The U.S. Food and Drug Administration granted full approval Monday to the COVID-19 vaccine developed by Pfizer and BioNTech, whose shots are now the first to move beyond emergency status since the pandemic began.
The highly anticipated move is effective for people 16 and older. The vaccine will remain available under emergency use authorization for children 12-15 years old and for a third dose in individuals with certain underlying medical conditions, according to the FDA.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement.
“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,” she said.
The full approval was expected to boost confidence in the vaccine, potentially encouraging some of the 85 million unvaccinated Americans to get the shots. Months after the federal government made COVID-19 vaccines widely available and free to all adults, about 40% of people 12 and older still have not been vaccinated, according to the U.S. Centers for Disease Control and Prevention.
“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,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Monday’s announcement also means Pfizer and BioNTech will be allowed to market their vaccine, which is not permitted under emergency status. The two companies plan to market the vaccine as Comirnaty, the FDA said.
Pfizer Chairman and CEO Albert Bourla celebrated the accomplishment on social media.
“Every day, I wake up proud of our team at @Pfizer. Proud of the work we do. Proud of the difference we are making. And I am especially proud today,” Bourla tweeted.
“It is our hope that this news will instill even further public confidence in our vaccine and the science that made it possible,” he said.
