Johnson & Johnson’s pharmaceutical business Janssen has secured the European Commission (EC) marketing authorisation for its Ebola vaccine regimen for the prevention of Ebola Virus Disease.
The company’s new Ebola vaccine regimen is indicated for active immunisation for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species.
The regulatory approval enables Janssen to collaborate with the World Health Organization (WHO) on vaccine pre-qualification, which is expected to accelerate the registration of its preventive Ebola vaccine regimen in African countries and provide expanded access to people who need it most.
Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “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.”
The Ebola vaccine includes Ad26.ZEBOV as the first dose and MVA-BN-Filo as the second dose
Janssen said that its Ebola vaccine regimen has been specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and above.
The regimen includes Ad26.ZEBOV as the first dose, developed based on Janssen’s AdVac viral vector technology, and MVA-BN-Filo as the second dose, designed based on Bavarian Nordic’s MVA-BN technology, administered approximately eight weeks later.
The company has submitted two Marketing Authorisation Applications (MAAs) to the European Medicines Agency (EMA) for the vaccines composing two-dose regimen, comprising Zabdeno and Mvabea.
The EC marketing authorisation has been granted under exceptional circumstances, supported by the EMA’s Committee for Medicinal Products for Human Use (CHMP)’s positive opinion and accelerated assessment of the MAAs.
Janssen vaccines and prevention BV managing director Johan Van Hoof said: “I am enormously grateful for the dedication from everyone who has been a part of this development, including our many global strategic partners for their extraordinary commitment to helping make this regimen a reality.
“The devastating 2014 outbreak of Ebola in West Africa grew exponentially, overwhelming healthcare systems. In less than six years, with the strength of global public-private collaborations, we have an approved Ebola vaccine which could help those most in need, with the ultimate goal of preventing outbreaks before they start.”
