccines cause fertility problems in women or men.

August 12, 2021

HHS announced mandating COVID-19 vaccination for staff who serve in federally operated health care and
clinical research facilities and interact with, or have the potential to come into contact, patients. HHS staff
included employees, contractors, trainees, and volunteers as well as members of the U.S. Public Health
Service Commissioned Corps.

August 12, 2021

FDA amended both the Pfizer and Moderna EUAs to allow for the use of an additional dose in certain
immunocompromised individuals, specifically in solid organ transplant recipients or those who are
diagnosed with conditions that are considered to have an equivalent level of immunocompromise.l

August 13, 2021

ACIP recommended using an additional dose of Pfizer and Moderna COVID-19 vaccines in certain
immunocompromised individuals. CDC Director adopted ACIP’s recommendations.

August 16, 2021

Pfizer submitted phase 1 data to FDA to support the evaluation of a booster dose of its COVID-19 vaccine.m

August 18, 2021

HHS recommended booster shots for those that have received the Pfizer or Moderna vaccines, pending an
FDA review and ACIP recommendations. HHS said it was prepared to offer booster shots beginning the
week of September 20 and starting 8 months after an individual’s second dose.

August 18, 2021

The White House announced that HHS would develop new regulations requiring nursing homes to require
that all of their workers be fully vaccinated against COVID-19 as a condition of participating in the Medicare
and Medicaid programs.

August 23, 2021

FDA licensed the Pfizer vaccine for those aged 16 years and older (marketed as Comirnaty) for the
prevention of COVID-19 disease. The vaccine remained available under an emergency use authorization for
use in individuals aged 12 to 15 years.

August 25, 2021

Moderna submitted a completed biologics license application to FDA. As part of the application, Moderna
requested the application be given priority review.

September 1, 2021

Moderna initiated its submission of data to FDA for the evaluation of a booster dose of its COVID-19
vaccine.m

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Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

Date

Event

September 9, 2021

The White House announced that
•
HHS would develop regulations requiring health care workers in hospitals, home health care facilities,
or other medical facilities that treat Medicare and Medicaid patients be fully vaccinated;
•
the Department of Labor was developing an emergency rule to require all employers with 100 or more
employees to ensure their workforce were fully vaccinated or showed a negative COVID-19 test at least
once a week;
•
the Department of Labor would require employers with 100 or more workers to give those workers paid
time off to get vaccinated;
•
the President would sign an executive order requiring all executive branch federal employees be
vaccinated; and
•
the President would sign an executive order requiring all federal contractors be vaccinated.

September 17, 2021

FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss EUA request for a
booster dose of the Pfizer vaccine. Committee voted against recommending the authorization of a booster
dose for those aged 16 years and older citing data demonstrating an increased risk for adverse cardiac
events, particularly among males aged 16 to 17 years, and limited data on whether this risk may be
increased after a booster dose. Committee voted for recommending the authorization of a single booster
dose at least 6 months after completion of the primary series for use in individuals aged 65 years and
older.m

September 22, 2021

FDA amended the Pfizer EUA to allow for use of a single booster dose to be administered at least 6 months
after completion of the primary series in
•
individuals aged 65 years and older;
•
individuals aged 18 through 64 years at high risk of severe COVID-19; and
•
individuals aged 18 through 64 years whose frequent institutional or occupational exposure puts them
at high risk of serious complications of COVID-19 including severe illness.m

September 23, 2021

ACIP recommended a booster dose of the Pfizer vaccine at least 6 months after the completion of the
primary series for
•
individuals aged 65 years and older,
•
residents of long-term care facilities,
•
individuals aged 50 through 64 years with underlying medical conditions, and
•
individuals aged 18 through 49 years with underlying medical conditions, based on their individual riskbenefit analysis.m

September 24, 2021

CDC recommended the following groups should receive a booster dose of the Pfizer vaccine at least 6
months after the completion of a primary series:
•
individuals aged 65 years and older,
•
residents in long-term care settings, and
•
individuals aged 50 through 64 years with underlying medical conditions.
CDC also recommended the following groups may receive a booster dose of the Pfizer vaccine 6 months
after the completion of a primary series, based on their individual benefits and risks:
•
individuals aged 18 through 49 years with underlying medical conditions and
•
individuals aged 18 through 64 years who are at increased risk of COVID-19 exposure and
transmission because of occupational or institutional setting.m

October 5, 2021

Johnson & Johnson announced that it had submitted data for the Janssen COVID-19 vaccine to FDA for the
evaluation of a booster dose of its COVID-19 vaccine.m

October 6, 2021

Pfizer submitted a request to FDA to amend its EUA for its COVID-19 vaccine to include those aged 5
through 11 years.

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Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

Date

Event

October 14, 2021

FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss EUA request for a
booster dose of the Moderna vaccine. Committee voted to recommend authorizing a single booster dose to
be administered at least 6 months after completion of the primary series in
•
individuals aged 65 years and older;
•
individuals aged 18 through 64 years at high risk of severe COVID-19; and
•
individuals aged 18 through 64 years whose frequent institutional or occupational exposure puts them
at high risk of serious complications of COVID-19 including severe illness.m

October 15, 2021

FDA’s Vaccines and Related Biological Products Advisory Committee met to discuss EUA request for a
booster dose of the Janssen vaccine. Committee voted to recommend authorizing a single booster dose to
be administered at least 2 months after completion of the single-dose primary regimen in individuals aged
18 years and older.m

October 20, 2021

The White House announced a plan for distributing and communicating about COVID-19 vaccinations for
children aged 5 through 11 years, if authorized by FDA and recommended by CDC.n

October 20, 2021

FDA amended the Moderna EUA to allow for use of a single booster dose to be administered at least 6
months after completion of the primary series in
•
individuals aged 65 years and older;
•
individuals aged 18 through 64 years at high risk of severe COVID-19; and
•
individuals aged 18 through 64 years with frequent institutional or occupational exposure to the virus
that causes COVID-19.m
FDA amended the Janssen EUA to allow for use of a single booster dose to be administered at least 2
months after completion of the single-dose primary regimen in individuals 18 years of age and older
FDA authorized “mix and match” for the booster dose—that is, authorizing the use of any available COVID19 vaccine for use as a booster dose regardless of which COVID-19 vaccine was used as the primary
series or single-dose primary series.
FDA amended the Pfizer EUA to clarify that individuals aged 18 through 64 years with frequent institutional
or occupational exposure to the virus that causes COVID-19 were eligible for a booster dose, without
reference to whether that exposure put them a high risk of severe COVID-19.

October 21, 2021

ACIP recommended a booster dose of the Moderna vaccine at least 6 months after the completion of the
primary series and a booster dose of the Janssen vaccine at least 2 months after the completion of the
single-dose primary regimen, as authorized by FDA.m

October 21, 2021

CDC adopted ACIP’s recommendations, stating that individuals in the following groups who received the
Pfizer vaccine or the Moderna vaccine were eligible for a booster dose 6 months or more after their the
completion of a primary series:
•
individuals aged 65 years and older,
•
individuals aged 18 years and older living in long-term care settings,
•
individuals aged 18 years and older who have underlying medical conditions, and
•
individuals aged 18 years and older who work or live in high-risk settings.m
CDC also recommended a single booster dose to be administered 2 months or more after receiving the
Janssen single-dose primary regimen for individuals 18 years of age and older
CDC stated its recommendations allowed for the “mix and match” of a booster dose—that is, the use of any
available COVID-19 vaccine for use as a booster dose regardless of which COVID-19 vaccine was used as
the primary series or single-dose primary series.

Source: GAO analysis of information from the Department of Defense (DOD), the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), CDC’s ACIP,
the Federal Emergency Management Agency (FEMA), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), and transcripts of press conferences by White
House and HHS officials. | GAO-22-104457

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Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

Note: The timeline represents selected events related to COVID-19 vaccine implementation—
prioritizing, allocating, distributing, and administering vaccine doses—and federal communication
efforts from November 2020 through October 21, 2021.
a
ACIP defines health care personnel as paid and unpaid persons serving in health care settings who
have the potential for direct or indirect exposure to patients or infectious materials. Long-term care
facility residents are defined as adults who reside in facilities that provide a range of services,
including medical and personal care, to persons who are unable to live independently. See Kathleen
Dooling et al., “The Advisory Committee on Immunization Practices’ Interim Recommendation for
Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020,” Morbidity and Mortality
Weekly Report, vol. 69, no. 49 (2020).
b
Pfizer and BioNTech developed this COVID-19 vaccine together, which this report refers to as the
Pfizer vaccine. The Secretary of Health and Human Services may declare that circumstances,
prescribed by statute, exist justifying the emergency use of certain medical products, such as
vaccines. Once a declaration of an emergency has been made, FDA may temporarily allow use of
unlicensed vaccines through an emergency use authorization (EUA). For FDA to issue an EUA for a
vaccine, it must be reasonable to believe that the vaccine may be effective and that the known and
potential benefits of the vaccine outweigh the known and potential risks, among other statutory
criteria. See 21 U.S.C. § 360bbb-3. FDA has indicated that issuance of an EUA for a COVID-19
vaccine for which there is adequate manufacturing information would require a determination by FDA
that the vaccine’s benefits outweigh its risks based on data from at least one well-designed phase 3
clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.

Typically, FDA must license a vaccine before it can be marketed in the U.S. See 42 U.S.C. § 262.
Any COVID-19 vaccine that initially receives an EUA from FDA is expected to work toward
submission of a biologics license application, according to FDA guidance. See Department of Health
and Human Services, Food and Drug Administration, Emergency Use Authorization for Vaccines to
Prevent COVID-19: Guidance for Industry, (Silver Spring, Md.: May 2021).
c
For the purposes of ACIP’s recommendation, non-health care frontline essential workers include
firefighters, police officers, corrections officers, food and agricultural workers, U.S. Postal Service
workers, manufacturing workers, grocery story workers, public transit workers, those who are in the
education sector (teachers and support staff) as well as daycare workers. According to CDC, about
49 million persons, including non-health care frontline essential workers and individuals aged 75
years and older were recommended for vaccination in phase 1b, and an additional 129 million
persons were recommended for vaccination in phase 1c (including about 28 million individuals aged
65-74 years). See Kathleen Dooling et al., “The Advisory Committee on Immunization Practices’
Updated Interim Recommendation for Allocation of COVID-19 Vaccine—United States, December
2020,” Morbidity and Mortality Weekly Report, vol. 69, no. 51-52 (2021).
d
Department of Health and Human Services, Centers for Disease Control and Prevention, COVID-19
Vaccination Program Interim Playbook for Jurisdictions Operations Annex—Considerations for
Increasing COVID-19 Vaccination: Reaching and Increasing Uptake in Priority Populations, version
1.0, (Atlanta, Ga.: Jan.11, 2021). According to CDC, this document was a supplement to CDC’s
interim playbooks to assist state and other jurisdictions with COVID-19 vaccine implementation. See
Department of Health and Human Services, Centers for Disease Control and Prevention, COVID-19
Vaccination Program Interim Playbook for Jurisdiction Operations, version 1.0 (Atlanta, Ga.: Sept. 16,
2020) and COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, version 2.0
(Atlanta, Ga.: Oct. 29, 2020).
e
White House, National Strategy for the COVID-19 Response and Pandemic Preparedness
(Washington, D.C.: Jan. 21, 2021).

In addition to its initial guidance on community vaccination centers, FEMA published five additional
versions of its guidance on community vaccination centers between February 2021 and April 2021.
For the final version, see Department of Homeland Security, Federal Emergency Management
Agency, Community Vaccination Centers Playbook, Final (Washington, D.C.: April 23, 2021).

f

g
Federally supported health centers generally receive Health Center Program grants from HRSA
under section 330 of the Public Health Service Act (42 U.S.C § 254b) and provide primary care
services in medically underserved areas. Some organizations meet all Health Center Program
requirements but do not receive federal grant funding through the section 330 program. However,
these centers, which are known as “look-alikes,” receive other benefits, such as higher
reimbursement rates from the Medicare and Medicaid programs and may receive grants through
other federal programs. We use the term “federally supported health centers” to refer to both “look-

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Appendix II: Timeline of Key Events Related to
COVID-19 Vaccine Implementation through
October 21, 2021

alikes” and those health centers that receive grants under section 330 of the Public Health Service
Act.
Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

h

Under the Public Readiness and Emergency Preparedness (PREP) Act, licensed health
professionals and other individuals authorized to administer a countermeasure under state law are
protected from liability under federal and state law for administering covered countermeasures
against COVID-19, including the COVID-19 vaccines. HHS may identify additional categories of
persons, known as “qualified persons”, to be afforded such protections. See Pub. L. No. 109-148, div.
C, 119 Stat. 2680, 2818 (2005) (codified as amended at 42 U.S.C. §§ 247d-6d et seq.). See HRSA
Notice, 86 Fed. Reg. 14462 (Mar. 16, 2021).

i

j
The Rural Health Clinic COVID-19 Vaccine Distribution Program distributed 99,760 vaccine doses to
141 rural health clinics, as of September 15, 2021, according to HHS.

Although FEMA’s vaccination center pilot program ended, the agency continued to support
community vaccination centers managed and operated by states and other jurisdictions (using doses
allocated to the jurisdictions) by providing federal personnel, funding, and material, such as medical
equipment and supplies, according to agency officials.

k

According to CDC, an additional dose is administered when the initial immune response following a
primary vaccine series is likely to be insufficient.

l

According to CDC, a booster dose is a dose of vaccine administered when the initial sufficient
immune response to a primary vaccine series is likely to have waned over time.

m

n
As of October 21, 2021, no vaccines had been authorized or licensed for children under 12 years,
but Pfizer had requested FDA to authorize its COVID-19 vaccine children aged 5 years to 11 years.
FDA’s Vaccines and Related Biological Products Advisory Committee was scheduled to meet on
October 26, 2021, to discuss a request for authorization of Pfizer’s COVID-19 vaccine for children
aged 5 through 11 years.

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Appendix III: Vaccine Finder and the Vaccine
Administration Management System
Appendix III: Vaccine Finder and the Vaccine
Administration Management System

The Centers for Disease Control and Prevention (CDC) developed tools
to help the public locate where vaccines were available and to schedule a
vaccination appointment. Specifically:
VaccineFinder is an online tool previously developed by CDC and
Boston’s Children’s Hospital to provide users information on the locations
of providers offering vaccinations, such as for seasonal influenza. As the
national supply of COVID-19 vaccine increased, CDC updated
VaccineFinder to include information about COVID-19 vaccines.
VaccineFinder, however, provided no or limited information on COVID-19
vaccines in March 2021 when vaccine demand was increasing. The
public also could not schedule appointments on VaccineFinder; instead,
users were given a link to a second website or a phone number to
schedule appointments. When information was not available on COVID19 vaccines on VaccineFinder, some states created their own platforms
to help health care providers and the public find available vaccination
appointments, according to selected health officials. In May 2021, CDC
updated VaccineFinder for COVID-19 vaccines with a new website,
https://www.vaccines.gov, which is dedicated specifically to COVID-19
vaccines.
Vaccine Administration Management System (VAMS) is an online tool
CDC developed that states or other jurisdictions, federal agencies, or
other organizations could opt to use to help manage COVID-19 vaccine
administration. For example, in jurisdictions that used the system, the
public could use VAMS to schedule vaccination appointments. Ten
jurisdictions, three federal agencies, and one multi-state health system
were using VAMS as of June 2021, according to CDC officials. State
health officials from one state using VAMS said health care providers
reported some problems with VAMS, including difficulties completing their
registration, which is needed to upload information about vaccination
appointments into VAMS, and correcting record errors in a timely manner
in some instances. VAMS was initially only available in English; it was
made available in Spanish in April 2021, according to health officials from
one state.

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Appendix IV: Comments from the
Department of Health & Human Services
Appendix IV: Comments from the Department
of Health & Human Services

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Appendix IV: Comments from the Department
of Health & Human Services

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Appendix IV: Comments from the Department
of Health & Human Services

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Appendix IV: Comments from the Department
of Health & Human Services

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Appendix V: GAO Contact and Staff
Acknowledgments
Appendix V: GAO Contact and Staff
Acknowledgments

GAO Contact

Alyssa M. Hundrup, (202) 512-7114, hundrupa@gao.gov

Staff
Acknowledgments

In addition to the contact named above Kim Yamane (Assistant Director),
Gay Hee Lee (Analyst in Charge), Sam Amrhein, George Bogart, Linda
McIver, Fatima Sharif, and Meghan Shrewsbury made key contributions
to this report. Other contributors to this report were Anne Hopewell,
Ethiene Salgado-Rodriguez, and Lillian Riehl Schultze.

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Related GAO Products
Related GAO Products

COVID-19: Additional Actions Needed to Improve Accountability and
Program Effectiveness of Federal Response. GAO-22-105051.
Washington, D.C.: October 27, 2021.
COVID-19: Continued Attention Needed to Enhance Federal
Preparedness, Response, Service Delivery and Program Integrity.
GAO-21-551. Washington, D.C.: July 19, 2021.
COVID-19: Efforts to Increase Vaccine Availability and Perspectives on
Initial Implementation. GAO-21-443. Washington, D.C.: April 14, 2021.
COVID-19: Sustained Federal Action Is Crucial as Pandemic Enters Its
Second Year. GAO-21-387. Washington, D.C.: March 31, 2021.
Operation Warp Speed: Accelerated COVID-19 Vaccine Development
Status and Efforts to Address Manufacturing Challenges. GAO-21-319.
Washington, D.C.: February 11, 2021.
COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity,
and Other Challenges Require Focused Federal Attention. GAO-21-265.
Washington, D.C.: January 28, 2021.
COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal
Response. GAO-21-191. Washington, D.C.: November 30, 2020.
COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic
Development, but More Transparency Needed on Emergency Use
Authorizations. GAO-21-207. Washington, D.C.: November 17, 2020.
COVID-19: Federal Efforts Could Be Strengthened by Timely and
Concerted Actions. GAO-20-701. Washington, D.C.: September 21, 2020.
COVID-19: Opportunities to Improve Federal Response and Recovery
Efforts. GAO-20-625. Washington, D.C.: June 25, 2020.
Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be
Incorporated into Future Planning, GAO-11-632. Washington, D.C.: June
27, 2011.

(104457)

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