Sequential Safety Surveillance of RSVpreF Vaccination During Pregnancy Early in the Postapproval Period

What is the safety profile of a bivalent respiratory syncytial virus prefusion F subunit–based vaccine (RSVpreF) for maternal immunization to protect newborns?In this cohort study of 13 619 RSVpreF-exposed pregnancies, a sequential surveillance analysis found no association between RSVpreF vaccination during pregnancy and preterm birth and 6 other prespecified safety concerns; however, potential elevated risks for pregnancy-associated hypertensive disorders, premature rupture of membranes (PROM), and preterm PROM could not be ruled out, due to limited confounding control available in the early postlicensure period.In this study, no association between RSVpreF vaccination during pregnancy and preterm birth was found, but some potential safety outcomes during early postlicensure surveillance could not be ruled out, which should be investigated further in future epidemiological studies.

Corresponding Author: Ashley I. Michnick, PharmD, PhD, Department of Population Medicine, Harvard Medical School ashley_michnick@hphci.harvard.edu).

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