Pfizer-BioNTech’s COVID Vaccine Gets Full Approval From The FDA

The Food and Drug Administration has formally approved Pfizers COVID-19 vaccine. The vaccine, developed by Pfizer and its partner BioNTech, is the very first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines. “While this and other vaccines have satisfied the FDAs extensive, clinical requirements for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high requirements for security, efficiency, and making quality the FDA requires of an authorized item,” acting FDA Commissioner Janet Woodcock stated in a declaration.

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“Currently there are still trials continuous here,” Dr. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, told press reporters. “The company has to await the companies to send. … Obviously, we will move swiftly, but first the trials have to be ended up … and the information require to be submitted to us.” The FDA acted Monday without convening a popular public meeting of expert advisers to veterinarian details about the vaccine and make recommendations to the regulator. As part of the approval process, the vaccine also got a brand name: Comirnaty. The FDA states thats pronounced “koe-mir-na-tee.” Since Sunday, 73% of adults in the U.S. have actually had at least one dose of the Pfizer, Moderna or Johnson & & Johnson vaccines. Pfizers vaccine is most frequently administered, accounting for about 56% of the dosages administered overall, according to data from the Centers for Disease Control and Prevention. Modernas COVID-19 vaccine remains under the FDAs evaluation, but its approval is expected to follow in the future.

Patrick T. Fallon/AFP via Getty Images

The vaccine, developed by Pfizer and its partner BioNTech, is the very first COVID-19 vaccine to be subject to a complete evaluation by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines. “While this and other vaccines have satisfied the FDAs strenuous, clinical standards for emergency use permission, as the first FDA-approved COVID-19 vaccine, the public can be really confident that this vaccine meets the high standards for security, efficiency, and producing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement. Approval could lead to more vaccinations A June survey from the Kaiser Family Foundation found that 31% of unvaccinated individuals stated they would be more likely to get a COVID-19 vaccine as soon as one gets full approval from the FDA. “While millions of people have actually already securely received COVID-19 vaccines, we acknowledge that for some, the FDA approval of a vaccine might now impart additional confidence to get immunized,” Woodcock stated. Modernas COVID-19 vaccine stays under the FDAs review, however its approval is expected to follow in the near future.

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” Let me say this loudly and clearly: If youre one of the millions of Americans who stated that they will not get the shot until it has final and full approval of the FDA, it has actually now taken place,” he said. The president also encouraged organizations to “step up their vaccine requirements.”

Patrick T. Fallon/AFP via Getty Images

A nurse is handed a dosage of the Pfizer COVID-19 vaccine before administering it to an university student during a mobile vaccination clinic at California State University, Long Beach on Aug. 11.

A nurse is handed a dose of the Pfizer COVID-19 vaccine before administering it to a college trainee throughout a mobile vaccination clinic at California State University, Long Beach on Aug. 11.

Approval could lead to more vaccinations A June poll from the Kaiser Family Foundation found that 31% of unvaccinated people stated they would be more likely to get a COVID-19 vaccine as soon as one gets complete approval from the FDA. “While millions of people have already securely received COVID-19 vaccines, we acknowledge that for some, the FDA approval of a vaccine may now impart additional confidence to get vaccinated,” Woodcock stated. FDA officials have acknowledged the interest in vaccination for children in that age group but were unable Monday to offer a timeline for a choice on use of the vaccine for those under 12.

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