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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However, recruitment for adult trials remains robust, OWS’ Slaoui says.
Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s phrasing of voting question complicated meeting but resulted in minimal harm.
After the various turnovers, the panel will be one person smaller, and while the agenda includes familiar topics, including maintaining placebo controls after a vaccine is available, the presentation order will be different.