FDA Grants First Full Approval to Pfizer-BioNTech COVID-19 Vaccine

The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.

The Food and Drug Administration (FDA) has approved the Pfizer-BioNTech COVID-19 vaccine, making it the first COVID-19 vaccine to gain full approval. The vaccine will be marketed as Comirnaty.

Comirnaty is indicated for the prevention of COVID-19 in individuals 16 years of age and older; however, the vaccine remains available under Emergency Use Authorization (EUA) for those 12 to 15 years of age and for administration of a third dose in certain immunocompromised individuals.

The approval of Comirnaty was based on a review of updated data from an ongoing, randomized, controlled, blinded clinical trial which included approximately 44,000 participants 16 years of age and older, along with previously submitted data that supported the EUA, such as manufacturing process and clinical data. Findings from the trial support the 91% vaccine efficacy for Comirnaty in preventing COVID-19 disease. The FDA conducts its own analyses of the information in the Biologics License Application to make sure the vaccine is safe and effective.

As for safety, the prescribing information for Comirnaty includes postmarketing data indicating increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The most commonly reported adverse reactions for individuals 16 years of age and older were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

Comirnaty contains mRNA, which is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. In their news release, the FDA specified that the mRNA in Comirnaty is only present in the body for a short time and is not incorporated into, nor does it alter, an individual’s genetic material.

Comirnaty has the same formulation as the EUA vaccine and is administered as a series of 2 doses, 3 weeks apart.

Additionally, a booster dose for the vaccine will be available to the wider population pending authorization by the FDA and recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). The Companies are also currently assessing the vaccine in trials in children ages 6 months to 11 years of age; trial results for the 5 to 11 age group are expected first in September.

Speaking about today’s approval, acting FDA Commissioner Janet Woodcock, MD, said “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 US.”


  1. FDA Approves First COVID-19 Vaccine. News release. US Food and Drug Administration. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
  2. Comirnaty [package insert]. Mainz, Germany and New York, NY: BioNTech and Pfizer, Inc.; 2021.

This article originally appeared on MPR