Technically Speaking: FDA Issues EUA for Pfizer-BioNTech mRNA Vaccine; CDC Approves Its Use and Provides Clinical Guidance
Published on in Vaccine Update for Healthcare Providers
Published on in Vaccine Update for Healthcare Providers
On Dec. 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 Dec. 11–12 and voted to recommend the use of Pfizer’s mRNA vaccine in people 16 years of age and older, and on Dec. 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 Dec. 11–12 meeting are provided below:
Several key resources from FDA and CDC are listed below. CDC is updating COVID-19 information on its webpages frequently.
Contributed by: Deborah Wexler, MD
Categories: Vaccine Update December 2020, Technically Speaking
Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.
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