The U.S. Government’s Role in Domestic and Global COVID-19 Vaccine Supply and Distribution: Frequently Asked Questions

The U.S. Government’s Role in Domestic and Global COVID-19 Vaccine Supply and Distribution: Frequently Asked Questions

Updated February 17, 2022
The U.S. Government’s Role in Domestic and Global COVID-19
Vaccine Supply and Distribution: Frequently Asked Questions
This In Focus answers frequently asked questions regarding
domestic use. As of March 2021, a total of 100 million
U.S. funding and support for domestic and global vaccine
Janssen Pharmaceuticals, Inc., vaccine doses had been
supply and distribution, including Coronavirus Disease
purchased for domestic use. These doses were purchased in
2019 (COVID-19) vaccines. Unless otherwise stated,
August 2020. Additionally, the U.S. government has
information is current as of February 17, 2022.
executed contracts with Sanofi Pasteur and GSK,
Domestic Vaccine Development, Purchasing, and
AstraZeneca, and Novavax Inc. that included provisions for
Distribution
federal ownership of a certain number of doses (100
Which federal agencies funded the development and
million, 300 million, and 100 million, respectively). These
manufacturing of COVID-19 vaccines? Numerous
vaccines currently lack an Emergency Use Authorization
federal entities supported COVID-19 vaccine development
(EUA) or Food and Drug Administration (FDA) approval.
and manufacturing, including the National Institutes of
Originally, these vaccine doses were purchased with the
Health (NIH), the Biomedical Advanced Research and
intent for domestic use, but they currently have an
Development Authority (BARDA), the Department of
unspecified planned usage.
Defense (DOD), and others, both within and separately
How much money has BARDA awarded for COVID-19
from the Operation Warp Speed (OWS) initiative. See CRS
vaccine development, manufacturing, and purchasing?
In Focus IF11951, Domestic Funding for COVID-19
BARDA, in partnership with DOD, has committed about
Vaccines: An Overview for more information. This section
$29 billion for COVID-19 vaccine development,
focuses on domestic BARDA efforts.
manufacturing, and purchasing among the seven
What agreements did the U.S. government enter into
aforementioned vaccine manufacturers. Per the BARDA
with vaccine manufacturers for COVID-19 vaccine
COVID-19 Medical Countermeasure Portfolio website,
development, manufacturing, and purchase? Sanofi
awards include $12 billion to Pfizer; $2 billion to Sanofi
Pasteur and GSK, ModernaTX, Janssen Pharmaceuticals,
Pasteur and GSK; $9.6 billion to ModernaTX; $2 billion to
AstraZeneca, Novavax, Merck, and the International AIDS
Janssen Pharmaceuticals; $1.6 billion to AstraZeneca; $1.6
Vaccine Initiative (IAVI) entered into agreements with
billion to Novavax Inc; and $38 million to Merck and IAVI.
BARDA for the manufacturing and development of
How do state and local health departments order
COVID-19 vaccines. In some cases, these agreements
vaccines? What systems are used to track orders and
included provisions for advance purchase of completed
distribution, and are data regarding distribution
vaccines that ensured the U.S. government would own a
publicly available? The U.S. government continues to
certain number of doses that resulted from federal
determine the maximum number of COVID-19 vaccine
investment. Six awards were made solely for the purpose of
doses per manufacturer that each of the 64 state, local, and
purchasing doses from six manufacturers: Pfizer, Sanofi
territorial health jurisdictions can order based on their
Pasteur and GSK, ModernaTX, Janssen Pharmaceuticals,
population over age 18. Additionally, federal providers
AstraZeneca, and Novavax. Two manufacturers, Merck and
(e.g., VA, DOD, HHS) and participating nongovernment
IAVI, received a base award for accelerating the
entities (e.g., pharmacy chains) can place orders based on
development of a COVID-19 vaccine but did not include
their populations of need. These jurisdictions and providers
provisions for the purchase of doses.
can independently determine how many doses to order, up
How many COVID-19 vaccines has the U.S. government
to this threshold amount, and place their order using the
purchased for domestic use? Roughly 1.2 billion doses of
Vaccine Tracking System (VTrckS). VTrckS also allows
COVID-19 vaccines have been purchased by the U.S.
the Centers for Disease Control and Prevention (CDC) to
government for domestic use.
monitor vaccine allocations, distribution, and shipments.
Roughly 677.2 million vaccine doses have been delivered
Per Pfizer, as of October 28, 2021, a total of 600 million
domestically, of which 80.9% had been administered.
Pfizer vaccine doses have been purchased for domestic use.
(The original July 2020 agreement with BARDA and DOD
Is the U.S. government meeting its domestic vaccination
included a provision for ownership of 100 million doses,
goals? In December 2020, then President-elect Joseph R.
with the option to purchase an additional 500 million doses.
Biden Jr. announced the intention of administering 100
Based on public statements, those additional doses were
million vaccines in his first 100 days in office; this goal was
purchased in 2020 and 2021 and totaled 550 million, the
met within the first 58 days of his administration. In May
majority of which were for adult/adolescent doses.) Per the
2021, the Biden Administration announced the goal of
Department of Health and Human Services (HHS), as of
administering one dose to 70% of the eligible population by
June 2021 (the most recent data available), a total of 500
July 4, 2021; the 70% threshold was attained in August
million ModernaTX vaccine doses had been purchased for
2021. Currently, the Biden Administration is focused on
vaccinating the unvaccinated and providing booster doses.
https://crsreports.congress.gov

The U.S. Government’s Role in Domestic and Global COVID-19 Vaccine Supply and Distribution: Frequently Asked
Questions
Global Vaccine Distribution and Funding
70% vaccination coverage in LMICs by mid-2022. The
How much foreign assistance has Congress
Task Force on COVID-19 Vaccines, Therapeutics and
appropriated for COVID-19 vaccine distribution and
Diagnostics for Developing Countries (the Task Force),
related efforts? Congress has appropriated roughly $17
established on May 31, 2021, by the International Monetary
billion for international COVID-19 response, including $4
Fund (IMF), the World Bank Group, WHO, and the World
billion to Gavi, the Vaccine Alliance, for U.S. membership
Trade Organization (WTO), is seeking to raise $50 billion
in the COVID-19 Vaccine Global Access Initiative
in support of COVAX and ACT-A goals.
(COVAX, the vaccines arm of the Access to COVID-19
Where is the global community in meeting these
Tools Accelerator [ACT-A], led by the World Health
targets? The pace of vaccination in low-income countries
Organization [WHO] and others) and approximately $2.3
would reportedly need to increase to nearly 20 times current
billion for global vaccine readiness efforts total
levels to achieve these targets. Globally, more than 10.5
approximately $2.3 billion. CDC has committed an
billion shots have been administered, the majority in high-
additional $800 million for international COVID-19
income countries. At least 78 countries have not secured
response and related vaccine efforts. The remaining $11
enough COVID-19 vaccine doses to meet global targets of
billion is being used for a variety of foreign assistance
vaccinating 70% of their population by the middle of 2022.
efforts to respond to the effects of the pandemic.
In low-income countries, 5.5% of people have been fully
Is there a central strategy and/or coordinating
vaccinated (defined as the number of doses in a full
mechanism governing U.S. government global vaccine
regimen of a specific immunization scheme; for example,
distribution efforts? On December 6, 2021, the United
two doses of the Moderna or Pfizer vaccine). It remains to
States Agency for International Development (USAID)
be seen how the emergence of new variants (such as
announced the U.S. Government’s Initiative for Global
Omicron), and the need for booster shots for more complete
Vaccine Access (Global VAX) to accelerate U.S. vaccine
protection against severe disease will affect countries’
delivery. Focus areas include bolstering cold chain supply
ability to meet these targets.
and logistics, service delivery, vaccine confidence and
Who are the top donors to COVAX, and of those that
demand, local planning, and vaccine safety and
have promised COVID-19 vaccine doses, how many
effectiveness in low- and middle-income countries
have been delivered? Per the Task Force, other top vaccine
(LMICs). Global efforts build on U.S. commitments to
donors to COVAX are Germany (99 million promised, of
COVAX. USAID is implementing Global VAX activities
which 85 million have been shipped), France (72 million
using $2.3 billion from P.L. 117-2, with a focus on safe
promised; 55 million delivered), the United Kingdom (50
vaccine delivery and storage, building in-country vaccine
million promised; 23 million delivered). The United States
manufacturing capacity and knowledge sharing, and Rapid
has promised 513 million doses to COVAX, of which 195
Response Surge Support (e.g., improving oxygen
million have been delivered.
production and delivery), among other things.
What contracts does COVAX have with vaccine
How is the Biden Administration deciding how to
manufacturers? COVAX has reportedly formalized
allocate domestically purchased COVID-19 vaccines for
contracts, worth roughly $12 billion, for over 4 billion
global use? The U.S. government has promised to donate
doses with 11 vaccine manufacturers (AstraZeneca, Clover
1.2 billion vaccine doses globally. The White House stated
Biopharmaceuticals, Janssen Pharmaceuticals Inc.,
75% of donated doses will be shared through COVAX to
ModernaTX Inc., Novavax Inc., Pfizer Inc., Sanofi Pasteur
maximize the number of vaccines available for the largest
and GSK, Serum Institute of India, Sinopharm, and
number of countries and at-risk populations within
Sinovac). COVAX Advanced Market Commitment dose
countries. The remaining 25% will be shared directly with
purchases are capped at $3 per dose (average market rate
countries in need, those experiencing COVID-19 surges,
for COVID-19 vaccines are $3-$40 per dose).
and countries requesting immediate U.S. assistance.
Are there enough COVID-19 vaccines for the world’s
Which countries have received COVID-19 vaccines
population? What factors are hindering global vaccine
from the United States? How many doses has the United
access? Global COVID-19 vaccine production is at
States committed to donate and how many have been
approximately 1.5 billion doses per month, meaning that
distributed? The U.S. government is the leading donor of
hypothetically there is sufficient vaccine supply to provide
COVID-19 vaccines globally, and according to the State
2.5 vaccine doses for every person in the world by June
Department, has shipped 454 million COVID-19 vaccines
2022. Global health experts identify equitable distribution
to 110 countries, including 127 million doses to countries in
as the key current issue. WHO, the Task Force, and others
sub-Saharan Africa; 96 million doses in East Asia and the
have called on manufacturers to waive intellectual property
Pacific; 63 million doses in Latin America and the
protections on COVID-19 vaccines so that more
Caribbean; 128 million doses in South and Central Asia; 33
manufacturers can produce doses, and for high-income
million doses in the Middle East and North Africa; and 5.6
countries to donate resources for vaccine rollout in LMICs,
million doses to Moldova, Ukraine, Kosovo, and Georgia.
pay their “fair share” of ACT-A funding needs, swap
What is the status of COVAX, ACT-A, and the
vaccine delivery schedules with countries in need, and
Multilateral Leaders Task Force? COVAX has shipped 1
accelerate dose donation commitments to COVAX.
billion COVID-19 vaccines to 144 countries and
economies. Donors have committed $815 million toward
Sara M. Tharakan, Analyst in Global Health and
2022 targets, some $16 billion less than WHO sought to
International Development
reach ACT-A strategic plan targets, including to achieve
https://crsreports.congress.gov

The U.S. Government’s Role in Domestic and Global COVID-19 Vaccine Supply and Distribution: Frequently Asked
Questions

Taylor R. Wyatt, Analyst in Public Health Emergency
Management
IF12013

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