FDA advisers back Pfizer’s maternal RSV vaccine after voicing safety concerns

Whether Pfizer’s maternal respiratory syncytial virus (RSV) vaccine candidate increases the risk of preterm birth dominated discussions at a meeting last week of the committee advising the US Food and Drug Administration (FDA).1 While all members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted positively on efficacy, four out of 14 voted that the data were not adequate to support safety.As The BMJ revealed earlier this month,2 Pfizer’s clinical trials showed increased levels of preterm births among vaccinated women, and GSK, which was working on a similar vaccine, halted vaccination in its phase 3 trials after observing an increase in neonatal deaths and preterm births.34Paul Offit, professor of paediatrics at the Children’s Hospital of Philadelphia and VRBPAC member who voted “no” on safety, said at the meeting that he had “no problem” with efficacy. On safety, however, “the GSK experience” troubled him.5 “If preterm births are in…
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