Pfizer-BioNTech’s COVID Vaccine Receives Full FDA Approval – Houston Public Media

A nurse receives a dose of the Pfizer Covid-19 vaccine before giving a college student during a Long Beach Public Health Covid-19 mobile vaccination clinic on the California State University Long Beach (CSULB) campus on August 11, 2021 is administered in Long Beach, California.

Updated August 23, 2021 at 2:58 p.m. ET

The Food and Drug Administration has officially approved Pfizer’s COVID-19 vaccine. The eagerly awaited decision replaces the emergency approval granted by the agency last December.

Developed by Pfizer and its partner BioNTech, the vaccine is the first COVID-19 vaccine to undergo full regulatory review and approval that puts the vaccine on par with other vaccines on the market.

Full approval could make it easier for employers, the military, and universities to mandate vaccinations and could reassure some people who are reluctant to get the vaccine.

“While this and other vaccines have met the FDA’s rigorous scientific standards for emergency approval, as the first FDA-approved COVID-19 vaccine, the public can feel very confident that this vaccine meets the high standards of safety, efficacy and manufacture meets the quality that the FDA requires from an approved product, ”said Acting FDA Commissioner Janet Woodcock in a statement.

President Biden took up the announcement in remarks to the nation Monday afternoon to urge more people to be vaccinated as soon as possible.

“Let me put this out loud and clear, if you are one of the millions of Americans who said they wouldn’t get the syringe until it got full and final approval from the FDA, it is now,” he said. “The moment you’ve been waiting for is here. It’s time to get vaccinated. Get it today. “

The president also encouraged companies to “increase their vaccine needs”.

Approval could lead to more vaccinations

A June survey by the Kaiser Family Foundation found that 31% of unvaccinated people said they were more likely to receive a COVID-19 vaccine once one gets full FDA approval.

“While millions of people have already safely received COVID-19 vaccines, we recognize that FDA approval of a vaccine may now create additional confidence for some to get vaccinated,” said Woodcock. “Today’s milestone brings us one step closer to changing the course of this pandemic in the US”

Full FDA approval is for anyone 16 years of age or older. People between the ages of 12 and 15 can still receive the vaccine under the existing emergency permit.

There is no timeline for children under 12

This approval does not extend to children under 12 years of age. FDA officials have recognized interest in vaccinating children in this age group, but were unable to come up with a timeline for a decision on Monday to use the vaccine for anyone under the age of 12.

“Studies are still ongoing here,” said Dr. Peter Marks, director of the FDA’s Center for the Evaluation and Research of Biologics, told reporters. “The agency has to wait for the companies to get in touch. … Of course we will move forward quickly, but first the tests have to be completed … and the data has to be presented to us. “

The FDA acted Monday without convening a usual public meeting of technical advisors to review information about the vaccine and make recommendations to the regulator.

As part of the approval process, the vaccine was also given a brand name: Comirnaty. The FDA says the “koe-mir’-na-tee” is pronounced.

By Sunday, 73% of adults in the US had received at least one dose of the Pfizer, Moderna, or Johnson & Johnson vaccines. Pfizer’s vaccine is the most commonly administered vaccine, accounting for about 56% of total doses given, according to data from the Centers for Disease Control and Prevention.

Moderna’s COVID-19 vaccine is still under FDA review, but approval is expected in the near future.

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