Approach to Strain Selection and the Propagation of Viral Stocks for Venezuelan Equine Encephalitis Virus Vaccine Efficacy Testing under the Animal Rule
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DOI: 10.3390/v11090807
Abstract: Licensure of a vaccine to protect against aerosolized Venezuelan equine encephalitis virus (VEEV) requires use of the U.S. Food and Drug Administration (FDA) Animal Rule to assess vaccine efficacy as human studies are not feasible… read more here.
Keywords: selection; viral stocks; propagation viral; vaccine ... See more keywords
Bridging Animal and Human Data in Pursuit of Vaccine Licensure
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DOI: 10.3390/vaccines10091384
Abstract: The FDA Animal Rule was devised to facilitate approval of candidate vaccines and therapeutics using animal survival data when human efficacy studies are not practical or ethical. This regulatory pathway is critical for candidates against… read more here.
Keywords: animal rule; vaccine licensure; animal human; licensure ... See more keywords