FDA issues EUA for Pfizer-BioNTech mRNA vaccine; CDC approves its use and provides clinical guidance
December 2020
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TECHNICALLY SPEAKING | |
FDA issues EUA for Pfizer-BioNTech mRNA vaccine; CDC approves its use and provides clinical guidance | |
Published December 2020 | |
On December 11, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States for use in people 16 years of age and older.
The Advisory Committee on Immunization Practices (ACIP) met on December 11–12 and voted to recommend the use of Pfizer’s mRNA vaccine in people 16 years of age and older, and on December 13, CDC published ACIP’s Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine—U.S., December 2020 as a Morbidity and Mortality Weekly Report (MMWR) Early Release. While MMWR publications should always be consulted for official guidance, additional highlights of ACIP’s clinical guidance discussed at the committee’s December 11–12 meeting are provided below:
Several key resources from FDA and CDC are listed below. CDC is updating COVID-19 information on its web pages frequently. From FDA From CDC
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