AMA and EMA issue joint guidance for Bundibugyo Ebola vaccine development
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The AMA and EMA have released a joint position paper on advancing candidate vaccines against Ebola disease caused by Bundibugyo virus (BDBV). The guidance aims to move candidates through clinical trial phases as quickly as possible while maintaining rigorous scientific evaluation and protecting trial participants. It sets minimum requirements for starting 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 sufficient platform data, postponing or waiving certain animal toxicity studies can be scientifically justified. Trials in children and pregnant women should begin once adequate initial adult safety data are available.
Written by a model from the reports · updated 3 hours ago
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- ema.europa.euPickAMA and EMA issue joint guidance on Ebola vaccine development
The African Medicines Agency and EMA have issued a joint position paper supporting faster movement of candidate vaccines against Bundibugyo virus (BDBV) Ebola disease through clinical trial phases while maintaining rigorous scientific evaluation and participant safeguards. The paper sets 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.
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