The Priority Review

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Bundibugyo virus

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  1. Regulation

    AMA and EMA issue joint guidance on Ebola vaccine development

    The EMA's Emergency Task Force and the African Medicines Agency released a joint position paper outlining minimum requirements for clinical trials of Bundibugyo virus vaccines, including guidance on when animal toxicity studies may be waived. The paper also recommends early trials in Africa, a single-dose vaccine preference, and a ring trial design for Phase III studies.