FDA Gives Pfizer Vaccine Full Approval

Shot had been under emergency use authorization

Up to now, the three COVID-19 vaccines administered in the U.S. were given under an emergency use authorization. After nine months and more than 200 million doses, the Pfizer/BioNTech vaccine has received full approval from the FDA for people ages 16 and older. Pfizer will market the shot under the name Comirnaty.  

“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 Janet Woodcock, M.D., said. “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.”  

Indeed, many have cited the “experimental” nature of the vaccines as a reason for their hesitancy. The full approval paves the way for vaccine mandates across the public and private sectors. The Pentagon said it will require military service members to be vaccinated, and many colleges and universities will make it mandatory for students and faculty on campus. 

Moderna has applied for full approval for its mRNA vaccine, and Johnson & Johnson expects to apply this year. It seems likely the FDA would grant both vaccines full approval given their track record over millions of doses. Johnson & Johnson shots were briefly paused after a very small number of women experienced blood clots after their shot but resumed after a review. The FDA’s standards are quite high, and they have had a lot of data on the Pfizer vaccine to pore over. 

“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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research.