Ebola Vaccine Trials May Be Limited by Waning Epidemic
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Experimental Ebola vaccines to be tested in West Africa may go through an alternative path for U.S. regulatory approval because a waning epidemic is making it difficult to collect the full array of data normally gathered in clinical trials.
The vaccines, developed by the U.S. National Institutes of Health, GlaxoSmithKline Plc, Merck & Co. and NewLink Genetics Corp., may be filed to regulators using human safety and immune response results from trials in Liberia and Sierra Leone, together with efficacy data from earlier animal studies, National Institute of Allergy and Infectious Diseases Director Anthony Fauci told reporters on a conference call. Regulatory approval of new drugs usually requires both safety and efficacy data in humans.