FDA approves Pfizer, BioNTech Covid vaccine booster for certain populations

The Food and Drug Administration amended the emergency use authorization for the Pfizer (PFE) -BioNTech (BNTX) Covid-19 vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: 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 SARS-CoV-2 puts them at high risk of serious complications of Covid-19. The authorization applies only to the Pfizer-BioNTech Covid vaccine. “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,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.