FDA grants full approval to Pfizer-BioNTech’s Covid shot, clearing path to more vaccine mandates
The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech’s Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates.
Up until now, the mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an emergency use authorization that was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention.
Federal health officials had been under mounting pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech’s vaccine ever since the drugmakers submitted their application to the agency in early May. The companies submitted a Biologics License Application, which secures full approval, to the FDA on May 7 for patients age 16 and up.
FDA scientists evaluated “hundreds of thousands of pages” of vaccine data from 40,000 trial participants, according to the U.S. agency. The vaccine was found to be 91% effective in preventing Covid – slightly lower than the 95% efficacy rate trial data showed when the shot was authorized late last year and before the delta variant took hold in the U.S.
Pfizer’s vaccine met the agency’s “high standards for safety, effectiveness, and manufacturing quality,” acting FDA Commissioner Janet Woodcock said in a statement. “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.”
The FDA held a media briefing Monday morning to discuss the approval.
Although more than 60% of the total U.S. population has had at least one dose of a Covid vaccine, many Americans say they are still hesitant about getting vaccinated, even as the highly contagious delta variant spreads. Full approval may convince some Americans that the shots are safe, doctors and epidemiologists say. In fact, a survey from the Kaiser Family Foundation found 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines receives full approval.
Full approval is “more psychological than anything else,” said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “I mean you already have more than 320 million doses administered that are out there. The vaccines already have an enormous safety and efficacy profile.”
U.S. approval is also likely to spur a new wave of vaccine mandates from corporate America. Major companies – from Walt Disney to Walmart – have already told some or all of their employees that they must get fully vaccinated against Covid this fall. Still, some private businesses may have felt hesitant about requiring the shots, before full approval, even though they had the legal authority to do so, said Dorit Reiss, a professor of law at UC Hastings College of the Law.
The Pentagon said it would make vaccinations mandatory for service members “no later” than the middle of September, or sooner if the FDA grants full approval earlier.
“You’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that,” White House chief medical officer Dr. Anthony Fauci said Aug 8, when asked about full approval of the vaccines. “The time has come. … We’ve got to go the extra step to get people vaccinated.”
This article originally appeared in CNBC. Read more here.
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