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- Source: European Medicines Agency https://www.ema.europa.eu/en/news/ama-ema-issue-joint-guidance-ebola-vaccine-development
The European Medicines Agency's Emergency Task Force and the African Medicines Agency have published joint guidance on how clinical trials for vaccines against Ebola disease caused by Bundibugyo virus should be launched quickly, the two bodies said, following an expert consultation they hosted with the World Health Organization on 24 August 2026.
Key facts
- The joint position paper (reference EMA/228242/2026) was issued by the European Medicines Agency's Emergency Task Force and the African Medicines Agency.
- A scientific consultation with experts was hosted by the AMA, the EMA and the World Health Organization on 24 August 2026.
- Cases of Bundibugyo virus Ebola disease have been detected in the Democratic Republic of the Congo, Uganda, Kenya and Nigeria.
- The guidance sets out minimum requirements for starting trials and calls on African national regulatory authorities to approve them promptly.
- A single-dose vaccine is described as the preferred option for rapid deployment during an outbreak.
What does the guidance recommend?
According to the position paper, vaccine candidates should move through the different clinical trial phases as rapidly as possible given the ongoing public health emergency in the Democratic Republic of the Congo, while rigorous scientific evaluation and adequate safeguards for trial participants, including vulnerable groups, are maintained.
The document sets out the minimum requirements for launching trials and offers advice on trial design. It also urges African national regulatory authorities to approve such trials without delay so that development of vaccines aimed specifically at Bundibugyo virus can be accelerated.
Which studies could be skipped?
The guidance explains when it may be scientifically justified to postpone or waive certain animal toxicity studies for vaccines built on well-characterised platforms, such as mRNA and some viral-vector vaccines. It says such studies might also be deferred or dropped where safety data already exist from other vaccines using the same platform technology, particularly where different antigens have not altered the overall safety profile.
Ideally, early-stage trials should be run in the African region so that the move to larger efficacy studies in affected populations is as efficient as possible. Non-human challenge studies should be carried out to establish that a vaccine has a chance of working before it advances to Phase II/III trials.
How would efficacy be tested?
A single-dose vaccine is preferred because it would be simpler to deploy quickly during an outbreak, the paper says. To assess whether vaccination prevents disease, it proposes a platform pivotal study at Phase III based on enrolling and randomising people who have had close contact with a confirmed case, a so-called ring trial, as a valid approach. Several vaccine candidates could potentially be assessed within the same trial.
Because Bundibugyo virus disease also affects children and pregnant women, studies in these groups should begin once sufficient initial safety data from adults are available, according to the guidance.
What happens next?
Vaccine developers are urged to engage early with regulators, including the African Medicines Agency and the relevant national regulatory authorities in Africa, to obtain scientific and regulatory advice, ease clinical trial assessments and ensure that regulatory requirements are met for any eventual authorisation of promising vaccines.
The position paper is published alongside the Emergency Task Force's recommendations and material from the World Health Organization and the African Medicines Agency, an African Union body. For European regulators, the joint approach extends the bloc's emergency vaccine-assessment work into a direct partnership with African authorities, and the document's call for early developer engagement points to trial applications being filed with African regulators as the next practical step.
Source: European Medicines Agency
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