EMA与AMA就Bundibugyo病毒埃博拉疫苗研发发布联合指导文件

EMA’s Emergency Task Force (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 paper was developed following a scientific consultation with relevant experts, hosted by AMA, EMA and the World Health Organization (WHO) on 24 August 2026.

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. At the same time, rigorous scientific evaluation and sufficient safeguards for participants in clinical research, including vulnerable groups, must be maintained. The position paper outlines the minimum requirements to start clinical trials and provides advice on trial design. It also encourages timely approval of these trials by African national regulatory authorities (NRAs) to accelerate the development of vaccines specifically targeting BDBV.

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. Such studies might also be postponed or waived where there is existing safety data from other vaccines using the same platform technology, particularly where different antigens have not affected the overall safety profile.

Ideally, early trials should be conducted in the African region to make the transition to larger efficacy trials in affected populations as efficient as possible. Non-human challenge studies should be performed to make sure that vaccines have a chance of being effective before they progress to Phase II/III clinical trials. A single-dose vaccine is preferred as it would be easier to deploy rapidly during an outbreak.

To assess whether vaccination prevents disease, the position paper proposes a platform pivotal study (Phase III) based on inclusion and randomisation of people who have been in close contact with a confirmed case (ring trial) as a valid approach. Multiple vaccine candidates could potentially be evaluated in the same trial. As disease caused by BDBV also affects children and pregnant women, studies in these groups should begin once sufficient initial safety data from adults is available.

Vaccine developers should engage early with regulators, including AMA and the relevant National Regulatory Authorities in Africa to obtain scientific and regulatory advice, facilitate clinical trial assessments and ensure that regulatory requirements are met for the potential authorisation of promising vaccines.