Editor’s note: This story was updated at 11:07 a.m., Aug. 23.
Aug. 23, 2021 — The FDA has granted full approval for the Pfizer COVID-19 vaccine.
It is the first COVID-19 vaccine to be fully licensed in the U.S. It will be marketed under the trade name Comirnaty.
The approval applies to people ages 16 and older. The vaccine is still available for emergency use for those ages 12 through 15.
The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny of the clinical trial data by the agency.
Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities.
Public health advocates have seen full approval as an important tool to increase vaccination rates in the U.S. and had criticized the FDA for taking so long to grant the license. The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.
“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,” acting FDA Commissioner Janet Woodcock, MD, said in an FDA news release.
“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.,” Woodcock said.
In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.
The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.
Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.
The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.
The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.
Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation — clinically known as myocarditis or pericarditis — especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.
The prescription information includes warnings on these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.