The Priority Review

Regulation Brief

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.

Primary source

EMA news release, October 23, 2026

AMA and EMA issue joint guidance on Ebola vaccine development

Read the source: AMA and EMA issue joint guidance on Ebola vaccine development ema.europa.eu

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