Coronavirus: FDA grants full approval of Pfizer-BioNTech COVID-19 vaccine

WASHINGTON — The Food and Drug Administration on Monday gave full approval to the COVID-19 vaccine developed by Pfizer and BioNTech as the delta variant of the virus continues to drive new infections and hospitalizations nationwide.

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The announcement, first reported by The Washington Post, made the Pfizer-BioNTech vaccine the first to earn full approval from the FDA.

The vaccine was fully approved for use in people aged 16 and older. It remains available under emergency use authorization for those between the ages of 12 and 15, and for moderately and severely immunocompromised people seeking an additional dose of the vaccine, according to the FDA.

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“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,” Woodcock said Monday in a 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.”

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Pfizer and BioNTech officials had begun the process to seek full approval in May. Officials said Monday that the drug will now be marketed under the brand name Comirnaty.

The two-dose mRNA vaccine, which has been available in the U.S. under an emergency use authorization since December 2020, has so far been used to fully vaccinate more than 92 million people across the U.S., according to data from the Centers for Disease Control and Prevention. As of Sunday, the last date for which data was available, 204.7 million doses of the vaccine have been administered, the most of any of the available vaccines.

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Pfizer CEO Albert Bourla said in a statement obtained by Stat News that the decision from regulators “affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.”

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives,” he said.

The vaccine approval comes as officials work to encourage vaccine skeptics to get their shots amid a surge in COVID-19 cases due to the prevalence of the highly transmissible delta variant and ongoing vaccine hesitancy, according to public health officials. A June survey from the Kaiser Family Foundation found that three in 10 unvaccinated people “would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to receive full approval from the FDA.”

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On Monday afternoon, President Joe Biden urged the unvaccinated to get their shots, saying that the rise of the delta variant has been “causing a pandemic of the unvaccinated.”

“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,” he said. “The moment you’ve been waiting for is here. It’s time for you to go and get your vaccination -- and get it today. Today.”

Full approval of the Pfizer-BioNTech vaccine is expected to allow for more public and private organizations to mandate COVID-19 vaccination, according to The New York Times. Earlier this month, during a meeting with high school students in Topeka, Kansas, Education Secretary Miguel Cardona said officials would likely consider mandating COVID-19 vaccines for school staff after the vaccine was fully approved.

“I believe that once that process happens and it’s finally approved outside of the emergency approval … I do think we are going to have those conversations,” he said.

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Several states have imposed limited vaccine mandates for state employees, health care workers and others. In Washington state, Gov. Jay Inslee has mandated COVID-19 vaccination for all K-12 and higher education employees, according to KIRO-TV.

A poll released Monday from The Associated Press and the NORC Center for Public Affairs Research found that 59% of Americans support vaccination requirements for teachers while 55% support vaccine requirements for students who are eligible to be vaccinated. Support for student vaccinations was lower among parents, with 42% backing the requirement, according to the AP.

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As of Sunday, more than 51% of all Americans, or 170.8 million people, have been fully vaccinated against COVID-19. Nearly 61% of the population, or 201.4 million people, have gotten at least one vaccine dose, according to CDC.

Research has shown that fully vaccinated people can spread the highly transmissible delta variant of the virus, which accounts for more than 80% of all COVID-19 cases reported nationwide; however, officials have noted that vaccination protects well against severe and life-threatening symptoms of the viral infection.

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Since the start of the pandemic, officials have confirmed 37.7 million infections and reported more than 628,000 deaths across the U.S., according to numbers compiled by Johns Hopkins University. Nearly 212 million COVID-19 cases have been reported worldwide, resulting in 4.4 million deaths, according to Johns Hopkins.