The European Medicines Agency's Emergency Task Force (EMA-ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential vaccines against Ebola disease caused by Bundibugyo virus (BDBV), the EMA said. The paper was developed following a scientific consultation hosted by AMA, EMA and the World Health Organization (WHO) on 24 August 2026.

Source: European Medicines Agency (EMA)

Given the ongoing public health emergency in the Democratic Republic of the Congo (DRC), with cases also detected in Uganda, Kenya and Nigeria, candidates for BDBV vaccines should move through the different clinical trial phases as quickly as possible, while rigorous scientific evaluation and safeguards for participants, including vulnerable groups, are maintained, the EMA said. The paper outlines minimum requirements to start trials, gives advice on trial design, and encourages timely approval by African national regulatory authorities.

Source: EMA

African and European regulators called for faster clinical trials in the paper made available to the News Agency of Nigeria (NAN) on Monday, Realnews Magazine reported, adding that early-stage trials should ideally be conducted in Africa and that a single-dose vaccine was identified as preferable because it could be deployed rapidly during an outbreak.

Source: Realnews Magazine, reporting NAN availability on Monday

The paper 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, the EMA said. Non-human challenge studies should still be performed to make sure vaccines have a chance of being effective before they progress to Phase II/III trials.

Source: EMA

To assess whether vaccination prevents disease, the paper proposes a platform pivotal Phase III study based on including and randomising people who have been in close contact with a confirmed case - a ring trial - with multiple candidates potentially evaluated in the same trial. Studies in children and pregnant women should begin once sufficient initial safety data from adults is available, the EMA said. Agence Europe, reporting the joint recommendations on 26 October, likewise noted the ring-trial design for Phase III and the preference for initial phases in Africa with healthy adults.

Source: EMA; Agence Europe