Abstract
Yellow Fever (YF), a mosquito-borne viral disease caused by yellow fever virus (YFV), remains endemic in tropical Sub-Saharan Africa and South America. The 17D live-attenuated vaccine has significantly reduced YF incidence with minimal risk of vaccine-associated adverse events, including Yellow Fever Vaccine–fever-associated Neurotropic Disease (YEL-AND) and Yellow Fever Vaccine–Associated Viscerotropic Disease (YEL-AVD). This study investigates the potential of Real-World Evidence (RWE) to enhance vaccine surveillance by analyzing electronic health records (EHRs) from the TriNetX platform, which identified a total of 15,835 individuals who were vaccinated with the Stamaril® YF vaccine between 2017 and 2021 in the United States. We compared adverse event rates obtained from RWE with those reported by the manufacturer in a recent study of Stamaril® used in the United States during this period. Our findings were consistent with those published previously and suggest no significant increase in adverse medical outcomes post-vaccination across all age groups, particularly in long-term analysis. This proof-of-concept study underscores the value of RWE in monitoring vaccine safety and supports its potential to complement traditional surveillance methods, offering a robust tool for continuous post-marketing vaccine evaluation.
Original language | English (US) |
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Article number | 126758 |
Journal | Vaccine |
Volume | 48 |
DOIs | |
State | Published - Feb 27 2025 |
Keywords
- Biostatistics
- Electronic health records
- Flavivirus
- Real-world evidence
- Vaccine
- Yellow Fever
ASJC Scopus subject areas
- Molecular Medicine
- General Immunology and Microbiology
- General Veterinary
- Public Health, Environmental and Occupational Health
- Infectious Diseases