FDA Grants Full Approval To Pfizer, The First COVID-19 Vaccine

covid 19 vaccines
Photo by Daniel Schludi on Unsplash

For some who have not gotten vaccinated against COVID-19, news that the FDA granted full approval to the first COVID-19 vaccine — the Pfizer-BioNTech COVID-19 Vaccine — which will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older is a game changer.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose (booster shot) in certain immunocompromised individuals.

The FDA conducted a thorough evaluation of the data and information submitted in the Biologics License Application (BLA) for Comirnaty before making a determination that the vaccine is safe and effective in preventing COVID-19 in individuals 16 years of age and older.

Follow-up data from this ongoing clinical trial was analyzed by FDA to determine the safety and effectiveness of Comirnaty. The updated analysis to determine effectiveness for individuals 16 years of age and older included approximately 20,000 Comirnaty and 20,000 placebo recipients who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Overall, the vaccine was 91% effective, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.

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