MedPage Today May 16, 2023
— But agency reviewers flag numerical imbalance in premature deliveries
A maternal respiratory syncytial virus (RSV) vaccine candidate prevents infections in infants and comes with “generally favorable” safety data, said FDA staff in briefing documents released ahead of an advisory committee meeting this week, but the reviewers “noted potential uncertainty based on the numerical imbalance in premature deliveries.”
On Thursday, members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will weigh in on whether the available data support the safety and efficacy of Pfizer’s RSV prefusion F protein vaccine when given to mothers in the second or third trimester of pregnancy for preventing RSV-related lower respiratory tract illness in infants, including severe cases.
The FDA recently approved the...
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