EMA and AMA call for accelerated Bundibugyo Ebola vaccine trials

The European Medicines Agency (EMA) and the African Medicines Agency (AMA) have issued a joint position paper calling for the rapid commencement of clinical trials for vaccines targeting the Bundibugyo (BDBV) Ebola virus strain. This move follows scientific consultations involving the World Health Organization (WHO).

The urgency stems from an ongoing public health emergency in the Democratic Republic of the Congo, with cases also identified in Uganda, Kenya, and Nigeria. The position paper outlines minimum requirements for starting trials and provides recommendations for their design, emphasizing the need for rigorous scientific evaluation and the protection of vulnerable participants.

To accelerate development, the agencies are encouraging national regulatory authorities in African countries to grant timely approvals. The document also discusses scientific justifications for potentially postponing or bypassing certain animal toxicity studies for vaccines utilizing established technological platforms, such as mRNA and certain viral vector vaccines.