The African Medicines Agency (AMA) and EMA’s Emergency Task Force (ETF)  have published a joint position paper to support the advancement of Bundibugyo virus (BDBV) vaccines into clinical trials. The position paper, which was created following scientific consultation jointly convened by the AMA, EMA and the WHO on August 24, 2026, bringing together relevant expertise, provides guidance for the timely start of clinical trials to encourage the potential authorisation of vaccines against Ebola disease caused by BDBV.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 without unnecessary delays while maintaining rigorous scientific evaluation. At the same time, sufficient safeguards for participants in clinical research, including vulnerable groups, are needed. 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.

As explained in the paper, product-specific repeat-dose toxicity studies are not necessarily needed to support the initiation of Phase I or II clinical trials for vaccines with well-characterised platform data (such as mRNA and certain viral-vector vaccines). Repeat-dose toxicity studies should be further postponed or waived where preclinical toxicity data from multiple vaccine candidates using the same platform technology demonstrate that different antigens do not adversely affect the overall safety profile. Non-clinical and clinical safety data from other vaccines developed using the same platform technology against similar pathogens would further support waiving such preclinical studies.

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 are encouraged to engage early with AMA and the relevant National Regulatory Authorities in Africa to obtain scientific and regulatory advice, facilitate coordinated clinical trial assessments and ensure that evidence-generation plans address the requirements for subsequent regulatory decisions.