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FDA Staff Call RSV Vaccine ‘Generally Favorable’ Despite Red Flags

  • May 18, 2023

Preterm births, low birth weight and infant developmental delay, were all noted as adverse events in Pfizer’s RSV vaccine clinical trials, but FDA reviewers apparently don’t think such events are serious enough to withhold approval for the shot. Pfizer submitted the trial data May 18, 2023, to the FDA’s Vaccines and Related Biological Products Advisory Committee with both serious and nonserious trial events listed. But after listening to the briefing, the panel indicated they...
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