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New interim data from two RSV vaccination seasons show that getting the RSV vaccine (Abrysvo) during pregnancy doesn't raise safety concerns for moms or babies. In fact, vaccinated pregnancies had a slightly lower rate of preterm births compared to unvaccinated ones. Researchers say the findings add to a growing body of real-world evidence supporting maternal RSV vaccination.
When Pfizer's maternal RSV vaccine (Abrysvo) was first approved in the U.S., lingering questions about pregnancy safety — particularly around preterm birth — kept some clinicians and parents on the fence. Now, new interim data covering two full vaccination seasons are offering some much-needed reassurance.
Researchers from Harvard Pilgrim Health Care Institute analyzed outcomes from over 131,000 eligible live-birth pregnancies across five U.S. health plans. They matched 17,297 vaccinated pregnancies with unvaccinated counterparts and found no concerning patterns in preterm birth, hypertension, or other major maternal and newborn outcomes. Notably, vaccinated pregnancies had a lower rate of preterm births than unvaccinated ones.
By the Numbers:
Why it matters: Early safety concerns about preterm birth had led to the vaccine being licensed for use later in pregnancy. These findings, while interim and not yet definitive, strengthen the case for maternal RSV vaccination and give clinicians more confidence to recommend it — ultimately helping protect newborns from a virus that can be dangerous in the first months of life.