Interim Safety of RSVpreF Vaccination During Pregnancy

Ashley I Michnick; Sarah C MacDonald; Austin Cosgrove; Sruthi Adimadhyam; Fang Zhang; Andrew B Petrone; Katherine E Round; Sampada Gandhi; Nana Koram; Olympia E Anastasiou; Heather Rubino; Maria Maddalena Lino; Djeneba A Djibo; Jennifer L Kuntz; Shelly-Ann M Love; Cheryl N McMahill-Walraven; Kristin Palmsten; Anna E Wentz; Judith C Maro; Richard Platt; Susan E Andrade

doi:10.1001/jama.2025.23452

Interim Safety of RSVpreF Vaccination During Pregnancy

JAMA. 2026 Feb 3;335(5):456-459. doi: 10.1001/jama.2025.23452.

Authors

Ashley I Michnick^{1

2}, Sarah C MacDonald³, Austin Cosgrove², Sruthi Adimadhyam^{1

2}, Fang Zhang^{1

2}, Andrew B Petrone², Katherine E Round², Sampada Gandhi³, Nana Koram³, Olympia E Anastasiou³, Heather Rubino³, Maria Maddalena Lino³, Djeneba A Djibo⁴, Jennifer L Kuntz⁵, Shelly-Ann M Love⁶, Cheryl N McMahill-Walraven^{4

7}, Kristin Palmsten⁸, Anna E Wentz⁶, Judith C Maro^{1

2}, Richard Platt^{1

2}, Susan E Andrade^{1

2}

Affiliations

¹ Department of Population Medicine, Harvard Medical School, Boston, Massachusetts.
² Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
³ Worldwide Medical and Safety, Pfizer Inc, New York City, New York.
⁴ CVS Health, Blue Bell, Pennsylvania.
⁵ Kaiser Permanente Northwest Center for Health Research, Portland, Oregon.
⁶ Carelon Research, Wilmington, Delaware.
⁷ Now with Glade Oak, Inc, Philadelphia, Pennsylvania.
⁸ Pregnancy and Child Health Research Center, HealthPartners Institute, Minneapolis, Minnesota.

PMID: 41505122
PMCID: PMC12784259 (available on 2026-07-08)
DOI: 10.1001/jama.2025.23452

No abstract available

Plain language summary

This interim analysis of an ongoing retrospective cohort study uses data from 5 US health plans to assess safety of a bivalent prefusion F subunit–based respiratory syncytial virus (RSV) vaccine administered during pregnancy during the first full RSV season after US Food and Drug Administration approval (from September 22, 2023, through June 14, 2024).