THE U.S. Food and Drug Administration (FDA) has given full approval to the Pfizer-BioNTech COVID-19, the first vaccine against the coronavirus to be licensed in the nation.
The agency made the announcement on Monday, August 23, saying that Pfizer’s vaccine will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
The vaccine will also continue to be available under emergency use authorization (EUA) for individuals aged 12 to 15, and for the administration of a third dose in certain immunocompromised individuals.
“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,” said Acting FDA Commissioner Janet Woodcock.
“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.,” she added.
Pfizer’s COVID-19 vaccine has been available under EUA in the U.S. since December 11 of last year for people age 16 and older, and the authorization was later expanded in May to include those 12 and older.
According to the FDA, the vaccines approved by their agency undergo the standard process for reviewing the quality, safety and effectiveness of medical products.
For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA), a comprehensive document that is submitted to the agency providing very specific requirements.
For Comirnaty, the agency noted, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.
The FDA also conducted its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the agency’s standards for approval.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said 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.,” he added.
For his part, U.S. President Joe Biden touted the FDA approval as “an important moment” in the country’s fight against the COVID-19 pandemic.
He also urged the “millions” of Americans who have been waiting for full approval to get vaccinated as soon as possible.
“If you’re one of the millions of Americans who’ve said that they will not get the shot until it has full and final approval of the FDA: it has now happened. The moment you’ve been waiting for is here. It is time for you to go get your vaccination. And get it today,” said Biden.
To date, more than 200 million people in the U.S. have received the Pfizer vaccine.
