AMA and EMA issue joint guidance on Ebola vaccine development

AMA and EMA have issued a joint position paper calling for candidate vaccines against Ebola disease caused by Bundibugyo virus (BDBV) to move through clinical trial phases as quickly as possible while maintaining rigorous scientific evaluation and participant safeguards. The paper sets out minimum requirements to start clinical trials and recommends a single-dose vaccine, non-human challenge studies, and a Phase III ring trial based on randomised inclusion of close contacts of confirmed cases. For candidates with well-characterised platform data, postponing or waiving certain animal toxicity studies can be scientifically justified; trials in children and pregnant women should begin once sufficient initial adult safety data are available.