Nonadjuvanted Bivalent Respiratory Syncytial Virus Vaccination and Perinatal Outcomes

Nonadjuvanted Bivalent Respiratory Syncytial Virus Vaccination and Perinatal Outcomes

July 8, 2024 | Moeun Son, MD, MSCI; Laura E. Riley, MD; Anna P. Staniczenko, MD, MSc; Julia Cron, MD; Steven Yen, MS; Charlene Thomas, MS; Evan Sholle, MS; Lauren M. Osborne, MD; Heather S. Lipkind, MD, MS
A nonadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) protein subunit vaccine was approved for use in pregnant individuals during the 2023-2024 RSV season. This retrospective observational study evaluated the association between prenatal RSVpreF vaccination and perinatal outcomes in 2973 pregnant individuals who delivered between September 2023 and January 2024. Of these, 34.5% had evidence of RSVpreF vaccination. The primary outcome was preterm birth (PTB), defined as less than 37 weeks' gestation. No significant association was found between RSVpreF vaccination and increased risk of PTB after adjusting for potential confounders. However, there was an increased risk of hypertensive disorders of pregnancy (HDP) in the time-dependent model. No significant differences were found in other pregnancy and neonatal outcomes between vaccinated and unvaccinated groups. The study found that RSVpreF vaccination was not associated with an increased risk of PTB or perinatal outcomes. These data support the safety of prenatal RSVpreF vaccination, but further investigation into the risk of HDP is needed. The study highlights the importance of prenatal RSVpreF vaccination in reducing RSV-related complications in infants. The findings suggest that the vaccine is safe for use in pregnant individuals, but more research is required to fully understand its effects.A nonadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) protein subunit vaccine was approved for use in pregnant individuals during the 2023-2024 RSV season. This retrospective observational study evaluated the association between prenatal RSVpreF vaccination and perinatal outcomes in 2973 pregnant individuals who delivered between September 2023 and January 2024. Of these, 34.5% had evidence of RSVpreF vaccination. The primary outcome was preterm birth (PTB), defined as less than 37 weeks' gestation. No significant association was found between RSVpreF vaccination and increased risk of PTB after adjusting for potential confounders. However, there was an increased risk of hypertensive disorders of pregnancy (HDP) in the time-dependent model. No significant differences were found in other pregnancy and neonatal outcomes between vaccinated and unvaccinated groups. The study found that RSVpreF vaccination was not associated with an increased risk of PTB or perinatal outcomes. These data support the safety of prenatal RSVpreF vaccination, but further investigation into the risk of HDP is needed. The study highlights the importance of prenatal RSVpreF vaccination in reducing RSV-related complications in infants. The findings suggest that the vaccine is safe for use in pregnant individuals, but more research is required to fully understand its effects.
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