USA – FDA convenes adcomm for Pfizer COVID booster

The US Food and Drug Administration (FDA) announced late Wednesday afternoon that it plans to hold an advisory committee meeting on 17 September to discuss a third booster shot of the Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 years and up.

« The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency’s advisory committee to inform our decision-making,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the FDA in Brief announcement.

Pfizer and its German partner, BioNTech, announced last week that they had initiated a rolling submission to FDA for a booster dose of their fully approved vaccine, now known as Comirnaty, for individuals aged 16 years and up…