On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine, making it the first COVID-19 vaccine out of the three that had been authorized for emergency use in the United States to receive full approval by the FDA.
For months, people who were hesitant about getting vaccinated claimed the COVID-19 vaccines were pushed through too fast under emergency use and said they were waiting for them to be fully approved by the FDA. Now that the Pfizer COVID-19 vaccine received its FDA approval in less than four months, some people are claiming it was approved faster than other vaccines.
Did the Pfizer COVID-19 vaccine receive the FDA’s fastest vaccine approval ever?
Yes, the Pfizer COVID-19 vaccine received the FDA’s fastest vaccine approval ever.
WHAT WE FOUND
Each drug or vaccine marketed in the United States must go through a detailed FDA review process before receiving full approval. In 1992, under the Prescription Drug User Fee Act (PDUFA), the FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times — standard review and priority review. On its website, the FDA says a priority review designation means the FDA’s goal is to take action on an application within six months, compared to 10 months under standard review.
On Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine received emergency use authorization (EUA) from the FDA after primary efficacy analysis demonstrated the vaccine to be 95% effective against COVID-19 beginning 28 days after the first dose. Pfizer says 170 confirmed cases of COVID-19 were evaluated during this trial, with 162 observed in the placebo group versus eight in the vaccine group. According to Pfizer, the data demonstrated the vaccine was well tolerated across all populations with over 43,000 participants enrolled.
To get full FDA approval, Pfizer needed to provide the agency with more data in the form of a biologics license application (BLA). In May 2021, the company submitted its BLA with an analysis of 44,000 participants — the vast majority of whom had received their second dose.
Pfizer announced the FDA had formally accepted its BLA requesting approval of the company's COVID-19 vaccine for people 16 years old and older on July 16. The FDA granted the application priority review at that time and said the agency planned to complete the review far in advance of the PDUFA goal date of Jan. 2022. Then, on Aug. 23, the FDA officially approved the Pfizer-BioNTech COVID-19 vaccine.
According to the FDA, approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. The FDA evaluates data and information included in the manufacturer’s submission of a BLA. The agency also conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
The FDA says the BLA submitted by Pfizer “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.”
In an email to VERIFY, an FDA spokesperson said, “this is the fastest a vaccine has been fully approved by the FDA.”
“Generally speaking, most vaccines are assigned standard review under PDUFA, with some notable exceptions — for instance, Gardasil or Ebola, which were both assigned priority review, but Ebola did not have a Vaccines and Related Biological Products Advisory Committee (VRBPAC),” the spokesperson continued.
According to Dr. Janet Woodcock, the acting commissioner of the FDA, the expedited process did not shortchange any safety standards.
"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 Woodcock.
The Pfizer-BioNTech COVID-19 vaccine will now be marketed as COMIRNATY® and used for the prevention of COVID-19 disease in individuals who are 16 years old and older.
Woodcock hopes the FDA’s approval of the vaccine will inspire more people to get vaccinated.
“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.,” said Woodcock.
Dr. Anna Durbin, a professor of International Health at Johns Hopkins Bloomberg School of Public Health, also hopes the vaccine’s approval will change the minds of people reluctant to get vaccinated.
“I'll be very interested to see if this does change people's minds because I think the message that we've sort of been trying to get out there all along is that although they were authorized under emergency use authorization, there was still a tremendous amount of safety data available for those vaccines, probably more safety data than we've had for any vaccine at any stage of approval,” said Durbin.
Pfizer says it intends to submit a supplemental BLA to support potential full FDA approval of COMIRNATY in individuals 12 through 15 years of age once the required data is available. Children in that age group remain eligible to receive the Pfizer COVID-19 vaccine under the EUA granted by the FDA on May 10.