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By Ishika Dangayach, 2:00 PM ET
The Food and Drug Administration (FDA) granted completeapproval to Pfizer and BioNTech SE's COVID-19 vaccines on Monday, making it thefirst such authorization from the U.S. medicines regulator to encourage more people to get vaccination amid the growing Delta variant.
The FDA cleaned the vaccination first in December forpersons 16 years old and older, following the demonstration of a great deal ofefficacy in avoiding COVID-19 symptoms. The two-dose injection has subsequentlybecome the most jabbed COVID-19 vaccine in the U.S.
Since the drugs industry filed its application to the agencyin early May, federal health regulators have been pressured by the scientificcommunity and advocacy organizations to completely approve Pfizer and BioNTechvaccines, CNBC reported.
“The FDA’s approval of this vaccine is a milestone…. whileother vaccines have met the FDA’s rigorous, scientific standards for emergencyuse authorization, as the first FDA-approved COVID-19 vaccine, the public canbe 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, M.D, in a statement.
Pfizer is now authorized to advertise the vaccine tophysicians, providers, and the general public under the brand Comirnaty, aswell as alongside other approved medicines.
The vaccine also qualifies to be prescribed off-label, which may include booster doses, according to FDA.
“The FDA has officially approved the Pfizer COVID-19vaccine…this FDA approval should give added confidence that this vaccine issafe and effective.” President Joe Biden wrote on Twitter. “If you're notvaccinated yet, now is the time.”
After the FDA’s approval, the Pentagon said it will makeupdates to necessitate that all U.S. military staff be vaccinated.
“We have not lost sight that the COVID-19 public healthcrisis continues in the U.S. and that the public is counting on safe andeffective vaccines,” said Peter Marks, M.D., Ph.D., director of FDA’s Centerfor Biologics Evaluation and Research, in a statement. The public and themedical community can be confident that although we approved this vaccineexpeditiously, it was fully in keeping with our existing high standards forvaccines in the U.S.
Last Week, Biden advised that an adult with two dosed regimensshould be given a third injection of an mRNA vaccine, such as Pfizer amid the rising contagious coronavirus variant.
The FDA has already been provided with data demonstrating byPfizer that a third of their vaccine enhances the immune system to levels higherthan those of the normal two dose regime against the original virus and theBeta/Delta versions. As an addendum to full approval, Pfizer is planning to file a booster approval application.
Several companies, including Disney, Facebook, Google, Microsoft, Tyson Foods, United Airlines, and Walmart, have announced vaccination mandates for employees. Indiana University will require students and workers to be vaccinated against COVID-19,
Inputs from WSJ