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# FDA Approves Pfizer-BioNTech Vaccine
- URL: https://www.fdaweb.com/fda-approves-pfizer-biontech-vaccine/
- Published: 2021-08-23T12:00:00.000Z
- Updated: 2026-09-14T17:11:23.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149987

FDA has approved the first Covid-19 vaccine — Pfizer-BioNTech’s vaccine that is now under the trade name Comirnaty — for use in individuals 16 years of age and older. The vaccine continues to be available under an emergency use authorization (EUA) for individuals 12 through 15 years of age and as a booster shot (third dose) in those who are immunocompromised. The original EUA was granted 12/11/2020.  

Approval was based on FDA’s review of updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population,” an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine?ref=fdaweb.com) says. “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,” it says. The trial data showed that the vaccine was 91% effective in preventing Covid-19 disease.  

The most commonly reported side effects by those receiving the vaccine were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. “Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech Covid-19 vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose,” the agency says. “The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms.”