Johnson & Johnson has announced the submission of Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen.
The company’s Janssen division is seeking license for the drug for the prevention of Ebola Virus Disease (EVD) specifically caused by Zaire ebolavirus species.
The company confirmed that two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo), on the back of a decision from the EMA’s Committee for Medicinal Products for Human Use (CHMP) to grant an Accelerated Assessment for the applications in September.
It is “vital that we ensure global preparedness for Ebola given that the world’s largest Ebola outbreaks have taken place in the last six years alone, with the latest currently underway in the Democratic Republic of the Congo (DRC),” said Paul Stoffels, chief scientific officer of Johnson & Johnson.
He continued, “With an understanding that vaccines have an important role to play in countering this epidemic threat, we look forward to the EMA’s review of our applications for licensure.”
The MAAs are supported by data from Phase I, II and III clinical studies evaluating the safety and immunogenicity of the vaccine regimen in adults and children, and data pooled from more than 6,500 volunteers across the U.S., Europe and Africa over 10 clinical studies.
Currently, the company is also in discussions with the US Food and Drug Administration (FDA) to define the required data set for filing of the Janssen Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway.
