GSK Halts Enrollment In Maternal RSV Vaccine Trials As Setback Intensifies
The company has not revealed any details of the potential safety issue that led to the decision.
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Results from a Phase III trial testing the RSV vaccine Arexvy in adults 50-59 met the two primary endpoints, potentially opening the door to a wider adult market.
Abrysvo is recommended for use in pregnant people 32-36 weeks gestation if administered from September to January. For infants whose mothers were not vaccinated in this window, nirsevimab is recommended for prevention of respiratory syncytial virus infection.
The vaccine, already approved for adults, was approved for pregnant women to protect infants from birth up to six months from complications caused by respiratory syncytial virus.