US-based healthcare company Johnson & Johnson announced on Friday that Janssen Pharmaceutical Companies is seeking approval from the European Medicines Agency (EMA) for an investigational Ebola vaccine regimen.
The firm has submitted marketing authorisation applications (MAAs) to the EMA to prevent Ebola Virus Disease (EVD) caused by Zaire ebolavirus species. The Ebola vaccine regimen includes Ad26.ZEBOV as the first dose that is based on the company's AdVac technology, and MVA-BN-Filo as the second dose that is based on Bavarian Nordic's MVA-BN technology.
The company has submitted applications based on the data from phase one, two and three clinical studies that are evaluating the safety and immunogenicity of the vaccine regimen in adults and children, preclinical studies and immunobridging analyses.
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