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Public Policy Newsletter Article

Government Gears up for First Covid Vaccinations in December

  • 2020-12-03T16:00:00.000+0000
  • Author: Laure Fabrega

On November 24, Department of Health and Human Services (HHS) Secretary Alex Azar, Operation Warp Speed (OWS) Chief Science Adviser Moncef Slaoui, and OWS Chief Operating Officer Gustave Perna gave an update on covid-19 vaccine and therapeutic allocation and distribution. Please find below information as communicated by the agency officials:

The federal government is planning to distribute vaccine doses to all 64 jurisdictions in the country within 24 hours of FDA authorization of a vaccine, with administration beginning as soon as the product arrives. CVS will be ready to vaccinate nursing home residents within 48 hours of FDA authorization.

Pfizer and Moderna have the two vaccine candidates that the government is currently preparing for, including running field exercises for shipment procedures. Pfizer applied for an emergency use authorization (EUA) of its vaccine on November 20 (Moderna will file on November 30). The FDA will consult with its advisory board on the Pfizer vaccine on December 10 and about a week later for the Moderna vaccine.

Both products had very successful results during phase 3 trials (95% efficacy for Pfizer; 94.1% for Moderna). AstraZeneca received 90% efficacy for one part of its trial, 62% for another, with a combined total protection at 70% (trials in the UK and Brazil). Scientists are currently examining the differences, including different input (half dose v. full dose) and have enrolled 11,000 subjects in the US trial.

On November 20, allocation numbers went to the 64 jurisdictions. After conversations with experts and governors, OWS decided to distribute doses based on a population per capita formula. New allocations will be sent to jurisdictions weekly after the initial distribution. OWS is maintaining a minimum safety stock to assess initial distribution and will release the safety stock to ensure maximum use once they’re confident about jurisdictions’ handling of the vaccines.

Each jurisdiction will decide how to distribute to local providers approved by the states. While the National Academies of Sciences, Engineering, and Medicine, the Advisory Committee on Immunization Practices (ACIP), and HHS are making their own allocation recommendation, the states will ultimately decide where and who to ship their allocated doses.

The initial distribution will be 6.4 million doses, with OWS planning to distribute about 40 million by the end of the year. OWS hopes to have the most vulnerable, including nursing home residents, vaccinated by the end of the year; senior citizens, health care workers and first responders by the end of January; and the general population by the end of Q2 2021.

Jurisdictions also received the minimum requirements of the vaccine administration (975 doses for Pfizer and 100 doses for Moderna). They will have up to 20 days to administer the Pfizer doses (30 days for Moderna doses). OWS is confident that second doses will be available adequately (after 21 days for Pfizer, 28 days for Moderna). Jurisdictions are ready for both vaccines and requirements.

According to OWS, Pfizer is working hard to be ready to get vaccines to the sites as directed by states, including registering products through a jurisdiction, delivering products, and explaining to local administration sites how to open and manage products. Pfizer has already tested 4 locations, is currently testing 10 more, then will move to the remaining 54.

On the therapeutic side, as of November 24, 120,000 courses of Eli Lilly’s monoclonal antibody, Bamlanivimab, had already been distributed to 2,400 treatment sites, with another 50,000 courses to be shipped the following week. 35,000 courses of Regeneron’s antibody cocktail, casirivimab and imdevimab, were also distributed, providing two treatment options for mild-to-moderate covid-19 patients not hospitalized but at risk of progressing.

FDA also granted Lilly an EUA for baricitinib, an already FDA-approved treatment for rheumatoid arthritis, to be used with Gilead’s Remdesivir, which has been shown to reduce hospital stay. More than 250,000 patients have received convalescent plasma. Lastly, Merck has acquired OncoImmune, which holds promising phase 3 clinical trial data that has showed a 50% reduction in mortality with hospitalized patients.