FDA Approves First COVID-19 Vaccine Save

Today, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine, manufactured by Pfizer-BioNTech COVID-19 the vaccine, now marketed as Comirnaty (koe-mir’-na-tee), is approved for the prevention of COVID-19 disease in individuals 16 years of age and older.

This long-awaited approval is the result of a Priority Review granted by the FDA. 

The current emergency use authorization (EUA) will still apply to children 12 through 15 years of age and as a third dose "booster" for immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

The Pfizer-BioNTech COVID-19 vaccine has been available under EUA since Dec. 11, 2020 to provide immediate relief of the COVID-19 pandemic while the FDA amassed and analyzed all efficacy and safety data that lead to todays full FDA approval. 

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older. 

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.  More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The side effect profile of this vaccine has not been changed, with common adverse events (AE) being pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Pfizer and the FDA are committed to an ongoing evaluation of rarely reported, serious AE (myocarditis and pericarditis) and the safety of the vaccine in pregnancy and in children under 16 yrs. of age.

More than 204 million people in the United States already have received the Pfizer/BioNTech vaccine (~56% of all doses administered). Currently 73% of adults have had at least one dose of a COVID-19 vaccine (from Pfizer, Moderna or Johnson & Johnson).