FDA Approves Pfizer-BioNTech COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) recently approved the Pfizer-BioNTech COVID-19 Vaccine “for the prevention of COVID-19 disease in individuals 16 years of age and older.”  The vaccine will be marketed as Comirnaty, and will continue to be available under emergency use authorization (EUA) “for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”  The FDA analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients, which showed Comirnaty was 91% effective in preventing COVID-19 disease.  The FDA evaluated safety data from 22,000 vaccine and 22,000 placebo recipients, as well as post-authorization safety surveillance data pertaining to myocarditis and pericarditis.  Vaccine safety will continue to be monitored by the FDA and Centers for Disease Control and Prevention (CDC), and the FDA is requiring BioNTech “to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination.”