The messenger RNA (mRNA)-based BNT162b2, to be marketed as Comirnaty, will be indicated for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will also continue to be available under emergency use authorization (EUA), for adolescents ages 12–15 years of age, as well as for the administration of a third “booster” dose in specified immunocompromised individuals.