Pfizer's COVID-19 Vaccine Wins Full Approval from the FDA
upstart writes:
Pfizer's COVID-19 vaccine wins full approval from the FDA:
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.
[...] The Pfizer vaccine will now be marketed as Comirnaty, said the FDA.
Also at Washington Post and CNN.
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