Congressional Research Service IN11556.6 (Domestic Funding for COVID-19 Vaccines: An Overview)

Summary

A Congressional Research Service Insight, IN11556 (version 6), updated March 29, 2021, giving an overview of appropriations for selected domestic COVID-19 vaccine activities. It states that the U.S. Food and Drug Administration has authorized three COVID-19 vaccines for emergency use, and that under the Trump Administration federal vaccine efforts were largely organized under Operation Warp Speed (OWS), led by the Department of Health and Human Services and the Department of Defense, with coordinated interagency efforts continuing under the Biden Administration. It notes that many of these efforts have been funded by appropriations in COVID-19 relief acts, especially funding to U.S. Public Health Service agencies and accounts.

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INSIGHTi

Domestic Funding for COVID-19 Vaccines:
An Overview

Updated March 29, 2021
To date, the U.S. Food and Drug Administration (FDA) has authorized for emergency use three
Coronavirus Disease 2019 (COVID-19) vaccines; additional vaccines may become available within
months. Federal efforts to develop, manufacture, regulate, purchase, and distribute vaccines have
involved a number of agencies. Under the Trump Administration, such efforts were largely organized
under Operation Warp Speed (OWS) led by the Department of Health and Human Services (HHS) and the
Department of Defense (DOD). Coordinated interagency efforts continue under the Biden Administration.
Many aspects of federal domestic vaccine efforts have thus far been funded by appropriations in COVID-
19 relief acts, especially funding to U.S. Public Health Service (PHS) agencies and accounts. The
following provides an overview of appropriations for selected domestic COVID-19 vaccine related
activities. (With the exception of the mandatory funding provided by the American Rescue Plan Act of
2021 (ARPA), all funding amounts discussed below are classified as discretionary.) The following is
meant to inform a general understanding of available funding, but may not capture every federal account
that can be used for vaccine-related activities. In general, many of the HHS appropriations are available
for multiple years or until expended, and some of the funding is transferrable between accounts by the
HHS Secretary. This product does not address financing for vaccine administration, global vaccination
funding, or related allocations and spending.

Research and Development, Regulation, Manufacture, and Purchase
COVID-19 vaccine research and development (R&D), regulation, manufacture, and purchase have been
largely supported by a collaboration among several federal agencies, including the National Institutes of
Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), FDA, DOD,
and others (formerly OWS). Six vaccines were chosen for coordinated federal support under OWS. Some
vaccine R&D has been supported by NIH, BARDA, and DOD separately from the OWS efforts.
For R&D, funding has been provided to accounts at NIH, DOD, and the Public Health and Social
Services Emergency Fund (PHSSEF; parent account for BARDA) for COVID-19 related R&D, including
vaccine R&D. In addition, over $50 billion in PHSSEF funding has been made available until September
24, 2024 for a broad set of medical countermeasures and surge capacity purposes, including for the

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development, manufacture, and purchase of vaccines and related supplies. Separately, FDA has received
broad supplemental appropriations for its regulatory and other activities.
ARPA (P.L. 117-2) further provides appropriations that can be used for activities under this heading (all
ARPA funds are mandatory appropriations):
 Section 2303 provides $6.05 billion to HHS, available until expended, for research,
development, manufacturing, production, and the purchase of vaccines, therapeutics, and
ancillary medical products and supplies—available for COVID-19 (or SARS-CoV-2), its
variants, and any disease with potential for creating a pandemic.
 Section 2304 provides $500 million to FDA, available until expended, for a broad set of
activities, including for its review of the performance, safety, and effectiveness of
vaccines; inspection of vaccine manufacturing facilities; and oversight of the vaccine
supply chain.
 Section 3101 provides $10 billion, available until September 30, 2025, for activities
under the Defense Production Act with respect to medical supplies and equipment for the
pandemic, including for vaccines and related supplies. Funds can support the purchase,
production, and distribution of such supplies. After September 30, 2022, funds can be
used to meet critical public health needs with respect to any pathogen that the President
has determined has the potential for creating a public health emergency.

Domestic Vaccination Programs
The Centers for Disease Control and Prevention (CDC), in collaboration with other agencies, has led
efforts with state, local, tribal, and territorial (SLTT) jurisdictions to plan and implement a nationwide
vaccination program. Agencies with health care programs (e.g., Indian Health Service, IHS) have
separately managed vaccination programs among employees and covered populations. The Biden
Administration has expanded the role of additional agencies (e.g., the Federal Emergency Management
Agency, FEMA) in vaccination programs, though CDC remains in a leading role.
Earlier in the pandemic, before vaccines were available, CDC had received broad supplemental
appropriations for its pandemic-related activities in March 2020, and used some of this funding for
vaccination program grants and planning. The Consolidated Appropriations Act, 2021 enacted in
December, 2020 (P.L. 116-260) made available $8.75 billion to CDC specifically for vaccination-related
activities, available until September 30, 2024. Of this total, at least $4.5 billion was designated for SLTT
grants (or cooperative agreements), of which $210 million must be transferred to IHS and a separate
amount of not less than $300 million was designated for “high-risk and underserved populations,
including racial and ethnic minority populations and rural communities.” Funding from the Disaster
Relief Fund has also been used to support FEMA’s vaccination efforts, including by reimbursing certain
costs for SLTT programs and supplying direct assistance (e.g., supplies, personnel) to vaccination sites.
With the expanded role of federally qualified health centers in the vaccination program, prior related
appropriations may also be relevant.
ARPA (P.L. 117-2) further provides appropriations that can be used for activities under this heading (all
ARPA funds are mandatory appropriations). There are many provisions with implications for vaccination
programs, though the following are particularly relevant:
 Section 2301 provides $7.5 billion to CDC, available until expended, for activities to
plan, promote, distribute, administer, monitor, and track COVID-19 vaccines. Funds may
be awarded as SLTT grants, and the HHS Secretary is directed to award supplemental
funding to eligible awardees that received grants under Consolidated Appropriations,
2021 (P.L. 116-260) based on an alternative formula allocation as specified.
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 Section 2302 provides $1 billion for vaccine confidence activities at CDC, available until
expended. Funds are to be used for providing further information and education about
vaccines and improving vaccination rates, including through activities in Public Health
Service Act Section 313 (amended by Section 311 in Division BB of Consolidated
Appropriations, Act 2021, P.L. 116-260) which directs CDC to award grants or contracts
for a national, evidence-based campaign on the safety and effectiveness of vaccines.
Other appropriations in the law also have implications for vaccination programs, for example, funding for
public health workforce in Section 2501, community health centers in Section 2601, and outreach to older
adults in Section 2921. Additional funding of $50 billion for the Disaster Relief Fund has also been
provided in Section 4005 that can support FEMA’s expanded activities.

Author Information

Kavya Sekar
Analyst in Health Policy

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IN11556 · VERSION 6 · UPDATED

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