Bavarian Nordic A/S (CPH:BAVA), a biotechnology company focused on the development, manufacture and commercialisation of life-saving vaccines, announced on Wednesday the grant by the European Commission of marketing authorisation for MVABEA (MVA-BN Filo) together with ZABDENO (Ad26.ZEBOV), which collectively constitute Janssen's Ebola vaccine regimen.

This approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in May 2020. The vaccine regimen is indicated for active immunisation for prevention of disease caused by Ebola virus in individuals aged one year and above.

According to the company, the marketing authorisation has been granted to Janssen Vaccines & Prevention BV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ), which obtained a worldwide licence to develop, manufacture and commercialise MVA-BN Filo from Bavarian Nordic in 2014.

The 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.

In connection with the approval of MVABEA by the European Commission, Bavarian Nordic will receive a milestone payment of USD10m under the licence agreement with Janssen.

This will not impact its financial guidance for the full year 2020, the company clarified.