Terminology - US COVID-19 vaccine rollout plan (Plan de déploiement des vaccins COVID-19 aux USA)

 Copyright Françoise Herrmann

The US rollout for COVID 19 vaccines and vaccinations is managed by Operation Warp Speed (OWS), funded through the CARES Act, on March 27, 2020. Operation Warp Speed (OWS) is an interagency partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD) with the mission to coordinate federal efforts to accelerate the development, acquisition, and distribution of COVID-19 “medical countermeasures”. Additional federal agencies collaborating with the HHS include the Centers for Disease Control (CDCs), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).

OWS has supported the development and acquisition of six different COVID-19 vaccine candidates, two of which the Federal Drug Agency (FDA) authorized for emergency use in December 2020. A total of approximately one billion doses have been ordered, for the approximately 330 million people living in the US. Doses exceed the number of people, considering that 2 doses are required for all vaccines, except the Johnson & Johnson single-dose vaccine (OWS Contracts, Dec. 22, 2020).

OWS vaccine and vaccination information is summarized below.

THE VACCINES

WHO GETS IT FIRST?

FDA-AUTHORIZED FOR ER USE (EUA) PFIZER (US) & BIONTECH (DE)  Type: mRNA  Effectiveness: 95%  Supply: 40 M doses by end of 2020  200M doses ordered  Storage: ultracold -70◦C  Trial Phase: Phase II/III  FDA EUA: issued Dec. 11, 2020  MODERNA Inc. (US)  Type : mRNA  Effectiveness : 94.5%  Supply: 20M doses by end of 2020  200M doses ordered  Storage: Cold storage, 6 months @ -20 ◦C  Refrigerator 30 days @ -2◦C to -8◦C  Trial Phase : Phase III  FDA EUA : issued Dec. 18, 2020  YET TO FILE FOR APPROVAL ASTRAZANECA (UK) – OXFORD UNIV. (UK)  Type: Recombinant viral-vector  Supply: 300 million doses ordered  Storage: Refrigerator (-2◦C to -8◦C)  Trial Phase: Phase II/III  JOHNSON & JOHNSON (US)  Type: Single-dose, Recombinant viral vector  Supply: 100 million doses ordered  Storage: Refrigerator (3 months -2◦C to -8◦C)  Trial Phase: Phase III  Expected FDA file date: February 2021  NOVARAX Inc.  Type: Adjuvanted recombinant nanoparticle protein  Supply: 100 million doses ordered  Storage: Refrigerator (-2◦C to -8◦C)  Trial Phase: Phase III  SANOFI/GLAXOSMITHKLINE  Type: Adjuvanted recombinant nanoparticle protein  Supply: 100 million doses ordered  Storage: Refrigerator (-2◦C to -8◦C)  Trial Phase: Phase I/II

PHASE 1A: STARTING IN DECEMBER 2020 Healthcare workers Nursing home & long-term care facility residents PHASE 1B: POSSIBLY STARTING IN JANUARY 2021  Non-healthcare essential workers Over 70s Over 65s Over 60s Over 50s People with chronic health conditions LATER PHASES: BY SPRING 2021 Young adults Young children

Note: Temperatures are listed in degrees Celsius. 

References

Astrazaneca – Staff (Nov. 13, 2020) AZD1222 vaccine met primary efficacy endpoint in preventing.    https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html

Biomedical Advanced Research and Development Authority (BARDA)   https://www.phe.gov/about/barda/Pages/default.aspx

Danner, C.  & M. Stieb (Dec. 18, 2020) What We Know About the U.S. COVID-19 Vaccine Distribution Plan.   https://nymag.com/intelligencer/2020/12/what-we-know-about-u-s-covid-19-vaccine-distribution-plan.html

CARES Act https://www.congress.gov/bill/116th-congress/senate-bill/3548/text?q=product+actualizaci%C3%B3n

Centers for Disease Control (CDCs) www.cdc.gov

CDC- Information about the Pfizer-BioNTech COVID-19 Vaccine. Dec. 22, 2020.  https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html

CDC - Information about the Moderna COVID-19 Vaccine. Dec. 23,2020.   https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Moderna.htm l

CDC – Different COVID-19  vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html

Department of Defense (DOD) https://dod.defense.gov/

Federal Drug Administration (FDA) COVID-19 vaccines  https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

Health & Human Services https://www.hhs.gov/ 

Health & Human Services (HSS) - Explaining Operation Warp Speed (OWS).   https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

Johnson & Johnson https://www.jnj.com/coronavirus

Moderna Inc. https://www.modernatx.com/

National Institutes of Health (NIH) www.nih.gov

Novarax Vaccine technology (Novarax website)  https://www.novavax.com/our-unique-technology#:~:text=Our%20recombinant%20nanoparticle%20vaccine%20technology,a%20variety%20of%20viral%20pathogens.

Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials. Congressional Research Service Reports. Dec, 22, 2020.   https://crsreports.congress.gov/product/pdf/IN/IN11560

Pfizer Staff (Dec. 11, 2020) Pfizer and Biontech celebrate historic first authorization in the U.S. of vaccine to prevent COVID-19.   https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-celebrate-historic-first-authorization

Sanofi/GSL (Dec. 11, 2020) Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly.   https://www.sanofi.com/-/media/Project/One-Sanofi-Web/Websites/Global/Sanofi-COM/Home/media-room/press-releases/2020/2020-12-11-07-00-00-2143517-en.pdf