The FDA Commissioner granted emergency use authorization (EUA) of the Pfizer/BioNTech COVID19 vaccine on Friday. The decision was made by following last Thursday’s FDA’s Vaccines and Related Biological Products Advisory Committee meeting. Here’s a top line summary of the FDA’s analysis Pfizer/BioNTech’s application.
The CDC’s Advisory Committee on Immunization Practices also held meetings on over the weekend and recommended that the Pfizer vaccine be given to “persons 16 years of age and older in the U.S. population under the FDA’s emergency use authorization“. Importantly, they voted to add the vaccine to the immunization schedules. Within 15 days of being added to the schedule health plans need to cover administration of the vaccine.
While the clinical trial didn’t include people 16 or 17 years old, that age group was added because many folks in this age range work in fields that put them at risk for exposure. The Committee recommended that pregnant women be able to choose whether to be vaccinated (encouraging them have a conversation with their physician before vaccinating).
While no pregnant women were in the trials, 23 became pregnant after administration of the vaccine. The Committee was in consensus that persons who have had severe allergic reactions to other vaccines should talk with their doctor before being vaccinated.
The ACIP recommendations aren’t on their website yet but I expect them to be posted soon. The CDC Director still needs to approve the recommendations, which I expect to happen later today.
Now that the Pfizer vaccine has EUA status and the ACIP has made their recommendation, the vaccine can now be distributed and used even though it hasn’t been fully approved by the FDA. Because of the ACIP decision, health plans will be required to pay for the administration of the vaccine (15 days after the CDC director approves the ACIP recommendation).
The federal government contracted with the companies to manufacture the vaccine during their Phase III clinical trial- agreeing to pay for the vaccine even if it had not been granted EUA or Approval. Therefore there is already a stockpile of vaccine available for distribution.
Maricopa will be receiving 47,000 doses next week and Pima 11,000. Vaccination at assisted living and skilled nursing facilities is being handled via a state contract with that effort beginning the week between Christmas and New Years. My sources tell me that rural counties will get their first vaccine the week of December 21.
A statewide stakeholder meeting met last week to prioritize the initial doses of vaccine (see the priority populations here).
Note: The New England Journal of Medicine published a study of the Safety and Efficacy of the Vaccine last Thursday. Overall, a two-dose regimen of the vaccine provided 95% protection against Covid-19 and the safety over the 2-month study period was similar to other viral vaccines. The safety profile found short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
