GAO-21-443, COVID-19: Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation

COVID-19

Efforts to Increase

Vaccine Availability

and Perspectives on

Initial Implementation

Report to Congressional Addressees

April 2021

GAO-21-443

United States Government Accountability Office

Highlights of GAO-21-443, a report to

congressional addressees

April 2021

COVID-19

Efforts to Increase Vaccine Availability and

Perspectives

on Initial Implementation

What GAO Found

The federal government has taken several actions to increase the availability of

COVID-19 vaccine doses and indicated it expects to have enough doses

available for all adults in the United States by the end of May. As of April 1, 2021,

the government had purchased 1.2 billion doses of one- and two-dose regimen

vaccines. Also, vaccine companies reported making additional manufacturing

sites operational, among other actions to expand capacity and mitigate

challenges.

Federal officials said projecting future availability of vaccine doses can be

difficult, in part because of uncertainty surrounding complex manufacturing

processes. Given this uncertainty, coupled with the significant manufacturing and

distribution increases needed to have enough vaccine doses available for all

adults, managing public expectations is critical. GAO’s prior work has found that

timely, clear, and consistent communication about vaccine availability is essential

to ensure public confidence and trust, especially as initial vaccine implementation

did not match expectations.

COVID-19 Vaccination Site

Stakeholders GAO interviewed identified challenges with initial COVID-19

vaccine implementation. For example, some stakeholders said states often did

not have information critical to distribution at the local level, such as how many

doses they would receive and when. The federal government has begun

initiatives—outlined in a national response strategy—to improve implementation,

such as creating new vaccination sites. In its March 2021 distribution strategy,

CDC provided a high-level description of its activities and noted that more details

would be included in future reports to Congress. To meet the expectations set by

recent announcements, such as the planned expansion of vaccine eligibility to all

adults and the introduction of tools to help individuals find vaccines, it will be

imperative that the federal government effectively coordinate and communicate

its plans, as GAO recommended in September 2020.

View GAO-21-443. For more information,

contact

Alyssa M. Hundrup at (202) 512-7114

[email protected].

Why GAO Did This Study

Providing the public with safe and

effective vaccines to prevent COVID

19 is crucial to mitigating the public

health and economic impacts of the

disease

. The U.S. had almost 30

million reported cases and over

45,000 reported deaths as of March

27, 2021.

he federal government took

a critical step in December 2020 in

authorizing the first two COVID

-19

vaccines and beginning distribution of

doses across the nation. The

government

had distributed about

180.6

million vaccine doses, and about

147

.8 million doses had been

administered, as of

March 27, 2021,

according to

Centers for Disease

Control and Prevention

(CDC) data.

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, among other issues, actions

the federal government has taken to

increase the availability of COVID

-19

vaccine doses, and challenges with

initial vaccine implementation

—that is,

prioritizing, allocating, distributing, and

administering vacc

ine doses—

identified by stakeholders and steps

the federal government has taken to

improve vaccine implementation.

GAO reviewed documents from the

Departments of Defense and Health

and Human Services, transcripts of

public briefings, data from

CDC, and

interviewed or received written

responses from federal officials,

vaccine company representatives, and

select public health stakeholders.

GAO

incorporated technical comments from

the Department of Defense, the

Department of Health and Human

Services, and t

he Federal Emergency

Management Agency as appropriate.

Page i GAO-21-443 COVID-19 Vaccines

Letter 1

Background 6

The Federal Government’s Contracting Approach Aimed to

Accelerate Vaccine Development and Manufacturing While

Mitigating Cost Risk to the Government 16

The Federal Government Has Purchased Additional Vaccine

Doses and Helped Mitigate Manufacturing Challenges to

Increase Vaccine Availability 24

Stakeholders Identified Challenges with Initial COVID-19

Vaccination; the Federal Government Has Taken Some Steps

to Help Improve Vaccine Implementation 32

Agency Comments 44

Appendix I GAO Contact and Staff Acknowledgments 47

Related GAO Products 48

Tables

Table 1: Status of Six COVID-19 Vaccine Candidates under the

DOD and HHS Partnership, as of March 27, 2021 8

Table 2: Manufacturing Partners for the Six COVID-19 Vaccine

Candidates under the DOD and HHS Partnership, as of

March 2021 9

Table 3: Summary of Selected Payment and Termination Terms

and Conditions Contained in the Production Awards for

the Six Operation Warp Speed Vaccine Candidates, July

2020-November 2020 19

Table 4: Contracted Amount of COVID-19 Vaccine Doses under

the Department of Defense (DOD) and Department of

Health and Human Services (HHS) Partnership, by

Vaccine Company, as of April 1, 2021 24

Table 5: Status of Manufacturing Capacity Expansion Efforts for

Six COVID-19 Vaccine Candidates under the DOD and

HHS Partnership, as of March 2021 29

Table 6: Examples of Challenges with Initial COVID-19 Vaccine

Implementation Reported by Stakeholders, as of

February 1, 2021 33

Contents

Page ii GAO-21-443 COVID-19 Vaccines

Table 7: Changes by the Federal Government to the Initial

COVID-19 Vaccine Implementation between November

2020 and mid-February 2021 35

Figures

Figure 1: Department of Defense (DOD) and Department of

Health and Human Services (HHS) Obligations for

COVID-19 Vaccine Candidates under the DOD and HHS

Partnership, as of March 14, 2021 7

Figure 2: Potential Choke Points in Scaling Up Vaccine Production

Related to Key Manufacturing Challenges 11

Figure 3: Daily Count of Doses of COVID-19 Vaccine

Administered and Reported to CDC as of March 27, 2021 15

Figure 4: Number of Doses of COVID-19 Vaccine Released in the

U.S. per Week (in millions), as of March 29, 2021 26

Figure 5: Number of Vaccine Doses Distributed in the U.S. per

Week, as of March 27, 2021 30

Abbreviations

ACIP Advisory Committee on Immunization Practices

CDC Centers for Disease Control and Prevention

COVID-19 Coronavirus Disease 2019

DOD Department of Defense

EUA emergency use authorization

FDA Food and Drug Administration

FEMA Federal Emergency Management Agency

HHS Department of Health and Human Services

National Strategy National Strategy for the COVID-19 Response and

Pandemic Preparedness

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.

Page 1 GAO-21-443 COVID-19 Vaccines

441 G St. N.W.

Washington, DC 20548

April 14, 2021

Congressional Addressees

Providing the public with safe and effective vaccines to prevent

Coronavirus Disease 2019 (COVID-19) is crucial to mitigating the public

health and economic impacts of the disease and ending the pandemic.

There have been almost 30 million reported cases of COVID-19 and over

545,000 reported deaths in the United States as of March 27, 2021.

Given this catastrophic loss of life and the pandemic’s devastating effects

on the U.S. economy, as well as new potentially harmful variants of

SARS-CoV-2, the virus that causes COVID-19, vaccines are essential for

preventing COVID-19 and related serious outcomes, such as

hospitalization or death.

In December 2020, the United States took an important step to protect

the public against COVID-19 as the first COVID-19 vaccines—developed

in a shorter time than any previous vaccine—were authorized for

emergency use and administered.

With three COVID-19 vaccines now

authorized for emergency use as of March 27, 2021, more than 91.7

million people had received at least one vaccine dose and more than 50.1

Data on COVID-19 cases in the U.S. are based on aggregate case reporting to the

Centers for Disease Control and Prevention (CDC) and include probable and confirmed

cases as reported by states and jurisdictions. CDC COVID-19 counts are subject to

change due to delays or updates in reported data from states and territories. 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 have not been tested or may not have sought

medical care. CDC’s National Center for Health Statistics COVID-19 death counts in the

U.S. are based on provisional counts from death certificate data, which do not distinguish

between laboratory-confirmed and probable COVID-19 deaths. Provisional counts are

incomplete due to an average delay of 2 weeks (a range of 1–8 weeks or longer) for death

certificate processing.

For more information on the accelerated COVID-19 vaccine development process, see

GAO, Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and

Efforts to Address Manufacturing Challenges. GAO-21-319, (Washington, D.C.: Feb. 11,

2021). GAO has also produced an interactive dashboard that integrates multiple data

sources to visualize the status of vaccine development, which may be found at

https://ows.gaoinnovations.gov/.

Letter

Page 2 GAO-21-443 COVID-19 Vaccines

million people had been fully vaccinated, according to Centers for

Disease Control and Prevention (CDC) data.

Implementing a nationwide COVID-19 vaccination program is a highly

complex undertaking involving many players. It involves multiple federal

agencies, the private sector, state, local, and territorial jurisdictions, tribal

officials, and health care providers, who must coordinate and work

together to make the vaccine available to the public.

At the federal level,

efforts to support vaccine development, manufacturing, and distribution to

states and other jurisdictions have been led by a partnership between the

Department of Defense (DOD) and the Department of Health and Human

Services (HHS) announced in May 2020, then known as Operation Warp

Speed. As of January 20, 2021, the federal government no longer uses

the name Operation Warp Speed, but the DOD and HHS partnership has

continued.

Through Operation Warp Speed and the continued DOD and HHS

partnership, the federal government has obligated at least $20 billion as

of March 14, 2021, mostly through awards to six vaccine companies for

COVID-19 vaccine candidates, with various development and

manufacturing activities associated with these awards. Initial awards

made from March 2020 through June 2020 were generally to fund

vaccine development efforts, including clinical trials, and later awards

made from July 2020 through December 2020 were generally for vaccine

manufacturing or the purchase of vaccine doses. Since then, the

Two of the COVID-19 vaccines being administered as of this date were two-dose vaccine

regimens and one was a single dose. According to CDC, the count of people receiving at

least one dose represents the total number of people who received at least one dose of a

COVID-19 vaccine, including those who received the single-dose vaccine. The count of

fully vaccinated people represents the number of people who have received the second

dose of a two-dose COVID-19 vaccine regimen and those who received the single-dose

COVID-19 vaccine.

For COVID-19 vaccination there are 64 jurisdictions including all 50 states, territories,

and local health programs in Chicago, the District of Columbia, Houston, New York City,

Philadelphia, and San Antonio.

DOD and HHS’s partnership is to continue through May 1, 2021, per an extension of a

memorandum of understanding between the two departments. According to officials

working under Operation Warp Speed and the continued partnership, the leadership

structure is generally the same, but personnel in some key senior leadership positions

have changed. In this report, we use “Operation Warp Speed” to reference the actions the

partnership had taken while it was operating under that name and refer to the “DOD and

HHS partnership” for actions after January 20, 2021.

Page 3 GAO-21-443 COVID-19 Vaccines

government has purchased additional vaccine doses through exercising

options on previously awarded contracts.

Since June 2020, we have cited the critical importance of planning for the

development, manufacturing, distribution, and administration of COVID-

19 vaccines.

We recommended, in September 2020, that the Secretary

of Health and Human Services, with support from the Secretary of

Defense, establish a time frame for documenting and sharing a national

plan for distributing and administering COVID-19 vaccines, ensure that

such a plan is consistent with best practices for project planning and

scheduling, and ensure that the plan outlines an approach for how efforts

would be coordinated across federal agencies and nonfederal entities.

We also have noted the importance of 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 to help ensure public confidence

and trust, which in turn could encourage vaccine use. In January 2021,

we reported that initial vaccine implementation did not match

expectations, and we reiterated the vital importance of federal planning,

leadership, and coordination.

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 is part of our body of work in response to the CARES Act and

focuses on the federal government’s efforts related to COVID-19

vaccines. Specifically, in this report, we describe

(1) how the initial awards made under Operation Warp Speed address

specific terms and conditions, including government rights to intellectual

property;

(2) actions the federal government has taken to increase the availability of

COVID-19 vaccine doses;

We have released a series of products on the federal government’s response to COVID-

19 since June 2020, including the government’s efforts related to COVID-19 vaccines and

therapeutics. See the related products section of this report for a list of those products.

Pub. L. No. 116-136, § 19010, 134 Stat. 281, 579-81 (2020). This report also responds,

in part, to a bipartisan request from the House Select Subcommittee on the Coronavirus

Crisis for GAO to examine Operation Warp Speed.

Page 4 GAO-21-443 COVID-19 Vaccines

(3) challenges with initial vaccine implementation—that is, prioritizing,

allocating, distributing, and administering vaccine doses—identified by

stakeholders and steps the federal government has taken to improve

vaccine implementation.

To describe how the awards made under Operation Warp Speed address

specific terms and conditions—such as pricing, payment, termination

terms and conditions, and government rights to intellectual property and

data—we reviewed DOD and HHS acquisition documents related to

Operation Warp Speed, including award documents, statements of work,

and related amendments for the six vaccine candidates for awards made

from March 2020 through November 2020.

We reviewed data reported

by Federal Procurement Data System-Next Generation through March

14, 2021 and agreements from DOD, HHS, and Advanced Technology

International.

All award amounts are based on Federal Procurement

Data System–Next Generation obligations data. We assessed the

reliability of data reported to the Federal Procurement Data System-Next

Generation by performing electronic testing and by comparing this

information to the contract documents we obtained. We determined that

the data were sufficiently reliable for the purposes of describing agencies’

reported contract obligations for the six vaccine candidates and other

vaccine-related obligations. In addition, we interviewed DOD and HHS

officials and coordinated with all six vaccine companies to better

understand their perspectives on the intellectual property provisions,

termination and payment terms and conditions, and the implications of the

foregoing.

To describe actions the federal government has taken to increase the

availability of COVID-19 vaccines doses, we reviewed information and

data from Operation Warp Speed and the continued DOD and HHS

partnership on the purchase, manufacture, and release of COVID-19

vaccine doses from July 2020 through March 2021.

We also reviewed

The six companies with COVID-19 vaccine candidates are AstraZeneca, Janssen,

Moderna, Novavax, Pfizer/BioNTech, and Sanofi/GSK. For the purpose of this report, we

refer to the Pfizer/BioNTech collaboration as “Pfizer” and to the Sanofi/GSK collaboration

as “Sanofi.” Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

Advanced Technology International manages the Medical Chemical, Biological,

Radiological and Nuclear Defense Consortium, a partnership with industry, academic, and

not-for-profit partners to support the DOD’s medical, pharmaceutical, and diagnostic

requirements.

According to DOD and HHS partnership officials, once through manufacturing and

quality assurance, the vaccine doses are released for distribution.

Page 5 GAO-21-443 COVID-19 Vaccines

CDC data on vaccine doses distributed to jurisdictions and federal entities

as of March 27, 2021. We also interviewed or received written responses

from the six companies with COVID-19 vaccine candidates and DOD,

HHS, and CDC officials about the data and the actions they had taken to

increase the availability of vaccines. We assessed the reliability of the

data from CDC and the DOD and HHS partnership by reviewing relevant

CDC documentation, such as documentation that defines data points,

including any caveats, and interviewing DOD and HHS partnership

officials about these data. We determined that these data were sufficiently

reliable for the purposes of our reporting objective.

To describe challenges with initial vaccine implementation—that is,

prioritizing, allocating, distributing, and administering vaccine doses—

identified by stakeholders and steps the federal government has taken to

improve vaccine implementation, we interviewed representatives of state,

territorial, and local health officials and health care providers who are

involved in vaccine distribution and administration efforts.

We also

reviewed documentation, such as recommendations published by CDC’s

Advisory Committee on Immunization Practices (ACIP), the White

House’s National Strategy for the COVID-19 Response and Pandemic

Preparedness (National Strategy) released in January 2021, White House

fact sheets issued in January and February 2021 related to vaccine

distribution, CDC’s COVID-19 Vaccination Program Interim Playbook for

Jurisdictions Operations Annex, CDC vaccine allocation data, and

vaccine administration data from CDC’s COVID Data Tracker website,

For perspectives of state, territorial, and local health officials, we reviewed documents

from and interviewed representatives from the Association of State and Territorial Health

Officials, Association of Immunization Managers, American Immunization Registry

Association, and the National Association of County and City Health Officials. We also

interviewed one public health infectious disease specialist who also serves as the Health

Officer for Public Health for a county that includes a major metropolitan area. We also

interviewed officials from the National Governors Association.

For perspectives of health care providers, we interviewed representatives from the

American Hospital Association, American Medical Association, American Nurses

Association, American College of Emergency Physicians, America’s Essential Hospitals,

Association for Health Care Resource & Materials Management, American Public Health

Association, and the National Association of Community Health Centers.

Page 6 GAO-21-443 COVID-19 Vaccines

among others.

In addition, we interviewed and reviewed written

responses from HHS and DOD officials, including officials from their

partnership and CDC, and reviewed documentation such as transcripts

from briefings during which the Secretary of Health and Human Services

or other federal officials provided information to the public about vaccine

distribution and administration efforts.

We conducted this performance audit from October 2020 to April 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.

To accelerate the availability of a vaccine to prevent COVID-19, DOD, on

behalf of HHS, awarded contracts and other transaction agreements

(referred to in this report as “agreements”) in 2020 to six vaccine

companies for different types of activities.

Operation Warp Speed

officials indicated in August 2020 that they selected the six vaccine

candidates from three vaccine-platform technologies that they considered

to be the most likely to quickly yield a safe and effective vaccine.

As of March 14, 2021, DOD and HHS had obligated at least $20 billion to

develop, manufacture, track, and distribute vaccines for COVID-19 under

See White House, National Strategy for the COVID-19 Response and Pandemic

Preparedness (Washington, D.C.: Jan. 21, 2021), accessed on January 21, 2021 at

https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-

COVID-19-Response-and-Pandemic-Preparedness.pdf and Department of Health and

Human Services, Centers for Disease Control and Prevention, COVID-19 Vaccination

Program Interim Playbook for Jurisdictions Operations Annex (Atlanta, Ga.: Jan. 11,

2021), accessed on February 4, 2021, https://www.cdc.gov/vaccines/covid-

19/downloads/COVID-19-vaccination-program-playbook-annex.pdf. For the CDC data

tracker see https://covid.cdc.gov/covid-data-tracker/#vaccinations (accessed Mar. 1,

2021).

For example, for some vaccine candidates, Operation Warp Speed and the continued

DOD and HHS partnership publicly announced support for both clinical development and

manufacturing activities; while for some candidates, it only announced support for the

manufacturing or purchase of vaccine doses.

For more information on the characteristics and development status of the individual

Operation Warp Speed vaccine candidates, see GAO-21-319.

Background

DOD and HHS

Partnership and COVID-

19 Vaccines

Page 7 GAO-21-443 COVID-19 Vaccines

Operation Warp Speed and the continued DOD and HHS partnership, as

shown in figure 1 below.

Figure 1: Department of Defense (DOD) and Department of Health and Human Services (HHS) Obligations for COVID-19

Vaccine Candidates under the DOD and HHS Partnership, as of March 14, 2021

Note: The DOD and HHS partnership was formerly known as Operation Warp Speed. We

used the HHS Operation Warp Speed website and HHS press releases to determine

which contract obligations to include in our analysis. For some vaccine candidates,

Operation Warp Speed and the continued DOD and HHS partnership publicly announced

support for both clinical development and manufacturing activities; while for some

candidates, it only announced support for the manufacturing or purchase of vaccine

doses. HHS announced two awards related to distribution for which we could not identify

obligations in the Federal Procurement Data System-Next Generation, which are not

included in the chart above.

Typically, before a vaccine can be marketed in the United States, it must

be licensed by the Food and Drug Administration (FDA).

An emergency

FDA—an agency within HHS—licenses biological products, including vaccines, through

review of a biologics license application.

Page 8 GAO-21-443 COVID-19 Vaccines

use authorization (EUA) allows for the temporary use of vaccines without

FDA licensure, provided certain statutory criteria are met.

As of March 27, 2021, FDA had issued EUAs for three COVID-19

vaccines: (1) Pfizer’s COVID-19 vaccine on December 11, 2020; (2)

Moderna’s COVID-19 vaccine on December 18, 2020, and (3) Janssen’s

COVID-19 vaccine on February 27, 2021.

There were no FDA-licensed

COVID-19 vaccines, as of March 27, 2021.

See table 1 for the status of

each of the six vaccine candidates under the DOD and HHS partnership,

as of March 27, 2021.

Table 1: Status of Six COVID-19 Vaccine Candidates under the DOD and HHS Partnership, as of March 27, 2021

Vaccine company

Started phase 3

clinical trials

Announced initial

findings from phase

3 clinical trials

Submitted

emergency use

authorization (EUA)

request to FDA

FDA issued EUA

Pfizer

●

Moderna

●

Janssen

●

AstraZeneca

●

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.

On February 4, 2021, FDA announced that it was assessing the impact of new SARS-

CoV-2 strains on authorized vaccines, and was working with companies and international

partners to evaluate the impact that each variant may have on the effectiveness of

authorized vaccines. FDA also stated that at the time, available information suggested that

the authorized vaccines remained effective in protecting the American public against

currently circulating strains of COVID-19. On February 22, 2021, FDA released an

updated version of its October 2020 guidance, Emergency Use Authorization for Vaccines

to Prevent COVID-19, to provide recommendations to companies seeking to amend their

EUAs for COVID-19 vaccines to address new variants.

On Tuesday, April 13, 2021, CDC and FDA released a joint statement recommending a

pause in the use of Janssen vaccine while CDC and FDA 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’s announcement occurred after we finalized our analyses for

this report, but we will continue to monitor this in our future work.

Any COVID-19 vaccine that initially receives an EUA from FDA is expected to ultimately

be reviewed and receive licensure through a biologics license application, according to

FDA guidance.

Page 9 GAO-21-443 COVID-19 Vaccines

Vaccine company

Started phase 3

clinical trials

Announced initial

findings from phase

3 clinical trials

Submitted

emergency use

authorization (EUA)

request to FDA

FDA issued EUA

Novavax

●

Sanofi

Source: GAO analysis of vaccine company, Operation Warp Speed, and Food and Drug Administration (FDA) information. | GAO-21-443

Note: The partnership between the Department of Defense (DOD) and the Department of Health and

Human Services (HHS) was formerly known as Operation Warp Speed.

Phase 3 clinical trials are performed after preliminary evidence suggesting effectiveness of a product

has been obtained, and are intended to gather additional information about safety and effectiveness.

These trials involve several hundred to thousands of volunteers, usually including participants who

are at increased risk for infection. Earlier phases generally involve fewer volunteers and test issues

such as safety of the product (phase 1) and the effectiveness of the product for a particular use and

additional safety information (phase 2).

During an emergency, as declared by the Secretary of Health and Human Services under 21 U.S.C.

§ 360bbb-3(b), FDA may temporarily authorize unlicensed vaccines through an EUA, provided certain

statutory criteria are met. 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

vaccines 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 ultimately be reviewed and

receive licensure through a biologics license application, according to FDA guidance.

Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

Novavax has announced findings from its final analysis of phase 3 clinical trial data from the United

Kingdom. As of March 27, 2021, it had not yet announced findings based on its phase 3 clinical trial in

the United States.

Sanofi announced in December 2020 that global phase 3 clinical trials could start during the second

quarter of 2021; pending positive data from a phase 2 study expected to start in February 2021. On

February 22, 2021, Sanofi announced the start of its phase 2 study.

The six vaccine companies with candidates under the DOD and HHS

partnership are working with different manufacturing partners, as of

March 2021, to make use of available manufacturing capacity, as shown

in table 2. These U.S. manufacturing partners are located at sites across

the country.

Table 2: Manufacturing Partners for the Six COVID-19 Vaccine Candidates under the

DOD and HHS Partnership, as of March 2021

Vaccine company

Drug substance

manufacturing partners for

U.S. market

Fill-Finish manufacturing

partners for U.S. market

Pfizer

All manufacturing is currently

being conducted by Pfizer

All manufacturing is currently

being conducted by Pfizer

Moderna

Lonza

Baxter BioPharma Solutions

and Catalent

COVID-19 Vaccine

Manufacturing and

Related Challenges

Page 10 GAO-21-443 COVID-19 Vaccines

Vaccine company

Drug substance

manufacturing partners for

U.S. market

Fill-Finish manufacturing

partners for U.S. market

Janssen

Emergent BioSolutions and

Merck

Catalent, Grand River Aseptic

Manufacturing, Merck

, and PCI

Pharma Services

AstraZeneca

Emergent BioSolutions

AMRI and PCI Pharma Services

Novavax

AGC Biologics and Fuji

Diosynth Biotechnologies

Jubilant HollisterStier and Par

Sterile Products

Sanofi

Fuji Diosynth Biotechnologies

Sanofi has not yet begun fill-

finish manufacturing for its

vaccine candidate

Source: GAO analysis of information from vaccine companies. | GAO-21-443.

Note: The Department of Defense (DOD) and Department of Health and Human Services (HHS)

partnership was formerly known as Operation Warp Speed.

Drug substance manufacturing is the production of bulk amounts of the vaccine drug substance.

Fill-finish manufacturing is the transfer of vaccine into sterile containers.

As of March 2021, the Merck drug substance and fill-finish facilities had not yet been activated and

will not be used to produce any of the initial 100 million COVID-19 vaccine doses that Janssen

provides to the U.S. government, according to a Janssen representative.

As we reported in November 2020 and February 2021, the federal

government is working with vaccine companies to help mitigate

challenges that could hinder vaccine manufacturing, including:

(1) limited manufacturing capacity,

(2) disruption to supply chains,

(3) difficult technology transfer processes, and

(4) gaps in workforce availability.

There are a number of potential manufacturing choke points that could

result from those manufacturing challenges, as shown in figure 2 below.

For example, the ability to hire and train personnel with the specialized

skills needed to run vaccine manufacturing processes can be a challenge

for even experienced manufacturers. We heard from representatives at a

facility manufacturing COVID-19 vaccines that filling open positions for

mid- to upper management had been a challenge. These positions are

GAO-21-319; GAO, COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic

Development, but More Transparency Needed on Emergency Use Authorizations,

GAO-21-207 (Washington, D.C.: Nov. 17, 2020).

Page 11 GAO-21-443 COVID-19 Vaccines

significant because manufacturing managers function as the technical

points of contact for production questions and are responsible for

managing safety, quality, and compliance with current good

manufacturing practices.

Figure 2: Potential Choke Points in Scaling Up Vaccine Production Related to Key Manufacturing Challenges

Page 12 GAO-21-443 COVID-19 Vaccines

Vaccine implementation, following authorization or licensure, involves

several key steps (which may happen concurrently) and various

stakeholders. The stakeholders include several federal agencies and

multiple state and local stakeholders, including the DOD and HHS

partnership, CDC, private industry, jurisdictions, local health departments,

tribal officials, and health care providers.

• Prioritization. ACIP issues recommendations to the CDC Director for

target groups to receive initial vaccine doses based on its review of

data, including vaccine safety and efficacy data.

These

recommendations as adopted are not binding on jurisdictions, and

jurisdictions can adopt different approaches. In addition, the Secretary

of Health and Human Services may issue directives regarding

prioritization and eligibility for COVID-19 vaccinations, according to

HHS.

• Allocation. The DOD and HHS partnership determines the amount of

COVID-19 vaccine allocated for 64 jurisdictions, which include all U.S.

states, territories, the District of Columbia and local health programs

in Chicago, Houston, New York City, Philadelphia, and San Antonio.

According to DOD and HHS partnership officials, allocations are

based on each jurisdiction’s adult population. The partnership also

allocates additional doses to jurisdictions for American Indian/Alaskan

Native populations that elected to receive vaccines through the state

Within priority groups are separate target groups that are added as vaccine supply

increases. For example, ACIP recommended that when vaccine supplies are not sufficient

to meet demand, vaccine should be offered in phases. In December 2020, ACIP

recommended that phase 1 include the target groups of 1a (residents of long-term care

facilities and health care workers), 1b (persons 75 years and older and frontline essential

workers), and 1c (persons aged 65-74 years and persons aged 16-64 years with medical

conditions that increase the risk for severe COVID-19). ACIP is comprised of medical and

public health experts who make recommendations on the use of vaccines in the civilian

population of the United States. Its recommendations serve as public health guidance for

safe use of vaccines and other related products. If adopted by the CDC Director, ACIP’s

recommendations are published as official HHS/CDC recommendations in the Morbidity

and Mortality Weekly Report. See COVID-19 ACIP Vaccine Recommendations, accessed

March 9, 2021, https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html.

Included in the vaccines allocated to the jurisdictions were vaccine doses for the federal

government’s Pharmacy Partnership for Long-Term Care Program, which has facilitated

on-site vaccination of residents and staff at long-term care facilities. In addition to the

vaccine doses allocated to the 64 jurisdictions, the DOD and HHS partnership directly

allocates vaccine doses to five federal entities (the Bureau of Prisons, DOD, Department

of State, Indian Health Service, and Veterans Health Administration).

Implementation of COVID-

19 Vaccines

Page 13 GAO-21-443 COVID-19 Vaccines

instead of through the Indian Health Service.

According to HHS

data, 10 jurisdictions are receiving these additional doses—called

“Sovereign Nation Supplements” by the DOD and HHS partnership—

in their allocations.

In addition, vaccine doses are also being made available through

other federal efforts. For example, in February 2021, the

administration announced that vaccine doses would go to specific

mass vaccination clinics, pharmacy partnerships, and federally

qualified health centers. These allocations are in addition to the

jurisdiction and federal entity allocations.

• Distribution. Health care providers receiving COVID-19 vaccine

doses from their jurisdictions’ allocations place orders for vaccines

that the jurisdictions review and approve.

Vaccine doses and

ancillary supplies (such as syringes) are distributed to jurisdictions

and health care providers from a central distributor, except for Pfizer’s

vaccine doses, which are shipped to jurisdictions and health care

providers directly from the manufacturer. According to CDC, vaccine

doses are considered “delivered” when the jurisdictions and other

sites receive them.

• Administration. Health care providers administer vaccines at

administration sites, including pharmacies, hospitals, long-term care

facilities, federally qualified health centers, rural health centers,

physician offices, colleges and universities, and mass-vaccination

Tribal health programs and Urban Indian Organizations can decide to receive vaccines

either through the Indian Health Service or through the jurisdiction in which they are

located.

The maximum number of doses a jurisdiction can approve for order is an order cap set

for each jurisdiction based on the allocated amount. When the number of doses ordered

by health care providers exceeds the jurisdiction’s order cap, not all orders will be

approved.

Where vaccines are delivered within a jurisdiction can vary and depends on what

jurisdictions have specified in their vaccine implementation planning. Moderna’s vaccine is

delivered in lot sizes of 100 doses, while the Pfizer vaccine is delivered in lot sizes of

1,170 doses as of February 16, 2021. In some cases, vaccines are delivered to a

centralized site within a jurisdiction and then further subdivided into smaller lot sizes for

delivery to additional sites, such as facilities in rural areas, for administration; in other

cases, vaccines are directly delivered to sites for administration, such as to large health

care systems that have the needed storage and handling capability, according to CDC.

Page 14 GAO-21-443 COVID-19 Vaccines

clinics.

After administration, health care providers must record the

vaccination data for each individual vaccinated in the appropriate data

systems for their jurisdiction within 72 hours, according to CDC.

As of March 27, 2021, CDC data showed the federal government had

distributed about 180.6 million doses of COVID-19 vaccine, and health

care providers reported administering about 147.8 million COVID-19

vaccine doses, which includes both first and second doses

administered.

See figure 3 below for the number of doses reported to

CDC as administered, for each day from mid-December 2020, when

vaccine doses were first administered, through March 27, 2021.

Only those providers participating in the CDC COVID-19 Vaccination Program may

administer COVID-19 vaccines. These providers must sign a CDC COVID-19 Vaccination

Program Provider Agreement and adhere to all requirements outlined in the agreement.

Federally qualified health centers operate as part of the Health Center Program

administered by the Bureau of Primary Health Care within the Health Resources and

Services Administration. The Health Center Program provides grants to federally qualified

health centers under section 330 of the Public Health Service Act. See 42 U.S.C. § 254b.

For patients administered a vaccine requiring two doses, health care providers should

use redundant methods and systems, such as phone calls, emails, or text messages to

remind patients to obtain their second dose, according to CDC’s COVID-19 Vaccination

Program Interim Playbook for Jurisdiction Operations.

Vaccine doses distributed is the total number that have been delivered to jurisdictions,

retail pharmacies, long-term care facilities, Federal Emergency Management Agency and

Health Resources and Services Administration partner sites, and federal entities.

However, for Palau, Micronesia, Marshall Islands, Guam, American Samoa, and Northern

Marianas Islands, total counts of COVID-19 vaccine doses distributed include doses

marked as shipped in CDC’s Vaccine Tracking System since December 13, 2020.

Page 15 GAO-21-443 COVID-19 Vaccines

Figure 3: Daily Count of Doses of COVID-19 Vaccine Administered and Reported to CDC as of March 27, 2021

Note: Data show the number of COVID-19 vaccine doses administered in the U.S. as reported to

CDC by state, territorial, and local public health agencies, and federal entities, since the national

vaccine program began on December 14, 2020, and include doses administered through all vaccine

partners including jurisdictional partner clinics, retail pharmacies, long-term care facilities, Federal

Emergency Management Agency and Health Resources and Services Administration partner sites,

and federal entity facilities. The data were accessed April 1, 2021. As of March 27, 2021, three

COVID-19 vaccines were authorized for emergency use; two of these vaccines are two-dose

regimens and the third vaccine requires one dose. The number of doses administered on a given day

may be affected by several factors, such as weekend days, holidays, weather, and vaccine

availability. On February 19, 2021, officials from the White House COVID-19 Response Team said

severe weather across the country impacted vaccine distribution and administration in all 50 states.

Further, officials said the shipment of 3 days’ worth of vaccine doses—about 6 million doses—was

delayed due to weather.

On January 21, 2021, the White House issued its National Strategy for

COVID-19 Response and Pandemic Preparedness.

The National

Strategy identifies seven goals for a coordinated response to address the

COVID-19 pandemic and outlines several ongoing and new actions to

White House, National Strategy for the COVID-19 Response and Pandemic

Preparedness (Washington, D.C.: Jan. 21, 2021), accessed on January 21, 2021 at

https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-

COVID-19-Response-and-Pandemic-Preparedness.pdf.

National Strategy for

COVID-19 Response and

Pandemic Preparedness

Page 16 GAO-21-443 COVID-19 Vaccines

help achieve the administration’s goals.

The National Strategy states

that, among other things, the federal government will ensure the

availability of safe, effective vaccines for the American public through

actions to purchase and manufacture doses sufficient to vaccinate the

U.S. population.

From March to November 2020, the federal government awarded

contracts and agreements to six vaccine companies to accelerate the

development of safe and effective COVID-19 vaccines while balancing

the risk to the government in doing so. Specifically, during this time, the

federal government made awards for vaccine development, manufacture,

or purchase of an initial 600 million doses with an estimated value of

$12.8 billion.

These awards were made, according to DOD and HHS

partnership officials, in anticipation that some of the vaccine candidates

would subsequently receive authorization or licensure. By providing

significant funding up front, these officials told us, the government took on

some financial risk, which enabled the companies to accelerate vaccine

development and production. However, the government also incorporated

safeguards in the contracts and agreements to mitigate its financial risk,

by including, for example, payment and termination language intended to

limit the government’s liability if a vaccine candidate is not authorized or

licensed.

In effect, according to DOD officials, the government aimed to

balance financial risks and help ensure that the government would

The seven goals are: (1) restore trust with the American people; (2) mount a safe,

effective, and comprehensive vaccination campaign; (3) mitigate spread through

expanding masking, testing, data, treatments, health care workforce, and clear public

health standards; (4) immediately expand emergency relief and exercise the Defense

Production Act; (5) safely reopen schools, businesses, and travel while protecting

workers; (6) protect those most at risk and advance equity, including across racial, ethnic,

and rural/urban lines; and (7) restore U.S. leadership globally and build better

preparedness for future threats.

From March to April 2020 before Operation Warp Speed was formally established, HHS

made awards to three companies—Janssen, Moderna and Sanofi—for development

and/or clinical studies. After Operation Warp Speed was established in May 2020, DOD

awarded additional contracts and agreements for vaccine manufacturing. We refer to all

these awards as part of the Operation Warp Speed effort. The production awards allow

the government to purchase additional doses through options or follow-on awards. In

October, DOD made an additional award to AstraZeneca for 200 million doses. The Pfizer

and Moderna vaccines received EUAs on December 11, 2020 and December 18, 2020

respectively, and the federal government awarded an additional contract and exercised a

contract option for an additional 200 million doses from Pfizer, and exercised options for

an additional 200 million doses from Moderna.

According to DOD officials, another risk mitigation strategy included negotiating a

requirement for domestic, large-scale vaccine manufacturing, which was intended to avoid

manufacturing-related risks and better ensure timely delivery.

The Federal

Government’s

Contracting Approach

Aimed to Accelerate

Vaccine Development

and Manufacturing

While Mitigating Cost

Risk to the

Government

Page 17 GAO-21-443 COVID-19 Vaccines

receive a sufficient number of vaccine doses, even if one or more

companies’ efforts failed to produce a viable vaccine.

DOD and HHS officials told us that they took a different contracting

approach with each of the six vaccine companies as each came to the

negotiating table with differing levels of product maturity and

manufacturing capability. For example, with the exception of Pfizer, the

federal government provided funding to five companies for some level of

vaccine development including for activities such as preclinical and

clinical trials. According to DOD and HHS partnership officials, this

funding gave the government insight into vaccine development or

manufacturing that it did not have with Pfizer. For example, according to

these officials, the five other vaccine companies agreed to allow DOD and

HHS partnership officials in their manufacturing facilities to provide in-

depth visibility into production capabilities and any challenges that may

arise.

Our review of awards made to the six Operation Warp Speed vaccine

candidates through November 2020 found that the specific terms and

conditions the federal government negotiated with the companies varied.

For example:

• Pursuant to Pfizer’s July 2020 agreement with the U.S. government,

which awarded Pfizer $1.95 billion, the government agreed to pay a

firm-fixed-price of $19.50 per dose for the first 100 million doses of the

Pfizer COVID-19 vaccine. To minimize financial risk to the

government, the parties agreed that the government would pay Pfizer

only after its vaccine received authorization or licensure from FDA and

as the doses were delivered. Further, Pfizer and the government

agreed that if Pfizer should cease to develop the vaccine due to

emerging safety or efficacy data, the government would be able to

terminate the July 2020 agreement and put into effect a no-cost

settlement to end the performance under the agreement within 30

days of notifying the company.

• In April 2020, HHS awarded an agreement with Moderna for $430

million for clinical trials and other aspects of vaccine development,

which included providing the government insight into the vaccine

candidate’s progress toward viability.

Subsequently, in August 2020,

The agreement also included manufacturing scale up and validation of manufacturing

capacities.

Page 18 GAO-21-443 COVID-19 Vaccines

DOD awarded Moderna a production contract and obligated $1.2

billion to manufacture 100 million doses at a price of $12.25 per dose

with options to buy 400 million more.

DOD agreed to pay Moderna

incrementally for meeting certain milestones without requiring

Moderna to first obtain an EUA or licensure.

In the event that

Moderna failed to obtain an EUA or licensure, DOD would be able to

terminate the contract in whole or in part. According to Operation

Warp Speed officials, this approach assisted the company with cash

flow by providing interim payments. Further, the government could

unilaterally decide that it would not exercise any of the four options

included in the award, which provided for 100 million doses each at a

cost of $16.50 per dose.

For the other four vaccine companies, the federal government provided

different levels of support for vaccine development, but DOD negotiated

similar payment and termination terms and conditions in their production

agreements. These payment and termination terms and conditions

enabled the government to adjust its reliance on the various companies

as time progressed and more was known about their vaccine candidates,

according to DOD officials we interviewed.

DOD’s approach to event-based terminations and termination in the

federal government’s best interests is similar to the approach used in

most federal contracts. For example, DOD could terminate its agreements

with AstraZeneca or Janssen for an event-based reason such as if FDA

placed clinical trials on hold for a certain amount of time (AstraZeneca) or

revoked an existing EUA (both companies).

DOD could also terminate

its agreements with several companies if it determined that doing so was

in the government’s interests. The government would then pay the

relevant company for work performed in accordance with the agreement

terms. Table 3 summarizes the selected payment and termination terms

While the contract has a firm-fixed price of $12.25 per dose for the first 100 million

doses, it also included an incentive of $3.00 per dose for meeting an EUA deadline of

January 31, 2021. As Moderna’s vaccine received an EUA on December 18, 2020, the

company is eligible to receive the additional incentive payment.

See Federal Acquisition Regulation § 52.232-32 (Performance-Based Payments).

FDA may revise or revoke an EUA if the circumstances giving rise to the emergency

declaration no longer exist, the statutory criteria for issuance are no longer met, or

revocation is appropriate to protect public health or safety. For example, an EUA may be

revoked if new data become available indicating that the vaccine is not safe or effective. In

general, unless it is revoked, an EUA will remain in effect for the duration of the

emergency declaration. See 21 U.S.C. § 360bbb-3(f) and (g).

Page 19 GAO-21-443 COVID-19 Vaccines

and conditions that were included in the vaccine agreements we reviewed

in the stated timeframe.

Table 3: Summary of Selected Payment and Termination Terms and Conditions Contained in the Production Awards for the

Six Operation Warp Speed Vaccine Candidates, July 2020-November 2020

Company/initial award

date/value/quantity

Payment Termination

Pfizer

July 2020

$1.95 billion

100 million doses

No payment until biologics license

application (BLA) or emergency use

authorization (EUA) obtained and as

doses are delivered pursuant to the

agreement.

If Pfizer ceases to develop the vaccine for reasons

enumerated in the agreement, or if the EUA is revoked and the

federal government determines after a reasonable time that it

is not likely to be restored, the government can terminate the

agreement. A no-cost settlement to end Pfizer’s performance

is expected within 30 days of the government providing notice.

Moderna

August 2020

$1.2 billion

100 million doses

Payment for meeting incremental

milestones without EUA required.

If Moderna fails to obtain an EUA, the federal government can

terminate the contract. The government can also terminate the

contract for convenience otherwise, in accordance with FAR §

52.249-2. The government reduced the stop-work period to no

more than 30 days, less than the usual 90-day period under

Federal Acquisition Regulation (FAR) § 52.242-15, in

consideration of the expedited award and performance under

the contract. In the event that the government issues a stop-

work order and Moderna continues to work, Moderna shall not

be entitled to an equitable adjustment by the government.

Janssen

August 2020

$1 billion

100 million doses

Payment for meeting incremental

milestones without EUA required.

If Janssen ceases to develop the vaccine for reasons

enumerated in the agreement, or if the EUA is revoked and the

federal government determines after a reasonable time that it

is not likely to be restored, the government can terminate the

agreement. Janssen would be entitled to full payment for

regimens for which manufacturing had been completed, but

which had not yet been delivered. With respect to regimens for

which manufacturing had been initiated but not completed,

Janssen would be entitled to payment of a proportion of the

price based on percentage of the work performed, among

other things.

If Janssen fails to comply with current good manufacturing

practices and that failure results in a material adverse effect,

Janssen will have 30 days to cure the failure. If Janssen fails to

take appropriate action the government can terminate the

contract.

Page 20 GAO-21-443 COVID-19 Vaccines

Company/initial award

date/value/quantity Payment Termination

AstraZeneca

October 2020

$1.2 billion

100 million doses

Payment for meeting incremental

milestones without EUA required.

The federal government can terminate its agreement with

AstraZeneca for certain event-based reasons, including the

Food and Drug Administration (FDA) placing clinical trials on

hold by FDA for a certain period of time, FDA revoking an

existing EUA, or AstraZeneca discontinuing development for

safety or efficacy reasons. The government can also terminate

its agreement if DOD decides termination is in its best

interests.

In the event the government terminates the contract for event-

based reasons, AstraZeneca is entitled to payment based on a

percentage of work completed and reasonable charges that

AstraZeneca can demonstrate resulted from the termination. In

addition to the foregoing, in the event of a termination in the

government’s best interest, AstraZeneca will be paid in full for

certain milestones regardless of percentage of work

completed.

Novavax

July 2020

$1.6 billion

100 million doses

Payment for meeting incremental

milestones without EUA required.

The government may terminate work under the agreement if

the government determines that a termination is in its interest.

The government and Novavax will negotiate equitable

reimbursement for work performed toward accomplishment of

the task or tasks of individual projects.

Sanofi

July 2020

$1.8 billion

100 million doses

Payment for meeting incremental

milestones without EUA required.

The government may terminate work under the agreement if

the government determines that a termination is in its interest.

The government and Sanofi will negotiate equitable

reimbursement for work performed toward accomplishment of

the task or tasks of individual projects.

Source: GAO analysis of Federal Procurement Data System – Next Generation data, award and other acquisition related documents and information provided by Operation Warp Speed officials. |

GAO-21-443

The federal government did not provide funding for development of the Pfizer vaccine; instead, it

purchased doses. Subsequent to this Department of Defense (DOD) other transaction agreement,

DOD awarded Pfizer a separate contract for 100 million doses in December 2020. DOD exercised a

contract option for 100 million additional doses in February 2021.

DOD exercised options under Moderna’s contract in December 2020 for 100 million doses and in

February 2021 for an additional 100 million doses.

Subsequent to this DOD other transaction agreement, in October 2020, DOD awarded AstraZeneca

a contract for 200 million additional doses.

According to DOD and HHS officials, the intellectual property underlying

the vaccine technology for the six vaccine candidates—including

intellectual property necessary for the formula and know-how to produce

it—was developed by the vaccine companies, or, in part, by the

government, before any funding was provided under Operation Warp

Speed and the continued DOD and HHS partnership. As a result, the

government does not have rights to the majority of intellectual property

developed prior to Operation Warp Speed-related efforts, according to

these officials.

Federal Government

Rights to Intellectual

Property Generally Limited

to Technical Data

Page 21 GAO-21-443 COVID-19 Vaccines

DOD and HHS contracting officials stated that they evaluated the

preexisting intellectual property to ensure that the companies had the

legal rights either through ownership or license to the patents that were

needed to enter into an agreement with the government to develop or

produce vaccines. According to DOD officials, this evaluation was also

done to determine whether any previous federal government investment

existed, and if so, to determine the scope of any previous investment and

rights and to inform each party’s negotiating position. For example, these

officials said that during the contract award process a DOD legal team

worked with HHS and Defense Advanced Research Projects Agency

attorneys to discuss related prior work to form a basis for the

negotiations.

Officials said DOD concluded that the government did not

own, in whole or in substantial part, the underlying intellectual property or

associated patents that the six companies identified as essential to

developing or manufacturing their specific vaccine candidates. For

example, DOD’s contract with Moderna includes an attachment

identifying Moderna’s background intellectual property. Moderna has also

publicly identified seven issued U.S. patents relevant to its vaccine, none

of which listed government inventors. At the same time, government

officials and company representatives noted that government scientists

had contributed to Moderna’s vaccine development and that some

government co-owned intellectual property could result from those

contributions.

DOD officials said in the absence of full rights to the underlying

intellectual property, and as part of DOD’s strategy to ensure the

availability of vaccines, they developed a unique contract clause to

address a potential scenario in which a vaccine company cannot ensure

Generally, the government only has rights in a company’s preexisting or “background”

intellectual property if there has been some previous agreement with the company. We

have found past instances in which the government and vaccine companies entered into

agreements to develop vaccine technology, but we do not have enough information about

the technology that was developed under those agreements or the nature of the rights that

were negotiated. For example, DOD’s price and cost analysis for the Moderna vaccine

noted that the Defense Advanced Research Project Agency awarded Moderna an up-to-5-

year, $24.6 million grant in October 2013 to research and develop its mRNA platform.

However, DOD’s price analysis did not provide additional information on this grant or

resulting patent information. DOD officials said DOD conducted a separate assessment of

the government’s underlying interest or co-ownership of background intellectual property

used in producing the new COVID-19 vaccine. We did not independently assess or

validate DOD’s process to review the company’s background intellectual property

assertions nor did we review the specific terms of the company’s previous government-

funded efforts.

Page 22 GAO-21-443 COVID-19 Vaccines

sufficient supply of doses subject to the terms of the contract or

agreement, and makes a business decision to stop production or sale of

the vaccine, or files for bankruptcy, among other things. For these

situations, DOD worked with companies to negotiate additional

government rights requiring the company to license the intellectual

property necessary to pursue FDA authorization or licensure, if required,

and manufacturing of the vaccine so that a third party may produce the

vaccine for exclusive sale to the government.

DOD officials said the intellectual property licensed would include the

vaccine formula and the technical know-how to produce it.

DOD officials

indicated, however, that implementing this approach would have some

practical limitations and considerations, such as whether the costs and

time associated with transferring technology to a third party might

outweigh the benefits. For example, the government or third party would

need to have the expertise and facilities necessary to use the licensed

intellectual property. These officials said they would need to determine

whether it would instead be more prudent to buy additional vaccine doses

from another company.

The additional rights DOD negotiated to allow for third-party

manufacturing of a vaccine do not apply in other potential scenarios,

which include:

• if a vaccine company experiences quality control or manufacturing

problems under its existing contract but does not make a business

decision to stop production or sale of the vaccine,

• if the government wants to increase the availability of a particular

vaccine by authorizing a different vaccine company to manufacture it,

• if a company significantly increases its proposed vaccine price on

subsequent contracts (i.e., an attempt to “price gouge”).

This language was included in five of the six companies’ contracts or agreements,

excluding Pfizer. According to DOD officials, DOD was unable to negotiate with Pfizer to

include third party manufacture as a remedy in its agreement due to the government’s lack

of involvement in the Pfizer vaccine’s development. Pfizer officials noted that Pfizer’s

agreement does not allow the government to “march-in,” as that term is defined in 35

U.S.C. § 203, and according to their agreement, government funding was limited to

payment for doses.

Page 23 GAO-21-443 COVID-19 Vaccines

While these other potential scenarios could create similar risks and

challenges, DOD officials identified mitigating circumstances or strategies

that minimized the risk. For example, DOD officials told us that the

expected availability of multiple vaccines would promote competition

between multiple vaccine companies and would make any price gouging

unlikely. Further, DOD officials stated that should the government need to

increase domestic manufacturing capacity to make certain vaccines, it

could invoke the Defense Production Act.

For example, the government

could modify existing priority ratings for specific companies to allow them

to obtain materials more quickly or they could expand manufacturing

capacity for supplies such as syringes.

DOD and HHS contracting officials noted that they are not aware of any

new intellectual property that will be created in the form of a “subject

invention” as a result of U.S. government funding for the Operation Warp

Speed-related contracts and agreements.

However, DOD generally

negotiated rights to the technical data—typically the scientific or

engineering data—generated under the production contract or

agreements, as applicable.

According to DOD contracting officials, the data the government may

obtain under the contracts and other agreements is generally limited to

technical data derived from the manufacturing scale-up process, such as

batch records and quality-related data. Generally, officials said, this

technical data gives the government insights into the vaccine production

process. In addition, having government representatives on site at

manufacturing plants allows them to observe the production process and

The Defense Production Act, as delegated, generally provides federal agencies

authority to, among other things, place priority ratings on contracts so that they receive

priority treatment over any other unrated contracts or orders if necessary to meet the

delivery or performance dates specified in the order; and provide financial incentives to

help maintain, restore, or expand the domestic industrial base. See Pub. L. No. 81-774, 64

Stat. 798 (1950) (codified, as amended, at 50 U.S.C. § 4501, et seq.); Exec. Order No.

13,603, 77 Fed. Reg. 16,651 (Mar. 22, 2012); 15 C.F.R. Part 700, Sch. 1 (2020).

DOD and HHS partnership officials stated that all six vaccine candidates have priority

ratings under the Defense Production Act.

The term “subject invention” means “any invention of a contractor conceived or first

actually reduced to practice in the performance of work under a funding agreement.” 35

U.S.C. § 201(e).

Page 24 GAO-21-443 COVID-19 Vaccines

any challenges that arise.

The related technical data the companies

provide allows for government oversight of production activities and

regulatory compliance according to DOD officials, but not access to the

vaccine formulas or know-how required to produce them.

The DOD and HHS partnership has taken several actions to increase the

availability of COVID-19 vaccine doses. As of March 25, 2021,

partnership officials stated that their aim is to have enough vaccine doses

distributed for all adults in the U.S.—about 265 million people—by the

end of May 2021.

They told us they expect to meet this time frame given

their additional purchase of vaccine doses and manufacturing expansion

efforts, which will lead to increased distribution of vaccines to jurisdictions

and federal partners, as described below.

Purchasing vaccine doses. As of April 1, 2021, DOD and HHS have

announced the purchase of at least 1.2 billion COVID-19 vaccine doses,

including 200 million doses each from Pfizer and Moderna, to be

manufactured and released by May 31, 2021 (see table 4). This is a

significant increase from the total of 600 million vaccine doses the federal

government had contracted to purchase as of November 2020.

Table 4: Contracted Amount of COVID-19 Vaccine Doses under the Department of Defense (DOD) and Department of Health

and Human Services (HHS) Partnership, by Vaccine Company, as of April 1, 2021

Vaccine company

Contracted amount

(millions of doses)

Contracted amount expected by the

end of May 2021 (millions of doses)

Emergency use

authorization (EUA)

Pfizer

300

200



Moderna

300

200



Janssen

100



AstraZeneca

300

TBD

Novavax

100

TBD

Sanofi

100

TBD

Total

1,200

487

Source: GAO analysis of award and other acquisition related documents and information from HHS, DOD, Advanced Technology International, and vaccine companies. | GAO-21-443

According to Pfizer representatives, since Pfizer did not accept U.S. government funding

under its agreement, the agreement did not include a “person in plant” provision to allow a

federal government official to observe its vaccine production process.

FDA authorized Pfizer’s vaccine for individuals 16 years of age and older, and

authorized Moderna’s vaccine for individuals 18 years of age and older. DOD and HHS

partnership officials told us that some vaccine companies have begun clinical trials for

adolescent and pediatric populations. On March 2, 2020, the White House announced

there would be sufficient doses for all adults in the U.S. by the end of May 2021.

The Federal

Government Has

Purchased Additional

Vaccine Doses and

Helped Mitigate

Manufacturing

Challenges to

Increase Vaccine

Availability

Page 25 GAO-21-443 COVID-19 Vaccines

Note: The contracted amount includes base and exercised options.

The federal government first awarded Pfizer an other transaction agreement for 100 million vaccine

doses. On December 22, 2020, the federal government awarded Pfizer a contract for an additional

100 million doses. On February 11, 2021, the government exercised another option in the Pfizer

contract for an additional 100 million doses, for a total of 300 million doses to be delivered by the end

of July 2021.

According to a company representative, Pfizer remains on track to fulfill its commitment to the federal

government to reach the 200 million doses mark by the end of May, and 300 million total doses by the

end of July.

The federal government first contracted with Moderna for 100 million vaccine doses. On December

11, 2020, the federal government announced that it had exercised an option with Moderna for an

additional 100 million doses. This was followed by an announcement on February 11, 2021, that the

government had exercised another option with Moderna for an additional 100 million doses, for a total

of 300 million doses.

The federal government awarded AstraZeneca an other transaction agreement for 100 million doses,

and later awarded AstraZeneca a contract for an additional 200 million doses, for a total of 300 million

doses, which will be provided to the government on a rolling basis, according to the company.

According to an AstraZeneca representative, the federal government and AstraZeneca are working

closely on a delivery schedule for the doses.

According to a Novavax representative, the company was also awarded a DOD contract in June

2020 that includes the delivery of 10 million doses. We do not include that amount in this table.

According to a Novavax representative, delivery of doses is dependent upon an EUA being granted

by the Food and Drug Administration.

According to a Sanofi representative, the release of the company’s vaccine doses is dependent upon

results of the phase 3 clinical study evaluating safety and efficacy, which is expected to begin in the

second quarter of 2021.

The 400 million purchased doses of the Pfizer and Moderna vaccines

expected by May 31, 2021 would be enough to fully vaccinate—that is to

provide 2 doses for each person being vaccinated, as necessary for each

of these vaccines—about 200 million people. In addition, Janssen is

expected to provide 87 million doses of its 1-dose vaccine by the end of

May 2021, which would be enough to vaccinate an additional 87 million

people. Combined with the expected 400 million doses from Moderna and

Pfizer (enough for 200 million people), the government would have

enough doses to vaccinate 287 million people which would exceed the

DOD and HHS partnership’s aim to have enough vaccine doses available

for all adults in the U.S. by the end of May 2021. Federal officials also

said that expected manufacturing of the AstraZeneca and Novavax

vaccine candidates would add to this total if those vaccine companies

request and receive EUAs to allow those vaccines to be marketed in the

United States.

Manufacturing and releasing vaccine doses. As of March 29, 2021,

226 million vaccine doses of the Pfizer, Moderna, and Janssen vaccines

had been manufactured and released, according to officials from the DOD

Page 26 GAO-21-443 COVID-19 Vaccines

and HHS partnership.

The number of vaccine doses released increased

notably at the end of February (see figure 4). According to information

from partnership officials, between December and mid-February of 2021,

an average of 8 million doses of the Pfizer and Moderna vaccines were

released per week. Between February 22, 2021, and March 29, 2021, this

increased to an average of 24 million doses per week. Representatives

from Pfizer and Moderna publicly stated that their vaccine manufacturing

rates would increase to 13 million doses per week for Pfizer by mid-March

and over 40 million doses per month—over 9 million doses per week—for

Moderna by April.

Figure 4: Number of Doses of COVID-19 Vaccine Released in the U.S. per Week (in millions), as of March 29, 2021

According to the DOD and HHS partnership, once through manufacturing and quality

assurance, the vaccine doses are released for distribution.

Page 27 GAO-21-443 COVID-19 Vaccines

Note: Numbers presented here are doses that have been released—that is, they have passed the

quality assurance process after manufacturing and been released for distribution, according to

officials from partnership between the Department of Defense (DOD) and Department of Health and

Human Services (HHS), formerly known as Operation Warp Speed.

DOD and HHS partnership officials said that they expect the rate of

vaccine doses manufactured and released to continue to increase. DOD

and HHS partnership officials and vaccine company representatives

described ways in which they continue to work together to mitigate

manufacturing challenges in order to increase manufacturing rates.

Specifically:

• Manufacturing capacity. Some vaccine companies have sought to

expand their capacity through making additional manufacturing sites

operational or modifying existing production facilities to manufacture

enough doses to fulfill their contracts with the federal government.

DOD and HHS partnership officials told us that they were working to

ensure that bottlenecks do not occur by helping companies obtain

additional fill-finish capacity for vaccines, with priority going to

vaccines with EUAs. For example, officials stated that they were

working with Catalent to add an additional production line at

Catalent’s fill-finish facility, which handles fill-finish manufacturing for

the Moderna and Janssen vaccines. Pfizer is also adding two

production lines at one of its fill-finish facilities. According to DOD

officials, the U.S. Army Corps of Engineers supported the fill-finish

facility upgrades by working with contractors to provide an additional

layer of quality control on behalf of the U.S. government. Officials

further stated that the U.S. Army Corps of Engineers leverages its

relationships with state and local governments in support of

manufacturers obtaining their permits and working with the

manufacturer’s suppliers in expediting the shipment of equipment and

supplies. Table 5 summarizes the status of the manufacturing

capacity expansion efforts for the six vaccine candidates under the

DOD and HHS partnership.

• Supply chains. Most vaccine company representatives indicated that

supply constraints were not impeding their manufacturing process as

of March 2021, and the companies have continued to utilize prioritized

contracts under the Defense Production Act to expedite the receipt of

supply constrained materials. These companies generally reported

that the priority rating process had been beneficial in providing

uninterrupted supply of materials. However, Janssen representatives

stated that providing priority ratings for multiple companies producing

COVID-19 vaccines may have unintended negative consequences,

such as creating constrained supplies for other life-saving medicines

Page 28 GAO-21-443 COVID-19 Vaccines

and unnecessary stockpiling of supplies that may be at risk of being

prioritized under the Defense Production Act. DOD and HHS

partnership officials also provided information that priority ratings for

COVID-19 vaccine materials are beginning to crowd out producers of

non-COVID-related life-saving therapies and medicines, including the

seasonal flu vaccine.

According to HHS, the administration is aware and working through

wider supply-chain disruptions resulting from the U.S. government use

of the Defense Production Act. HHS officials stated that it is important

to note that the supply-chain constraints are a result of unprecedented

global demand as global manufacturing races to produce vaccine for

more than 7 billion people using existing manufacturing infrastructure.

They further stated that the U.S. government’s use of the Defense

Production Act allows for prioritization of U.S. government contracts

for U.S.-based manufacturing, but it is not the primary cause of

shortages.

Additionally, partnership officials provided information on efforts to

mitigate risks from supply constrained materials. For example, officials

identified the potential risk of limited production capability for at least

one raw material for which supply has been hindered by (1) a fire at a

domestic facility which is delaying delivery of the material from this

facility by 4 to 10 weeks, and (2) an explosion at a foreign facility that

has required production to be shifted to a facility in a different country.

According to information provided by partnership officials, they are

closely monitoring shipments of this material from remaining foreign

sources and believe that this supply issue is unlikely to impact near-

term production due to supplies vaccine companies already have.

However, these supply disruptions highlight the overall fragility of the

global supply chain and the risks of relying on raw materials from a

small number of primarily foreign sources.

• Available workforce. The six vaccine companies indicated that

workforce gaps were not impeding their manufacturing process as of

March 2021. However, there continues to be a need to recruit and

train the highly skilled workforce needed to run vaccine production

processes.

As of March 2021, DOD personnel were continuing to

serve as quality control staff at the Emergent BioSolutions

manufacturing partner site until the company could hire the required

For example, Janssen representatives noted that each of the company’s manufacturing

partner sites continues to have vacancies, with sites that are still ramping up production

having a greater numbers of vacancies. Pfizer representatives stated that hiring staff with

specialized skills is always a challenge, but in general the company has been successful

in hiring qualified people.

Page 29 GAO-21-443 COVID-19 Vaccines

personnel, according to partnership officials. Although the DOD

personnel were originally scheduled to depart in mid-February 2021,

partnership officials told us that DOD personnel were extended to stay

until mid-April as Emergent BioSolutions continued to recruit, hire, and

train additional staff.

Table 5: Status of Manufacturing Capacity Expansion Efforts for Six COVID-19

Vaccine Candidates under the DOD and HHS Partnership, as of March 2021

Vaccine

company

U.S. manufacturing capacity expansion efforts

Pfizer

Has made and continues to make improvements and expansion at its

current facilities

Moderna

Completed work on near-term planned capacity; contracted with an

additional fill-finish manufacturing partner; making new capital

investments to increase capacity at its owned and partnered

manufacturing facilities

Janssen

Continuing to add additional manufacturing capacity, including

contracting with an additional manufacturing partner

AstraZeneca

Operating at full capacity in the United States

Novavax

Continuing to explore options for additional manufacturing capacity

Sanofi

Large-scale manufacturing has been delayed due to the results of the

combined phase 1 and 2 clinical trial

Source: GAO analysis of information from vaccine companies. | GAO-21-443.

Note: The Department of Defense (DOD) and Department of Health and Human Services (HHS)

partnership was formerly known as Operation Warp Speed.

Distributing vaccine doses. As of March 27, 2021, the partnership had

distributed 180.6 million total doses, according to data from CDC. The

number of vaccine doses distributed to jurisdictions and federal partners

has varied each week since the process began in December 2020. From

February 28, 2021 to March 27, 2021, the partnership distributed an

average of about 21.1 million doses of the Pfizer, Moderna, and Janssen

vaccines per week (see figure 5).

Because the Pfizer and Moderna

vaccines are 2-dose vaccines and the Janssen vaccine is a 1-dose

vaccine, this average weekly number of doses from each manufacturer

We chose this 4-week period to include the initial release of the Janssen vaccine during

the week of February 28, 2021, plus 3 additional weeks to reflect week-to-week variation.

The 21.1 million average number of doses per week included about 11.0 million doses of

Pfizer, 8.9 million doses of Moderna, and 1.2 million doses of Janssen vaccines (when

rounding).

Page 30 GAO-21-443 COVID-19 Vaccines

corresponds to enough doses each week for about 11.2 million people to

eventually be fully vaccinated.

Figure 5: Number of Vaccine Doses Distributed in the U.S. per Week, as of March

27, 2021

Note: Vaccine doses distributed is the total number that have been delivered to jurisdictions, retail

pharmacies, long-term care facilities, Federal Emergency Management Agency and Health

Resources and Services Administration partner sites, and federal entities. However, for Palau,

Micronesia, Marshall Islands, Guam, American Samoa, and Northern Marianas Islands, total counts

of COVID-19 vaccine doses include doses marked as shipped in CDC’s Vaccine Tracking System

since December 13, 2020. For COVID-19 vaccination there are 64 jurisdictions including all 50 states,

territories, and local health programs in Chicago, the District of Columbia, Houston, New York City,

Philadelphia, and San Antonio.

For the week ending on February 27, 2021, the national doses distributed totals show larger than

typical daily increases. This is an accurate reflection of the data and is the result of weather events

causing a backlog of vaccine distributed to many parts of the United States.

DOD and HHS partnership officials noted that projecting future vaccine

dose availability beyond approximately 3 weeks is inherently uncertain, in

part because of the complex manufacturing processes for biologics like

Page 31 GAO-21-443 COVID-19 Vaccines

vaccines, as well as the manufacturing challenges discussed earlier.

Further, while they indicated that they expect the number of vaccine

doses distributed to increase each week in line with the expected

increases in vaccine manufacturing, there may be slight differences due

to the time it takes to package and ship the doses.

With the expected increases in vaccine manufacturing and distribution,

HHS announced on March 17, 2021 that the Acting Secretary of Health

and Human Services was directing all states, Tribes, and territories to

make all adults in the U.S. eligible for the vaccine by May 1, 2021.

Effective communication on vaccine availability will be critical to manage

public expectations, particularly given the uncertainty with future

projections and the significant effort required to manufacture and

distribute sufficient vaccine doses available for all adults in the U.S. In

particular, having sufficient vaccine doses available by the end of May

2021 will generally require an increase of more than half of weekly

distribution amounts compared to the average weekly rate for February

28 through March 27, 2021.

In our prior work on the H1N1 influenza pandemic, we found that although

the federal government was able to purchase and distribute millions of

doses of H1N1 vaccine, the vaccine was not widely available when the

public expected it, and the failure to effectively manage public

expectations undermined government credibility.

As we reported in

January 2021, initial vaccine rollout did not match public expectations,

with initial numbers of distributed and administered COVID-19 vaccines

The manufacturing of vaccines can be more uncertain than drug-related manufacturing,

in part because vaccines often need to grow living material that can take time and be

imprecise. DOD and HHS partnership officials told us that projecting future vaccine doses

availability was also difficult because of the inherent challenge with scale-up and

production in a short timeframe.

On April 6, 2021, the President revised this, announcing that all states, Tribes, and

territories would be directed to make all adults in the U.S. eligible by April 19, 2021.

The average weekly rate from February 28 through March 27 corresponds to enough

doses each week for about 11.2 million people to eventually be fully vaccinated, based on

the number of 2-dose and 1-dose vaccines distributed during this time. We calculated that

this weekly rate would need to increase by about 59 percent, on average, to have enough

doses available by May 31 to eventually allow for all adults in the U.S. to be fully

vaccinated. Our calculation assumes that the proportion of 2-dose and 1-dose vaccines

would remain the same.

See GAO, Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be

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

Page 32 GAO-21-443 COVID-19 Vaccines

falling short of implementation expectations set by officials.

Further, as

we have reported since June 2020, timely, clear, and consistent

communication is essential to ensure public confidence and trust.

Stakeholders—including representatives of state, territorial, and local

health officials and health care providers—identified multiple challenges

with initial implementation of COVID-19 vaccination, which includes

prioritizing, allocating, distributing, and administering available vaccine

doses to individuals. Through our interviews with stakeholders conducted

from January 6 through February 1, 2021, when vaccine doses were

initially available, we found that state, territorial, and local health officials

and health care providers faced challenges such as competing priorities

with limited resources and lack of information needed for on-the-ground

planning for vaccine administration. Table 6 provides examples of

challenges in the initial COVID-19 vaccine implementation identified by

some of these stakeholders.

See GAO, COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and

Other Challenges Require Focused Federal Attention, GAO-21-265 (Washington, D.C.:

Jan. 28, 2021).

Stakeholders

Identified Challenges

with Initial COVID-19

Vaccination; the

Federal Government

Has Taken Some

Steps to Help

Improve Vaccine

Implementation

Stakeholders Identified

Multiple Challenges with

Initial COVID-19

Vaccination

Implementation, Which

Were Exacerbated by

Changing Federal

Procedures

Page 33 GAO-21-443 COVID-19 Vaccines

Table 6: Examples of Challenges with Initial COVID-19 Vaccine Implementation Reported by Stakeholders, as of February 1,

2021

Challenge

Description

Health officials and health care

providers faced competing

priorities with limited resources

Some stakeholders, including representatives of state, territorial, and local health officials and

health care providers, said that they faced challenges in trying to plan for and conduct vaccine

distribution and administration activities while also managing their other COVID-19 response

efforts, such as contract tracing. Prior to December 14, 2020, when vaccination began, some

stakeholders indicated limited resources were available for planning these efforts. For example,

some stakeholders said they needed to hire and train new staff to enhance existing data systems to

handle the anticipated increase in data collection or to run vaccination clinics, while also treating

patients.

Health officials and health care

providers lacked information on

vaccine shipments needed for

on-the-ground planning

Stakeholders said some state, territorial, and local health officials and health care providers lacked

information on vaccine shipments, such as on the number of doses they would receive and when

they would arrive, which is critical to planning for and administering vaccinations. For example, one

stakeholder noted not having this information makes it difficult for states to plan further distribution

to the local level. Another stakeholder noted that this information is critical for planning

vaccinations, particularly for health care providers in rural communities that may not have hospitals.

These communities might use mobile vans or recreational centers that require advance planning so

that people can be at a particular location on a specific day.

Health officials identified

challenges with reporting

administration data to the

Centers for Disease Control and

Prevention (CDC)

Stakeholders said some state, territorial, and local health officials have experienced challenges

affecting their ability to report vaccine administration data to CDC. For example, health officials in

one state had to update their data reporting systems with new functionality for the pandemic, and

there have been some interoperability challenges with getting access to administration data. One

stakeholder also noted there can be as much as a 4-5 day delay in reporting data from the health

care provider to CDC because health care providers have up to 72 hours to report administration

data to the jurisdictions and jurisdictions have 24 hours to review these data before reporting them

to CDC.

Local health departments and

health care providers could not

plan for their vaccination efforts

because they were not included

in federal planning efforts, which

focused on coordination at the

jurisdictional (e.g., state) level

Some local health departments and some health care providers did not participate in planning

exercises organized by the federal government because federal planning efforts focused on

coordination at the jurisdictional (e.g., state) level, according to stakeholders. Thus, stakeholders

said some local health departments and some health care providers did not have key information

needed for planning, such as when and how many vaccine doses would be arriving. This lack of

information affected some local health departments’ and some health care providers’ ability to

coordinate and plan, including their ability to develop their own community education and

messaging around vaccination.

Local health departments and

health care providers were

uncertain on who to vaccinate or

where to provide vaccinations

Some local health departments were not initially informed when jurisdictions deviated from federally

recommended groups targeted for vaccination, resulting in uncertainty about who they should

vaccinate, according to one stakeholder representing local health officials. For example, when the

Secretary of Health and Human Services recommended expanding the initial vaccination target

group from persons aged 75 and older to those 65 and older, this stakeholder said there was little

or no planning done by local communities, including by local health departments and health care

providers, for such an expansion.

Additionally, some hospital officials did not initially know whether they were responsible for

vaccinating health care providers in their community who were eligible to be vaccinated but were

not affiliated with a particular hospital, according to one stakeholder. Similarly, unaffiliated providers

did not know where or when they could get vaccinated when they were in the initial priority group

for vaccination, according to another stakeholder.

Page 34 GAO-21-443 COVID-19 Vaccines

Challenge

Description

Health care providers did not

have information from an

authoritative source to combat

misinformation and vaccine

hesitancy

Some stakeholders said health care providers needed science-based information to combat

misinformation and vaccine hesitancy during the initial vaccine implementation. For example, one

stakeholder noted that certain spokespeople made inaccurate statements about who could be

vaccinated. Further, some heath care providers were hesitant to be vaccinated because of

misinformation about the vaccines, resulting in a lower proportion of health care staff in long-term

care facilities willing to be vaccinated than initially expected, according to some stakeholders.

Additionally, another stakeholder noted that health care providers of color were more likely to

refuse a COVID-19 vaccine when offered than their white counterparts, and a second stakeholder

said that some members of the public remain hesitant to be vaccinated, in part, due to

misinformation about the vaccines.

Source: GAO analysis of interviews with representatives of state, territorial, and local health officials, and health care providers from January 6, 2021, through February 1, 2021. | GAO-21-443

Note: These challenges were examples identified collectively by stakeholders and not by every

stakeholder interviewed.

Prior to the beginning of vaccine administration on December 14, 2020, approximately $340 million

had been made available from CDC to jurisdictions for vaccine preparedness. Of this $340 million,

the Department of Health and Human Services announced $200 million would be awarded on

September 23, 2020, and an additional $140 million would be awarded on December 15, 2020.

For the purposes of this report, vaccine hesitancy refers to a delay in acceptance of vaccines despite

availability. Those who are vaccine hesitant are a middle group along a continuum that ranges

between those who fully accept vaccines on one end and those who are strongly opposed to

vaccines on the other. An individual’s vaccine hesitancy can apply to all vaccines or to a specific

vaccine.

Some stakeholders indicated these challenges were exacerbated by

unanticipated changes from the federal government. For example, in

December 2020, ACIP recommended that, when initial vaccine supplies

were expected to be limited, vaccine doses should first be offered to

health care personnel and long-term care facility residents. Next, vaccine

doses should be offered to persons aged 75 and older and non–health

care, frontline essential workers. As more vaccine doses became

available, ACIP recommended vaccination be expanded to include

persons aged 65 and older.

However, during a press conference on

January 12, 2021, the Secretary of Health and Human Services

recommended that the target group be expanded to include those aged

ACIP recommendations for phased allocation provide guidance for federal, state, and

local jurisdictions while vaccine supply is limited. To inform policy options for ACIP, the

committee’s COVID-19 Vaccines Work Group, comprising experts in infectious diseases,

vaccinology, vaccine safety, public health, and ethics, held 28 meetings to review data

regarding vaccine candidates, COVID-19 surveillance, modeling of allocation scenarios,

and vaccination program implementation issues. In its deliberations, ACIP considered

scientific evidence regarding COVID-19 epidemiology, ethical principles, and vaccination

program implementation. ACIP recommendations are reviewed by the CDC Director and,

if adopted, are published as official CDC/HHS recommendations in the Morbidity and

Mortality Weekly Report, https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm695152e2-

H.pdf.

Page 35 GAO-21-443 COVID-19 Vaccines

65 and older and people under 65 with a documented co-morbidity before

additional vaccine doses became available.

At the same time, jurisdictions experienced an unexpected decline in their

second-week allocations of vaccine doses and some said they received

mixed messages from the federal government on vaccine availability. See

table 7 for changes made by the federal government regarding COVID-19

vaccinations that occurred during the initial vaccine implementation

through mid-February 2021. Some stakeholders expressed frustration

with these unanticipated changes and stressed the need for more

predictable information and guidance going forward, underscoring the

need for clear and consistent coordination and communication by the

federal government to help ensure more effective vaccine

implementation.

Table 7: Changes by the Federal Government to the Initial COVID-19 Vaccine Implementation between November 2020 and

mid-February 2021

Change

Date

Event

Expansion of

recommended target

groups to receive initial

supplies of vaccine doses

beyond initial

recommendations

Dec. 1-2, 2020

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on

Immunization Practices (ACIP) recommended that when supplies of COVID-19

vaccines are limited, vaccination should be offered in a phased approach. ACIP

recommended that vaccines in the initial phase of the vaccination program (phase 1a)

be offered to (1) health care personnel, and (2) residents of long-term care facilities.

The CDC Director adopted ACIP’s recommendation for priority groups for the initial

phase of the COVID-19 vaccination program.

Dec. 20-21, 2020

ACIP recommended that after phase 1a, vaccination should be offered in phase 1b to:

(1) persons aged 75 and older and (2) frontline essential workers (non-healthcare);

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. The CDC Director

adopted ACIP’s updated recommendations for priority groups for allocation of COVID-

19 vaccine doses.

Jan. 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.

Jan. 21, 2021

The White House released the National Strategy for the COVID-19 Response and

Pandemic Preparedness (National Strategy) that encouraged jurisdictions to open

vaccination to persons age 65 and older and essential workers.

Page 36 GAO-21-443 COVID-19 Vaccines

Change

Date

Event

Changes in number of

doses, including in states’

and other jurisdictions’

second week allocations

of the Pfizer and Moderna

vaccines

Late Dec. 2020

For 51 jurisdictions (93 percent of the 55 jurisdictions for which data were available),

the number of Pfizer vaccine doses included in their second week’s allocation was

more than 25 percent lower than were included in their first week’s allocation,

according to CDC data.

An Operation Warp Speed official explained that the number of doses available for

allocation in the second week of the Pfizer vaccine implementation was lower [than

initially understood] and so the actual allocations made were lower than had originally

been communicated to jurisdictions.

For 54 jurisdictions (98 percent of the 55 jurisdictions for which data were available),

the number of doses available for allocation in the second week of Moderna vaccine

implementation was about 65 percent lower than their first allocation.

Jan. 6, 2021

The Food and Drug Administration (FDA) determined six doses instead of five doses

can be obtained from the Pfizer vaccine vials by using “low dead-volume” syringes. If

standard syringes and needles are used, there may not be sufficient vaccine to extract

a sixth dose.

Changes in federal

management of vaccines

for second doses

Dec. 2, 2020

During a press conference, an Operation Warp Speed official said the federal

government would not distribute the second dose of vaccine to jurisdictions to ensure

that enough vaccine doses would be available for people to receive it. The official said

the federal government would distribute the second dose of the vaccine either 3 or 4

weeks later, depending on the vaccine.

Dec. 9, 2020

During a press conference, an Operation Warp Speed official said the federal

government set aside some vaccine doses from the initial total supply as part of a

reserve.

This official said that as the federal government became more confident in

the manufacturing and distribution process, a smaller reserve of vaccine doses would

be maintained.

Jan. 12, 2021

During a press conference, the Secretary of Health and Human Services said the

federal government was releasing its entire supply of vaccine for jurisdictions to order

rather than holding back second doses in a physical reserve until a 3- or 4-week time

period had passed. This statement led some jurisdictional officials (e.g., state officials)

to anticipate they would receive a larger weekly allocation of vaccine doses.

Jan. 15, 2021

In a press interview, the Secretary of Health and Human Services clarified that the

federal government did not have a stockpile of reserved second doses of vaccine.

Jan. 21, 2021

The National Strategy stated that the administration planned to end the policy of

holding back significant levels of vaccine doses. The National Strategy also noted that

to ensure the availability of second doses of vaccine, the administration would hold a

smaller reserve and closely monitor the development, production, and release of

vaccine doses, and use the Defense Production Act as needed to ensure adequate

supply.

Announced modifications

to how vaccines would be

allocated

Nov. 2020

In anticipation of the authorizations of the Pfizer and Moderna vaccines, Operation

Warp Speed officials reported that allocations would be made based on jurisdictions’

adult populations (i.e., those aged 18 years and older).

Page 37 GAO-21-443 COVID-19 Vaccines

Change

Date

Event

Jan. 12, 2021

In a press conference, the Secretary of Health and Human Services announced that

beginning in 2 weeks, vaccines would be allocated to jurisdictions based on the

percentage of doses each jurisdiction had administered along with the number of

residents aged 65 years and older residing in the jurisdiction.

Feb. 11, 2021

Department of Defense (DOD) and Department of Health and Human Services (HHS)

partnership officials said the allocation policy for jurisdictions would be based on

jurisdictions’ adult populations (i.e., those 18 and older).

Source: GAO analysis of CDC data on vaccine allocations, federal planning and other documents, transcripts of press conferences with Operation Warp Speed officials, which included HHS and DOD

officials, and interviews with federal officials. | GAO-21-443.

Note: COVID-19 vaccine implementation includes prioritization, allocation, distribution and

administration of any authorized or licensed COVID-19 vaccine. Also, as of January 2021, the

partnership between DOD and HHS has continued but is no longer referred to as Operation Warp

Speed.

CDC 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

Department of Health and Human Services, Centers for Disease Control and Prevention, “The

Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial

Supplies of COVID-19 Vaccine—United States, 2020,” Morbidity and Mortality Weekly Report,

(Atlanta, Ga.: Dec. 11, 2020), accessed on March 1, 2021,

https://www.cdc.gov/mmwr/volumes/69/wr/mm6949e1.htm.

ACIP recommendations are reviewed by the CDC Director and, if adopted, are published as official

HHS/CDC recommendations in the Morbidity and Mortality Weekly Report. See

https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html (accessed March 1, 2021) for

ACIP’s current COVID-19 vaccine recommendations. For the purposes of ACIP’s recommendation,

non-healthcare 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-healthcare

frontline essential workers and individuals aged ≥75 years are recommended for vaccination in phase

1b, and an additional 129 million persons are recommended for vaccination in phase 1c (including

about 28 million individuals aged 65-74 years).

White House, National Strategy for the COVID-19 Response and Pandemic Preparedness

(Washington, D.C.: Jan. 21, 2021), accessed on January 21, 2021 at

https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Respo

nse-and-Pandemic-Preparedness.pdf.

For COVID-19 vaccine implementation, there are 64 jurisdictions including all 50 states, territories,

the District of Columbia, and local health programs in Chicago, the District of Columbia, Houston,

New York City, Philadelphia, and San Antonio that receive vaccine allocations from Operation Warp

Speed and the continued HHS and DOD partnership. According to CDC, the Marshall Islands,

Micronesia, and Palau did not receive doses of the Pfizer vaccine due to logistical considerations with

ultra-cold storage requirements. American Samoa, Guam, and the Mariana Islands received their first

and second doses simultaneously to optimize transportation logistics. Alaska was allocated vaccine

doses the first and fourth weeks, but not the second or third week of Pfizer vaccine implementation.

Houston and San Antonio had their allocations consolidated with Texas.

According to CDC, for the Moderna vaccine, American Samoa, Guam, and the Mariana Islands

received their first and second doses simultaneously to optimize transportation logistics. Alaska, the

Marshall Islands, Micronesia, and Palau were allocated vaccine doses the third week but not the

second week of Moderna vaccine implementation. Houston and San Antonio had their allocations

consolidated with Texas.

Department of Health and Human Services, Food and Drug Administration, “Fact Sheet for

Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization

Page 38 GAO-21-443 COVID-19 Vaccines

(EUA) of the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)”,

accessed January 11, 2021, https://www.fda.gov/media/144413/download.

The second dose of the Pfizer vaccine should be administered 3 weeks after the first dose, and the

second dose of the Moderna vaccine should be administered 1 month after the first dose, according

to FDA.

The federal government maintained this emergency reserve of vaccine doses based on

recommendations from the National Security Council, according to federal officials.

In January 2021, HHS announced that CDC would provide more than $3

billion in awards using funds provided under the Consolidated

Appropriations Act, 2021, to jurisdictions to support vaccination-related

activities.

In addition, the American Rescue Plan Act of 2021, enacted in

March 2021, provided additional resources for vaccination activities. For

example, that act includes $7.5 billion for CDC to carry out activities to

plan, prepare for, promote, distribute, administer, monitor, and track

COVID-19 vaccines.

With the release of the National Strategy, the

federal government identified several specific initiatives for vaccine

implementation, as part of the larger COVID-19 response.

Several

examples of federal initiatives include:

Additional funding and resources for vaccine distribution and

administration. In accordance with a January 21, 2021 Presidential

Memorandum, the Federal Emergency Management Agency (FEMA) will

reimburse states, territorial, local, and tribal governments for costs

associated with COVID-19 response, which includes vaccine distribution

and administration, through the Disaster Relief Fund, which had a

The $3 billion in awards will be made through the CDC Immunization and Vaccines for

Children cooperative agreement, and funds will be allocated by a population-based

formula.

Pub. L. No. 117-2, § 2301, 135 Stat. 4, 37-38.

White House, National Strategy for the COVID-19 Response and Pandemic

Preparedness (Washington, D.C.: Jan. 21, 2021), accessed on January 21, 2021

https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-

COVID-19-Response-and-Pandemic-Preparedness.pdf.

The Federal Government

Has Taken Some Steps to

Help Improve COVID-19

Vaccine Implementation

Page 39 GAO-21-443 COVID-19 Vaccines

balance of about $61.4 billion, as of March 18, 2021, according to

FEMA.

On February 18, 2021, FEMA also reported it could support establishing

community vaccination centers and provide additional resources (e.g.,

clinical staff including nurses and emergency medical services personnel)

and additional ancillary supplies (e.g., gloves, masks, and syringes).

These community vaccination centers range from mobile sites that can

support the administration of 250 vaccine doses a day to those that can

support the administration of 6,000 vaccine doses a day.

According to

FEMA, as of March 26, 2021, the agency had partnered with California,

Florida, Georgia, Illinois, Michigan, New York, North Carolina, Ohio,

Pennsylvania, and Texas to establish community vaccination centers and

planned to partner with additional states in late-March and April 2021.

White House, Memorandum to Extend Federal Support to Governors’ Use of the

National Guard to Respond to COVID-19 and to Increase Reimbursement and Other

Assistance Provided to States, (Washington D.C.: Jan. 21, 2021), accessed on February

4, 2021, https://www.whitehouse.gov/briefing-room/presidential-

actions/2021/01/21/extend-federal-support-to-governors-use-of-national-guard-to-

respond-to-covid-19-and-to-increase-reimbursement-and-other-assistance-provided-to-

states/.

On February 2, 2021, the administration announced it would retroactively reimburse states

fully for FEMA-eligible services—including masks, gloves, emergency feeding actions,

sheltering at risk populations, and mobilization of the National Guard—back dated to the

beginning of the pandemic in January 2020 in the United States, according to FEMA.

White House, Memorandum on Maximizing Assistance from the Federal Emergency

Management Agency, (Washington D.C.: Feb 2, 2021), accessed on February 4, 2021,

https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/02/memorandum-

maximizing-assistance-from-the-federal-emergency-management-agency/.

According to FEMA, as of March 31, 2021, it had provided more than $4.49 billion to 42

states, the District of Columbia, five territories, and four Tribes for expenses related to

COVID-19 vaccination efforts.

Federal Emergency Management Agency, Community Vaccination Centers Playbook,

Version 4.0 (Washington, D.C.: Mar. 26 2021), accessed on March 30, 2021,

https://www.fema.gov/sites/default/files/documents/fema_community-vaccination-

centers_playbook_03-26-2021.pdf.

See FEMA’s website on its support of COVID-19 vaccination efforts, accessed on

February 26, 2021, https://www.fema.gov/disasters/coronavirus/vaccine-support.

According to FEMA, the sites are selected based on data analysis including the CDC’s

Social Vulnerability Index and other Census data as well as input from state and local

partners.

Page 40 GAO-21-443 COVID-19 Vaccines

The National Strategy also proposed augmenting the number of health

care providers available to administer vaccines by, for example, utilizing

the Army and Navy Medical Corps. According to FEMA, as of March 26,

2021, 6,838 federal personnel were deployed to 997 federally supported

vaccination sites across the country, including 2,905 DOD personnel and

2,108 FEMA and Department of Homeland Security personnel who were

directly supporting vaccination efforts. There were also an additional

2,800 personnel serving in non-clinical operational roles. In addition, as of

March 26, 2021, U.S. National Guard Bureau personnel were supporting

the COVID-19 response, including 1,916 vaccinators.

Earlier advance notice on vaccine allocations and increased

amounts of projected supply. On January 26, 2021, the White House

announced that the federal government would begin providing states,

Tribes, and territories with reliable vaccine allocation estimates 3 weeks

in advance—instead of the one-week look-ahead they had been

receiving—to give state and local leaders greater certainty around supply

so they can plan their vaccination efforts.

In addition, on March 9, 2021,

the White House announced that it would increase the overall weekly

vaccine supply to states, Tribes, territories, and others to more than 20

million doses. This amount was up from an earlier weekly vaccine supply

of 8.5 million doses.

Initiation of a federal retail pharmacy program. In January 2021, CDC

announced a federal partnership with retail pharmacies, including 21

national pharmacy partners and networks of independent pharmacies,

representing over 40,000 pharmacy locations nationwide. Described in

CDC’s COVID-19 Vaccination Program Interim Playbook for Jurisdictions

Operations Annex (annex), CDC noted that not all pharmacy locations

would receive vaccine doses in the initial stages of implementation, but

White House, Fact Sheet: President Biden Announces New Steps to Boost Vaccine

Supply and Increase Transparency for States, Tribe, and Territories (Washington, D.C.:

Jan. 26, 2021), accessed on February 4, 2021, https://www.whitehouse.gov/briefing-

room/statements-releases/2021/01/26/fact-sheet-president-biden-announces-new-steps-

to-boost-vaccine-supply-and-increase-transparency-for-states-tribes-and-territories/.

Page 41 GAO-21-443 COVID-19 Vaccines

instead, jurisdictions were to select one or more pharmacy partners,

based on a pre-selected list of partners.

According to CDC, the pre-selected pharmacy partners were chosen

based on CDC analysis that they could provide vaccine to those in

greatest need, including those at highest risk of becoming severely ill

from COVID-19 and those who are socially vulnerable. According to the

annex, as the vaccine supply increases, the number of participating retail

pharmacies will also increase. Selected pharmacies received their initial

vaccine doses, which were separate from vaccine allocations provided to

jurisdictions, on February 11, 2021, according to the White House. On

February 16, 2021, the White House announced that 2 million doses

would be going to pharmacies that week.

Initiation of a federal partnership with federally qualified health

centers. The National Strategy described a federal partnership with

federally qualified health centers, and during the week of February 22,

2021, federally qualified health centers began directly receiving vaccine

allocations from the federal government.

Similar to the federal

partnership with retail pharmacies, this program began with a phased-in

approach, initially including 25 sites. The health centers initially chosen

include those that serve a large volume of disproportionately affected

populations, including individuals experiencing homelessness, migrant or

seasonal agricultural workers, and those with limited English proficiency,

according to the Health Resources and Services Administration.

Across

this initial phase, the goal is to allocate 1 million doses, according to a

White House COVID-19 Response Team statement on February 9,

Department of Health and Human Services, Centers for Disease Control and

Prevention, COVID-19 Vaccination Program Interim Playbook for Jurisdictions Operations

Annex (Atlanta, Ga.: Jan. 11, 2021), accessed on February 4, 2021,

https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-vaccination-program-

playbook-annex.pdf.

According to CDC, pharmacies will be administering COVID-19 vaccine in accordance

with the prioritization groups determined by the appropriate public health authority (e.g.,

the state or local health department in coordination with the state governor).

These allocations to federally qualified health centers are separate from the allocations

provided to jurisdictions.

See the Health Resources and Services Administration’s Ensuring Equity in COVID-19

Vaccine Distribution—Engaging Federally Qualified Health Centers website, accessed on

February 26, 2021, https://www.hrsa.gov/coronavirus/health-center-program.

Page 42 GAO-21-443 COVID-19 Vaccines

2021.

As of March 8, 2021, 199 health centers were participating and 51

additional health centers were invited to participate in this program,

according to the Health Resources and Services Administration.

Enhancing the number of eligible vaccinators and expanding

eligibility for vaccination to all adults in the U.S. by April 19, 2021.

On March 11, 2021, the administration announced plans to allow other

qualified health care providers to administer COVID-19 vaccine, including

dentists, midwives, optometrists, paramedics, veterinarians, and medical

and nursing students.

The White House also announced expectations

that all eligibility restrictions would be lifted by May 1, 2021, making all

adults in the U.S. eligible for vaccination. On April 6, 2021, the White

House announced it was moving that date up, from May 1, 2021, to April

19, 2021. The White House also expects to launch various tools to make

it easier for individuals to identify where they can be vaccinated. These

federally supported tools include a “Find a Vaccination Website” and a 1-

800 number for a call center that will provide guidance and assistance to

those who may lack internet access. In addition, the administration stated

it would deploy technology teams to states who need assistance in

improving the websites their states’ are using to schedule vaccination

appointments.

Information published on vaccine safety. In January and February

2021, CDC published results from its analysis of COVID-19 vaccine

safety monitoring, including allergic reactions reported after receipt of the

Pfizer and Moderna vaccines in its Morbidity and Mortality Weekly Report

and in medical articles, including data on reported cases of anaphylaxis,

See https://www.whitehouse.gov/briefing-room/press-briefings/2021/02/09/press-

briefing-by-white-house-covid-19-response-team-and-public-health-officials-2/, accessed

on February 26, 2021.

White House, Fact Sheet: President Biden to Announce All Americans to be Eligible for

Vaccinations by May 1, Puts the Nation on a Path to Get Closer to Normal by July 4th.

(Washington, D.C.: Mar. 11, 2021), accessed on March 15, 2021,

https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/11/fact-sheet-

president-biden-to-announce-all-americans-to-be-eligible-for-vaccinations-by-may-1-puts-

the-nation-on-a-path-to-get-closer-to-normal-by-july-4th/.

Page 43 GAO-21-443 COVID-19 Vaccines

frequently reported adverse events, and deaths.

CDC also posted a

series of communication resources on its website, including tool kits for

health care providers, long term care facilities, employers of essential

workers, and community-based organizations that provide educational

information about the benefits of COVID-19 vaccination and address

common questions and concerns.

Additional guidance on equitable access promoting vaccination.

CDC’s January 2021 annex provided tools to jurisdictions on how to

increase vaccine confidence in priority populations. The document, which

focused, in part, on balancing equitable access with demand for vaccine,

included new guidance to jurisdictions on when and how to transition from

initial target populations to other priority populations and how to promote

increased vaccination.

These and other steps the federal government has initiated may take time

to implement at the federal, state, and local levels. Thus, it is too soon to

determine to what extent, these and other efforts outlined in the National

Strategy might help facilitate vaccine distribution and administration going

forward. As we have reported since June 2020, coordination and clear

and consistent communication across all levels of government and with

all stakeholders remains a critical component of a successful response to

the COVID-19 pandemic.

See, for example Department of Health and Human Services, Centers for Disease

Control and Prevention, “First Month of COVID-19 Vaccine Safety Monitoring—United

States, December 14, 2020—January 13, 2021, Morbidity and Mortality Weekly Report

(Atlanta, Ga.: Feb. 19, 2021), accessed February 26, 2021,

https://www.cdc.gov/mmwr/volumes/70/wr/mm7008e3.htm; “Allergic Reactions Including

Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine—United

States, December 21, 2020—January 10, 2021, Morbidity and Mortality Weekly Report

(Atlanta, Ga.: Jan. 22, 2021), accessed on February 26, 2021,

https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm; “Allergic Reactions Including

Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine—

United States, December 14-23, 2020, Morbidity and Mortality Weekly Report (Atlanta,

Ga.: Jan. 6, 2021), accessed on February 11, 2021,

https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm?s_cid=mm7002e1_w%E2%80

%8B; and T.T. Shimabukuro, M. Cole, J. R. Su, “Reports of Anaphylaxis After Receipt of

mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021” JAMA. Vol.

325, no. 11 (2021): pp. 1101–1102.

https://jamanetwork.com/journals/jama/fullarticle/2776557?resultClick=1 (accessed April 5,

2021).

See https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits.html, accessed

February 26, 2021.

Page 44 GAO-21-443 COVID-19 Vaccines

Finally, the Consolidated Appropriations Act, 2021, required the CDC

Director to provide Congress with an updated and comprehensive

COVID-19 vaccine distribution strategy within 30 days of the law’s

enactment (by January 26, 2021).

In March 2021, CDC prepared an

initial submission of the strategy that provides a high-level description of

the agency’s ongoing and planned distribution activities. For example, it

highlights enhancements for vaccine distribution that include efforts to

vaccinate high-risk and underserved populations (including ethnic

minority populations and rural communities). The strategy states that, to

date, CDC has provided $3 billion of the at least $4.29 billion it intends to

use as grants to state, local, tribal, and territorial jurisdictions for COVID-

19 vaccine distribution. According to the distribution strategy, details of

CDC’s efforts are still under development and will be included in

subsequent reports to Congress.

We provided a draft of this report to DOD, HHS, and FEMA for review and

comment. DOD, HHS, and FEMA provided technical comments, which

we incorporated as appropriate.

We are sending copies of this report to the appropriate congressional

committees, the Secretary of Health and Human Services, the Secretary

of Defense, FEMA, and other interested parties. In addition, the report is

available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact

Alyssa M. Hundrup at (202) 512-7114 or [email protected]. 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 I.

Alyssa M. Hundrup

Acting Director, Health Care

Pub. L. No. 116-260, div. M, tit. III, 134 Stat. 1182, 1912 (2020). This strategy is to be

updated and provided to Congress every 90 days through the end of fiscal year 2021.

Agency Comments

Page 45 GAO-21-443 COVID-19 Vaccines

List of Addressees

The Honorable Patrick Leahy

Chair

The Honorable Richard Shelby

Vice Chairman

Committee on Appropriations

United States Senate

The Honorable Ron Wyden

Chair

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

Chair

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

The Honorable Frank Pallone, Jr.

Chair

The Honorable Cathy McMorris Rodgers

Republican Leader

Committee on Energy and Commerce

House of Representatives

Page 46 GAO-21-443 COVID-19 Vaccines

The Honorable Bennie G. Thompson

Chair

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

The Honorable James E. Clyburn

Chair

Select Subcommittee on the Coronavirus Crisis

Committee on Oversight and Reform

House of Representatives

The Honorable Bill Foster

House of Representatives

The Honorable Mark E. Green, MD

House of Representatives

Appendix I: GAO Contact and Staff

Acknowledgments

Page 47 GAO-21-443 COVID-19 Vaccines

Alyssa M. Hundrup, (202) 512-7114, [email protected]

In addition to the contact named above Kelly DeMots (Assistant Director),

Alison Goetsch (Analyst in Charge), Nora Adkins, Darnita Akers, Jennie

Apter, La Sherri Bush, Kaitlin Farquharson, Ryan Han, Nicolaus Heun,

Katheryn Hubbell, Gay Hee Lee, Jason Lee, Jeff Mayhew, Linda McIver,

Christopher Murray, Patrick Netherclift, Angie Nichols-Friedman, Miranda

Riemer, Ethiene Salgado-Rodriquez, Fatima Sharif, Meghan Shrewsbury,

Will Simerl, and Kim Yamane made key contributions to this report.

Appendix I: GAO Contact and Staff

Acknowledgments

GAO Contact

Staff

Acknowledgments

Related GAO Products

Page 48 GAO-21-443 COVID-19 Vaccines

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