What's the Harm? A Risk Model to Quantify Human and Animal Adverse Events From Environmentally Distributed Modified Live-Vaccine Viruses : [Preprint]

Findings: A low risk of 0·18 (95% CI: 0·08, 0·36) vaccine-associated human deaths per 10 million baits was simulated for campaigns where SADB19 was distributed to foxes. However, consistent with international concern, our model predicts that SAD-B19 distributed to dogs could result in 3·35 (95% CI: 2·83, 3·98) vaccine-associated human deaths per 10 million baits. The model simulated no deaths for SPBN GASGAS. Human deaths during dog campaigns was particularly sensitive to dog bite rate, and human deaths during wildlife campaigns was particularly sensitive to animal uptake rate and human contact rate with unconsumed baits. Interpretation: This model highlights the safety of newer live-attenuated rabies vaccines and serves as a platform for standardized approaches to inform risk assessments. Funding Statement: Time for this study was funded through a co-agreement between the Pubic Health Institute and the Centers for Disease Prevention and control. The funding source had no role in the study design, analysis, preparation of the manuscript, or decision to publish the manuscript. Declaration of Interests: AV is a full time employee of a pharmaceutical company, IDT Biologika GmbH, which manufactures oral rabies vaccine baits. TM from the Friedrich- Loeffler-Institute received funding from IDT Biologika GmbH in the frame of a research cooperation for research into mechanisms of oral rabies vaccination and resulting immunity.