Pfizer's COVID-19 vaccine is now fully approved by the US Food and Drug Administration, making it the first shot against the coronavirus to get all the way through the regulatory review.
The FDA on Monday approved the mRNA vaccine against COVID-19 developed by Pfizer and its partner BioNTech for two doses, given three weeks apart, in people 16 years of age and older. The vaccine was previously being given under an emergency use authorization, which is still in place for the Moderna and Johnson & Johnson vaccines.
"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," said acting FDA Commissioner Janet Woodcock in a release. "Today's milestone puts us one step closer to altering the course of this pandemic in the US."
Full approval is expected to make it easier for local governments, schools and businesses to require vaccinations and may encourage people who are hesitant to get a shot. Three in 10 unvaccinated adults said they'd be more likely to get a vaccine if one moved from emergency authorization to full approval by the FDA, according to a June poll by the Kaiser Family Foundation.
During remarks on Monday, President Joe Biden urged unvaccinated Americans to get a shot now that Pfizer's vaccine is FDA-approved.
"If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened," Biden said. "The moment you've been waiting for is here. It's time for you to go get your vaccination. Get it today."
More than 203 million doses of the Pfizer vaccine have been administered in the US, according to data from the Centers for Disease Control and Prevention. The vaccine also has emergency authorization for use in children ages 12 to 15. Just over 60% of Americans age 12 and older are fully vaccinated against COVID-19.
As part of the process for the review, the FDA looked at data and information submitted for the emergency use authorization, along with "preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made," according to the release. The clinical trial included 44,000 people, half of whom received the vaccine. The vaccine was 91% effective in preventing COVID-19 in the trial, according to the FDA.
The Pfizer vaccine will now be marketed as Comirnaty, said the FDA.
Last week, health officials with the Biden administration said fully vaccinated adults who received the Pfizer or Moderna shots will be eligible for a booster shot starting next month. The plan, which still needs FDA and CDC approval, is meant to provide added protection as the delta variant surges across the US.
Moderna is also seeking FDA approval of its COVID-19 vaccine, though a decision reportedly may take several more weeks.