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EMA and African Medicines Agency set trial requirements for Bundibugyo Ebola vaccines

🇪🇺 EMA · Fri 23 Oct 2026

A joint position paper from EMA's Emergency Task Force and the AMA sets minimum requirements and design advice to speed clinical trials of vaccines against Bundibugyo virus.

EMA's Emergency Task Force and the African Medicines Agency (AMA) have published a joint position paper on the clinical development of vaccines against Ebola disease caused by Bundibugyo virus (BDBV). It sets out the minimum requirements for starting clinical trials and gives advice on trial design.

The paper follows a scientific consultation with experts on 24 August 2026, hosted by AMA, EMA and the World Health Organization. The agencies point to an ongoing public health emergency in the Democratic Republic of the Congo, with cases also detected in Uganda, Kenya and Nigeria. They say candidates should move through trial phases as quickly as possible, while rigorous scientific evaluation and safeguards for participants, including vulnerable groups, are maintained.

On nonclinical data, the paper explains when it may be scientifically justified to postpone or waive certain animal toxicity studies. This applies to vaccines with well-characterised platform data, such as mRNA and certain viral-vector vaccines, or where safety data exist from other vaccines on the same platform and different antigens have not changed the overall safety profile. Non-human challenge studies should be run before candidates advance to Phase II/III, and a single-dose vaccine is preferred because it would be easier to deploy in an outbreak.

For efficacy, the paper proposes a platform pivotal Phase III study as a valid approach. It would randomise close contacts of confirmed cases (a ring trial) and could assess several candidates in one trial. Early trials should ideally take place in Africa to ease the move to larger efficacy studies in affected populations. Studies in children and pregnant women should start once enough initial adult safety data are available.

The paper also encourages timely approval of these trials by African national regulatory authorities. Developers are urged to seek early scientific and regulatory advice from AMA and the relevant authorities to support trial assessment and any future authorisation. The document is published as EMA/228242/2026.

What it means for your team

  • Developers of BDBV vaccines should plan early engagement with AMA and African national regulators, not only EMA, to align on trial assessment and later authorisation.
  • Platform-based candidates (mRNA, certain viral vectors) may be able to postpone or waive some animal toxicity studies, but justification rests on well-characterised platform safety data.
  • Protocols should anticipate non-human challenge data before Phase II/III, a preference for single-dose regimens, and ring-trial designs that can test multiple candidates.
  • Safety teams should plan staged inclusion of children and pregnant women, following sufficient initial adult safety data.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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