AMA and EMA Issue Joint Guidance on Ebola Vaccine Development

The African Medicines Agency (AMA) and the European Medicines Agency (EMA) have published a joint position paper to support the timely initiation of clinical trials for potential vaccines against Ebola disease caused by the Bundibugyo virus (BDBV).

The paper follows a scientific consultation involving relevant experts, hosted by AMA, EMA, and the World Health Organization (WHO) on 24 August 2026.

Against the background of the ongoing public health emergency in the Democratic Republic of the Congo (DRC), with cases also detected in Uganda, Kenya, and Nigeria, the agencies emphasize the need to advance BDBV vaccine candidates through the different clinical trial phases as quickly as possible. At the same time, they stress that rigorous scientific evaluation and adequate safeguards for clinical research participants, including vulnerable populations, must remain in place.

Minimum Requirements for Clinical Trial Initiation

The joint position paper outlines the minimum requirements for starting clinical trials and provides recommendations on trial design. It also encourages timely approval of these trials by African national regulatory authorities (NRAs), with the aim of accelerating the development of vaccines specifically targeting BDBV.

The recommendations address several scientific and regulatory considerations, including the potential flexibility of certain nonclinical studies, the preferred sequence of clinical development, and approaches to evaluating vaccine effectiveness.

Flexibility in Nonclinical Safety Studies

The paper explains the circumstances in which certain animal toxicity studies may be postponed or waived.

This may be scientifically justified for vaccines developed using well-characterised platform technologies, including mRNA and certain viral-vector platforms. Such flexibility may also be considered when safety data are already available from other vaccines developed using the same platform, particularly when differences in antigens have not affected the overall safety profile.

These considerations are intended to support timely vaccine development while retaining an appropriate scientific basis for evaluating safety.

Recommendations for Clinical Trial Design

The position paper provides several recommendations concerning the planning and progression of clinical trials:

• Early clinical trials: Ideally, initial trials should take place in the African region to facilitate the transition to larger efficacy trials involving populations affected by the outbreak.
• Non-human challenge studies: These studies should be conducted to establish whether vaccine candidates have a reasonable prospect of effectiveness before progressing to Phase II/III clinical trials.
• Single-dose administration: A single-dose vaccine is preferred because it would be easier to deploy rapidly during an outbreak.

The paper also proposes a specific approach for evaluating vaccine effectiveness in later-stage development.

Proposed Phase III Platform Study

To assess whether vaccination prevents disease, the position paper proposes a platform pivotal study (Phase III) based on the inclusion and randomisation of individuals who have been in close contact with a confirmed case. This approach, known as a ring trial, is identified as a valid method for evaluating vaccine effectiveness.

The proposed design could also allow multiple vaccine candidates to be evaluated within the same trial.

The paper further recognizes that BDBV disease affects children and pregnant women. Studies involving these populations should therefore begin once sufficient initial safety data have been obtained from adults.

Early Regulatory Engagement and Coordination

The agencies emphasize the importance of early engagement between vaccine developers and regulatory authorities, including AMA and the relevant National Regulatory Authorities in Africa.

Early discussions are encouraged to obtain scientific and regulatory advice, facilitate clinical trial assessments, and ensure that applicable regulatory requirements are met in preparation for the potential authorisation of promising vaccine candidates.

This coordination is particularly relevant to clinical development programmes involving multiple countries and regulatory jurisdictions. Effective planning of trial applications, study documentation, and regulatory interactions can help support the progression of clinical research. Baupharma provides support through its Clinical Research services, covering clinical operations, regulatory support, clinical data management, and biostatistics and medical writing.

Conclusion

The joint position paper from AMA and EMA sets out recommendations intended to accelerate the clinical development of vaccines targeting Bundibugyo virus while maintaining scientific rigor and participant protection.

By addressing nonclinical study flexibility, clinical trial design, the proposed Phase III platform approach, and early regulatory engagement, the paper provides a coordinated framework to support vaccine development in response to the ongoing public health emergency.

The agencies emphasize that accelerating development must go hand in hand with rigorous scientific evaluation and appropriate safeguards for all clinical research participants.

Read the full announcement: AMA and EMA Issue Joint Guidance on Ebola Vaccine Development.