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Pfizer Vaccines Medical COVID-19 Vaccine Updated Information


On August 22, 2024, the FDA approved the supplemental Biologics License Application for COMIRNATY® (COVID-19 Vaccine, mRNA), for individuals 12 years and older and granted emergency use authorization for Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 11 years of age for the companies’ KP.2-adapted monovalent COVID-19 vaccines.1

Pfizer’s Vaccines US Medical Affairs Team is hosting the following brief educational webinars:

For more information see:

Comirnaty (COVID-19 Vaccine, mRNA): Full Prescribing Information

Pfizer-BioNTech’s COVID-19 Vaccine:  EUA Fact Sheet

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Emergency uses of COVID-19 vaccines from BioNTech and Pfizer, including Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula), have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. Emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical products under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

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