AMA and EMA joint guidance to accelerate BDBV Ebola vaccine trials
- Joint position paper sets minimum requirements to start clinical trials and gives trial-design advice following an AMA–EMA–WHO consultation on 24 August 2026.
- Allows postponement or waiver of certain animal toxicity studies for vaccines with well‑characterised platform data, including mRNA and some viral‑vector platforms.
- Recommends early trials in Africa, non‑human challenge studies before Phase II/III, and preference for single‑dose vaccines to ease outbreak deployment.
- Proposes a platform Phase III ring trial enrolling contacts of confirmed cases, permitting multiple candidates in one study; children and pregnant women to be included after adult safety data.
Scope and rationale
EMA’s Emergency Task Force and the African Medicines Agency published a joint position paper after a scientific consultation on 24 August 2026 to support timely start of clinical trials for vaccines against Bundibugyo virus (BDBV) amid an ongoing public‑health emergency in the Democratic Republic of the Congo, with cases also detected in Uganda, Kenya and Nigeria.
Preclinical requirements
The paper outlines minimum requirements to start trials and explains when it may be scientifically justified to postpone or waive certain animal toxicity studies for vaccines with well‑characterised platform data, such as mRNA and certain viral‑vector vaccines, or where safety data exist from other vaccines using the same platform.
Trial design and conduct
It advises conducting early trials in the African region, performing non‑human challenge studies before progression to Phase II/III, and favors single‑dose vaccines for rapid outbreak deployment. For efficacy assessment it proposes a platform pivotal Phase III ring trial enrolling close contacts of confirmed cases and allowing multiple candidates in the same trial.
Population and regulatory interaction
Because BDBV affects children and pregnant women, studies in these groups should start once sufficient adult safety data are available. Developers are advised to engage early with AMA and national regulatory authorities in Africa to obtain scientific and regulatory advice and to facilitate trial approvals and potential authorisation.
Source: EMA