Approach to Strain Selection and the Propagation of Viral Stocks for Venezuelan Equine Encephalitis Virus Vaccine Efficacy Testing under the Animal Rule
Licensure of a vaccine to protect against aerosolized Venezuelan equine encephalitis virus (VEEV) requires use of the U.S.Food and Drug Administration Therapuetic Skin (FDA) Animal Rule to assess vaccine efficacy as human studies are not feasible or ethical.An approach to selecting VEEV challenge strains for use under the Animal Rule was developed,