FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine
January 11, 2021 (Issue: 1615)
The FDA has issued an Emergency Use Authorization
(EUA) for the Pfizer-BioNTech mRNA-based vaccine
for prevention of COVID-19 in persons ≥16 years old.
- FP Polack et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med 2020 Dec 10 (epub).
- CDC. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine — United States, December 14–23, 2020. MMWR Morb Mortal Wkly Rep 2021 January 6 (epub).
- FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Available at: https://bit.ly/37fX1NG. Accessed December 17, 2020.
- ACOG. Vaccinating pregnant and lactating patients against COVID-19. December 13, 2020. Available at: http://bit.ly/2Kt7AnS. Accessed December 17, 2020.
- Pfizer. Pfizer-BioNTech COVID-19 vaccine U.S. distribution fact sheet. November 20, 2020. Available at: https://bit.ly/37bL6zw. Accessed December 17, 2020.
- CDC Advisory Committee on Immunization Practices (ACIP). ACIP presentation slides: December 2020 meeting. December 1, 2020. Available at: https://bit.ly/37wZx1f. Accessed December 17, 2020.
- CDC. COVID-19 vaccination program interim playbook for jurisdiction operations – October 29, 2020. Version 2.0. Available at: https://bit.ly/37SIp63. Accessed December 17, 2020.
- CDC. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. January 6, 2021. Available at: http://bit.ly/38i7CIH. Accessed January 7, 2021.
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