The FDA Once Again Grants "Emergency Use" Authorization To Pfizer And Moderna's Covid-19 Vaccines

The Food and Drug Administration has once again granted "Emergency use authorization" to Pfizer-BioNTech and Moderna for their Covid-19 vaccine "Booster" shots.

Today, the U.S. Food and Drug Administration amended the emergency use authorizations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.

In June, the agency's Vaccines and Related Biological Products Advisory Committee voted overwhelmingly to include an omicron component in COVID-19 booster vaccines.

The FDA also made a revision to the EUA for the "Monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older."

With today's authorization, the FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively.

"The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research.

"We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations. The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization."

https://beckernews.com/the-fda-once-again-grants-emergency-use-authorization-to-pfizer-and-modernas-covid-19-vaccines-46682/