News / 24 October 2026

EMA and AMA publish joint position paper on Bundibugyo Ebola vaccine trials

24 October 2026 · Based on: European Medicines Agency

EMA's Emergency Task Force 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).^[1] It followed a scientific consultation with experts hosted by AMA, EMA and the World Health Organization (WHO) on 24 August 2026.^[1]

The paper responds to an ongoing public health emergency in the Democratic Republic of the Congo, with cases also detected in Uganda, Kenya and Nigeria.^[1] It says BDBV vaccine candidates should move through the clinical trial phases as quickly as possible, while rigorous scientific evaluation and sufficient safeguards for participants, including vulnerable groups, must be maintained.^[1] It outlines minimum requirements to start clinical trials, gives advice on trial design, and encourages timely approval of trials by African national regulatory authorities.^[1]

On preclinical work, 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.^[1] Such studies might also be postponed or waived where other vaccines using the same platform already have safety data, particularly where different antigens have not affected the overall safety profile.^[1]

For early development, the paper says trials should ideally be conducted in the African region, so that the move to larger efficacy trials in affected populations is as efficient as possible.^[1] It says non-human challenge studies should be performed before vaccines progress to Phase II/III trials, and that a single-dose vaccine is preferred because it would be easier to deploy rapidly during an outbreak.^[1]

To assess whether vaccination prevents disease, the paper proposes a platform pivotal Phase III study that includes and randomises people who have been in close contact with a confirmed case (a ring trial) as a valid approach.^[1] Multiple vaccine candidates could potentially be evaluated in the same trial.^[1] Studies in children and pregnant women should begin once sufficient initial safety data from adults is available.^[1] Developers are advised to engage early with regulators, including AMA and the relevant National Regulatory Authorities in Africa, to obtain scientific and regulatory advice.^[1]

This article summarises an official publication for learning purposes. It is not investment advice and makes no forecast of prices or outcomes. Read the original source before relying on any detail.