Real-world evidence of yellow Fever vaccination data-driven study

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.

Keywords: Biostatistics; Electronic health records; Flavivirus; Real-world evidence; Vaccine; Yellow Fever.