The Federal Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age or older with the new name Comirnaty on August 23, 2021.

Vaccinations for children aged 12 to 15 continue to be available under emergency use.

Because Comirnaty is approved for some people and not others, a new consolidated fact sheet has been developed.

Other COVID-19 vaccines produced by Moderna and Johnson & Johnson are still categorized as allowed under emergency use.