January 10, 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
ModernaTX vaccine doses had been purchased for
domestic and global vaccine supply and distribution, and
domestic use. As of March 2021, a total of 100 million
U.S. spending on Coronavirus Disease 2019 (COVID-19)
Janssen Pharmaceuticals, Inc., vaccine doses had been
vaccines. Unless otherwise stated, information is current as
purchased for domestic use. These doses were purchased in
of January 10, 2022.
August 2020. Additionally, the U.S. government has
Domestic Vaccine Development, Purchasing, and
executed contracts with Sanofi Pasteur and GSK,
Distribution
AstraZeneca, and Novavax Inc. that included provisions for
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
from the Operation Warp Speed (OWS) initiative. See CRS
How much money has BARDA awarded for COVID-19
In Focus IF11951, Domestic Funding for COVID-19
vaccine development, manufacturing, and purchasing?
Vaccines: An Overview for more information. This product
BARDA, in partnership with DOD, has committed about
focuses on domestic BARDA efforts.
$29 billion for COVID-19 vaccine development,
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 Inc., Janssen
Pasteur and GSK; $9.6 billion to ModernaTX; $2 billion to
Pharmaceuticals Inc., AstraZeneca, Novavax Inc., and
Janssen Pharmaceuticals; $1.6 billion to AstraZeneca; $1.6
Merck and IAVI entered into agreements with BARDA for
billion to Novavax Inc; and $38 million to Merck and IAVI.
the manufacturing and development of COVID-19
vaccines. In some cases, these agreements included
How do state and local health departments order
provisions for advance purchase of completed vaccines that
vaccines? What systems are used to track orders and
ensured the U.S. government would own a certain number
distribution, and are data regarding distribution
of doses that resulted from federal investment. Pfizer Inc.
publicly available? The U.S. government continues to
accepted funding only for advance purchase of vaccines,
determine the maximum number of COVID-19 vaccine
not for development and manufacturing. Other subsequent
doses per manufacturer that each of the 64 state, local, and
awards were made solely for the purpose of purchasing
territorial health jurisdictions can order based on their
doses from six manufacturers: Pfizer, Sanofi Pasteur and
population over age 18. Additionally, federal providers
GSK, ModernaTX, Janssen Pharmaceuticals, AstraZeneca,
(e.g., VA, DOD, HHS) and participating nongovernment
and Novavax, Inc. Merck and IAVI received a base award
entities (e.g., pharmacy chains) can place orders based on
for accelerating the development of a COVID-19 vaccine
their populations of need. These jurisdictions and providers
that did not include provision for purchase of doses.
can independently determine how many doses to order, up
to this threshold amount, and place their order using the
How many COVID-19 vaccines has the U.S. government
Vaccine Tracking System (VTrckS). VTrckS also allows
purchased for domestic use? Roughly 1.2 billion doses of
the Centers for Disease Control and Prevention (CDC) to
COVID-19 vaccines have been purchased by the U.S.
monitor vaccine allocations, distribution, and shipments.
government for domestic use.
Roughly 639.7 million vaccine doses have been delivered
Per Pfizer, as of October 28, 2021, a total of 600 million
domestically, of which 81.2% had been administered.
Pfizer vaccine doses have been purchased for domestic use.
Is the U.S. government meeting its domestic vaccination
(The original July 2020 agreement with BARDA and DOD
goals? In December 2020, then President-elect Joseph R.
included a provision for ownership of 100 million doses,
Biden Jr. announced the intention of administering 100
with the option to purchase an additional 500 million doses.
million vaccines in his first 100 days in office; this goal was
Based on public statements, additional doses purchased in
met within the first 58 days of his administration. In May
2020 and 2021 total 550 million, the majority of which
2021, the Biden Administration announced the goal of
were for adult/adolescent doses.) Per the Department of
administering one dose to 70% of the eligible population by
Health and Human Services (HHS), as of June 2021 (the
July 4, 2021; the 70% threshold was attained in August
most recent data available), a total of 500 million
https://crsreports.congress.gov

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The U.S. Government’s Role in Domestic and Global COVID-19 Vaccine Supply and Distribution: Frequently Asked
Questions
2021. Currently, the Biden Administration is focused on
million toward 2022 targets. WHO reports a funding gap of
vaccinating the unvaccinated and providing booster doses.
$6.97 billion to reach ACT-A strategic plan targets, to
Global Vaccine Distribution and Funding
achieve 70% vaccination coverage in LMICs by mid-2022.
How much foreign assistance has Congress
The 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 working toward COVAX’s
in the COVID-19 Vaccine Global Access Initiative
targets, improving transparency and data sharing, and
(COVAX, the vaccines arm of the Access to COVID-19
seeking $50 billion in support of COVAX and ACT-A
Tools Accelerator [ACT-A], led by the World Health
goals.
Organization [WHO] and others). U.S. government
Where is the global community in meeting these
commitments for global vaccine readiness efforts total
targets? The pace of vaccination in low-income countries
approximately $1.3 billion. In addition, CDC has
would reportedly need to increase to nearly 20 times current
committed $800 million for COVID-19 response and
levels to achieve these targets. Globally, more than 7 billion
vaccine-related efforts. The remaining $11 billion is being
shots have been administered, the majority in high-income
used for a variety of foreign assistance efforts to respond to
countries. At least 50 countries are falling short of global
the effects of the pandemic.
vaccination targets; less than 25% of their populations are
Is there a central strategy and/or coordinating
fully 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 (in many high-income
delivery. Focus areas include bolstering cold chain supply
countries a three-dose regimen is becoming the norm), will
and logistics, service delivery, vaccine confidence and
affect countries’ ability to meet these targets.
demand, local planning, and vaccine safety and
Which other countries/entities are top donors to
effectiveness in low- and middle-income countries
COVAX, and of those that have promised COVID-19
(LMICs). Global efforts build on U.S. commitments to
vaccine doses, how many have been delivered? Per the
COVAX. Global VAX activities will be implemented using
Task Force, other top vaccine donors to COVAX are the
$400 million from P.L. 117-2, with a focus on safe vaccine
European Union (464 million promised, of which 57
delivery and storage, building in-country vaccine
million have been shipped), France (120 million promised;
manufacturing capacity and knowledge sharing, and Rapid
19 million delivered), the United Kingdom (120 million
Response Surge Support (e.g., improving oxygen
promised; 8 million delivered), and Germany (175 million
production and delivery), among other things.
promised; 15 million delivered). The United States has
How is the Biden Administration deciding how to
promised 857 million doses to COVAX, of which 131
allocate global COVID-19 vaccine dose donations? The
million have been delivered.
U.S. government has promised to donate 1.2 billion vaccine
What contracts does COVAX have with vaccine
doses globally. The White House stated 75% of donated
manufacturers? COVAX has formalized contracts for over
doses will be shared through COVAX to maximize the
4 billion doses with nine vaccine manufacturers
number of vaccines available equitably for the largest
(AstraZeneca, Clover Biopharmaceuticals, Janssen
number of countries and at-risk populations within
Pharmaceuticals Inc., ModernaTX Inc., Novavax Inc.,
countries. The remaining 25% will be shared directly with
Pfizer Inc., Sanofi Pasteur and GSK, Sinopharm, and
countries in need, those experiencing COVID-19 surges,
Sinovac). COVAX Advanced Market Commitment doses
and countries requesting immediate U.S. assistance.
are capped at $3 per dose. These contracts are reportedly
Which countries have received COVID-19 vaccines
worth at least $12 billion.
from the United States? How many doses has the United
Are there enough COVID-19 vaccines for the world’s
States committed to donate and how many have been
population? What factors are hindering global vaccine
distributed? The U.S. government is the leading donor of
access? Global COVID-19 vaccine production is at
COVID-19 vaccines globally, and according to the State
approximately 1.5 billion doses per month, meaning that
Department, has shipped 365 million COVID-19 vaccines
hypothetically there is sufficient vaccine supply to achieve
to 110 countries, including 103 million doses to sub-
global vaccination targets. Global health experts identify
Saharan Africa; 89 million doses to East Asia and the
equitable distribution as the key current issue. WHO has
Pacific; 60 million doses to Latin America and the
called on countries to donate resources for vaccine rollout
Caribbean; 84 million doses to South and Central Asia; 24
in LMICs, and for wealthy nations to swap vaccine delivery
million doses the Middle East and North Africa; and 4.1
schedules with countries in need, accelerate dose sharing,
million doses to Moldova, Ukraine, Kosovo, and Georgia.
and fulfill donation commitments to COVAX.
What is the status of COVAX, ACT-A, and the
Sara M. Tharakan, Analyst in Global Health and
Multilateral Leaders Task Force? COVAX has shipped
967 million COVID-19 vaccines to 144 participant
International Development
countries and economies. Donors have committed $300
https://crsreports.congress.gov

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

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


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https://crsreports.congress.gov | IF12013 · VERSION 1 · NEW

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