Tregunno, C., et al. AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine (Adjuvanted RSVPreF3): Review of the First 2 Years of Post-Marketing Safety Surveillance

Drug Saf, 2026 Aug 1. PMID: 42541670

Are you interested in a comprehensive two-year post-marketing safety surveillance of the AS01E-adjuvanted RSVPreF3 vaccine? This paper employs the liposomal saponin-based AS01E adjuvant system, highlighting its real-world safety profile in adults aged 60 and older. Given the critical role of saponin-based adjuvants like AS01E in enhancing immunogenicity, especially in older populations where immune responses are diminished, this study provides valuable evidence supporting the vaccine’s safety and consistent benefit-risk ratio outside controlled trials. 

Notably, the research identifies a large dataset of over 13 million doses and thousands of adverse event reports, demonstrating that most AEs are mild and confirming no increased risk for rare but serious conditions such as Guillain–Barré syndrome or atrial fibrillation.

This two-year post-marketing surveillance affirms that the AS01E adjuvant system in the RSVPreF3 vaccine maintains a favorable safety profile consistent with clinical trial data. The extensive real-world evidence demonstrates that the saponin-based adjuvant effectively enhances immunogenicity without introducing new safety concerns in older adults. These findings support the continued use of AS01E-adjuvanted vaccines in immunization programs aimed at protecting vulnerable populations against respiratory syncytial virus, underscoring the importance of vigilant post-marketing safety monitoring for saponin-based adjuvants in widespread immunization efforts.

Click here to access the full scientific paper.