Johnson & Johnson has secured European approval for its Janssen Pharmaceutical Companies’ 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.
“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 Johnson & Johnson.