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INSIGHTi
Operation Warp Speed Contracts for
COVID-19 Vaccines and Ancillary
Vaccination Materials
December 22, 2020
Operation Warp Speed (OWS) is an interagency partnership between the Department of Health and
Human Services (HHS) and the Department of Defense (DOD) that coordinates federal efforts to
accelerate the development, acquisition, and distribution of COVID-19 medical countermeasures.
Collaborating HHS components include the Centers for Disease Control and Prevention (CDC), the
National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority
(BARDA). Although the stated goals of OWS include therapeutics and diagnostics, most of the money
awarded to date has focused on vaccines. This Insight summarizes OWS’s vaccine-related contracts,
including those for ancillary vaccination materials (e.g., needles and vials).
OWS is currently supporting seven vaccine candidates through funding research and development,
funding increases in manufacturing capacity, and/or advance purchase contracts. Table 1 provides
information regarding these contracts, as well as details regarding the vaccine candidates themselves,
including storage temperature, technology type, and preliminary effectiveness. OWS has invested in
multiple candidates and different underlying technologies to protect against the risk of one or more
vaccine candidates failing to demonstrate safety or efficacy at any point in the development process.
Vaccine development, like drug development, in general, is typically an expensive process that takes 10 or
more years. To speed up the vaccine development process, OWS implemented a number of measures.
One measure, as stated by HHS, is that OWS supported increased manufacturing capacity for some of the
vaccine candidates while they were still being tested, rather than the normal practice of waiting to scale-
up until testing is complete. This is considered “at-risk,” in that the government is paying to build
facilities to manufacture a vaccine candidate that might not prove to be safe or effective. Vaccine
candidates that received support from OWS for vaccine development include Moderna, Janssen
Pharmaceuticals, Sanofi/GSK, and Merck/IAVI, whereas the other three candidates participated in OWS
through federal purchase of vaccine doses only. Production of vaccine doses simultaneously with safety
and efficacy testing has helped ensure that vaccine doses are ready to deploy as soon as they have been
approved for use by the Food and Drug Administration (FDA). The Pfizer/BioNTech vaccine received
Emergency Use Authorization (EUA) from the FDA on December 11, 2020, and the Moderna vaccine
received similar approval status on December 18, 2020. Distribution of these two vaccines has thus begun
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according to guidelines approved by the CDC. Because OWS has purchased these vaccines, all doses are
to be federally owned and provided at no cost to the American public.
Table 1. Vaccine Candidates Supported by Operation Warp Speed
Contracts with BARDA and Other Federal Agencies
Doses Current Phase
Contract
per
(Preliminary
Company
Type
Value
Specifications
Person Effectiveness)
Storage
Pfizer/BioNTech
mRNAa
$1.9B
100 mil ion doses
2
Phase II/III (95%)
Ultra cold storage (-70⁰ C)
EUA Issued
Moderna, Inc.
mRNA
$3.1B
200 mil ion doses
2
Phase III (94.5%)
Cold storage (6 mos, -20⁰ C)
$955M
Development
EUA Issued
Refrigerator (30 days, -2⁰ to -8⁰ C)
AstraZeneca/
Viral
$1.2B
300 mil ion doses
2
Phase II/III (70%)
Refrigerator (-2⁰ to -8⁰ C)
Oxford Univ.
Vectorb
Johnson & Johnson Viral
$1B
100 mil ion doses
1
Phase III
Refrigerator (3 mos, -2⁰ to -8⁰ C)
(Janssen
Vector
$456M
Development
Pharmaceuticals,
Inc.)
Novavax, Inc.
Proteinc
$1.6B
100 mil ion doses
2
Phase III
Refrigerator (-2⁰ to -8⁰ C)
Sanofi/GSK
Protein
$2.04B
100 mil ion doses
2
Phase I/II
Refrigerator (-2⁰ to -8⁰ C)
$30.8M
Development
Merck/IAVI
Viral
$38M
Developmentd
1
Phase I
Unknown
Vector
Sources:
https://www.pfizer.com/news/hot-topics/covid_19_vaccine_u_s_distribution_fact_sheet
https://www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx?filter=vaccine
https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-longer-shelf-life-its-covid-19-
vaccine
https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html
https://www.washingtonpost.com/health/2020/09/23/coronavirus-vaccine-jj-single-shot/
https://ir.novavax.com/news-releases/news-release-details/novavax-announces-positive-phase-1-data-its-covid-19-vaccine
https://www.statnews.com/2020/09/03/sanofi-gsk-covid19-vaccine-human-trials/
https://www.sanofi.com/en/media-room/press-releases/2020/2020-10-15-14-00-00
https://www.statnews.com/2020/05/26/merck-aims-to-begin-human-tests-of-two-different-covid-19-vaccines-this-year/
https://www.iavi.org/phocadownload/iavi_fact_sheet_coronavirus-vaccine-program.pdf
Note: Current as of December 22, 2020.
a. Messenger RNA (mRNA) vaccines contain harmless virus genetic material that codes for a protein that is found on
the virus’s surface. The body then recognizes this protein as foreign and initiates an immune response.
b. Viral vector vaccines contain a weakened version of the live virus that has most of the harmful parts of the COVID-19
genetic code removed.
c. Protein subunit vaccines contain harmless pieces of the COVID-19 virus (protein), which the body recognizes as
foreign and mounts an immune response against.
d. Only Moderna, Janssen Pharmaceuticals, Sanofi/GSK, and Merck/IAVI have received funding from OWS to support
vaccine development. Pfizer/BioNTech, AstraZeneca/Oxford University, and Novavax have participated in OWS
solely through federal purchase of vaccine doses.
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The Government Accountability Office has noted difficulty in assessing the transparency of the full
supply chain and production of vaccines and ancillary supplies. Shortages of ancillary vaccination
supplies that could potentially delay the vaccination campaign have also been of concern. Monitoring and
addressing potential supply issues may thus be of interest to Congress as vaccines are distributed
throughout the country. Table 2 provides OWS contract awards for needles, syringes, glass vials, and vial
alternatives.
Table 2. Federal Government Contracts for Ancillary COVID-19 Vaccine Supplies
Needles, Syringes, Glass Vials, and Vial Alternatives
Company
Contract Value
Specifications
ApiJect Systems America
$138 mil ion
100 mil ion prefil ed syringes by the end of 2020
Expansion of manufacturing capacity to produce 500
mil ion prefil ed syringes in 2021
Corning Pharmaceutical
$204 mil ion
Expansion of manufacturing capacity to produce an
Technologies
additional 164 mil ion Valor Glass vials per year if
needed
SiO2 Materials Science
$143 mil ion
Expansion of manufacturing capacity to produce 120
mil ion glass-coated plastic containers per year if
needed
Becton, Dickinson and Co.
$42.3 mil ion
Expansion of manufacturing capacity to produce
needles and syringes
Smiths Medical, Inc.
$20.6 mil ion
Expansion of manufacturing capacity to produce
needles and syringes
Retractable Technologies, Inc.
$53.6 mil ion
Expansion of manufacturing capacity to produce safety
needles and syringes
Retractable Technologies, Inc.
$83.8 mil ion
320 mil ion needles and syringes
Marathon Medical Corp.
$27.5 mil ion
Duopross Meditech Corporation
$48 mil ion
134 mil ion safety syringes by the end of 2020
500 mil ion safety syringes over a 12-month period
Cardinal Health Inc.
$15 mil ion
(August 2020 – August 2021)
Gold Coast Medical Supply, LP
$14 mil ion
HTL STREFA Inc.
$12 mil ion
Quality Impact, Inc.
$9 mil ion
Medline Industries, Inc.
$6 mil ion
Sources:
https://www.medicalcountermeasures.gov/barda/influenza-and-emerging-infectious-diseases/coronavirus/pharmaceutical-
manufacturing-in-america/?filter=all
https://www.defense.gov/Newsroom/Releases/Release/Article/2302139/dod-awards-104-mil ion-for-procurement-of-
syringes-in-support-of-us-covid-19-va/
https://www.usaspending.gov/award/CONT_AWD_75A50120F33003_7505_75A50118D00012_7505
https://www.usaspending.gov/award/CONT_AWD_75A50120F33004_7505_75A50118D00013_7505
https://news.bloomberglaw.com/health-law-and-business/pandemics-next-medical-shortage-vaccine-needles-syringes
https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
Notes: Current as of December 22, 2020.
Congressional Research Service
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Author Information
Simi V. Siddalingaiah
Analyst in Health Economics
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