The European Commission (EC) has approved Johnson & Johnson group Janssen’s Ebola vaccine regimen for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above.
Two marketing applications were submitted to the European Medicines Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo).
Ad26.ZEBOV, the first dose, is based on Janssen’s AdVac viral vector technology, and MVA-BN-Filo, the second dose, is based on Bavarian Nordic’s MVA-BN technology, administered approximately eight weeks later.
Marketing authorisation under exceptional circumstances was granted following accelerated assessment of the applications and a positive opinion by the agency's human medicines committee.
The vaccine regimen is specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and above. It will be used to support preventive vaccination in countries most at risk of outbreaks, as well as for other at-risk groups such as healthcare workers, biosafety level 4 (BSL4) laboratory workers, military personnel deployed in the affected regions, airport staff and visitors to high-risk countries.
Janssen is now collaborating with the World Health Organisation (WHO) on vaccine pre-qualification, “which should help accelerate registration of its preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need,” J&J noted.
“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,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer of J&J.