FDA advisory panel discusses COVID-19 vaccine expansion for Pfizer/BioNTech

The US Food and Drug Administration (FDA) is meeting to discuss amending the emergency use authorization of the Pfizer/BioNTech vaccine for children aged 5 to 11 years.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is holding an all day meeting on October 26, 2021, to discuss the request from Pfizer/BioNTech to amend the Emergency Use Authorization to include children aged 5 to 11 years.

At the meeting, the Centers for Disease Control and Prevention will present on the epidemiology of COVID-19 in children and known safety signals which includes myocarditis in adolescents and young adults. Following a presentation from Pfizer-BioNTech for the expanded authorization, a review of the submission will occur as well an analysis of benefit versus risk. A 1 hour open public hearing session will occur at 1 PM.

The proceedings can be viewed live here.