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

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

Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner

Monovalent mRNA COVID-19 vaccines are no longer authorized for emergency use in the United States. FDA and CDC guidance is to check inventory and dispose of monovalent mRNA vaccines according to state and local regulations.

for Consumers:

• EUA Recipient Fact Sheet - Pfizer-BioNTech COVID-19 vaccine, Bivalent_TrisSuc_3mcg, 10mcg, 30mcg

for Healthcare professionals:

• Emergency Use_Full Prescribing Info_HCP Fact Sheet Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)_TrisSuc_ 3mcg "maroon", 10mcg "orange" and 30mcg "gray"