This article reviews data encompassing the pharmacology, efficacy, and safety of RSVpreF (Abrysvo®), a subunit vaccine approved to prevent respiratory syncytial virus (RSV) in adults aged ≥60 years, infants via maternal transfer of antibodies, and adults aged 18 to 59 at increased risk of severe disease, including immunocompromised populations.
Data Sources:
A literature review was conducted in PubMed, MEDLINE, National Institutes of Health Clinical Trials Registry, and ClinicalTrials.gov from inception through May 2026, using the search terms Abrysvo, RSVpreF, RSV vaccine, and respiratory syncytial virus. Articles from reference lists were included to identify potentially relevant literature. Guidance documents, including Food and Drug Administration (FDA) briefing documents, package inserts, and recommendations from Advisory Committee on Immunization Practices were included.
Study Selection and Data Extraction:
Data were limited to human clinical studies published in the English language, which evaluated the efficacy, immunogenicity, and safety of RSVpreF.
Data Synthesis:
Eight studies are included describing RSVpreF, consisting of 1 phase I, 2 phase II, 4 phase III, and 1 phase IV clinical study.
Relevance to Patient Care and Clinical Practice in Comparison to Existing Agents:
To protect vulnerable infants, maternal immunization is recommended as a single dose between 32 and 36 weeks of gestation, typically from September through January. Current clinical guidance recommends vaccination for all adults aged ≥75, and those aged 60 to 74 with one or more risk factors for severe RSV disease.
Conclusion:
RSVpreF provides protection against RSV for older adults, high-risk/immunocompromised populations, and infants via maternal transfer. RSVpreF effectively reduces the incidence of severe lower respiratory tract infections, bronchiolitis, and hospitalizations.
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