During a multicountry Ebola emergency, the agencies outline when existing safety data could justify postponing some animal tests to help human trials begin sooner.
The African Medicines Agency and the European Medicines Agency’s Emergency Task Force have published joint guidance to help developers begin human trials of vaccines against Ebola disease caused by Bundibugyo virus. The paper sets minimum requirements and recommends trial designs; African national regulators would still need to approve proposed trials.
In its 23 October announcement, the European Medicines Agency cited the ongoing public-health emergency in the Democratic Republic of the Congo, with cases also detected in Uganda, Kenya and Nigeria. The agencies recommend moving vaccine candidates through trial stages as quickly as possible while maintaining rigorous scientific evaluation and safeguards for participants.
The paper follows a scientific consultation with experts hosted by the two agencies and the World Health Organization on 24 August 2026.
The guidance explains when certain animal toxicity studies, which assess harmful effects, may be postponed or waived. That requires scientific justification based on well-understood data about the vaccine platform—the underlying technology—or existing safety data from other vaccines using the same platform. The paper highlights cases where different antigens, the components used to trigger an immune response, have not changed the overall safety profile.
This does not remove the need for other animal studies. Before candidates advance to Phase II/III human trials, the guidance calls for non-human challenge studies, in which subjects are exposed to the virus, to assess whether the vaccines have a chance of working. Those studies would not establish that vaccination prevents disease in people.
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To establish whether vaccination prevents disease, the paper proposes a pivotal Phase III study using a ring-trial approach. Researchers would enrol people who had been in close contact with a confirmed case and assign them by chance to trial groups. A shared study could potentially evaluate several vaccine candidates.
Because Bundibugyo Ebola disease also affects children and pregnant women, the guidance recommends starting studies in these groups once sufficient initial safety data from adults are available.
The agencies favour conducting early trials in Africa where possible, making it easier to move into larger studies of whether vaccines work in affected populations. They also prefer a single-dose vaccine because it would be easier to deploy rapidly during an outbreak.
The recommended next step is for developers to consult the African Medicines Agency and relevant national regulators early. Those discussions would help developers prepare trial applications and meet requirements for possible vaccine authorisation.
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The team will advise the EU Delegation in Abuja, while ECDC has offered Nigerian authorities help to track infections and prevent their spread.
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