On Monday, the Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine for individuals 16 years and older.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said in a statement issued Monday. “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.”
COVID-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson have all previously been granted emergency use authorization (EUA) after meeting the FDA’s safety and efficacy requirements.
“Our scientific and medical experts conducted a comprehensive and thoughtful evaluation of this vaccine,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
He later added, in part, “although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
“There are universities and businesses that have been considering putting in vaccine requirements to create a safer workplace or learning environment,” Murthy said. “And I think this announcement from the FDA would likely encourage them and make them feel more comfortable.”
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