Pfizer/BioNTech COVID-19 Vaccine's Positive Advisory Committee Complicated By Pediatric Issues
US FDA expected to quickly clear the first emergency use authorization for a COVID-19 vaccine following 17-4 VRBPAC vote, but a disorganized committee ending made it unclear why some members voted no. Pediatric data was at issue for at least two voters, though.
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J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.
With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.
CBER Director Peter Marks said the VRBPAC may need to opine on the immunogenicity data gathered for vaccine updates.