Parallel Paths to Licensing the First Wildlife Rabies Vaccine in the United States
摘要
During the early 1990s three simultaneous wildlife rabies outbreaks in the United States (US) forced state and federal disease prevention agencies to find a novel approach to rabies prevention. One outbreak, that spread along the entire Atlantic Coast, was caused by translocation of rabid raccoons from Florida into Appalachian hunting camps. The second was a dog-rabies virus variant infecting coyotes along the US-Mexico border in south Texas. A third was in the west-central plains of Texas where there was a dramatic increase in endemic gray fox rabies cases. To address these outbreaks a new recombinant poxvirus vectored oral rabies vaccine (ORV) was developed, initially for evaluation in raccoons. Public and private entities collaborated under unusual circumstances to meet US veterinary rabies vaccine licensing requirements as well as new environmental release requirements for genetically modified organisms. The US licensure of RABORAL V-RG® (V-RG) for raccoons in 1997, and the coyote claim added in 2002, were milestone events in this vaccine’s history. The V-RG vaccine was the first US wildlife rabies biologic, the first US licensed veterinary ORV, and the first US vectored-recombinant rabies vaccine. Its use led to elimination of the canine rabies virus variant from the US in 2007, Texas grey fox rabies in 2013, and reduced raccoon rabies in the eastern US. This chapter is a compilation of the authors’ memories and perceptions about obtaining the vaccine license and claim. Licensing of the V-RG vaccine is a public health success story filled with instances of negotiation, collaboration, and logical evaluations that required a determined focus by all parties to reach a new goal in rabies prevention and control.