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Domestic Funding for COVID-19 Vaccines: An Overview (IF11951, October 19, 2021)

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                                                                                                            October 19, 2021
Domestic Funding for COVID-19 Vaccines: An Overview
Federal efforts to develop, manufacture, purchase, and          medical R&D in the Defense Health Program account with
distribute Coronavirus Disease 2019 (COVID-19) vaccines         some flexibility to reallocate other funds toward R&D.
have involved a number of agencies. Many of these efforts
have thus far been funded by appropriations in COVID-19         BARDA and Other R&D, Manufacture, and Purchase:
relief acts, especially funding to the Department of Health     In the FY2020 and FY2021 supplemental appropriations
and Human Services (HHS) U.S. Public Health Service             acts, over $50 billion in Public Health and Social Services
(PHS) agencies and accounts in FY2020 and FY2021                Emergency Fund (PHSSEF) funding, available until
supplemental appropriations and in the American Rescue          September 30, 2024, is for a broad set of medical
Plan Act (ARPA, P.L. 117-2) budget reconciliation measure       countermeasures and surge capacity purposes, including for
enacted in March 2021.                                          the development, manufacture, and purchase of vaccines
                                                                and related supplies. The PHSSEF account funds BARDA,
The following provides an overview of both (1)                  the main entity that has awarded large funding agreements
appropriations and (2) allocations and obligations for          to pharmaceutical companies for vaccine development,
selected domestic COVID-19 vaccine related activities.          manufacture, and purchase. Not less than $23.2 billion is set
(With the exception of the mandatory funding provided by        aside for BARDA in the FY2020 and FY2021 supplemental
ARPA, all funding amounts discussed below are classified        appropriations that can be used for vaccine-related efforts.
as discretionary.) The following is meant to inform a
general understanding of relevant funding, but does not         ARPA further provides two relevant mandatory
capture every federal account that can be used for vaccine-     appropriations: (1) in Section 2303, $6.05 billion, available
related activities. Many of the below appropriations are        until expended, to HHS for R&D, manufacturing,
available for broad purposes; vaccine-related purposes are      production, and purchase of vaccines and other medical
one potential use of funds. In general, many of the HHS         products—available for COVID-19, SARS-CoV-2 or its
appropriations mentioned are available for multiple years or    variants, and any disease with potential for creating a
until expended, and some of the funding is transferrable        pandemic; and (2) in Section 3101, $10 billion, available
between accounts by the HHS Secretary. This product does        until September 30, 2025, for activities under the Defense
not address financing for vaccine administration (e.g.,         Production Act (DPA) for the purchase, production and
health insurance coverage) or global vaccination funding        distribution of medical supplies, including vaccines and
(although some of the funding for research and                  related supplies, among others. Both of these ARPA
development [R&D], manufacture, and purchase has                appropriations have been assigned to HHS accounts—the
flexibility for international uses).                            first to PHSSEF and the second to a new HHS DPA
                                                                account.
Appropriations
                                                                Domestic Vaccination Programs
Research and Development, Manufacture, and                      The Centers for Disease Control and Prevention (CDC), in
Purchase                                                        collaboration with other agencies, has led efforts with state,
COVID-19 vaccine R&D, manufacture, and purchase have            local, tribal, and territorial (SLTT) jurisdictions to plan and
been largely supported by a collaboration among several         implement a nationwide vaccination program. Agencies
federal agencies, including the National Institutes of Health   with health care programs (e.g., the Veterans Health
(NIH) and the Biomedical Advanced Research and                  Administration and Indian Health Service [IHS]) have
Development Authority (BARDA) of HHS, and DOD—                  separately managed vaccination programs among
formerly Operation Warp Speed (OWS) and now the                 employees and covered populations. The Biden
Countermeasures Acceleration Group (CAG). Six vaccines          Administration has also expanded the role of additional
were chosen for coordinated federal support under OWS.          agencies (e.g., the Federal Emergency Management Agency
Some vaccine R&D has been supported by NIH, BARDA,              [FEMA]) in vaccination programs.
and DOD separately from the OWS/CAG efforts.
                                                                CDC: Earlier in the pandemic, before vaccines were
NIH and DOD: FY2020 and FY2021 supplemental                     available, CDC had received broad supplemental
appropriations to NIH and DOD for COVID-19-related              appropriations for its pandemic-related activities in March
R&D can fund vaccine R&D. In the FY2020 and FY2021              2020, and used some of this funding for vaccination
supplemental appropriations acts, NIH received over $1.5        program grants and planning. Since then, CDC has received
billion, available until September 30, 2024, broadly for        several appropriations specifically for vaccine-related
COVID-19 related research. The CARES Act (P.L. 116-             activities:
136) provided DOD with $415 million for COVID-19
                                                                 Vaccination Programs and SLTT grants. For efforts
                                                                    to plan, promote, distribute, administer, monitor, and
                                               https://crsreports.congress.gov
                                                                   Domestic Funding for COVID-19 Vaccines: An Overview

   track COVID-19 vaccines, CDC received a total of            DOD: As communicated to CRS in May 2021, DOD has
   $16.25 billion in FY2021, including $8.75 billion in the    allocated $534.9 million for COVID-19 vaccine R&D and
   Coronavirus Response and Relief Supplemental                had obligated $506.4 million by that time. These COVID-
   Appropriations Act, 2021 (CRRSA), enacted in                19 vaccine R&D efforts are separate from OWS/CAG
   December, 2020 (P.L. 116-260, Division M), available        vaccine R&D. DOD has also been managing some
   until September 30, 2024; and $7.5 billion in ARPA          OWS/CAG vaccine-related funding on behalf of HHS,
   Section 2301, available until expended. Of the $8.75        utilizing its acquisition capabilities and authorities—
   billion in CRRSA, at least $4.5 billion is designated for   especially for purchase and manufacturing agreements.
   SLTT grants (or cooperative agreements), of which
   $210 million must be transferred to IHS, and a separate     Further Considerations and Outlook
   amount of not less than $300 million is designated for      Future domestic COVID-19 vaccine funding needs remain
   “high-risk and underserved populations, including racial    uncertain. Federally supported vaccination efforts may be
   and ethnic minority populations and rural communities.”     underway for some time with the ongoing vaccine booster
   The ARPA provision directs CDC to award                     effort; potential for additional boosters and pediatric
   supplemental funding to eligible awardees that received     vaccines; and a significant percentage of the age 12 and
   grants under CRRSA based on a specified alternative         older population that remains unvaccinated. Additional
   formula.                                                    COVID-19 vaccine R&D may also help develop new
                                                               vaccines, especially for new variants. Balances of
 Vaccine Confidence. CDC also received $1 billion for         previously appropriated funds may remain available to fund
   vaccine confidence activities in ARPA Section 2302.         such efforts. The House Energy & Commerce committee
                                                               “Build Back Better Act” legislative recommendations,
FEMA: Funding from the Disaster Relief Fund (DRF) has          finalized on September 15, 2021, in response to
been used to support FEMA’s vaccination efforts, including     reconciliation directives in S.Con.Res. 14, would provide
by reimbursing certain costs for SLTT programs and             further vaccine-specific funding, including $1.25 billion for
supplying direct assistance (e.g., supplies, personnel) to
                                                               vaccine confidence and $2 billion for global and domestic
mass vaccination sites. ARPA Section 4005 provides             vaccine production capacity (neither is specific to COVID-
additional funding of $50 billion for the DRF that can         19 vaccines) in addition to other broader public health
support FEMA’s expanded activities.                            funding that could be used for vaccine-related efforts. In the
                                                               future, Congress may also consider the conditions under
Other Funding: Many appropriations in the supplemental         which domestic COVID-19 vaccination efforts could shift
appropriations acts and throughout ARPA can support            to routine public-private vaccine financing and
domestic vaccination efforts, for example, funding for         administration approaches—no longer requiring sole
public health workforce in ARPA Section 2501, and for
                                                               federal purchase or support of mass vaccination sites and
community health centers in ARPA Section 2601 and
                                                               coordinated distribution.
earlier appropriations. According to National Conference of
State Legislatures data, some states and other jurisdictions   Table 1. Related CRS Products
have used part of the CARES Act-funded Department of
Treasury Coronavirus Relief Fund grants for vaccination          HHS Appropriations
efforts. For the similar ARPA-funded State and Local
                                                                 CRS Report R46711, U.S. Public Health Service: COVID-19
Fiscal Recovery Fund programs, Treasury guidance notes
                                                                 Supplemental Appropriations in the 116th Congress
supporting vaccination efforts as a potential use of funds.
                                                                 CRS Report R46834, American Rescue Plan Act of 2021 (P.L.
Allocations and Obligations                                      117-2): Public Health, Medical Supply Chain, Health Services, and
As summarized above, many appropriations can support             Related Provisions
vaccine-related activities. The following summarizes             Non-HHS Appropriations and Roles
selected information on vaccine-specific allocations and         CRS Insight IN11273, COVID-19: The Basics of Domestic Defense
obligations.                                                     Response
HHS: As reported by the Government Accountability                CRS Report R46715, FEMA Assistance for Vaccine Administration
Office (GAO), as of May 31, 2021, HHS allocated $40.2            and Distribution: In Brief
billion toward vaccine-related activities (those of BARDA,       CRS Report R46298, General State and Local Fiscal Assistance
NIH, and CDC) specifically for R&D, manufacture,                 and COVID-19: Background and Available Data
purchase, distribution, and related activities. Of this          CRS Insight IN11665, The American Rescue Plan Act, Section
amount, $25.1 billion had been obligated (GAO-21-551).           9901—The Coronavirus State Fiscal Recovery Fund
These amounts do not account for some activities, such as
                                                                 CRS Insight IN11664, The American Rescue Plan Act, Section
some CDC SLTT vaccine-related grants. Separately, $9.97
                                                                 9901—The Coronavirus Local Fiscal Recovery Fund
billion of the $178 billion Provider Relief Fund was
allocated for “vaccine and therapeutic development and           Other Vaccine Financing and Funding
procurement activities” as of March 2021 (GAO-21-387).           CRS Insight IN11609, COVID-19 Vaccine: Financing for Its
                                                                 Administration
FEMA: According to FEMA, $5.9 billion had been                   CRS In Focus IF11796, Global COVID-19 Vaccine Distribution
obligated from the DRF for vaccination efforts as of
September 20, 2021.

                                              https://crsreports.congress.gov
                                                                  Domestic Funding for COVID-19 Vaccines: An Overview

                                                                                                                  IF11951

Kavya Sekar, Analyst in Health Policy




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