Pfizer received a full FDA approval for its Covid vaccine, here's what's next:
Expect more people to get vaccinated after being reassured by the regulatory process - or because their job demands it.n Monday, the Food and Drug Administration granted full approval for Pfzer/BioNTech’s Covid-19 vaccine, now marketed under the name Comirnaty, for everyone aged 16 and up. “This is a pivotal moment for our country in the fight against the pandemic,” said acting FDA Commissioner Janet Woodcock. The move comes 8 months after the FDA first authorized the vaccine for emergency use.
While it may seem like a long time for the first full vaccine approval given the scope of the pandemic, this is actually record time. It took 97 days from when Pfizer finished submitting its entire application, which is around 40% faster than usual, the FDA said. “Our efforts to move as quickly as possible have in no way sacrificed scientific standards or the integrity of our process,” Woodcock added. Around 170.8 million people, or 60 percent of the U.S.
in other words, get vaccinated or face consequences. This could mean additional testing, masking or social distancing requirements for unvaccinated staff. It may also mean that more government agencies will require vaccinations with very few exceptions, as New York City did today for teachers, and the Pentagon is expected to do for the military.
While most employers will have broad authority to require their staff to get vaccinated, unionized workplaces likely need to negotiate with their respective unions. “There has to be an out for people who have medical reasons not to be vaccinated and religious reasons not to be vaccinated. That’s going to carry over now to the full approval situation,” Mark McClellan, a former FDA commissioner and director of the Duke-Margolis Center for Health Policy said in a press briefing.
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