FDA grants Pfizer-BioNTech COVID-19 vaccine full approval

The Food and Drug Administration (FDA) on Monday 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."

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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. The full licensure announced Monday stems from a so-called biologics license application, building on previously-submitted pre-clinical and clinical data, information relating to the manufacturing process, vaccine quality data and site inspections.

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"Our scientific and medical experts conducted an incredibly thorough 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."

The FDA completed review of the vaccine, now marketed as Comirnaty, in just over three months, or some 40% faster than usual, Marks said. During the review process, the FDA evaluated updated clinical trial data on vaccine efficacy among 40,000 participants aged 16 years and older, half of whom received a placebo. Trial results indicated the vaccine was 91% effective in preventing COVID-19 disease, though data will continue to be monitored as real-world evidence suggests waning immunity over time. 

The FDA also evaluated vaccine safety among 44,000 trial participants aged 16 and older, with available follow-up safety data extending at least four months post-second dose for over half of trial participants. The most common side effects among participants included pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever. Data also demonstrated an increased risk of myocarditis, or heart inflammation, among males under 40, with males aged 12-17 facing the highest observed risk. However, available data suggest most patients' symptoms have resolved, Marks said.

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The approval on Monday also paves the way for the Pentagon to mandate the vaccine among 1.3 million active-duty service members. Full licensure has been widely anticipated to boost confidence in those otherwise hesitant to receive the shot under emergency approval. U.S. Surgeon General Vivek Murthy told Chris Wallace on "Fox News Sunday" that full approval might lead to an increase in vaccination rate.

"There are universities and businesses that have been considering putting in vaccine requirements in order 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."