October 27, 2026: The African Medicines Agency (AMA) and the European Medicines Agency (EMA) have issued joint guidelines aimed at accelerating the development and clinical testing of vaccines against the Bundibugyo virus (BDBV), which causes a form of Ebola disease.
The guidance seeks to fast-track clinical trials while maintaining strict scientific standards and protecting participants, particularly vulnerable groups.
The joint position paper, published by EMA’s Emergency Task Force (ETF) and AMA, follows scientific consultations convened with the World Health Organization (WHO) on August 24, 2026.
According to the agencies, the initiative comes amid a public health emergency in the Democratic Republic of the Congo (DRC), with cases also reported in Uganda, Kenya and Nigeria.
The regulators emphasized the need to advance potential vaccines through clinical trial phases without unnecessary delays while ensuring rigorous safety assessments.
Under the guidelines, vaccine developers using established technologies, including messenger RNA (mRNA) and certain viral-vector platforms, may be exempted from repeating some toxicity studies where sufficient safety evidence already exists.
The agencies explained that existing safety data from vaccines developed using similar technologies could support faster progression into early-stage human trials.
They recommended conducting initial trials in Africa to facilitate larger studies among populations at risk of infection.
The guidelines also propose evaluating vaccine effectiveness through Phase III clinical trials involving people who have had close contact with confirmed Ebola patients, an approach commonly known as ring vaccination trials.
Multiple vaccine candidates could be assessed under the same trial framework.
The agencies further recommended prioritizing single-dose vaccines because they would be easier to administer during outbreaks.
They said studies involving children and pregnant women should begin once sufficient preliminary safety data have been obtained from adult participants.
Vaccine developers have also been encouraged to engage early with AMA and national regulatory authorities across Africa to secure scientific guidance, coordinate clinical trial assessments and facilitate regulatory decisions.
The agencies maintained that closer collaboration between African and European regulators could accelerate the availability of safe and effective vaccines against Bundibugyo virus disease while maintaining appropriate safeguards for research participants. -Press release
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