GSK stopped developing a vaccine for pregnant women to protect newborns against syncytial virus (RSV) after identifying an increased risk of preterm births. Pfizer won approval of its nearly identical vaccine after the company said the increased rate of preterm births in its trials was statistically insignificant.

GSK on Thursday provided more details on the clinical trials for its maternal respiratory syncytial virus (RSV) vaccine. The company halted the trials and stopped developing the vaccine in February 2022, after identifying an increased risk of preterm birth among vaccinated mothers.

The details, published in a peer-reviewed article in the New England Journal of Medicine (NEJM), came after GSK previously reported the increased risk and subsequent termination of the trials to regulators, GSK’s investors and in the press.

According to the NEJM article, GSK was unable to identify a mechanism by which the vaccine caused the preterm births. However, the company also couldn’t identify any causes other than the vaccine being investigated.

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