European Commission has granted marketing authorization for Mvabea + Zabdeno vaccine regimen for treatment of Ebola.- Janssen Vaccines + Bavarian Nordic.

Bavarian Nordic A/S announced that the European Commission has granted marketing authorization for Mvabea (MVA-BN Filo) together with Zabdeno (Ad26.ZEBOV), which collectively constitute Janssen’s Ebola vaccine regimen. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in May 2020.

The vaccine regimen is indicated for active immunization for prevention of disease caused by Ebola virus in individuals aged one year and above The marketing authorization has been granted to Janssen Vaccines & Prevention B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson who obtained a worldwide license to develop, manufacture and commercialize 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 USD 10 million under the license agreement with Janssen. This will not impact the Company’s financial guidance for the full year 2020