Johnson & Johnson has announced that the European Commission (EC) has granted Marketing Authorisation for Janssen’s preventive Ebola vaccine. This marks the first major regulatory approval of a vaccine developed by Janssen.
The Ebola vaccine regimen leverages Janssen’s AdVac® technology, plus Bavarian Nordic’s established MVA-BN® technology. Janssen’s AdVac® technology is also being used to develop a vaccine candidate to prevent COVID-19.
The European Commission (EC) has granted the Marketing Authorisation for Janssen’s Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is now collaborating with the World Health Organization (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.
Two Marketing Authorisation Applications (MAAs) were submitted to the European Medicines Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Marketing Authorisation under exceptional circumstances has been granted following Accelerated Assessment of the MAAs and a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Janssen’s Ebola vaccine regimen is indicated for active immunisation for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged one year and above.
Janssen’s Ebola vaccine regimen is specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and above. As such, 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.
The regimen includes Ad26.ZEBOV as the first dose, based on Janssen’s AdVac® viral vector technology, and MVA-BN-Filo as the second dose, based on Bavarian Nordic’s MVA-BN® technology, administered approximately eight weeks later.
“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, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.
The worst Ebola outbreak to date was the West African epidemic, which caused nearly 30,000 cases and more than 11,000 deaths in 2014-2016. The world’s second worst Ebola outbreak on record began in the Democratic Republic of the Congo (DRC), in 2018. It has since caused more than 3,000 cases and over 2,000 deaths – a mortality rate of 65%.