Pfizer-BioNTech COVID-19 Vaccine(also known as BNT162b2)
This product information is intended only for residents of the United States.
This product is exclusively distributed within the U.S. under an Emergency Use Authorization from FDA.
The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years 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. Please see EUA Fact Sheet at www.cvdvaccine.com.
- Pfizer-BioNTech Covid-19 Vaccine Emergency Use Authorization Fact Sheet for Recipients and Caregivers
for Health Care Professionals:
- Pfizer-BioNTech Covid-19 Vaccine Emergency Use Authorization Combined Full Prescribing Information and Fact Sheet