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European Commission announces approval for Janssen’s Ebola vaccine

Published on 02/07/20 at 11:07am
Photo by NIAID

Johnson & Johnson announced that the European Commission has granted Marketing Authorisation for its Janssen Ebola vaccine.

Two Marketing Authorisation Applications (MAAs) were submitted to the European Medicines Agency (EMA) for the vaccines that are made up of Zabdeno and Mvabea. The MAAs also received a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP) and is indicated for active immunisation and prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above.

Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, said: “The European approval of Janssen’s Ebola vaccine regimen is a landmark moment – both for our Company and in the world’s battle against the deadly Ebola virus. Building on our history, we are committed to bringing forward vaccines to help overcome the threat of some of the world’s most life-threatening infectious diseases.”

Janssen is also collaborating with the World Health Organization on vaccine pre-qualification to accelerate its registration of its treatment in Africa.

60,000 people so far have been vaccinated with the treatment in clinical studies that took place in the Democratic Republic of Congo and Rwanda. Data from Phase 1, 2 and 3 trials was presented at the 2019 European Congress of Clinical Microbiology & Infectious Disease, and showed the vaccine was well tolerated and induced a robust immune response to the disease.

Johan Van Hoof, Managing Director, Janssen Vaccines and Prevention B.V. also commented on the vaccine approval, and said: ““I am enormously grateful for the dedication from everyone who has been a part of this development, including our many global strategic partners for their extraordinary commitment to helping make this regimen a reality.

“The devastating 2014 outbreak of Ebola in West Africa grew exponentially, overwhelming healthcare systems. In less than six years, with the strength of global public-private collaborations, we have an approved Ebola vaccine which could help those most in need, with the ultimate goal of preventing outbreaks before they start.”

Conor Kavanagh

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