Pfizer-BioNTech COVID-19 Vaccine Gets Full FDA Approval

FDA has granted full approval to Pfizer and BioNTech’s COVID-19 vaccine for individuals 16 years of age and older. 

This vaccine, previously known as the Pfizer-BioNTech COVID-19 Vaccine, will now be marketed as Comirnaty. Comirnaty is the first COVID-19 vaccine to be fully FDA approved. 

“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, MD, said in the announcement. 

“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,” Woodcock continued. 

In December 2020, FDA issued the first emergency use authorization for a COVID-19 vaccine to Pfizer and BioNTech, allowing for distribution across the country. 

The vaccine continues to be available under the emergency use authorization, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. 

FDA stated that approved vaccines undergo a standard process for reviewing the quality, safety, and effectiveness of medical products. The agency evaluates data and information included in the manufacturer’s submission of a biologics license application. 

Comirnaty’s biologics license application builds on the “extensive data” and previously submitted information supporting the emergency authorization.

This data includes preclinical and clinical data, as well as details of the manufacturing process, vaccine testing results, and inspections of the sites. 

Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, stated that medical experts conducted a thorough evaluation of Comirnaty, such as scientific data and information included in thousands of pages.

FDA also conducted its own analyses of Comirnaty’s safety and effectiveness and performed a detailed assessment of the manufacturing processes.

“We have not lost sight that the COVID-19 public health crisis continues in the US 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 US,” Marks concluded.