Emergency uses of the vaccine have not been approved or licensed by US FDA but have been authorized to prevent COVID-19 in ages 6mo+. See Fact Sheets: https://t.co/qTUHCJZMwZ
— Pfizer Inc. (@pfizer) August 30, 2023
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. Please see EUA Fact Sheets at http://www.cvdvaccine-us.com.
https://www.cvdvaccine-us.com/?linkId=150477712
h/t A Deplorable Neanderthal