On June 17, 2022, the Pfizer & BioNTech COVID-19 vaccine received Emergency Use Authorization (EUA)* from the U.S. Food and Drug Administration (FDA) for 6 month-olds to 4 year-olds. The FDA previously granted EUA for the Pfizer & BioNTech COVID-19 vaccine for individuals 5 years and older on October 29, 2021.

We are immensely grateful to the clinical trial volunteers and their families who helped make this milestone possible. Thank you for your contributions to science and for helping families and children like you around the world.

 

*Emergency uses of the vaccine 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 12 years of age and older, in individuals 5 through 11 years of age, or in individuals 6 months through 4 years of age, as appropriate. The emergency uses are 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.