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Pfizer-BioNTech vaccine gets green signal from FDA

PUBLISHED ON 2021-08-23 23:28:00 EST Ishika Dangayach


The Food and Drug Administration (FDA) granted complete approval to Pfizer and BioNTech SE's COVID-19 vaccines on Monday, making it the first 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 for persons 16 years old and older, following the demonstration of a great deal of efficacy in avoiding COVID-19 symptoms. The two-dose injection has subsequently become the most jabbed COVID-19 vaccine in the U.S.

Since the drugs industry filed its application to the agency in early May, federal health regulators have been pressured by the scientific community and advocacy organizations to completely approve Pfizer and BioNTech vaccines, CNBC reported.

“The FDA’s approval of this vaccine is a milestone…. while 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, M.D, in a statement.

Pfizer is now authorized to advertise the vaccine to physicians, providers, and the general public under the brand Comirnaty, as well 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-19 vaccine…this FDA approval should give added confidence that this vaccine is safe and effective.” President Joe Biden wrote on Twitter. “If you're not vaccinated yet, now is the time.”

After the FDA’s approval, the Pentagon said it will make updates to necessitate that all U.S. military staff be vaccinated.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, in a statement. The public and the medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

Last Week, Biden advised that an adult with two dosed regimens should 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 by Pfizer that a third of their vaccine enhances the immune system to levels higher than those of the normal two dose regime against the original virus and the Beta/Delta versions. As an addendum to full approval, Pfizer is planning to file a booster approval application.

Several companies, including DisneyFacebookGoogleMicrosoftTyson FoodsUnited 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

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