The Pfizer-BioNTech vaccine, which will be marketed as Comirnaty, is fully authorized for people 16-years-old and older, while people aged 12 through 15 can still receive the vaccine under the emergency use grant. Pifzer’s shot was granted emergency use authorization in December 2020.
Administration of a third dose, or booster shot, is also still under emergency use approval for individuals with suppressed immune systems or certain medical conditions, though booster shots will be available to all U.S. citizens in the coming weeks.
Janet Woodcock, M.D., the acting FDA commissioner, said in a press release the approval of Comirnaty was a “milestone” for battling the 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,” Woodcock said.
Members of the FDA addressed the media on Monday. In the briefing, Woodcock said that the FDA’s “efforts to move as quickly as possible” in approving the Pfizer-BioNTech vaccine did not “sacrifice scientific standards, or the integrity of our process.”
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, explained some details of the administration’s review and criteria for approval. He also addressed misinformation being spread about vaccines, such as that they cause infertility, contain microchips and can cause infections and death
“Let me be clear: these claims are simply not true,” Marks said.
Woodcock said that the administration is still in the process of reviewing data on the vaccine in children under 12, as well as booster shots for all Americans, before issuing full approval.
Marks declined to comment on the status of the Moderna COVID vaccine’s review, which uses similar mRNA technology as Comirnaty and received emergency use approval from the FDA days after Pfizer-BioNTech.
President Joe Biden also addressed the nation on COVID-19 and vaccines Monday, calling the FDA’s approval a “key milestone” in the U.S. fight against the virus. He urged people waiting for the shot’s full approval to get their vaccine, “and get it today.”
Biden reiterated previous messages that COVID-19 remains a “pandemic of the unvaccinated,” and called on more companies to require the shot to “reach millions more people” in the vaccination campaign.
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“Let me be clear, there are cases where vaccinated people do get COVID-19, but they’re far less common than unvaccinated people getting COVID-19. And most importantly, their conditions are far less severe,” he said.
Biden said that the FDA’s approval of the Pfizer vaccine is “the gold standard,” and urged Americans to get the shot he described as easy, safe and effective.
“Together, we’ve made significant progress in just seven months. We just have to finish the job, with science, facts and confidence,” Biden said.
Additionally, the U.S. administered more than one million shots for three straight days last week, a first since June.
“Remember when we were trying to get 70 percent of the people over 18 at least one shot? Well, we’ve not only gotten that done, we’ve gotten 71% of everyone aged 12 and older their first shot. That’s over 200 million Americans, and over 170 million are now fully vaccinated,” Biden said.
One of these tools is vaccination, which he encouraged among everyone in the circle of a child too young to get vaccinated. He also encouraged parents to mask their children when they leave the house.
“That’s how we can best keep our kids safe. As I’ve said before, the pandemic of the unvaccinated is a tragedy that is preventable. People are dying, and will die, who don’t have to,” he said.
“Today, I’m calling on more companies in the private sector to step up the vaccine requirements that will reach millions more people,” he said.
He said that the business, nonprofit, state and local leaders who were waiting for full FDA approval now have the green light from the administration.
“As I said last week, vaccination requirements have been around for decades. Students, healthcare professionals, our troops are typically required to receive vaccination to prevent everything from polio, smallpox, measles, mumps, rubella,” he said.
“Why? Because we did such a good job of vaccinating those most at risk,” Biden said.
He reiterated calls for Americans to get the shot, saying the “sooner you get fully vaccinated, the sooner you’ll be fully protected.”
“Today, we’ve hit another milestone, a key milestone in our nation’s fight against COVID,” he said.
He addressed the “millions of Americans” who said they would get the shot once it was fully approved, stating that “it has now happened.”
“The moment you’ve been waiting for is here. It’s time for you to go get your vaccination, and get it today,” he said.
Earlier Monday, Biden tweeted from the official @POTUS account that the FDA authorization should “give added confidence that this vaccine is safe and effective.”
The administration has given emergency approval for boosters for certain immunocompromised people, but full support is yet to come for the rest of the U.S. population.
Acting FDA Commissioner Janet Woodcock said during a media briefing Monday that the administration needs to review data to determine the “safety and efficacy” of authorizing a third dose. The Biden administration recently issued an official recommendation that all Americans start getting third shots in the fall, or eight months after being fully vaccinated.
Moderna’s emergency use approval was given on Dec. 18, 2020, seven days after Pfizer-BioNTech received the same authorization for their vaccine. Both the Pfizer and Moderna vaccines use mRNA technology and have shown similar rates of effectiveness in preventing contraction of the virus and severe infection.
However, data coming out of Israel shows that “with time, immunity does tend to wane.”
“So, that’s something we’ll be following closely, and obviously will be leading into consideration of the thoughts regarding boosters, etcetera, as we move into the fall,” Marks said.
This includes an examination of the effects on those who are pregnant and infants whose carriers were vaccinated while pregnant, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Woodcock stated that children are “not just small adults” and the FDA need more insight on the appropriate doses for children under 12. She added that the FDA does not encourage off-label use of the vaccines.
The Pfizer-BioNTech vaccine is fully approved for people aged 16 and older, while people aged 12 through 15 can get the shot under emergency use authorization.
“Getting a COVID-19 vaccine can save your life,” he said, reiterating hopes from Acting FDA Commissioner Janet Woodcock that Monday’s approval could give people the confidence to get the shot.
However, the vaccine “may not always” prevent infections and transmissions of the virus from person to person, he said.
Woodcock said that the “unprecedented timeline” of three months of review for the vaccine coincided with a “meticulous” process.
“The public can be confident that this vaccine meets the FDA gold standards for safety, effectiveness and manufacturing quality that we require for an approved product,” Woodcock said.
