Johnson & Johnson’s pharmaceutical firm Janssen has secured a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for its investigational Ebola vaccine regimen.

The company has filed two marketing authorisation applications (MAAs) with the EMA seeking regulatory approval for the vaccines in the regimen, Ad26.ZEBOV and MVA-BN-Filo.

The vaccine Ad26.ZEBOV is administered as the first dose and MVA-BN-Filo is administered as the second dose, after approximately eight weeks.

The Ad26.ZEBOV has been developed using the company’s original AdVac viral vector technology, along with the company’s PER.C6 production cell line, while the MVA-BN-Filo is developed based on Bavarian Nordic’s MVA-BN technology.

Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “This outbreak in the DRC saw the first large-scale deployment of vaccines coordinated via a comprehensive public health response, which included Janssen’s novel investigational two-dose vaccine regimen.

“We are pleased with the Committee’s positive opinion as it brings us one step closer to achieving our ultimate vision at Johnson & Johnson to go further and prevent future Ebola outbreaks before they start and to help communities most at risk.”

Janssen’s investigational vaccine regimen includes Ad26.ZEBOV and MVA-BN-Filo

Janssen has specifically designed its investigational Ebola vaccine regimen to prevent Ebola Virus Disease caused by the Zaire ebolavirus species and to support the preventive vaccination in countries that are at risk of Ebola outbreaks.

The company is working in collaboration with the World Health Organization (WHO) on vaccine pre-qualification to expand the access of its investigational Ebola vaccine regimen to the people in need.

Janssen has vaccinated approximately 60,000 people with its investigational preventive Ebola vaccine regimen in clinical studies and vaccination initiatives, which indicated that the vaccine regimen is well-tolerated, inducing robust and durable immune responses.

Janssen Pharmaceutica global therapeutic area head, Vaccines, and Managing Director Johan Van Hoof said: “Today’s CHMP opinion confirms the potential of Janssen’s vaccine technology, which we hope to apply against a range of established and emerging epidemic threats, including the COVID-19 pandemic.

“If our investigational Ebola vaccine regimen is approved by the European Commission, this would be Janssen’s first vaccine approval and an important step forward in our efforts to help protect people at risk of Ebola Virus Disease.

“Our progress of accelerating the development and delivery of an Ebola vaccine would not have been possible without the expertise and dedication of our multiple partners around the world, for whom we are extremely grateful.”