Risk for Preterm Birth Stops Maternal RSV Vaccine Trial

A phase 3 trial of a maternal vaccine candidate for respiratory syncytial virus (RSV) was stopped early due to a higher risk of preterm births in the vaccine group compared to the placebo group. The trial, sponsored by GSK, involved 5328 pregnant women receiving the candidate vaccine or placebo. Data showed a 6.8% preterm birth rate in the vaccine group compared to 4.9% in the placebo group. The GSK vaccine had a slight increase in preterm labor and neonatal death, unlike the approved Pfizer vaccine. Further investigation is needed to understand the cause of the higher risk in low- to middle-income countries, where the medical need for maternal RSV vaccines is significant.

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