The U.S. Food and Drug Administration officially granted full approval to the Pfizer-BioNTech COVID-19 vaccine, which continues to be available under emergency use authorization (EUA) for individuals 12 years of age and older.
The FDA’s decision is expected to spur more vaccine requirements by hospitals, colleges, public employers, businesses and other organizations. Public health officials and healthcare professionals hope the full approval will motivate more U.S. adults to get vaccinated. About 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full FDA approval, according to a survey in June from the Kaiser Family Foundation.
“I am delighted that the FDA approved the Pfizer vaccine,” said Sergio Segarra, M.D., chief medical officer at Baptist Hospital, part of Baptist Health. “It is something that I personally was confident in. And I knew from its emergency use authorization that it’s something that is good for us. It is something that is effective with minor side effects. And it is the way to overcome this terrible pandemic that we’re in.”
As of Sunday, about 73 percent of U.S. of adults have had at least one dose of the Pfizer, Moderna or Johnson & Johnson vaccine. Pfizer-BioNTech’s is the most widely administered vaccine, accounting for about 56 percent of all doses, according to the U.S. Centers for Disease Control and Prevention (CDC).
“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,” said acting FDA Commissioner Janet Woodcock, M.D., in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The FDA action comes as the more contagious Delta variant has caused COVID-related hospitalizations to intensify nationwide, with the vast majority of patients being unvaccinated.
Since Dec. 11, 2020, the Pfizer-BioNTech vaccine — which will now be marketed as Comirnaty — has been available under EUA in individuals 16 years of age and older, and the EUA was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies. The FDA’s full approval applies to those 16 and older. People ages 12 through 15 can still receive the vaccine under the existing EUA.
“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,” stated Dr. Woodcock, the acting FDA commissioner.
As part of the review for approval, the FDA analyzed data from about 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 vaccine was 91 percent effective in preventing COVID-19 disease, the FDA said.
“The most commonly reported side effects by those clinical trial participants … 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.”
More than half of the clinical trial participants were followed for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least six months.
The FDA and the CDC have “monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner,” the FDA statement said.