Johnson & Johnson 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 children, 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.”
Johnson & Johnson has made a significant investment in Janssen’s Ebola vaccine regimen since its decision to accelerate the development program in 2014 in response to the West Africa epidemic. The company is grateful to its global partners who have helped to support and co-fund these efforts, including the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), the Innovative Medicines Initiative (IMI) funded through the EU Horizon 2020 programme, and the National Institutes of Health (NIH) at HHS.
Discussions with the U.S. Food and Drug Administration (FDA) are ongoing to define the required data set for filing of the Janssen Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. Janssen is also working in collaboration with the World Health Organization (WHO) to enable registration of the Ebola vaccine regimen in African countries.
On October 31, 2019, the company announced it will provide up to 500,000 regimens of its investigational vaccine for use in a new clinical trial organized by the DRC government and global health stakeholders in an effort to contain the country’s Ebola outbreak.