Kigali: The European Medicines Agency and the African Medicines Agency have set minimum requirements for starting clinical trials of a Bundibugyo Ebola vaccine, in a joint position paper published on 23 October 2026. The document aims to speed up development during an ongoing public health emergency in the Democratic Republic of the Congo while protecting trial participants, including children and pregnant women.

The paper comes from EMA’s Emergency Task Force and the African Medicines Agency, and it follows a scientific consultation that the two agencies convened with the World Health Organization on 24 August 2026. It targets developers of mRNA and viral-vector vaccines against Bundibugyo virus and the national regulatory authorities in Africa that must approve the studies. Reports on the outbreak say cases have also been confirmed in Uganda, Kenya and Nigeria.

On safety testing, the agencies allow some flexibility. Certain animal toxicology studies can be postponed or waived for mRNA and selected viral-vector platforms that already have an established safety record with other antigens, provided the new antigen does not materially change the overall safety profile. Any developer of a Bundibugyo Ebola vaccine that relies on this route will still need to explain the reasoning in its regulatory dossier.

The paper is firm on one point, however. Non-human primate challenge studies must be completed before a candidate enters Phase II or Phase III trials, so that biological activity is shown before efficacy is tested in people. The agencies also say early trials should take place within Africa, and they ask developers to open dialogue with the African Medicines Agency and national regulators early, covering scientific advice, trial assessment and authorisation.

For any Bundibugyo Ebola vaccine, national regulators are asked to expedite trial approvals given the outbreak. Studies in children and pregnant women are required once adult safety data reach a sufficient threshold.

The proposed trial design is built for speed. A single-dose regimen is favoured because it is easier to deploy in an outbreak, and a ring trial is proposed as the main efficacy design for pivotal Phase III studies. In a ring trial, people with confirmed close contact with a case are enrolled, and the design allows several candidates to be compared inside one platform trial rather than in separate studies.

For Europe the paper on the Bundibugyo Ebola vaccine shows how EMA now works as a partner rather than only a licensing body. By agreeing common expectations with African regulators before any candidate reaches the clinic, the agencies hope to avoid duplicated studies and delays between approval in one jurisdiction and another. The next measurable checkpoint will be how quickly national authorities approve trial applications submitted under the new framework.

Developers now have a clearer route, but time remains the constraint. A Bundibugyo Ebola vaccine has to move from preclinical work to field trials while the outbreak is still active, and the joint position paper is the first attempt to make the regulatory path short enough for that to happen.