Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® HAS NOT been approved or licensed by FDA

EUA Statement – read carefully to fully understand the limitation of use the vaccine is distributed under.

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older;

and 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.

Source: Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® HAS NOT been approved or licensed by FDA

Source: Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® HAS NOT been approved or licensed by FDA