Pfizer/BioNTech Vaccine Becomes First To Gain Full FDA Approval

The exterior of the US Food And Drug Administration building. Image Credit: grandbrothers/Shutterstock.com

The Pfizer/BioNTech COVID-19 vaccine has received full approval from the US Food and Drug Administration (FDA). The jab is the first of several being employed under emergency use authorization. The approval will allow schools, universities, government departments, and businesses to insist students and staff have had the vaccine.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” Acting FDA Commissioner Dr Janet Woodcock said in a statement.

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

The vaccine is approved for anyone aged 16 years and older and it will be now marketed as Comirnaty (pronounces koe-mir’-na-tee). It will remain available for individuals 12 to 15 under the previous emergency use authorization.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” added Dr Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “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. The public and 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."

Since the vaccine was approved for emergency use authorization over 204 million doses of vaccine have been administered in the United States.

 
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