RSV Vaccine Confirmed Safe for Mothers and Babies in New French Study
Paris, France – A large-scale French study has affirmed the safety of the Abrysvo vaccine for preventing respiratory syncytial virus (RSV) infections in newborns, offering reassurance as the vaccination campaign rolls out across the country. published November 14 in obstetrics and Gynecology, the research found no increased risk of adverse outcomes for mothers or babies linked to the vaccine.
RSV is a common virus that causes bronchiolitis, a potentially serious infection, especially in infants. The Abrysvo vaccine utilizes passive immunization, administered to pregnant women between 32 and 36 weeks of gestation, to protect their newborns. France’s vaccination campaign began on September 1st, aiming to shield vulnerable infants from severe illness.
The study, conducted by EPI-PHARE – a collaboration between the National Medicines safety Agency (ANSM) and the Cnam – analyzed data from the national health database (SNDS), encompassing over 29,000 vaccinated women who gave birth after 22 weeks of amenorrhea between September 15 and December 31, 2024. Researchers meticulously matched vaccinated women with a comparable group of unvaccinated women, accounting for factors like prior prematurity and influenza vaccination during pregnancy.
The analysis assessed risks including premature birth, delivery timing relative to vaccination, stillbirth, low birth weight, cesarean section, postpartum hemorrhage, preeclampsia/eclampsia/HELLP syndrome, and serious cardiovascular events.Results showed no elevated risk associated with abrysvo vaccination overall. However, the study identified a potential signal requiring further monitoring: a slight increase in the risk of premature birth among the 6% of women vaccinated before or at 32 weeks of amenorrhea.
“even though a causal link with vaccination cannot be established from this study, this trend, already reported in previous studies, is already the subject of reinforced monitoring,” the ANSM stated. The findings provide critical data supporting the ongoing vaccination program and highlight the importance of adhering to the recommended gestational age for vaccine administration.
