The Medical Letter on Drugs and Therapeutics
October 18, 2021
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Booster Dose of the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty)
October 18, 2021 (Issue: 1635)On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of...more
- FDA News Release. FDA authorizes booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations. September 22, 2021. Available at: https://bit.ly/3ilp0B1. Accessed September 30, 2021.
- CDC. CDC statement on ACIP booster recommendations. September 24, 2021. Available at: https://bit.ly/3o8uS42. Accessed September 30, 2021.
- 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). September 22, 2021. Available at: https://bit. ly/37fX1NG. Accessed September 30, 2021.
- SY Tartof et al. Six-month effectiveness of BNT162b2 mRNA COVID-19 vaccine in a large US integrated health system: a retrospective cohort study. 2021 August 23 (preprint). Available at: https://bit.ly/3CJwzJ8. Accessed September 30, 2021.
- Y Goldberg et al. Waning immunity of the BNT162b2 vaccine: a nationwide study from Israel. medRxiv 2021 August 30 (preprint). Available at: https://bit.ly/2XXy4Vr. Accessed September 30, 2021.
- YM Bar-On et al. Protection of BNT162b2 vaccine booster against Covid-19 in Israel. N Engl J Med 2021 September 15 (epub).
- AM Hause et al. Safety monitoring of an additional dose of COVID-19 Vaccine — United States, August 12–September 19, 2021. MMWR Morb Mortal Wkly Rep 2021 September 28 (epub).
- FDA. FDA review of effectiveness and safety of COMIRNATY (COVID-19 vaccine, mRNA) booster dose. Biologics License Application supplement. Vaccines and Related Biological Products Advisory Committee. September 17, 2021. Available at: https://bit.ly/2ZhqsgQ. Accessed September 30, 2021.
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