FAQ: FDA Approval of Pfizer COVID-19 Vaccine
September 2, 2021
What does it mean that the Pfizer COVID-19 vaccine has received full approval from the Food and Drug Administration (FDA)?
Receiving full approval means the Pfizer vaccine now carries the FDA's strongest endorsement of safety and effectiveness. This is based on thorough research and comprehensive data review over many, many months.
What did the approval process involve?
Full FDA approval only occurs when enough data demonstrate that the vaccines are safe and effective for the majority of people who receive them. After many months of studies and hundreds of millions having received a COVID-19 vaccine, the FDA has substantial information on how safe and effective the COVID-19 vaccines are in protecting people, how well they prevent severe disease, and how the vaccines are safely and consistently manufactured.
What data did the FDA review?
The Pfizer-BioNTech COVID-19 vaccine underwent the FDA’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 biologics license application (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 stated the BLA submitted by Pfizer “builds on the extensive data and information previously submitted that supported the EUA, such as pre-clinical 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.”
Is the Pfizer COVID-19 vaccine considered safer than the other two vaccines still under emergency use authorization?
Like the Pfizer vaccine, both of the currently FDA-authorized COVID-19 vaccines (single-dose Johnson & Johnson/Janssen and two-dose Moderna) have been proven safe and effective based on extensive research. Pfizer was the first COVID-19 vaccine manufacturer to complete the arduous application and rigorous inspection process for full approval.
Does FDA approval of the Pfizer vaccine apply to everyone 12 years old and up?
No. At this time, the vaccine has received full FDA approval for individuals who are 16 years and older. The vaccine is still under emergency use authorization (EUA) for those who are 12-15 years old until Pfizer files its application for this specific age group. The vaccine is also still under EUA for the third dose for immunocompromised individuals.
When will the other currently available COVID-19 vaccines be approved?
Moderna has applied for full approval, and its vaccine is still being evaluated. Johnson & Johnson has indicated that it will likely apply for full approval later this year.
Will the name of the Pfizer COVID-19 vaccine change with the FDA approval?
Comirnaty will be the brand name of the Pfizer mRNA COVID-19 vaccine. It will likely not be commercially available until 2022. Until more information is available, the Pfizer vaccine doses will continue to be distributed to states using the existing process.
Once Comirnaty is commercially available, will individuals have to pay for the vaccine?
Cost and pricing information is not yet available for the FDA-approved product.