FDA grants full approval to Pfizer-BioNTech Covid-19 vaccine
US Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech Covid-19 vaccine. Pfizer-BioNTech's Covid-19 vaccine has become the first jab to be granted full approval by the US Food and Drug Administration (FDA). The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease in individuals above 16 years of age.
Pfizer-BioNTech's Covid-19 vaccine has become the first jab to be granted full approval by the US Food and Drug Administration (FDA).
The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease in individuals above 16 years of age.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 to 15 years of age 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, M.D.
“While millions of people have already 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 US.”
Since December 11, 2020, the Pfizer-BioNTech Covid-19 vaccine has been available under EUA in individuals above 16 years of age, and the authorization was expanded to include those between 12 and 15 years of age on May 10, 2021.
EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
Managing the standard
FDA-approved vaccines undergo the agency’s 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 BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, 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 agency conducts its own analysis of information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.