Summary
The EMA’s Emergency Task Force and the African Medicines Agency published guidance on clinical trials for vaccines against Bundibugyo virus. It sets out ways to speed development while retaining participant safeguards and rigorous evaluation.
The European Medicines Agency’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) published joint guidance on 23 October 2026 for clinical development of vaccines against Ebola disease caused by Bundibugyo virus (BDBV). The position paper describes minimum requirements for starting trials and recommends approaches intended to move promising candidates through testing quickly while protecting participants.
The agencies developed the paper after a scientific consultation hosted by AMA, EMA and the World Health Organization on 24 August 2026. EMA says the guidance responds to a public health emergency in the Democratic Republic of the Congo, with cases also detected in Uganda, Kenya and Nigeria.
How the guidance balances speed and safety
The paper says some animal toxicity studies could be postponed or waived when a vaccine uses a platform with well-characterised data, including mRNA and certain viral-vector platforms. That may also be considered when safety information is already available from other vaccines using the same technology, particularly if changing the antigen has not altered the platform’s overall safety profile. These are conditional options for scientific assessment, not a general exemption for vaccine candidates.
The guidance recommends that early trials ideally take place in Africa. This could make the move to larger efficacy studies in affected populations more efficient. It also calls for non-human challenge studies before candidates proceed to Phase II/III trials, to assess whether they have a prospect of working. A single-dose vaccine is preferred because it could be easier to deploy rapidly during an outbreak.
The recommendations pair faster development with safeguards for people taking part in research, including vulnerable groups. Studies involving children and pregnant women should begin once sufficient initial safety data have been gathered in adults.
A proposed route to test efficacy
For assessing whether vaccination prevents disease, the paper proposes a platform pivotal study in Phase III that enrols and randomises people who have been in close contact with a confirmed case. This is a ring-trial approach: testing is organised around contacts of identified cases rather than enrolling only a broad, unselected population. The guidance says multiple vaccine candidates could potentially be assessed in the same trial.
The proposed design is intended to support evaluation in affected populations during an outbreak. The paper also urges developers to seek advice early from AMA and the relevant African national regulatory authorities. Early engagement can help with clinical-trial assessments and ensure that regulatory requirements for any potential authorisation are addressed.
The joint paper is clinical-development guidance, not an authorisation of a vaccine. Its central proposal is a faster, coordinated path for testing BDBV candidates, with decisions about study requirements and participant protection remaining part of the scientific and regulatory process.