Animal Rule - Poster - Challenges Facing Sponsors (Vaccines)
Author:
Mary Kate Hart, Ph.D.Summary:
No vaccine has yet been licensed using the Animal Rule. This regulatory approach still requires Sponsors to meet the manufacturing, quality, preclinical and clinical standards required under more traditional pathways to licensure. Licensure using animal models still poses the risk that the vaccine(s) may not work as intended in humans. Thus, efficacy testing using the Animal Rule could present a more complicated path to licensure than the more traditional route of efficacy testing in humans.
The biggest challenge is bridging animal and human responses following vaccination that supports the claim that the vaccine can provide clinical benefit to humans. Presented on July 13, 2009 at the Aerobiology in Biodefense III Conference in Cumberland, MD, this poster addresses challenges and efforts by Alliance for Biosecurity members and government to identify pathways forward.
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