EMA and African agency issue fast-track Ebola vaccine guidance

The European Medicines Agency’s Emergency Task Force and the African Medicines Agency have published a joint position paper setting minimum requirements to start clinical trials of potential vaccines against Ebola disease caused by Bundibugyo virus, urging that candidates move through trial phases as quickly as possible while safeguards for participants, including vulnerable groups, are maintained. The paper says certain animal toxicity studies may be postponed or waived where a vaccine uses a well characterised platform, such as mRNA or certain viral-vector technologies, with existing safety data, and it proposes a Phase III ring trial among close contacts of confirmed cases, with a single-dose vaccine preferred for rapid deployment during an outbreak. It says early trials should ideally be conducted in the African region, where the ongoing public health emergency in the Democratic Republic of the Congo has also seen cases detected in Uganda, Kenya and Nigeria, and that studies in children and pregnant women should begin once sufficient initial safety data from adults are available.