FDA Grants Full Approval To Pfizer-BioNTech’s Covid Shot!
On Monday, the Food and Drug Administration granted full approval to Pfizer and BioNTech Covid-19 vaccine — giving full approval to Pfizer’s COVID-19 vaccine for individuals 16 years and older.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. “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.”
According to CNBC citing the the U.S. agency, FDA scientists evaluated “hundreds of thousands of pages” of vaccine data from 40,000 trial participants. It was said that 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.
This latest move gives even more businesses, schools, and universities greater confidence to adopt vaccine mandates. The FDA is holding a media briefing at 11 a.m. Monday to discuss the approval.
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