African and European Regulators call for accelerated Ebola vaccine trials

The African Medicines Agency (AMA) and European Medicines Agency (EMA) have issued a joint position paper, developed following consultations with the World Health Organization (WHO), in response to the ongoing public health emergency in the Democratic Republic of the Congo (DRC), with cases also reported in Uganda, Kenya and - most recently - Nigeria.

The guidance sets minimum requirements for advancing experimental vaccines into clinical trials, with a particular focus on established messenger RNA (mRNA) and viral-vector technologies.

Regulators say certain preclinical toxicity studies could be postponed or waived where vaccine platforms have met safety requirements. However, animal immunogenicity testing remains necessary, alongside evidence supporting potential efficacy before late-stage trials.

Early clinical studies would preferably take place in Africa to facilitate rapid progression to larger efficacy trials in affected communities. Agencies would also prioritise single-dose vaccines because they could be deployed more quickly during outbreaks.

For Phase III studies, the agencies endorse a ring vaccination approach, in which close contacts of confirmed cases are randomly assigned to immediate vaccination or a control group. Such platform trials could evaluate multiple vaccine candidates simultaneously.

The guidance also emphasises the importance of including children and pregnant women, once sufficient supporting safety evidence becomes available. Paediatric studies should begin promptly following initial adult safety assessments.

National regulatory authorities are encouraged to accelerate clinical trial approvals, while developers are urged to seek early scientific advice to avoid unnecessary delays.

The agencies stress that faster development must not compromise participant protection or scientific rigour.

The initiative represents a co-ordinated regulatory effort to generate reliable evidence and facilitate timely access to effective vaccines against Bundibugyo virus, for which outbreak-responsive vaccine development remains an urgent public health priority.

Médecins Sans Frontières’ (MSF’s) has raised concern that nearly one in four confirmed Ebola cases in North Kivu province is a child. It has warned of the disproportionate impact of the disease on children and calls for more attention to their specific vulnerabilities, in both the medical and research response.

Stéphanie Hoffmann, project coordinator for MSF in Butembo, said: “Most of the paediatric cases admitted in our ETC in Butembo, North Kivu, over the summer, had already been hospitalised for other illnesses in several facilities during the days or weeks before their admission. Their family members did not have Ebola themselves, and it is highly likely that these children contracted the disease inside healthcare facilities.”