Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen’s Investigational Ebola Vaccine Regimen

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Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen’s Investigational Ebola Vaccine Regimen
Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated Assessment by European Medicines Agency
November 07, 2019
NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson today announced that its Janssen Pharmaceutical Companies have submitted Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola Virus Disease (EVD) caused by Zaire ebolavirus species. Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). In September 2019, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted an Accelerated Assessment for these applications.

“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, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “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 vaccine regimen includes Ad26.ZEBOV as the first dose, which is based on Janssen’s AdVac® technology, and MVA-BN-Filo as the second dose, which is based on Bavarian Nordic’s MVA-BN® technology and is administered approximately eight weeks later. The MAAs are supported by data from Phase 1, 2 and 3 clinical studies evaluating the safety and immunogenicity of the vaccine regimen in adults and children1-7, preclinical studies, and immunobridging analyses. To date, more than 6,500 volunteers across the U.S., Europe and Africa have participated in over 10 clinical studies of the Janssen vaccine.

“Our goal is to deliver a vaccine that can be used both in response to Ebola outbreaks, and also more proactively as a prophylactic tool to help countries protect their populations,” said Johan Van Hoof, M.D., Global Therapeutic Area Head, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica N.V. “We are grateful to our many global partners who have helped us reach this important stage of development.”…