Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2)

This product information is intended only for residents of the United States.

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

Previous COVID-19 vaccines are no longer available for use in the United States. FDA and CDC guidance is to check inventory and dispose of previous COVID-19 vaccines according to state and local regulations.

for Consumers:

• EUA Recipient Fact Sheet - Pfizer-BioNTech COVID-19 Vaccine, 3mcg and 10mcg

• Pfizer-BioNTech COVID-19 Vaccine - U.S. Medical Information Page - patient information, ways to contact Pfizer Medical & other resources

for Healthcare professionals:

• Emergency Use_Full Prescribing Info_HCP Fact Sheet Pfizer-BioNTech COVID-19 Vaccine, 3mcg and 10mcg

• Pfizer-BioNTech COVID-19 Vaccine - U.S. Medical Information Page - clinical & safety information, ways to contact Pfizer Medical & other resources