The two-day meeting of the Food and Drug Administration’s vaccine advisory committee has raised new uncertainties about the most-watched Big Pharma showdown of 2023: Pfizer and GSK’s race to bring the first RSV vaccines to market.
The safety and efficacy of both companies’ respiratory syncytial virus (RSV) vaccines in older adults eventually received the backing of the majority of the FDA’s advisers on the panel. But advisers raised significant questions about Pfizer PFE +0.71% vaccine, and some suggested that an additional Phase 3 study should be undertaken before the company’s vaccine receives FDA approval.