3rd Booster Dose Authorized for mRNA COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) announced it amended the emergency use authorization (EUA) for the Pfizer-BioNTech Comirnaty COVID-19 Vaccine to allow for the use of a single booster dose, to be administered at least six months after completion of the primary series.

This third dose of the Comirnaty vaccine is authorized at least six months following completion of their primary series for:

• individuals 65 years of age and older;
• individuals 18 through 64 years of age at high risk of severe COVID-19; and 
• individuals 18 through 64 years of age whose frequent institutional or occupational exposure to the SARS-CoV-2 coronavirus puts them at high risk of serious complications of COVID-19.

Today's FDA Authorization was granted to Pfizer Inc. and applied only to the two-dose Pfizer-BioNTech Comirnaty COVID-19 Vaccine and not the Moderna SpikeVax or Johnson & Johnson Janssen vaccines.

The FDA considered the data that the vaccine manufacturer submitted, the information presented at the Vaccines and Related Biological Products Advisory Committee meeting, and the committee's discussion, and has determined that based on the totality of the available scientific evidence, a booster 3rd dose of Pfizer-BioNTech Comirnaty COVID-19 Vaccine may be effective in preventing COVID-19.

And, that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use.

Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months, stated the FDA.

Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research, stated in the press release, "The FDA considered the committee's input and conducted its own thorough review of the submitted data to reach today's decision."

"We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines, and we will make further decisions as appropriate based on the data." 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.