Report GAO-22-104453, HHS and DOD Vaccine Responsibilities Transition — Government Accountability Office

Summary

A report to congressional addressees from the United States Government Accountability Office, GAO-22-104453, dated January 2022, with its letter dated January 19, 2022. Issued under a CARES Act provision, it examines the HHS-DOD COVID-19 Countermeasures Acceleration Group (CAG), formerly Operation Warp Speed, on transitioning its responsibilities to HHS and on developing a joint interagency lessons-learned review. According to HHS and DOD officials, the CAG dissolved and transitioned its responsibilities to HHS by December 31, 2021, as required by an April 2021 memorandum of understanding. GAO found that HHS lacks strategies for its workforce needs and a schedule consistent with best practices, and that the lessons-learned plan does not gather perspectives from vaccine companies. GAO makes five recommendations; HHS did not concur with the one on workforce needs.

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United States Government Accountability Office

Report to Congressional Addressees

January 2022

COVID-19
HHS and DOD
Transitioned Vaccine
Responsibilities to
HHS, but Need to
Address Outstanding
Issues

GAO-22-104453


January 2022

COVID-19
HHS and DOD Transitioned Vaccine Responsibilities
to HHS, but Need to Address Outstanding Issues
Highlights of GAO-22-104453, a report to
congressional addressees

Why GAO Did This Study

What GAO Found

Vaccines have played a crucial role in
battling the COVID-19 pandemic. The
CAG worked with vaccine companies
to develop COVID-19 vaccines, and
made available a sufficient supply for
all eligible people in the nation. An
April 2021 memorandum of
understanding between HHS and DOD
called for the transfer of remaining
CAG responsibilities to HHS and for
identification of lessons learned.

Starting in May 2020, federal efforts to accelerate the development,
manufacturing, and distribution of COVID-19 vaccines had been led by a
partnership between the Department of Health and Human Services (HHS) and
the Department of Defense (DOD). Formerly known as Operation Warp Speed,
the partnership was renamed the HHS-DOD COVID-19 Countermeasures
Acceleration Group (CAG). According to HHS and DOD officials, the CAG
dissolved and transitioned its responsibilities—including DOD-led vaccine
activities—to HHS by December 31, 2021, as required by an April 2021
memorandum of understanding between the two departments.
Manufacturing of COVID-19 Vaccines

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 things, the
CAG’s progress on (1) transitioning its
responsibilities to HHS, and (2)
developing a process for a joint
interagency lessons learned review.
GAO reviewed CAG transition and
contracting documents and interviewed
or received written responses from
CAG officials, federal agencies, and
representatives from the six vaccine
companies that worked with the CAG.

What GAO Recommends
GAO is making five recommendations
related to workforce needs, scheduling
best practices for vaccine-related
activities; and lessons learned from
key stakeholders.
HHS did not concur with GAO’s
recommendation on workforce needs.
GAO revised this recommendation
based on updated information, but
maintains that it continues to be valid,
as discussed in the report.

View GAO-22-104453. For more information,
contact Alyssa M. Hundrup at (202) 512-7114
or hundrupa@gao.gov

While HHS and DOD officials said they achieved transition milestones indicating
that HHS is ready to assume responsibilities formerly led by DOD, it is unclear
how HHS will address its workforce needs now that the CAG has dissolved.
Specifically, GAO found that HHS has assessed its workforce capabilities, but
lacks strategies for addressing these workforce needs. By formally providing its
support until HHS develops and implements these strategies, DOD can help
ensure that HHS can continue these responsibilities uninterrupted, including
responsibilities for addressing ongoing vaccine needs for boosters or for any
emerging COVID-19 variants. Moreover, HHS does not have a schedule that is
consistent with best practices to help it manage remaining vaccine-related
activities. Such a schedule could help HHS better plan actions and mitigate
delays, and be a source for identifying lessons learned for any future pandemics.
The CAG developed a plan for conducting a joint, interagency lessons-learned
review. This plan outlines an approach for collecting information—such as
perspectives on challenges—from CAG staff, and for sharing the plan with HHS.
However, the plan misses an opportunity to gather perspectives from key
external stakeholders, including vaccine companies, critical to developing
vaccines. Obtaining these perspectives could provide a more comprehensive
understanding of areas where the CAG was successful and opportunities for
improvement, which could help inform HHS’s ongoing and future vaccine work.

United States Government Accountability Office


Contents

Letter

1
Background
CAG Transitioned to HHS, but HHS Readiness to Assume All
Responsibilities Unclear
The CAG Began a Lessons-Learned Review Process, but Its
Plans Do Not Include Collecting Information from Stakeholders
Preliminary Lessons Learned from the CAG, Federal Agencies,
and Vaccine Company Representatives
Conclusions
Recommendations for Executive Action
Agency Comments and Our Evaluation

22
27
28
29

Status of U.S. COVID-19 Vaccine Candidates and Related
Obligations and Doses

34

Contract Techniques Used to Obtain COVID-19 Vaccines for
the U.S.

38

Abridged Assessment of the Countermeasures Acceleration Group’s
Schedule

42

Appendix IV

Comments from the Department of Health & Human Services

45

Appendix V

Comments from the Department of Defense

48

Appendix VI

GAO Contact and Staff Acknowledgments

51

Appendix I

Appendix II

Appendix III

Related GAO Products

6
9
19

52

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GAO-22-104453 HHS-DOD CAG Partnership


Tables
Table 1: Nine Lines of Effort for Transitioning DOD
Responsibilities in the CAG to HHS
Table 2: Status of the CAG’s Six Vaccine Candidates, as of
January 11, 2022
Table 3: Vaccine Doses Contracted for Purchase by the Federal
Government for Domestic Use, as of October 22, 2021
Table 4: Assessment of the CAG’s Integrated Master Schedule,
June 2021

11
34
37
43

Figures
Figure 1: Leading Practices of a Lessons-Learned Review
Process
Figure 2: HHS and DOD Obligations for COVID-19 Vaccine
Candidates and Others under the CAG, as of September
30, 2021

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GAO-22-104453 HHS-DOD CAG Partnership


Abbreviations
ASPR

Office of the Assistant Secretary for Preparedness
and Response
BARDA
Biomedical Advanced Research and Development
Authority
CAG
HHS-DOD COVID-19 Countermeasures
Acceleration Group
CAG Continuity Book DOD’s Countermeasures Acceleration Group
Continuity Book
CDC
Centers for Disease Control and Prevention
COVID-19
Coronavirus Disease 2019
DOD
Department of Defense
DPA
Defense Production Act
EUA
emergency use authorization
FAR
Federal Acquisition Regulation
FDA
Food and Drug Administration
HHS
Department of Health and Human Services
JPEO-CBRND
Joint Program Executive Office for Chemical,
Biological, Radiological, and Nuclear Defense
NIH
National Institutes of Health
OTA
other transaction agreement

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Letter

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

January 19, 2022
Congressional Addressees
Since the President declared the Coronavirus Disease 2019 (COVID-19)
pandemic a national emergency on March 13, 2020, the country has
reported more than 56 million confirmed cases and more than 830,000
deaths as of January 3, 2022, including a sharp increase in cases at the
end of December 2021 due largely to the Omicron variant. 1 In the second
year of the pandemic’s catastrophic effects, the federal government’s
efforts to help develop and make available an adequate supply of safe
and effective vaccines have been crucial to the nation’s ongoing recovery.
It is also critical that the federal government learn from its experiences
with accelerating vaccine production so that it can be prepared to meet
future vaccine needs for this pandemic—such as to counteract the
emergence of new variants—or for future pandemics. 2
To help make safe and effective vaccines available as quickly as
possible, in April 2020, the federal government announced the creation of
Operation Warp Speed, a partnership between the Department of Health
and Human Services (HHS) and the Department of Defense (DOD). In
April 2021, Operation Warp Speed was renamed the HHS-DOD COVID19 Countermeasures Acceleration Group (CAG), and for the purposes of
this report, we refer to both iterations of this partnership as the CAG.
The CAG was set up to support the acceleration of vaccine development,
manufacturing, and distribution to states, other jurisdictions, and federal
agencies and programs for vaccine administration. 3 As a part of those
1In addition to declaring a national emergency under the National Emergencies Act, the

President also declared a nationwide emergency under section 501(b) of the Robert T.
Stafford Disaster Relief and Emergency Assistance Act and approved major disaster
declarations for all 50 states, the District of Columbia, five territories, and three federally
recognized Indian tribes. On January 31, 2020, the Secretary of Health and Human
Services declared a public health emergency for the United States, retroactive to January
27, 2020.

2As of January 2022, the Centers for Disease Control and Prevention (CDC) had listed the

Delta and Omicron variants as variants of concern in the U.S. CDC had previously
characterized three other variants (Alpha, Beta, and Gamma) as variants of concern but
later downgraded them.

3Jurisdictions include all 50 states, the District of Columbia, eight U.S. territories, and a

small number of major cities.

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efforts, HHS and DOD awarded contracts and other transaction
agreements (OTA) to six vaccine companies and others for the
development and manufacturing of vaccines, the purchase of vaccine
doses, and the acquisition of other critical supplies and services. 4 The
CAG also coordinated with other external stakeholders, including federal
agencies, such as the Centers for Disease Control and Prevention (CDC),
on vaccine distribution planning, according to officials. 5
In December 2020, the first two COVID-19 vaccines—sponsored by
Moderna and Pfizer—were authorized by the Food and Drug
Administration (FDA) for emergency use. 6 The CAG began distributing
doses of these vaccines to states and others immediately upon their
authorization. As of January 2022, three COVID-19 vaccines (with the
third sponsored by Janssen) were available in the United States. 7
•

Pfizer’s vaccine was licensed for individuals ages 16 and older and
was also available under an emergency use authorization (EUA) for
individuals ages 12 to 15 years, as a lower dose for individuals ages 5
to 11 years, as a third dose for certain immunocompromised
individuals ages 5 years and older, and as a booster for individuals
ages 12 years and older.

4OTAs are flexible agreements that allow the parties to negotiate terms and conditions
without requiring parties to comply with certain federal procurement laws and regulations.
See 10 U.S.C. § 2371b. 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).
5For more information about the CAG, see our April 2021 report on the federal

government’s vaccine efforts. GAO, COVID-19: Efforts to Increase Vaccine Availability
and Perspectives on Initial Implementation. GAO-21-443 (Washington, D.C.: Apr. 14,
2021).

6The 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 has been made, FDA may temporarily allow use of
unlicensed vaccines through an emergency use authorization (EUA). For FDA to issue an
EUA for a vaccine, it must be reasonable to believe that the vaccine may be effective and
that the known and potential benefits of the vaccine outweigh the known and potential
risks, among other statutory criteria. See 21 U.S.C. § 360bbb-3. Pfizer developed its
COVID-19 vaccine in collaboration with BioNTech.

7Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

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•

Moderna’s vaccine was authorized for individuals ages 18 and older,
as a third dose for certain immunocompromised individuals ages 18
an older, and as a booster for individuals ages 18 and older.

•

Janssen’s vaccine was authorized for individuals ages 18 and older
and as a booster for the same population. 8

By September 2021, the federal government had acquired over 673
million doses of these three vaccines, sufficient to fully vaccinate 373
million people, in line with the CAG’s overall goal of having sufficient adult
vaccines for the American public. 9
An April 2021 memorandum of understanding between HHS and DOD
called for the two departments to coordinate plans to transition the CAG’s
responsibilities to HHS, including activities that had been led by DOD.
The memorandum also called for HHS and DOD to develop a joint
interagency process for incorporating lessons learned from the CAG’s
work into HHS’s continued operations, and to dissolve the CAG by
December 31, 2021.
The CARES Act includes a provision for us to report on the federal
response to the COVID-19 pandemic. Specifically, the act requires us to
monitor and oversee the federal government’s efforts to prepare for,
respond to, and recover from the pandemic. 10 This report is part of our
body of work in response to the CARES Act and focuses on the activities
of the CAG. 11

8All three vaccines (Janssen, Moderna, and Pfizer) were also authorized for use as a

heterologous (or “mix and match”) booster for individuals ages 18 years and older, as of
January 2022.

9According to CDC, as of October 2021, people were considered “fully vaccinated” 2

weeks after their second dose in a two-dose series, such as the Pfizer or Moderna
vaccine, or 2 weeks after a single-dose vaccine, such as the Janssen vaccine. As of
January 11, 2022, the term “fully vaccinated” did not include boosters.

10Pub. 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 (renamed the CAG in April 2021).
11We have regularly issued government-wide reports on the federal response to COVID19. For the latest report, see GAO, COVID-19: Additional Actions Needed to Improve
Accountability and Program Effectiveness of Federal Response, GAO-22-105051
(Washington, D.C.: Oct. 27, 2021). Our next government-wide report will be issued in
January 2022 and will be available on GAO’s website at https://www.gao.gov/coronavirus.
Also, see the GAO Related Products section at the end of this report for additional work
we have done on COVID-19 vaccines.

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In this report, we
1. examine the CAG’s progress on transitioning responsibilities to HHS
for developing, manufacturing, and distributing COVID-19 vaccines;
2. examine the CAG’s progress on developing a joint interagency review
process to identify lessons learned from its COVID-19 vaccine
development, manufacturing, and distribution efforts; and
3. describe preliminary lessons learned we obtained from the CAG,
selected federal departments, and vaccine company representatives
who coordinated with the CAG on COVID-19 vaccine development,
manufacturing, and distribution.
To address the first objective, we reviewed documents pertaining to the
CAG’s transition efforts, including the April 2021 memorandum between
HHS and DOD, and the CAG’s July 2021 transition plan. Specifically, we
reviewed the CAG’s transition readiness, including its efforts to establish
milestones to gauge its progress towards transition readiness, as required
by the April 2021 memorandum, and compared these efforts to selected
leading practices for agency reforms, including transitions, which we
identified in prior work. 12 We also reviewed the CAG’s efforts to assess
HHS’s workforce capacity to assume the CAG’s responsibilities and to
develop workforce strategies to address any workforce capacity gaps. We
also then compared these efforts to selected leading practices for both
agency reforms and strategic workforce planning. 13 We also obtained
information on the CAG’s plans to assess the need for continued use of
certain tools for tracking and managing remaining vaccine development,
12Specifically, we assessed HHS’s transition readiness efforts against the following

selected agency reform leading practices: (1) developing an implementation plan with key
milestones and deliverables to track implementation progress; (2) establishing a dedicated
implementation team to manage the reform process; and (3) designating leaders to be
responsible for the implementation of the proposed reforms. See GAO, Government
Reorganization: Key Questions to Assess Agency Reform Efforts, GAO-18-427
(Washington, D.C., June 13, 2018).

13Specifically, we assessed HHS’s efforts to assess its workforce capacity against the

leading practice for agency reform that agencies conduct strategic workforce planning to
determine whether they will have the needed resources and capacity, including the skills
and competencies, in place for the proposed reforms or reorganization. See GAO-18-427.
In addition, we also assessed these efforts against selected leading practices for strategic
workforce planning, including that agencies should determine the critical skills and
competencies needed to achieve programmatic results and develop strategies to address
gaps in critical skills and competencies. See GAO, Human Capital: Key Principles for
Effective Strategic Workforce Planning, GAO-04-39 (Washington, D.C., Dec. 11, 2003).

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manufacturing, and distribution activities. We compared HHS’s plans to
manage the scheduling of vaccine development, manufacturing, and
distribution activities to best practices for scheduling, as outlined in the
GAO Schedule Assessment Guide. 14 In addition, we conducted an
abridged assessment of the CAG’s schedule as of May 11, 2021. 15
To address the second objective, we reviewed documentation on the
progress the CAG had made as of October 2021 to develop a joint
interagency review process to identify lessons learned from its COVID-19
vaccine efforts. We interviewed CAG officials about its joint, interagency
plan to develop a lessons-learned process. We compared the CAG’s
lessons-learned plan to leading practices we and others have previously
identified for conducting a lessons-learned process, such as collecting
and disseminating lessons learned. 16 We also compared the departments’
plans with the Project Management Institute’s program management
standards, which call for program managers to engage with key
stakeholders. 17
To address the third objective, we reviewed DOD’s Countermeasures
Acceleration Group Continuity Book (CAG Continuity Book), which
14See GAO, Schedule Assessment Guide: Best Practices for Project Schedules, GAO-16

89G (Washington, D.C.: Dec. 22, 2015).

15Our abridged assessment of the CAG’s schedule focused on the extent to which it was
“well-constructed,” as defined in the GAO Schedule Assessment Guide. The “wellconstructed” characteristic is one of four general characteristics associated with highquality schedules, according to the guide, and we focused on it for this abridged
assessment because it reflects basic quality measures of a schedule.
16See GAO, Federal Real Property Security: Interagency Security Committee Should
Implement a Lessons-Learned Process, GAO-12-901 (Washington, D.C.: Sept. 10, 2012);
and Project Management: DOE and NNSA Should Improve Their Lessons Learned
Process for Capital Asset Projects, GAO-19-25 (Washington, D.C.: Dec. 21, 2018).
Department of the Army, Combined Arms Center, Center for Army Lessons Learned,
Establishing a Lessons Learned Program: Observations, Insights, and Lessons (Fort
Leavenworth, KS: June 2011).
17Project Management Institute, Inc., A Guide to the Project Management Body of
Knowledge (PMBOK® Guide), Sixth Edition, 2017; Project Management Institute, Inc.,
Implementing Organizational Project Management: A Practice Guide, First Edition, 2014.
PMBOK is a trademark of Project Management Institute, Inc. The PMBOK® Guide.
provides guidelines for managing individual projects, including collecting requirements and
defining the project’s scope. The Project Management Institute is a not-for-profit
association that provides global standards for, among other things, project and program
management. These standards are utilized worldwide and provide guidance on how to
manage various aspects of projects, programs, and portfolios.

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highlighted information about lessons learned that DOD officials within the
CAG documented over the course of the CAG’s COVID-19 response
efforts as of May 2021. 18 In June and July 2021, we also obtained written
responses or interviewed representatives from the six vaccine companies
that were awarded contracts or OTAs under the CAG—AstraZeneca,
Janssen, Moderna, Novavax, Pfizer, and Sanofi—about their experiences
working with the CAG on vaccine development, manufacturing, and
distribution. We also interviewed officials from the CAG and component
offices and agencies of HHS and DOD about their perspectives on
activities that worked well and any challenges they identified with the
CAG’s COVID-19 vaccine response efforts in June and July 2021. Within
HHS, we interviewed or obtained written responses from officials from the
Office of the Assistant Secretary for Preparedness and Response
(ASPR), Biomedical Advanced Research and Development Authority
(BARDA), CDC, FDA, and the National Institutes of Health (NIH). Within
DOD, our interviews included officials from the Joint Program Executive
Office for Chemical, Biological, Radiological, and Nuclear Defense
(JPEO-CBRND) and the Army Contracting Command. We selected these
offices and agencies because the CAG indicated that they were integral
to the CAG’s vaccine efforts.
We conducted this performance audit from July 2020 to January 2022 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.

Background

A June 2020 memorandum of understanding between HHS and DOD
established the CAG, then called Operation Warp Speed, with the primary
purpose of accelerating the development, production, and distribution of
COVID-19 vaccines. (See appendix I for information on the status of
vaccine candidates and obligations made under the CAG.)
The CAG was co-chaired by the Secretaries of Health and Human
Services and Defense, who appointed HHS and DOD officials to lead five
key initiatives: (1) vaccine development; (2) therapeutics; (3) supply,
18CAG officials from DOD said they provided the CAG Continuity Book to incoming CAG
personnel when they joined the partnership. DOD officials developed it to capture key
personnel’s mission, work streams, and lessons learned.

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production, and distribution; (4) security and assurance; and (5) research,
development, acquisition, and contracting. 19 In addition, the CAG had an
HHS Chief Advisor, an HHS Chief Operating Officer, and a DOD Chief of
Staff. 20
As of September 2021, DOD had assigned 76 officials from the Army, the
Navy, the Air Force, and the Marine Corps to work on the CAG’s five key
initiatives. HHS officials told us that the department generally did not
assign a specific number of staff to work directly on the CAG, but stated
that hundreds of officials from various HHS agencies, such as ASPR,
CDC, and NIH, have worked on CAG-related efforts.

DOD Designated Lead for
Most Vaccine-Related
CAG Activities

The April 2021 memorandum of understanding between HHS and DOD
designated DOD as the lead for implementing most vaccine-related
initiatives within the CAG, with HHS to provide support. In particular, the
memorandum tasked DOD with designating DOD officials to serve in the
following roles, leading three of the five key initiatives:
•

Director of vaccine development—directed and oversaw development
and testing of vaccines in coordination with the six vaccine companies
that were part of the CAG;

•

Director of supply, production, and distribution—implemented and
oversaw acquisition of supplies and vaccines, including having DOD
officials embedded in vaccine production factories to assist with
supply chain management and development of a federal
governmental plan to distribute these items to the jurisdictions and
other federal agencies and programs; and

•

Director of security and assurance—developed security measures for
the CAG, and a security plan to support production and distribution of
vaccines and supplies from the development phase to distribution.

The April 2021 memorandum also identified lead roles for DOD and HHS
on the two other key initiatives. The memorandum indicated that officials
from both departments shared responsibility for overseeing and
19This report focuses primarily on the CAG’s vaccine-related responsibilities.
20The Chief Advisor was responsible for providing technical advice regarding vaccine
development and manufacturing and coordinated CAG activities with other federal
departments. The Chief Operating Officer was responsible for coordinating the logistics,
supply chain, development, production, and delivery of vaccines, as well as supporting
HHS efforts under the CAG. The Chief of Staff supported the Chief Operating Officer in
leading the CAG.

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supporting the research, development, acquisition, and contracting
initiative, and it tasked HHS with designating a director to lead the
therapeutics initiative.

Plans to Transition CAG
Responsibilities to HHS

Leading Practices for
Agency Reforms

The April 2021 memorandum between HHS and DOD tasked HHS and
DOD to jointly develop a plan to transition all CAG responsibilities to HHS
and fully dissolve the CAG by December 31, 2021, with transition
activities to begin in the fall of 2021. 21 The April 2021 memorandum
stated that the transition plan was to include
•

a cross-walk plan that transfers DOD activities to HHS,

•

key milestones that must be achieved to ensure successful transition,

•

synchronization of transition planning to ensure uninterrupted support,
communications, and decision-making related to ongoing vaccinerelated activities, and

•

full incorporation of current efforts and lessons learned into the U.S.
National Vaccine Program. 22

Reforming and reorganizing the federal government is a major endeavor
that can include refocusing, realigning, or enhancing agency missions,
including transitions. We have previously identified leading practices for
federal agencies to follow when planning and implementing agency
reforms. 23 Examples of these leading reform practices include
•

identifying leaders to be responsible for the implementation of the
proposed reform;

•

establishing a dedicated implementation team that has the capacity,
including staffing, resources, and change management, to manage
the reform process;

21The original June 2020 memorandum between HHS and DOD specified that their
partnership would be in place until January 31, 2021. However, on January 14, 2021, HHS
and DOD extended their partnership until May 2021. Then, through their April 2021
memorandum, HHS and DOD further extended their partnership until the end of
December 2021, and renamed it the CAG.
22The U.S. National Vaccine Program is located in the Office of the Assistant Secretary for
Health within HHS. The program was established in 1986 and is responsible for the
research, development, and testing of all types of vaccines, such as for the influenza and
other infectious diseases, as well as the production, procurement, and distribution of
vaccines to the public, among others.
23See GAO-18-427.

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•

developing an implementation plan with key milestones and
deliverables to track implementation progress; and

•

conducting strategic workforce planning to determine whether the new
agency will have the needed resources and capacity, including the
skills and competencies, in place for the proposed reform.

CAG Transitioned to
HHS, but HHS
Readiness to Assume
All Responsibilities
Unclear
The CAG Completed its
Transition to HHS in
December 2021

In July 2021, the CAG established a team led by co-chairs from DOD and
HHS for transitioning all of the CAG’s responsibilities—particularly those
led by DOD—to HHS. The CAG also developed a transition plan, as
called for in the April 2021 memorandum of understanding between HHS
and DOD. These steps are consistent with selected leading reform
practices identified in our prior work, which highlight the importance of
establishing a dedicated implementation team and plan when an agency
undergoes an agency reform, such as a transition.
As part of the transition plan, CAG officials developed a crosswalk—as
required by the April 2021 memorandum—to guide the incremental
transfer of DOD-led responsibilities to HHS. Specifically, the crosswalk
organized the transition of responsibilities from DOD to HHS into nine
lines of effort. 24 These lines of effort identified DOD-led responsibilities
across the CAG’s five key initiatives that HHS was to assume as part of
the transition (see table 1). According to CAG officials, ASPR was the
HHS office in charge of leading the transition of CAG responsibilities,
including those led by DOD, to HHS. 25 In addition, CAG officials told us
that a new office within ASPR, called the HHS Coordination Operations
and Response Element, would be responsible for continuing all of the
24CAG officials told us in October 2021 that DOD officials led all nine lines of effort.
However, HHS officials told us in January 2022 that the Legal line of effort and the
Research and Clinical Trials for Vaccines and Therapeutics line of effort were already
supported by HHS officials and therefore were not transitioned from DOD to HHS.
25ASPR serves as the principal advisor to the Secretary of Health and Human Services on

all matters related to federal public health and medical preparedness and responses for
public health emergencies, among other things. 42 U.S.C. § 300hh-10(b)(1).

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CAG’s responsibilities. CAG officials told us in July 2021 that this new
office would remain in place at least during the COVID-19 pandemic, but
did not indicate whether it would be permanent.

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Table 1: Nine Lines of Effort for Transitioning DOD Responsibilities in the CAG to HHS
Line of Effort

Description

Vaccine and Therapeutics
Development and Manufacturing

Coordinates the management of private-sector vaccine and therapeutic manufacturing
capacity, assesses potential areas of vaccine and therapeutics supply risk and recommends
mitigation options, and supports the acquisition of equipment and materials for delivery of
vaccine doses.

Distribution and Administration of
Therapeutics

Supports HHS’s efforts to distribute COVID-19 therapeutics.

Analytics and Information Technology

Coordinates the requirements, design, and implementation of information networks.
Additionally, it is responsible for leading collaborative analysis of production forecast models
used by CAG leadership for decision-making.

Research and Clinical Trials for
Vaccines and Therapeutics

Provides advice and alignment of all aspects of research and clinical trials for COVID-19
vaccine and therapeutics, including supporting project coordination team efforts—such as
reviewing clinical trial protocol documents.

Comptroller

Oversees budget efforts and provides executive budget analysis to senior CAG officials. It
also acts as the financial liaison between HHS and DOD.

External Affairs

Provides public and legislative affairs support to CAG leadership and executive staff.
Specifically, it works to maintain an open and transparent dialogue with federal, state, and
local government, as well as interagency partners such as the Centers for Disease Control
and Prevention (CDC) and Biomedical Advanced Research and Development Authority
(BARDA).

Security and Assurance

Coordinates the programs designed to safeguard the development, manufacture, and
distribution of vaccines and therapeutics, and to prevent disruption across the vaccine supply
chain. Additionally, it provides industrial security for companies’ supply chains to identify and
mitigate foreign influence or threats.

Legal

Provides legal guidance, and serves as the designated ethics counsel for personnel that are
part of the CAG.

Supply, Production, and Distribution

Coordinates supply chain management, distribution, operations, and administration:
•
Supply chain management recommends the use and administration of Defense
Production Act ratings.
•
Distribution is responsible for monitoring and enabling the movement of vaccine products
from the distributor’s location to the administration site.
•
Operations is responsible overseeing vaccine production capacity, national and
international distribution, and administration of COVID-19 vaccines.
•
Administration is responsible for coordination activities and disseminating guidance to
states and federal partners to ensure timely and efficient distribution and administration
of COVID-19 vaccines.

Source: GAO analysis of information from the Department of Health and Human Services (HHS)-Department of Defense (DOD) COVID-19 Countermeasures Acceleration Group (CAG). | GAO-22-104453

Notes: The lines of effort outlined in this table represent all of the CAG’s responsibilities, according to
documentation we reviewed and interviews with CAG officials; however, our review was primarily
focused on the CAG’s vaccine-related responsibilities. CAG officials told us in October 2021 that
DOD officials led all nine lines of effort. However, HHS officials told us in January 2022 that the Legal
line of effort and the Research and Clinical Trials for Vaccines and Therapeutics line of effort were
already supported by HHS officials and therefore were not transitioned from DOD to HHS.

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Transition activities for each of the nine lines of effort began by October
15, 2021, according to CAG officials. For example, for each line of effort,
CAG officials said HHS and DOD started what they refer to as “left-seat,
right-seat” training, in which DOD officials trained their HHS counterparts
on activities they led for about 1 month, followed by HHS officials leading
activities with DOD officials assisting. CAG officials told us that the goal of
this “left-seat, right seat” training is to ensure that HHS is ready to
continue all of the CAG’s responsibilities using HHS’s own capabilities.
According to DOD and HHS officials, HHS completed its planned
transition activities and the CAG dissolved on December 31, 2021, as
called for in the April 2021 memorandum.
Additionally, CAG officials said HHS and DOD determined that DOD
would provide acquisition support to HHS through at least September
2023, based on a May 2021 memorandum regarding the need for
ongoing acquisition services related to vaccines, such as continued
purchases of vaccine doses and other supplies. DOD’s acquisition
support has played a significant role in fulfilling the CAG’s vaccine-related
responsibilities, such as by helping to enable increases in manufacturing
capacity and the purchase of vaccine doses and related supplies. DOD’s
contracting techniques, including solicitation approaches like broad
agency announcements and commercial solutions openings, allowed
DOD to obtain company input related to vaccine requirements, facility
expansion, and related supplies. 26 In addition, DOD used prototype OTA
and technology investment agreements to attract companies the
government does not normally do business with, including vaccine
companies, and to obtain vaccine-related items such as vials. 27
For more information on these and other contracting techniques used for
vaccine-related acquisitions under the CAG, see appendix II. DOD
acquisition officials told us they used some of these techniques for the

26A broad agency announcement is a notice from the government that requests scientific
or research and development proposals from private firms concerning certain areas of
interest to the government. See Federal Acquisition Regulation (FAR) § 35.016. The
commercial solutions opening pilot program allows DOD to mirror the contracting practices
that commercial companies normally use, enabling DOD to design projects, and negotiate
payment milestones, intellectual property rights, and other terms and conditions for a
desired completion period of within 60 days. See National Defense Authorization Act for
Fiscal Year 2017, Pub. L. No. 114-328, § 879, 130 Stat. 2000, 2312-13 (2016) (codified at
10 U.S.C. § 2303 note).
27Technology investment agreements are used to stimulate or support research to foster
the best technologies for future defense needs. See 32 C.F.R. Part 37 (2020).

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first time to address the COVID-19 pandemic, and doing so required a
high level of acquisition expertise and staff investment.
According to DOD officials, HHS and DOD are developing plans to
incrementally reduce DOD acquisition responsibilities and transition them
to HHS after September 2023. DOD officials told us that as of September
15, 2021, they did not have an estimated date for when they would
complete their acquisition transition plans, but the extension of DOD
support through September 2023 would allow sufficient time to complete
them.

It Is Unclear If HHS Is
Ready to Fully Assume the
CAG’s Responsibilities

Neither the CAG nor HHS have completed all the tasks necessary to
ensure that HHS is in a position to fully assume all of the CAG’s
responsibilities beginning January 1, 2022. In particular, HHS and DOD
officials indicated that they developed and completed transition
milestones showing HHS’s readiness to assume the CAG’s
responsibilities without a loss of capabilities. However, the documentation
HHS provided to us in January 2022 does not identify or describe such
milestones for all lines of effort or show how the milestones were
achieved. Similarly, although HHS conducted workforce assessments to
evaluate its workforce capacity for leading the lines of effort, it has not
developed and implemented strategies to address identified workforce
needs for some lines of effort. Further, HHS has not developed a
schedule to manage the remaining vaccine development, manufacturing,
and distribution activities.

Documentation Does Not
Identify Transition Milestones
or How They Were Achieved

The April 2021 memorandum between HHS and DOD and the CAG’s July
2021 transition plan specify that the CAG would develop milestones, by
August 2021, to gauge the progress of the transition and indicate when it
is ready to transfer responsibilities for each of the nine lines of effort to
HHS. 28 Developing such milestones is consistent with leading practices
we identified for agency reform practices. 29 In documentation HHS and
DOD provided to us in January 2022, the departments indicated that they

28The transition included nine lines of effort. In providing comments on a draft of this
report, HHS stated that two lines of effort—the Legal line of effort and the Research and
Clinical Trials for Vaccines and Therapeutics line of effort—were already supported by
existing staff within HHS and therefore did not require transition milestones.
29See GAO-18-427. One leading agency reform practice is that agencies should develop
and implement a plan with key milestones and deliverables to track progress for the
reform, such as a transition.

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developed and achieved transition milestones for the lines of effort by
December 2021.
While the transition is now complete, and responsibilities have been
transferred to HHS, the documentation the departments provided to us in
January 2022 did not identify or describe such milestones for all lines of
effort, or show how they were achieved. Specifically, CAG officials
provided finalized milestones for two lines of effort—the External Affairs
and the Comptroller lines of effort. For these lines of effort, the CAG
developed specific milestones to be achieved—such as the reconciliation
and handoff of CAG financial documents to HHS for the Comptroller line
of effort—in its transition progress assessment documentation. For five
other lines of effort, HHS provided documentation that a senior official
reviewed transition milestones and associated tasks and approved HHS
to assume responsibilities, but the documentation does not identify
specific milestones or show how they were achieved. For example,
documentation for the Supply, Production, and Distribution and Analytics
and Information Technology lines of effort identified transition tasks that
had not yet been completed, without an indication of when or by whom
those tasks would be finalized. According to HHS officials, milestones
were continuously adjusted based on a variety of factors as the transition
progressed. Without documentation of specific milestones and how they
were achieved, it is unclear how HHS determined its readiness to assume
the CAG’s responsibilities.

HHS Has Not Finalized
Strategic Workforce Planning

As of January 2022 HHS had conducted assessments of HHS’s
workforce capacity for seven lines of effort. 30 For two of these—
Comptroller and Vaccine and Therapeutics Development and
Manufacturing—HHS determined that it had a sufficient amount of
personnel in place with the required skills to continue the lines of effort’s
responsibilities. For another line of effort—External Affairs—HHS
completed a workforce assessment that showed it identified and filled a
position for a communication specialist. This action resulted in sufficient
capacity for that line of effort, according to HHS. However, for the
remaining four lines of effort, the transition documentation we reviewed
did not indicate that HHS had developed and implemented a workforce
strategy to resolve identified personnel gaps resulting from DOD’s
30The transition included nine lines of effort. In providing comments on a draft of this
report, HHS stated that two lines of effort—the Legal line of effort and the Research and
Clinical Trials for Vaccines and Therapeutics line of effort—were already supported by
existing staff within HHS and therefore did not require workforce assessments as part of
the transition from CAG to HHS.

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departure. For instance, activities under the Security and Assurance line
of effort include coordinating programs designed to safeguard the
development, manufacture, and distribution of vaccines, and to provide
industrial security for vaccine companies’ supply chains. The CAG’s
transition document for this line of effort indicated that the workforce
assessment found that HHS did not have the necessary staff to continue
the CAG’s responsibilities, and identified a need for multiple additional
contractors to maintain the line of effort’s capabilities. However, the
documentation did not identify a strategy for addressing this need.
In another example, activities under the Supply, Production, and
Distribution line of effort included providing assistance to vaccine
companies, such as through detailing DOD personnel to serve as
temporary quality control staff at vaccine manufacturing sites. According
to CAG officials, additional activities for this Supply, Production, and
Distribution line of effort included managing the supply of manufacturing
items and the allocation and distribution of vaccine doses to jurisdictions
and other entities. CAG officials’ assessment of this line of effort found
that HHS did not have the staff with the necessary specialized skills and
competencies—including communication and logistic expertise—to
continue the CAG’s responsibilities, according to officials. As a result,
officials stated that HHS awarded a contract on October 15, 2021 to bring
in personnel to help resolve those skill gaps. However, the transition
document we reviewed noted that as of December 1, 2021, HHS was
awaiting contractor personnel for the Supply, Production, and Distribution
line of effort while managing the limited availability of existing contracting
support, and that none of that particular line of effort’s responsibilities had
transitioned to HHS, raising questions about HHS’s readiness to take on
such work. 31
Our prior work shows that delays in developing and implementing
workforce strategies to address identified personnel gaps may be
problematic. For example, in our September 2020 report describing, in
part, medical supply management responsibility shifting to HHS related to
the COVID-19 pandemic, we found that it could be hard to hire the
acquisition staff with expertise in Defense Production Act (DPA)
contracting that ASPR had determined they would need to further support
31Our review of the transition document for the Supply, Production, and Distribution line of
effort indicated that DOD personnel would continue their responsibilities for this line of
effort, beyond December 31, 2021.

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COVID-19 vaccine and related supply acquisitions. 32 This misalignment of
staff needs with available resources could lead to skill gaps within HHS’s
workforce, and put HHS in jeopardy of successfully assuming all of the
CAG’s responsibilities. Determining critical workforce skills and
capabilities—and developing strategies to address any needs—also
follows selected leading practices identified by our prior work. 33
Given that DOD has specialized skills and competencies and had been
leading many of the CAG’s vaccine-related responsibilities before the
CAG dissolved, addressing workforce capacity needs is particularly
important, so that HHS can continue these responsibilities uninterrupted.
Without doing so, there is a risk that HHS may not have some of the
capabilities necessary to continue critical vaccine-related activities going
forward.

HHS Indicated It Will Continue
Using a Key Information
System, but Has Not
Developed a Schedule to
Manage Activities

As HHS was assuming the CAG’s responsibilities, HHS officials indicated
they planned to continue utilizing a key information system—Tiberius—for
tracking their ongoing COVID-19 vaccine manufacturing and distribution
activities. However, HHS has not developed a schedule to manage
remaining vaccine development, manufacturing, and distribution activities.
Tiberius. The CAG used Tiberius—an integrated information technology
database that incorporates information from outside sources, such as
vaccine companies and jurisdictions—to help manage and track its
COVID-19 vaccine manufacturing, distribution, and administration
activities. 34 In particular, according to CAG officials, Tiberius was the
principal information system used by jurisdictions to review weekly
vaccine allocations. Specifically, Tiberius received a data feed from the
electronic system the jurisdictions used to order their vaccines, and then
information from that data feed displayed various metrics for each

32See GAO, COVID-19: Federal Efforts Could be Strengthened by Timely and Concerted
Actions, GAO-20-701 (Washington, D.C., Sept. 21, 2020). The DPA facilitates the supply
and timely delivery of products, materials, and services to military and civilian agencies in
support of the national defense, including in response to emergency preparedness
activities. See Pub. L. No. 81-774, 64 Stat. 798 (1950) (codified, as amended, at 50
U.S.C. §§ 4501 et seq.).
33See GAO-18-427 and GAO-04-39.
34According to HHS and DOD officials, the federal government owns the Tiberius
software, but licenses the right to use its hosting platform from the private company that
established and maintains the platform.

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jurisdiction, such as the number of doses available to order and ordered
by a jurisdiction.
As part of the transition, HHS officials said they extended a key Tiberius
contract for software development through at least July 2022. 35
Additionally, HHS officials told us that the HHS Office of the Chief
Information Officer coordinated with officials from the CAG, CDC, and
ASPR to transition management of Tiberius to CDC. According to HHS
officials, CDC plans to integrate Tiberius into its existing systems, which
would allow CDC to continue using the system, as well as determine any
long-term plans for using Tiberius after July 2022.
Schedule. HHS has not developed a specific schedule to help manage
the remaining COVID-19 vaccine-related responsibilities once the CAG
dissolved—such as those related to managing the distribution of vaccine
doses for boosters or children, or to address any emerging COVID-19
variants. 36 According to the GAO Schedule Assessment Guide, a
schedule—as a normal part of project management—assists project
managers by providing a road map for systematic project execution,
defining when and how long work will occur, and indicating how each
activity within a project is related to others, among other benefits. 37 For
example, a schedule could include activities for distribution of sufficient
vaccine doses across the states and other jurisdictions for boosters, for
children, or for addressing variants. As such, a schedule—particularly one
that follows best practices such as including all activities, placing them in
sequence, assigning resources to them, and establishing their duration—
can help managers to identify and mitigate scheduling risks, such as
delays. According to the guide, a schedule for a completed project can
also be a valuable source of lessons learned—showing what actually
happened compared to expectations—when planning similar future
projects.
35CAG officials estimate that it will cost approximately $32 million per year to maintain and
continue to use Tiberius.
36Additionally, three COVID-19 vaccines that were part of the CAG remained in

development; as of January 2022, the AstraZeneca, Novavax, and Sanofi vaccines were
still in development and had not been authorized or licensed for use in the United States.

37See GAO-16-89G. Scheduling allows officials to decide between possible sequences of

activities, determine the flexibility of the schedule according to available resources, predict
the consequences of managerial action or inaction on events, and develop contingency
plans to mitigate risks.

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HHS officials told us that the department will no longer use an existing
schedule developed by the CAG, as the contract that supported the
CAG’s schedule has ended. 38 In addition, rather than developing a new
schedule, HHS officials told us that the department will instead rely on its
project coordination teams to manage the schedules for these activities,
by working with the Biomedical Advanced Research and Development
Authority (BARDA) and the vaccine companies. 39 However, officials have
not provided information on how this coordination would result in a
reliable schedule that follows best practices.
HHS officials also noted that the information once provided by the CAG’s
schedule will continue to be made available via the project coordination
teams and BARDA officials. However, our separate review of the CAG’s
schedule indicated that its information was not reliable. Specifically, we
found that the CAG’s schedule minimally or partially met best practices
associated with a “well-constructed” schedule, as defined in the GAO
Schedule Assessment Guide. 40 In particular, we found a number of
missing logical dependencies, which help show how activities that fall
behind in the schedule will affect succeeding activities that depend on
them, or how these delays would affect the overall project schedule. We
also could not identify a valid critical path, and determined the schedule
exhibited an unreasonable amount of total float. For more information

38In June 2020, the CAG developed a schedule to help manage the alignment of the
hundreds of individual tasks needed to support its efforts to develop, manufacture, and
distribute the various COVID-19 vaccines. Examples of these tasks include monitoring the
timing of clinical trials conducted by vaccine companies; vaccine quality control testing;
and the shipment of vaccine doses to specific sites across various jurisdictions for
administration.
39According to CAG officials, project coordination teams consisted of federal employees
and contractors from HHS and DOD who were responsible for coordinating vaccine
development and manufacturing efforts. Additionally, CAG officials told us these teams
also served as contact points between the federal government and each of the six vaccine
companies that were part of the CAG. Furthermore, CAG officials told us that collectively
the project coordination teams fell under the DOD-appointed Director of Vaccines, but
each of the six teams were led by HHS officials.
40A schedule is well-constructed if all its activities are logically sequenced with the most

straightforward logic possible. The best practices of a well-constructed schedule include
(1) logical sequencing of all activities—that is, listing the activities in the order in which
they are to be logically carried out; (2) confirming that the schedule has a valid critical
path—that is, the longest continuous sequence of activities in a schedule and the path that
defines the program’s earliest completion date or minimum duration; and (3) identifying
reasonable total float or slack—the amount of time an activity could be delayed before that
delay affects the program’s overall estimated finish date.

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about the CAG’s schedule, including our abridged assessment of it, see
appendix III.
Having a schedule that is consistent with identified best practices can
help officials have confidence in their ability to manage vaccine
development, manufacturing, and distribution efforts. Specifically,
developing a schedule that is consistent with best practices could help
HHS determine the amount of scheduling flexibility it has, predict the
consequences of managerial action or inaction in events, and develop
contingency plans to mitigate delays or other risks while completing
activities related to vaccines for boosters, for children, or for addressing
emerging variants. In addition, developing such a schedule would help
HHS to better archive the actual sequence of events for completing its
remaining activities, which could be a source of lessons learned to
analyze during its planning for any future pandemics.

The CAG Began a
Lessons-Learned
Review Process, but
Its Plans Do Not
Include Collecting
Information from
Stakeholders

The CAG began a joint interagency lessons-learned review process in
August 2021 to assess its COVID-19 vaccine development,
manufacturing, and distribution efforts, as called for by the April 2021
memorandum. Specifically, the CAG established an interagency
workgroup and a review process the CAG would use for collecting
lessons learned across each of the nine lines of effort, according to
officials. As of September 2021, CAG officials expected they would
complete their process of collecting lessons learned no later than
December 31, 2021, and that these lessons learned would be available to
help guide the transition of CAG responsibilities to HHS. However, we did
not receive updated information about the process’s completion. Officials
said they planned to compile the lessons learned collected across all nine
lines of effort into a single report, issued no later than March 31, 2022.
We found that the CAG’s lessons-learned plan—finalized in September
2021—aligns with some leading practices for conducting lessons-learned
reviews that we and others have identified, including collecting and
sharing information on any positive and negative experiences. 41 Figure 1
shows these leading practices.

41See GAO-21-8, GAO-20-104, GAO-19-25, and GAO-12-901. See also Center for Army
Lessons Learned, Establishing a Lessons Learned Program.

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Figure 1: Leading Practices of a Lessons-Learned Review Process

For example, the CAG’s lessons-learned plan delineates responsibilities
for collecting information on lessons learned by completing after-action
reports and exit interviews with CAG officials. 42 It states that prior to
departure from the CAG, every official assigned to the CAG should
provide input on lessons learned—such as their perspectives on
significant challenges and best practices—to their line of effort’s point of
contact for inclusion in an after-action report. 43 The lessons-learned plan
also includes an overview of how CAG officials would transfer or share
relevant records with HHS, so that HHS has the necessary information to
continue the work.

42According to the lessons-learned plan, the objective of the after-action reports and
associated exit interviews is to provide context to HHS regarding CAG operations and
decisions in order to streamline decision-making for efforts to respond to potential future
pandemics. The after-action reports will serve as a historic record of accomplishments
facilitated by the CAG.
43According to CAG officials, the Supply, Production, and Distribution line of effort was
subdivided into five separate sections. They said that while one official will continue to
serve as the primary point of contact, the official will coordinate with five other individuals
who are responsible for completing the after-action reviews for the five subdivided areas
under this specific line of effort.

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However, based on our review, the CAG’s lessons-learned plan did not
meet other leading practices. Specifically, the CAG’s planned interagency
review process did not include efforts to engage stakeholders in
identifying lessons learned. Leading practices emphasize the importance
of engaging with key stakeholders—that is, those entities who played
significant roles in supporting the CAG’s activities. As an example of
these leading practices, The Standard for Program Management,
produced by the Project Management Institute, states that program
managers should actively engage key stakeholders throughout the life
cycle of a program, which would include lessons-learned processes and
evaluation activities, such as completing after-action reviews. 44
According to CAG officials, the lessons-learned review process is
internally focused and does not outline an approach to collect information
from key stakeholders outside of the CAG, such as the vaccine
companies or other federal agencies that coordinated with the CAG. The
six vaccine companies, as well as several HHS and DOD component
offices and agencies, were key stakeholders that played significant roles
in the CAG’s COVID-19 vaccine development, manufacturing, and
distribution efforts. As such, they may have valuable contributions to
make to the lessons-learned reviews.
CAG officials said their lessons-learned review process was intended to
collect information internally from staff assigned to the CAG. Officials
added that CAG officials may have chosen to gather information from key
stakeholders outside the CAG—at their discretion during the lessonslearned process—but that there was no plan or requirement for them to
do so.
By expanding the lessons learned review to also obtain and incorporate
the perspectives of key external stakeholders, HHS and DOD could better
ensure that HHS has the full benefit of capturing perspectives from all of
the significant players involved in the CAG’s vaccine-related efforts.
Moreover, these perspectives could help provide a more comprehensive
understanding of what worked well and of areas for potential
44See Project Management Institute, Inc., A Guide to the Project Management Body of
Knowledge (PMBOK® Guide), Sixth Edition, 2017. GAO, Disaster Response: HHS Should
Address Deficiencies Highlighted by Recent Hurricanes in the U.S. Virgin Islands and
Puerto Rico, GAO-19-592 (Washington, D.C.: Sept. 20, 2019). The Project Management
Institute is a not-for-profit association that provides global standards for, among other
things, project and program management. These standards are utilized worldwide and
provide guidance on how to manage various aspects of projects, programs, and portfolios.

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improvement to help inform ongoing and any future vaccine development,
manufacturing, and distribution efforts.

Preliminary Lessons
Learned from the
CAG, Federal
Agencies, and
Vaccine Company
Representatives

Based on our review of information from and interviews with CAG
officials, federal agency officials, and vaccine company representatives in
June 2021 and July 2021, we identified some examples of preliminary
lessons learned. The preliminary lessons learned we identified covered
several areas, as described below.
Selecting multiple vaccine companies and platforms. According to
CAG officials, the CAG’s strategy to build a diverse portfolio of vaccine
candidates from multiple companies that use different platform
technologies worked well. 45 CAG officials highlighted the federal
government’s strategy to award contracts and OTAs to multiple vaccine
companies developing COVID-19 vaccines.
As we have previously reported, the federal government took on financial
risk to support or purchase doses of the six vaccine candidates by
enabling large-scale manufacturing to start while clinical trials were
ongoing, before their safety and effectiveness of the candidates was fully
known. 46 We noted that this approach helped to enable distribution of
vaccines as soon as possible upon receiving FDA authorization or
licensure.
CAG officials noted that including vaccine candidates from different
platforms—before knowing whether any would be successful—involved
significant costs but helped to allow multiple candidates to receive EUAs
within 9 months of establishing the CAG, and to have significant numbers
of manufactured doses available for distribution at the time the EUAs
were issued. We previously reported that because these platforms use
different mechanisms to stimulate an immune response, having a variety
of platforms decreases the risk of failure due to safety, effectiveness, or
manufacturing factors that may affect some platforms but not others.
45A vaccine platform is the mechanism used to stimulate an immune response in a
recipient.
46See GAO-21-319 and GAO-21-443. Pfizer funded the research and development of its

COVID-19 vaccine. The federal government agreed to pay for doses of Pfizer’s vaccine
upon FDA authorization or licensure and as the doses were delivered. HHS officials stated
that this agreement required the government to buy Pfizer vaccine doses upon
authorization or licensure, even if other vaccines were found to be more cost effective or
efficacious.

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Having multiple candidates also increased the chances that one or more
candidate would be successful. 47
Sharing expertise and coordinating across DOD, HHS, and vaccine
companies. Officials from the CAG, DOD, HHS, and NIH told us that
HHS’s expertise in the sciences and DOD’s expertise in planning,
logistics, programming, and contract management complemented each
other, and both were necessary to make the CAG’s COVID-19 vaccine
development, manufacturing, and distribution efforts successful.
Specifically, according to CAG officials, HHS worked with several vaccine
companies as they conducted clinical trials, focusing on the safety and
effectiveness of the vaccine candidates throughout the clinical trial
process. For example, NIH’s National Institute of Allergy and Infectious
Diseases made research staff available to several vaccine companies to
help collaborate on the companies’ clinical trials. NIH staff also helped
vaccine companies find sites to conduct clinical trials and solicit enrollees
for the trials.
In addition, the CAG DOD team provided operational and logistics
expertise, such as delivering personal protective equipment for the clinical
trial sites when needed, and installing mobile trailers if additional capacity
was required. HHS and DOD’s coordination worked well in this instance
and both agencies learned from each other, according to CAG officials.
In contrast, representatives from two vaccine companies told us that there
were initial coordination challenges in their interactions with the CAG,
which improved over time. For example, the representatives said that
they sometimes needed to report the same information multiple times to
officials from different federal agencies, or to different groups within the
same agency. They said that the multiple reporting requirements became
time consuming and distracting at times, and led to confusion about who
within the government was responsible for making decisions. According

47See GAO-21-319. It is also possible that a diverse portfolio of vaccine platforms could
offer additional benefits over time. Different vaccine platforms may also be more effective
in different individuals—for example, older adults or pediatric populations. Further, a
diverse portfolio of vaccine platforms may allow for the use of mixed vaccine platform
boosters. Scientific studies have shown that mixed boosters might help better address the
emergence of SARS-CoV-2 variants and decreasing immunity over time. For example,
mixed vaccine platform boosters may help stimulate different parts of the immune system,
resulting in better and longer-lasting immune responses, or decrease the risk of adverse
events from the original vaccine from developing or happening again.

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to these representatives, coordination and communication with the CAG
improved as they continued working with the officials over time.
Using project coordination teams. BARDA officials noted the
importance of forming project coordination teams to support vaccine
companies’ efforts, and including a leader (from BARDA, NIH, or DOD)
and a team of program managers and subject matter experts in all critical
areas of vaccine development and manufacturing. BARDA officials said
that in the fall of 2020, project coordination teams would meet daily with
each vaccine company to discuss the resources necessary to accelerate
vaccine development and to help identify scientific, technical, and
strategic risks and any plans for mitigating those risks, among other
things. According to CAG officials, the teams continued to conduct
meetings 4 times weekly to provide progress updates to the CAG’s
leadership and other stakeholders about any vaccine-related issues or
resource constraints.
Using supply chain managers and the DPA for vaccine
manufacturing. CAG officials said that they embedded federal
government supply chain managers to work at vaccine manufacturing
sites. According to CAG officials, this approach allowed for daily progress
updates to its leadership during the fall of 2020, and close coordination
between the federal government and manufacturing companies regarding
any supply chain issues that could affect manufacturing.
Representatives from two vaccine companies commented on the CAG’s
efforts to support manufacturing efforts through use of the Defense
Production Act (DPA), which has allowed companies to have priority
access to necessary materials. 48 Federal agencies used the DPA and
other actions more than 100 times to respond to the COVID-19 pandemic
and stabilize the medical supply chain through September 2021. 49 Use of
the DPA enabled one vaccine company, for example, to have priority

48Contracts with a priority rating under the DPA require a contractor to give preference to
these contracts over any other unrated contracts if the contractor cannot meet all required
delivery date needs for all contracts. See 50 U.S.C. § 4511.
49“Other actions” refers to industrial base expansion projects for medical supplies that
have similar goals but were not executed under the DPA Title III authority. See GAO,
COVID-19: Agencies Are Taking Steps to Improve Future Use of Defense Production Act
Authorities. GAO-22-105380. (Washington, D.C.: Dec. 16, 2021).

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access to lipids, bags, and filters to help manufacture its COVID-19
vaccine.
Representatives from one vaccine company said the use of the DPA in
limited circumstances could help secure supply-constrained raw materials
needed to produce COVID-19 vaccines. However, they added that the
company’s suppliers have noted that exercising the DPA can create
production challenges and disruptions, because it can restrict suppliers’
flexibility and ability to maximize capacity. 50
According to DOD’s CAG Continuity Book, use of the DPA requires close
coordination of priorities and deliveries to ensure production stability, and
is “not a miracle solution.” For example, the CAG Continuity Book notes
that domestic fill-finish capacity was limited even prior to the COVID-19
pandemic. It states that the need to use existing capacity to address
needs during the pandemic meant that less capacity was available for
other life-saving medicines. The CAG Continuity Book also emphasizes
the importance of expanding manufacturing capacity for future public
health emergencies, to ensure sufficient capacity for both routine
commercial business and the surge of increased capacity needs due to
the emergency.
Contracting for vaccine development and manufacturing. According
to CAG officials, constant communication between contracting, legal, and
scientific experts was key to obtaining the vaccines. Specifically, DOD’s
Joint Program Executive Office for Chemical, Biological, Radiological, and
Nuclear Defense (JPEO-CBRND) and Army Contracting Command used
their acquisition workforce expertise and prototype OTA authority—which
DOD officials say enabled command officials to negotiate terms and
conditions in agreements with five of the six vaccine companies. 51

50We previously reported on the unintended consequences that could result from use of
the DPA to expedite the receipt of supply-constrained materials for vaccine manufacturing
(i.e., creating constrained supplies for other life-saving medicines). See GAO-21-443.
51As we previously reported, OTAs can help agencies contract with entities that have not
previously done business with the federal government due to concerns about standard
contracting requirements. However, there may be challenges associated with their use,
including a risk of reduced accountability and transparency, which we addressed in prior
reports. See GAO, COVID-19 Contracting: Actions Needed to Enhance Transparency and
Oversight of Selected Awards, GAO-21-501 (Washington, D.C.: July 26, 2021) and GAO,
COVID-19 Contracting: Observations on Federal Contracting in Response to the
Pandemic, GAO-20-632 (Washington, D.C.: July 29, 2020).

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In addition, JPEO-CBRND officials said that using a flat organizational
structure—with direct contact between acquisition senior leaders and
staff—allowed for efficient communication, which enabled quick decisionmaking when it was necessary. For example, these officials told us that
having access to senior leadership on a regular basis, through the
leaders’ participation in work group meetings and team discussions,
helped to reduce the normal acquisition processing times for vaccines by
months. Officials added that senior leaders were prepared to review
contract documents quickly when they came in for approval, thereby
minimizing the contract award time.
CAG officials noted that a challenge they experienced was the initial lack
of enough acquisition staff to support the sustained high-volume, hightempo workload. JPEO-CBRND provided 10-12 employees in direct
support of CAG operations, embedded with the project coordination
teams, and asked them to work longer hours. According to CAG officials,
in approximately May 2021, JPEO-CBRND was authorized to acquire
about 75 additional employees and contractors, which helped to relieve
the burden on JPEO-CBRND staff.
Communicating COVID-19 vaccine-related activities to the public
and vaccine companies. CAG officials told us that the CAG helped to
support the federal government’s frequent public updates on vaccine
development, starting around November 2020. However, the officials
noted that the federal government could have better communicated with
the public to help people who were unfamiliar with vaccine development
understand the inherent unpredictability of the process. Specifically, CAG
officials explained that development of biologics, including vaccines, is
more unpredictable than other types of drug development and can lead to
unforeseen production failures. For example, actual production amounts
could be lower than estimated amounts due to the inherent fragility in the
process. CAG officials noted that the federal government could work to
better communicate expectations for some fluctuation in estimated

OTAs are generally exempt from federal procurement laws and regulations, allowing
intellectual property rights under each OTA to be tailored to suit the goals of the project.
Under an OTA, the parties can tailor provisions to address concerns about intellectual
property and unique government requirements and regulations. The parties are not
necessarily bound by FAR-based contract requirements. For example the Bayh-Dole Act
governs intellectual property rights in FAR-based contracts but not in OTAs. 35 U.S.C. §§
200-212. The FAR is the primary regulation for use by all executive agencies in their
acquisition of supplies and services with appropriated funds.

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amounts of available vaccine doses given the nature of vaccine
production.
Representatives from one vaccine company noted that ongoing
communication with the involved federal agencies allowed them to
continuously improve their plans for vaccine rollout. Another vaccine
company’s representatives stated that the federal agencies provided
guidance, feedback, and resources needed through each stage of their
clinical trial programs. According to these representatives, direct and
frequent communication with federal agencies helped to ensure the
vaccine company aligned with safety and effectiveness evaluation
practices expected of all federally-funded studies.

Conclusions

The accelerated development, manufacturing, and distribution of vaccines
has been a critical part of the U.S. response to the COVID-19 pandemic.
The federal government has shown it can rapidly and effectively mobilize
partnerships to produce safe and effective vaccines to help the nation
respond to and recover from the pandemic’s catastrophic effects. The
CAG partnership between HHS and DOD is an example of a quickly built
and effective partnership, as are related agreements between the federal
government and private vaccine companies.
As HHS assumes all responsibilities of the CAG, it is vital that the
department continues these activities without interruptions. This is
especially critical as the pandemic continues well into its second year and
the federal government looks to provide greater access to vaccines, such
as through the recent availability of boosters and vaccines for children, as
well as to prepare for emerging COVID-19 variants and for future
pandemics.
HHS and DOD stated that they developed and achieved milestones
indicating HHS’s readiness to assume the CAG’s responsibilities—a
critical step to ensuring the successful continuation of the CAG’s vaccine
work. However, available documentation does not identify most of these
milestones, nor does the documentation demonstrate how the milestones
were achieved. In addition, while HHS has assessed its workforce’s ability
to take on tasks that DOD had previously led within the CAG, HHS has
yet to address some of the workforce needs that it identified. By
developing and implementing a workforce strategy to address HHS’s
workforce needs, HHS and DOD can mitigate any risks and help ensure
that HHS is ready to continue the CAG’s work uninterrupted.

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Furthermore, HHS has not developed a schedule to help it manage
remaining vaccine development, manufacturing, and distribution activities.
Developing a schedule that is consistent with best practices would
provide a road map for systematic execution of vaccine-related activities,
as well as a means by which to help better plan actions, gauge progress,
and identify and resolve potential problems. In addition, such a schedule
could help HHS better archive the actual sequence of events for
completing its remaining activities, which could in turn provide a source of
lessons learned for any future pandemics.
Additionally, although HHS and DOD have begun their joint interagency
review to help inform HHS’s future vaccine activities, the departments do
not have plans to gather perspectives from stakeholders outside of the
CAG. By also obtaining and incorporating the perspectives of key external
stakeholders—such as from vaccine companies or other federal agency
officials who worked with the CAG—HHS and DOD have an opportunity
to obtain a more comprehensive understanding of what worked well and
of areas for potential improvement to inform ongoing and any future
vaccine development, manufacturing, and distribution efforts.

Recommendations for
Executive Action

We are making a total of five recommendations, including three to the
Secretary of Health and Human Services, and two to the Secretary of
Defense:
The Secretary of Health and Human Services, in coordination with DOD,
should develop and implement workforce strategies to address the
workforce needs it identified as part of the CAG’s transition to HHS.
(Recommendation 1)
The Secretary of Defense, in coordination with HHS, should establish a
mechanism—such as through an interagency agreement—to provide
support to HHS until it develops and implements workforce strategies to
address the workforce needs it identified as part of the CAG’s transition to
HHS. (Recommendation 2)
The Secretary of Health and Human Services should develop a schedule
that is consistent with the best practices established in the GAO Schedule
Assessment Guide to manage remaining vaccine-related responsibilities.
(Recommendation 3)
The Secretary of Health and Human Services, in coordination with DOD,
should expand the CAG’s lessons-learned review to also obtain and
incorporate input from key external stakeholders, such as vaccine

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companies and other federal agencies that coordinated with the CAG on
its vaccine-related responsibilities. (Recommendation 4)
The Secretary of Defense, in coordination with HHS, should expand the
CAG’s lessons-learned review to obtain and incorporate input from key
external stakeholders, such as vaccine companies and other federal
agencies that coordinated with the CAG on its vaccine-related
responsibilities. (Recommendation 5)

Agency Comments
and Our Evaluation

We provided a draft of this report to HHS and DOD for review and
comment. Both departments provided written comments, which are
reproduced in appendix IV and V, respectively. HHS also provided
technical comments, which we incorporated as appropriate. In written
comments from HHS, the department concurred with two
recommendations, and did not concur with two other recommendations.
In the draft report, provided to the departments in early December 2021
before the CAG dissolved, we recommended that HHS, in coordination
with DOD, should finalize and achieve transition milestones, to help
demonstrate HHS’s readiness to assume the CAG’s responsibilities
before DOD formally ended its support. At that time, the CAG had not
finalized transition milestones for seven of the nine lines of effort. HHS did
not concur with this recommendation because, according to HHS in its
comments on our draft report, the department had successfully completed
the planned transition of responsibilities to the newly established HHS
Coordination Operations and Response Element by its deadline of
January 1, 2022. HHS provided memos stating that milestones had been
achieved and detailing transition activities. While the memos did not
identify or describe such milestones or show how they were achieved, we
removed this draft recommendation because the CAG’s responsibilities
have transferred to HHS. Nonetheless, without a clear understanding of
what information the transition was based on—including the specific
milestones developed and how those were achieved—we remain
concerned that HHS has not demonstrated its readiness to fully assume
all responsibilities formerly undertaken by the CAG.
HHS also did not concur with the draft report’s second recommendation
to complete assessments of its workforce capacity and develop
corresponding workforce strategies. In its written comments on our draft
report, HHS stated this was because the department completed
workforce assessments by January 1, 2022, after we sent the draft report
for review. HHS also provided additional documents describing these
workforce assessments, and we revised our report to indicate that HHS

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had completed these assessments. However, as our report indicates, the
assessments also identified specific workforce needs, but do not include
strategies for addressing those needs. As a result, our report
recommends that HHS develop such strategies so that it can mitigate any
workforce-related risks and help ensure that it successfully continues its
work uninterrupted.
HHS concurred with our recommendation to develop a schedule to
manage remaining vaccine-related responsibilities, consistent with best
practices. In its written comments, HHS stated that its new office, the
HHS Coordination Operations and Response Element, will make
assessments regarding the future use of schedules, taking into
consideration the best practices established in the GAO Schedule
Assessment Guide. HHS also concurred with our recommendation to
expand the CAG’s lessons-learned review to obtain and incorporate input
from key external stakeholders.
In written comments from DOD, the department concurred with the two
recommendations directed to it. In the draft report, we recommended that
DOD establish a mechanism to formally provide support to HHS until
CAG transition milestones are finalized and achieved, and until HHS
completes its planned assessments of its workforce capacity and
develops corresponding workforce strategies. DOD stated that it
concurred with the recommendation, although transition milestones were
finalized and achieved by December 31, 2021. As noted above, we also
received documentation from HHS that it had finalized milestones and
developed workforce assessments. In light of this new information, we
modified our recommendation to DOD to provide support to HHS in
developing workforce strategies to address the workforce needs it
identified as part of the CAG’s transition to HHS. DOD also concurred
with our recommendation to expand the CAG’s lessons-learned review to
obtain and incorporate input from key external stakeholders.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Defense, the Secretary of Health and
Human Services, and other interested parties. In addition, the report is
available at no charge on the GAO website at http://www.gao.gov.

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

Alyssa M. Hundrup
Director, Health Care

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

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The Honorable Bennie G. Thompson
Chairman
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives
The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives
The Honorable Richard 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

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Appendix I: Status of U.S. COVID-19
Vaccine Candidates and Related Obligations
and Doses
Appendix I: Status of U.S. COVID-19 Vaccine
Candidates and Related Obligations and Doses

To support the Department of Health and Human Services (HHS)Department of Defense (DOD) COVID-19 Countermeasures Acceleration
Group (CAG) (formerly known as Operation Warp Speed), HHS and DOD
awarded contracts and other transaction agreements (OTA) to six vaccine
companies and others. 1 We reviewed the related contract documentation
and found that these contracts and OTAs were awarded for the
development and manufacturing of vaccines, the purchase of vaccine
doses, and the acquisition of other critical supplies and services. See
table 2 for the status of each of the six vaccine candidates as of January
11, 2022.
Table 2: Status of the CAG’s Six Vaccine Candidates, as of January 11, 2022
Vaccine company

Findings from phase
3 clinical trials announced

EUA in effecta

Biologics license
application (BLA) approvedb

AstraZeneca

●

-

-

Janssenc

●

18 and older; booster
for 18 and olderd

-

Moderna

●

18 and older; booster
for 18 and oldere

-

Novavax

●

-

-

Pfizerf

●

5-15 years; booster
for 12 and olderg

16 and olderh

Sanofii

-

-

-

Source: GAO analysis of information provided by vaccine companies, the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS)-Department of Defense (DOD)
COVID-19 Countermeasures Acceleration Group (CAG). | GAO-22-104453

Note: The CAG was formerly known as Operation Warp Speed. The columns provide information on
specific groups for which the vaccines are authorized or licensed.
a
The Secretary of Health and Human Services may declare that circumstances, prescribed by statute,
exist justifying the emergency use of certain medical products, such as vaccines. Once a declaration
of an emergency has been made, FDA may temporarily allow use of unlicensed vaccines through an
emergency use authorization (EUA), provided certain statutory criteria are met. 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.
b
FDA licenses biologics, such as vaccines, through review and approval of BLAs. FDA guidance
indicates that licensure is the goal for COVID-19 vaccine candidates, including those that first receive
an EUA.
c

Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

1The six vaccine companies are AstraZeneca, Janssen, Moderna, Novavax, Pfizer, and

Sanofi. Pfizer developed its COVID-19 vaccine in collaboration with BioNTech, and Sanofi
is developing its COVID-19 vaccine candidate in collaboration with GSK. Janssen
Pharmaceutical Companies are a part of Johnson & Johnson. OTAs are flexible
agreements that allow the parties to negotiate terms and conditions without requiring
parties to comply with certain federal procurement laws and regulations. See 10 U.S.C. §
2371b.

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Appendix I: Status of U.S. COVID-19 Vaccine
Candidates and Related Obligations and Doses

d
Janssen’s one-dose COVID-19 vaccine was first authorized for emergency use on February 27,
2021 for those 18 years of age and older. FDA amended the authorization for Janssen’s vaccine on
October 20, 2021 to allow a single booster dose to be administered to individuals 18 years and older
and who were vaccinated 2 or more months ago.
e
Moderna’s two-dose COVID-19 vaccine was first authorized for emergency use on December 18,
2020 for those 18 years of age and older. FDA has amended the authorization for Moderna’s vaccine
numerous times, including on August 12, 2021 to allow a third dose to be administered to certain
immunocompromised individuals; on October 20, 2021 to allow a single booster dose to be
administered 6 months or more after the initial two-dose series to certain groups of individuals; on
November 19, 2021 to allow a single booster dose to be administered 6 months or more after the
initial two-dose series to individuals ages 18 and older; and on January 7, 2022 to reduce the dosing
interval between the initial two-dose series and the booster from 6 months to 5 months.
f

Pfizer developed its COVID-19 vaccine in collaboration with BioNTech.

Pfizer’s two-dose COVID-19 vaccine was first authorized for emergency use on December 11, 2020
for those 16 years of age and older. FDA has amended the authorization for Pfizer’s vaccine
numerous times, including on May 10, 2021 to include individuals ages 12 to 15; on August 12, 2021
to allow a third dose to be administered to certain immunocompromised individuals; on September
22, 2021 to allow a single booster dose to be administered 6 months or more after the initial two-dose
series to certain groups of individuals; on October 29, 2021, FDA amended the authorization again to
allow for a lower dose of Pfizer’s vaccine to be administered to individuals ages 5 to 11; on November
19, 2021 to allow a single booster dose to be administered 6 months or more after the initial two-dose
series to individuals ages 18 and older; and on January 3, 2022 to allow a single booster dose to be
administered 5 months or more after the initial two-dose series to individuals 12 and older and to
allow a third dose to be administered to certain immunocompromised individuals ages 5 to 11.

g

On August 23, 2021, FDA licensed Pfizer’s COVID-19 vaccine for individuals 16 years and older.

h

Sanofi is developing its COVID-19 vaccine candidate in collaboration with GSK.

i

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Appendix I: Status of U.S. COVID-19 Vaccine
Candidates and Related Obligations and Doses

HHS and DOD Vaccinerelated Obligations

Our review found that, to support these vaccine candidates, HHS and
DOD had obligated at least $29.8 billion as of September 30, 2021, as
shown in figure 2.

Figure 2: HHS and DOD Obligations for COVID-19 Vaccine Candidates and Others under the CAG, as of September 30, 2021

Note: The Department of Health and Human Services (HHS)-Department of Defense (DOD) COVID19 Countermeasures Acceleration Group (CAG) 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. HHS and DOD awarded contracts and other transaction
agreements to six vaccine companies and others for the development and manufacturing of vaccines,
the purchase of vaccine doses, and the acquisition of other critical supplies and services. HHS
announced one award related to distribution for which we could not identify obligations in the Federal
Procurement Data System-Next Generation; that award is not included in the chart above.

These obligations were, in part, for contracting to purchase vaccine doses
for use in the U.S. As of October 22, 2021, 1.2 billion of these 1.7 billion
doses were for vaccines that had been authorized or licensed by the
Food and Drug Administration (FDA). (See table 3.)

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Appendix I: Status of U.S. COVID-19 Vaccine
Candidates and Related Obligations and Doses

Table 3: Vaccine Doses Contracted for Purchase by the Federal Government for
Domestic Use, as of October 22, 2021
Vaccine company

Contracted amount (millions of doses)

AstraZeneca

300

Janssena

100

Moderna

500

Novavax

100b

Pfizerc

600

Sanofid

100

Total

1,700e

Source: GAO analysis of award and other acquisition related documents and information from the Department of Health and Human
Services (HHS), the Department of Defense (DOD), Advanced Technology International, and vaccine companies. | GAO-22-104453

Note: The contracted amount includes base and exercised options. According to officials from the
HHS-DOD COVID-19 Countermeasures Acceleration Group (CAG), these doses were intended for
domestic use. However, according to these officials, as of September 30, 2021, 122.7 million doses
were donated by the federal government for international use.
Janssen Pharmaceutical Companies are a part of Johnson & Johnson.

a

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.
b

c

Pfizer developed its COVID-19 vaccine in collaboration with BioNTech.
Sanofi is developing its COVID-19 vaccine candidate in collaboration with GSK.

d

As of October 22, 2021, 1.2 billion of the 1.7 billion vaccine doses contracted for purchase were
authorized or licensed (the Janssen, Moderna, and Pfizer vaccines had received authorization or
licensure). COVID-19 vaccine candidates developed by AstraZeneca, Novavax, and Sanofi had not
been authorized or licensed as of this date.
e

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Appendix II: Contract Techniques Used to
Obtain COVID-19 Vaccines for the U.S.
Appendix II: Contract Techniques Used to
Obtain COVID-19 Vaccines for the U.S.

To support the Department of Health and Human Services (HHS)Department of Defense (DOD) COVID-19 Countermeasures Acceleration
Group (CAG) (formerly known as Operation Warp Speed), DOD and HHS
officials utilized multiple contracting techniques. 1 Specifically, DOD’s Joint
Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense (JPEO-CBRND) and Army Contracting Command
leveraged these techniques to obtain vaccine doses from six companies
in response to the COVID-19 pandemic. 2 Contracting techniques
employed to obtain COVID-19 vaccines included the following:
Broad agency announcements. DOD and HHS used broad agency
announcements to solicit vaccine rapid advanced research and
development and large scale manufacturing. A broad agency
announcement is a notice from the government that requests scientific or
research and development proposals from private firms concerning
certain areas of interest to the government. 3 Compared to a normal
request for proposals, a broad agency announcement does not provide a
standard—more specific—statement of work. Rather, it details a problem
statement and challenges, and it solicits a solution. Proposals submitted
by private firms in response to the announcement may lead to contracts.
According to officials from the JPEO-CBRND and Army Contracting
Command, vaccine-related broad agency announcements allowed them
to obtain input from private companies on how the federal government
could meet broad requirements on vaccine development and
manufacturing.
Other transaction agreements. DOD awarded prototype other
transaction agreements (OTA) to five of the six companies. 4 OTAs are
flexible agreements that allow the parties to negotiate terms and
conditions without requiring parties to comply with certain federal
1We reviewed contract documentation and conducted agency interviews to determine

which contract techniques HHS and DOD used.

2The six vaccine companies are AstraZeneca, Janssen, Moderna, Novavax, Pfizer, and

Sanofi. Pfizer developed its COVID-19 vaccine in collaboration with BioNTech, and Sanofi
is developing its COVID-19 vaccine candidate in collaboration with GSK. Janssen
Pharmaceutical Companies are a part of Johnson & Johnson.

3See Federal Acquisition Regulation (FAR) § 35.016. The Federal Acquisition Regulation

(FAR) is the primary regulation for use by all executive agencies in their acquisition of
supplies and services with appropriated funds.

4The contract with the sixth company was awarded in accordance with the FAR and

Defense FAR Supplement.

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Appendix II: Contract Techniques Used to
Obtain COVID-19 Vaccines for the U.S.

procurement laws and regulations. 5 This flexibility can help agencies
attract and contract with entities that have not previously done business
with the federal government due to concerns about standard contracting
requirements. 6 For example, OTAs are generally exempt from federal
procurement laws and regulations, allowing intellectual property rights
under each OTA to be tailored to suit the goals of the project. 7
However, our recent work to review specific aspects of COVID-related
OTAs found several challenges associated with their use, including a risk
of reduced accountability and transparency. 8 For example, agencies did
not accurately reflect all dollars obligated on COVID-19 OTAs in the
federal procurement database and, in cases where OTAs were awarded
through industry consortia, the agencies did not publicly report which
consortium members received the OTA awards because of limitations
with the federal procurement database. 9
Defense Production Act (DPA) awards and priority-rated contracts.
DOD and HHS provided priority ratings under the DPA to the contracts
with the six vaccine companies to expedite production. The DPA
facilitates the supply and timely delivery of products, materials, and
services to military and civilian agencies in support of the national
defense, including in response to emergency preparedness activities. 10
For example, agencies can require private companies to prioritize fulfilling
federal government contracts or orders before fulfilling contracts or orders
from other customers. DOD and HHS have also used the DPA to award
5See 10 U.S.C. § 2371b.
6See GAO, COVID-19 Contracting: Observations on Federal Contracting in Response to

the Pandemic, GAO-20-632 (Washington, D.C.: July 29, 2020).

7Under an OTA, the parties can tailor provisions to address concerns about intellectual

property and unique government requirements and regulations. The parties are not
necessarily bound by FAR-based contract requirements. For example, the Bayh-Dole Act
governs intellectual property rights in FAR-based contracts but not in OTAs. 35 U.S.C. §§
200-212.

8See GAO, COVID-19 Contracting: Actions Needed to Enhance Transparency and
Oversight of Selected Awards, GAO-21-501 (Washington, D.C.: July 26, 2021).
9A consortium is comprised of members which can include traditional contractors,

nontraditional companies, nonprofit organizations, and academic institutions interested in
a specific topic area.

10See Pub. L. No. 81-774, 64 Stat. 798 (1950) (codified, as amended, at 50 U.S.C. §§
4501 et seq.).

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Appendix II: Contract Techniques Used to
Obtain COVID-19 Vaccines for the U.S.

projects to expand domestic production of health and medical resources.
According to officials from the JPEO-CBRND and Army Contracting
Command, DPA authorities allowed them to ramp up vaccine production
whether they used an OTA or Federal Acquisition Regulation (FAR)based contract; they believe the DPA use has been instrumental in their
ability to quickly obtain vaccine doses.
For other efforts related to securing COVID-19 vaccines, such as
increasing manufacturing capacity and obtaining necessary supplies like
vials and syringes, DOD used the following contracting techniques:
Commercial solutions openings. The commercial solutions opening
pilot program allows DOD to mirror the contracting practices that
commercial companies normally use, enabling DOD to solicit company
input to design projects, and negotiate payment milestones, intellectual
property rights, and other terms and conditions for a desired completion
period of within 60 days. 11
According to officials from the JPEO-CBRND and Army Contracting
Command, they leveraged this authority to use commercial solutions
openings for the first time during the COVID-19 pandemic to solicit
companies for manufacturing facility expansion, including for production
of vaccine vials, and to acquire therapeutics. While this authority is set to
expire in September 2022, legislation may be enacted to extend the
authority.
Technology investment agreements. DOD used technology investment
agreements to obtain needed items, such as vials and syringes, as well
as for fill-finish work—the process of sealing bulk quantities of vaccines
into sterile containers. 12 A technology investment agreement is used to
stimulate or support research to foster the best technologies for future
defense needs. 13 According to DOD, technology investment agreements

11See National Defense Authorization Act for Fiscal Year 2017, Pub. L. No. 114-328, §

879, 130 Stat. 2000, 2312-13 (2016) (codified at 10 U.S.C. § 2303 note). The authority for
this pilot program will expire on September 30, 2022.

12Experts from three pharmaceutical industry groups we interviewed for a previous report
said there was a shortage of facilities with capacity to handle fill-finish manufacturing,
which could lead to production bottlenecks. See 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).
13See 32 C.F.R. Part 37 (2020).

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Appendix II: Contract Techniques Used to
Obtain COVID-19 Vaccines for the U.S.

are appropriate when research objectives are unlikely to be achieved
using other types of contract vehicles.

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Appendix III: Abridged Assessment of the
Countermeasures Acceleration Group’s
Schedule
Appendix III: Abridged Assessment of the
Countermeasures Acceleration Group’s
Schedule

Officials from the Department of Health and Human Services (HHS)Department of Defense (DOD) COVID-19 Countermeasures Acceleration
Group (CAG) (formerly known as Operation Warp Speed) created a
schedule to help manage, among other things, tasks needed to support
the CAG’s efforts to develop, manufacture, and distribute COVID-19
vaccines. 1
The GAO Schedule Assessment Guide has identified 10 best practices
associated with effective schedule estimating, collapsed into four general
characteristics that sound schedules should be: well-constructed,
comprehensive, credible, and controlled. 2 The best practices of a wellconstructed schedule include:
•

logical sequencing of all activities—that is, listing the activities in the
order in which they are to be logically carried out;

•

confirming that the schedule has a valid critical path— that is, the
longest continuous sequence of activities in a schedule and the path
that defines the program’s earliest completion date or minimum
duration; and

•

identifying reasonable total float or slack—the amount of time an
activity could be delayed before that delay affects the program’s
overall estimated finish date.

Our abridged analysis indicates that as of June 2021, the CAG’s schedule
partially met one best practice for a well-constructed schedule and
minimally met the remaining two, as shown in the table 4 below. For
example, we found the schedule was missing a significant number of
dependent logical links between related activities. As of June 2021,
around 41 percent of remaining incomplete activities in the schedule—
1Schedules typically define when and how long work will occur and how each activity is

related to the others. Scheduling allows program management to decide between possible
sequences of activities, determine the flexibility of the schedule according to available
resources, predict the consequences of managerial action or inaction on events, and
develop contingency plans to mitigate risks.

2A schedule is well-constructed if all its activities are logically sequenced with the most

straightforward logic possible. A comprehensive schedule includes all activities for both
the government and its contractors necessary to accomplish a program’s objectives as
defined in the program’s work breakdown structure. A schedule is credible if it is
horizontally traceable—that is, it reflects the order of events necessary to achieve
aggregated products or outcomes. Finally, a schedule is controlled if trained schedulers
update it regularly using actual progress and logic—based on information provided by
activity owners—to realistically forecast dates for program activities. See GAO, Schedule
Assessment Guide: Best Practices for Project Schedules, GAO-16-89G (Washington,
D.C.: Dec. 22, 2015).

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Appendix III: Abridged Assessment of the
Countermeasures Acceleration Group’s
Schedule

including manufacturing potential vaccine booster doses and developing
pediatric vaccine doses—were missing a logical link with other activities.
According to the GAO Schedule Assessment Guide, unless a schedule
identifies all logical dependencies, it will not indicate how activities that fall
behind in the schedule will affect succeeding activities that depend on
them, or how these delays would affect the overall project schedule.
Table 4: Assessment of the CAG’s Integrated Master Schedule, June 2021
GAO Schedule Assessment
Guide best practicesa

Extent
incorporated

Description

Sequencing. Schedules should be
planned so that important dates can
be met. To do this, activities must be
logically sequenced and linked—that
is, listed in the order in which they
are to be carried out and logically
linked so that activities that depend
on each other can all be completed.
The purpose of a logical relationship,
or dependency, is to depict the
sequence in which activities occur.

◑

b

Our analysis indicated that the CAG’s integrated master schedule missed a
significant number of logical links. In some cases, the schedule did not
transmit any adjustments for delays in activities deemed necessary to
complete other needed activities.
For example, the schedule called for a large-scale comparability study for
drug substances and products. Though the study was estimated to take 72
days, the schedule showed no effect on expected vaccine completion date
if the time frames for this study were extended to as long as 300 days.
Without the appropriate predecessor and successor links, the schedule did
not indicate how activities that fell behind early in the schedule would have
affected later activities that depended on them or the overall project
schedule. Additionally, in these instances, the schedule would not have
provided confidence to leadership regarding the schedule’s dates and
indications of key activities that had to be completed.

Critical path. Schedules should
identify a critical path—that is, the
sequence of activities that
determines the program’s earliest
completion date. The critical path
focuses the team’s energy and
management’s attention on the
activities that will lead to the
project’s success.

◔

c

Our analysis found that the sequence of activities through the schedule did
not result in a valid critical path because, among other issues, it was not
continuous and was missing logic links to other activities. That is, we could
not validate the sequence of critical activities necessary for the CAG to
complete a specified goal within its stated timelines, including the vaccine
milestones.
For example, a critical activity regarding a vaccine company’s clinical work
did not have a predecessor activity and therefore the schedule did not
show what other activities would have needed to be completed before this
work have begun. Without a valid critical path, leadership would not have
been able to use the schedule to provide realistic timeline estimates, or
identify the downstream effects of any changes that occur.

Total float. Schedules should
identify reasonable total float—that
is, the amount of time a predecessor
task can miss its finish date before
the delay affects the estimated finish
date.

◔

d

Our analysis identified an unreasonable amount of flexibility in the
schedule, so that some activities could have been delayed weeks, months,
or years before the schedule would have indicated to leadership an overall
delay in milestones. For example, a task which began phase 3 clinical trials
for a vaccine candidate could have been delayed 667 days before
transferring the delay to the vaccine milestone.
Incorrect float estimates may result in an invalid critical path, such that the
schedule would not have given reliable indicators of how leadership could
have shifted resources to support other critical activities, which could have
ultimately delayed completion of those activities.

Legend: ● = fully met, ◕ = substantially met, ◑ = partially met, ◔ = minimally met, ○ = not met

Source: GAO analysis of the integrated master schedule created by the Department of Health and Human Services (HHS)-Department of Defense (DOD) COVID-19 Countermeasures Acceleration Group
(CAG). | GAO-21-104453.

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Appendix III: Abridged Assessment of the
Countermeasures Acceleration Group’s
Schedule

Note: For the best practice assessment described here, we defined the five levels as follows: (1) fully
met – CAG officials provided complete evidence that satisfied the entire criterion; (2) substantially met
– CAG officials provided evidence that satisfied a large portion of the criterion; (3) partially met – CAG
officials provided evidence that satisfied about half of the criterion; (4) minimally met – CAG officials
provided evidence that satisfied a small portion of the criterion; and (5) not met – CAG officials
provided no evidence that satisfied any of the criterion.
See GAO, Schedule Assessment Guide: Best Practices for Project Schedules, GAO-16-89G
(Washington, D.C.: Dec. 22, 2015).

a

b
We evaluated the schedule against sequencing best practice criterion, such as measuring the
number of missing logic links.
c
We evaluated the schedule against critical path best practice criterion, such as assessing its
sequencing and comparing it to the longest path in the schedule.
d
We evaluated the schedule against total float best practice criterion, such as comparing the average
and median values of total float in the schedule and comparing it to the remaining duration of the
project schedule.

When we told CAG officials about our analysis, they explained that their
schedule was never intended to be fully completed due to time
constraints, and because the CAG’s work was already underway. For
example, CAG officials explained that the limitations in their schedule
were due to their work’s constricted timeline and the limited amount of
information they had regarding certain activities. Specifically, due to the
nature of the COVID-19 pandemic, officials said that they had to set
overall time frames within the schedule to finish the work as quickly as
possible. They also said that they did not consistently have reliable
information about the expected duration of some activities conducted by
vaccine companies or by different federal agencies, which in turn affected
their ability to develop a more specific schedule.
Nonetheless, they said that the schedule—although imperfect—allowed
them to better communicate the assumed time frames for activities across
the multiple organizations contributing to the CAG’s vaccine-related
efforts. The integrated master schedule could serve as a critical tool to
help HHS officials as they manage remaining vaccine development,
manufacturing, and distribution activities following the CAG’s dissolution;
however the limitations described above could make it less useful for
project execution, gauging progress, identifying and resolving potential
problems, and promoting accountability.

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

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

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

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Appendix V: Comments from the Department
of Defense
Appendix V: Comments from the Department
of Defense

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Appendix V: Comments from the Department
of Defense

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Appendix V: Comments from the Department
of Defense

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Appendix VI: GAO Contact and Staff
Acknowledgments
Appendix VI: GAO Contact and Staff
Acknowledgments

GAO Contact

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

Staff
Acknowledgments

In addition to the contacts named above Will Simerl (Assistant Director),
Jeffrey Mayhew (Analyst in Charge), Darnita Akers, Amy Andresen, Brian
Bothwell, La Sherri Bush, Michael Dickens, Anna Irvine, Katheryn
Summers Hubbell, Jason Lee, and Patrick Netherclift made key
contributions to this report. Other contributors to this report were Nora
Adkins, Jennie Apter, Kaitlin Farquharson, Lori Fields, Miranda Riemer,
Ethiene Salgado-Rodriguez, and Sarah Veale.

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GAO-22-104453 HHS-DOD CAG Partnership


Related GAO Products
Related GAO Products

COVID-19: Agencies Are Taking Steps to Improve Future Use of Defense
Production Act Authorities. GAO-22-105380. Washington, D.C.:
December 16, 2021.
COVID-19: HHS Agencies’ Planned Reviews Of Vaccine Distribution and
Communication Efforts Should Include Stakeholder Perspectives.
GAO-22-104457. Washington, D.C.: November 4, 2021.
COVID-19: Additional Actions Needed to Improve Accountability and
Program Effectiveness of Federal Response. GAO-22-105051.
Washington, D.C.: October 27, 2021.
COVID-19: Continued Attention Needed to Improve Federal
Preparedness, Response, and Service Delivery and Enhance Program
Integrity. GAO-21-551. Washington, D.C.: July 19, 2021.
COVID-19: Efforts to Increase Vaccine Availability and Perspectives on
Initial Implementation. GAO-21-443. Washington, D.C.: April 14, 2021.
COVID-19: Sustained Federal Action Is Crucial as Pandemic Enters Its
Second Year. GAO-21-387. Washington, D.C.: March 31, 2021.
Operation Warp Speed: Accelerated COVID-19 Vaccine Development
Status and Manufacturing Challenges. GAO-21-319. Washington, D.C.:
February 11, 2021.
COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity,
and Other Challenges Require Focused Federal Attention. GAO-21-265.
Washington, D.C.: January 28, 2021.
COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal
Response. GAO-21-191. Washington, D.C.: November 30, 2020.
COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic
Development, but More Transparency Needed on Emergency Use
Authorization. GAO-21-207. Washington, D.C.: November 17, 2020.
COVID-19: Federal Efforts Could Be Strengthened by Timely and
Concerted Actions. GAO-20-701. Washington, D.C.: September 21, 2020.
COVID-19: Opportunities to Improve Federal Response and Recovery
Efforts. GAO-20-625. Washington, D.C.: June 25, 2020.

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GAO-22-104453 HHS-DOD CAG Partnership


Related GAO Products

Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be
Incorporated into Future Planning, GAO-11-632. Washington, D.C.: June
27, 2011.

(104453)

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GAO-22-104453 HHS-DOD CAG Partnership


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