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Pfizer/BioNTech COVID-19 Vaccine's Positive Advisory Committee Complicated By Pediatric Issues

 
• By Sarah Karlin-Smith

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.

Five advisory committee members opted not to endorse Pfizer's vaccine, but they didn't get a chance to explain why. • Source: illustration based on committee slide

The US Food and Drug Administration’s vaccine advisory committee voted 17-4 with one abstention on 10 December in favor of issuing an emergency use authorization for Pfizer Inc. and BioNTech SE’s COVID-19 vaccine in individuals 16 years of age and older, likely guaranteeing the companies a swift and historic authorization.

But the abruptly curtailed meeting, which ended without the typical explanation of each panelist’s vote, left lingering questions about why nearly 25 percent of the Vaccines and Related Biological Products...

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