Publication

Interim Safety of RSVpreF Vaccination During Pregnancy

Journal of the American Medical Association
February 3, 2026
Authors:

Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R, Andrade SE

Capability:
Pregnancy & Mother-Infant Linked Studies
Multi-Site Methods & Coordination
Expertise:
Regulatory Research & Support
RWE Research & Consulting

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).

Access on PubMed

Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R, Andrade SE. Interim Safety of RSVpreF Vaccination During Pregnancy. JAMA. 2026 Feb 3;335(5):456-459. doi: 10.1001/jama.2025.23452. PMID: 41505122; PMCID: PMC12784259.