EMA Gives Positive Opinion on J&J Investigational Preventive Ebola Vaccine Regimen

Johnson & Johnson’s (J&J’s) Janssen Pharmaceutical Companies has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen for the prevention of the Ebola virus disease caused by the Zaire ebolavirus species, the company announced in a May 29, 2020 press release. The company submitted two marketing authorization applications (MAAs) to the EMA in support of the vaccines in a two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo).

The positive opinion follows the granting of an accelerated assessment for the MAAs by the CHMP in September 2019. The MAAs are supported by data from more than ten Phase I, II, and III clinical studies.

Janssen’s investigational Ebola vaccine regimen is specifically designed for preventive vaccination in countries that are at risk of Ebola outbreaks as well as for other at-risk groups, including healthcare workers, biosafety level 4 (BSL-4) lab workers, military deployed from other countries, airport staff, and visitors to high-risk countries. Janssen is collaborating with the World Health Organization (WHO) on vaccine pre-qualification to broaden access of the vaccine regimen to those most in need and enable registration in African countries. Approval of this two-dose regimen by the European Commission (EC) may help accelerate the process, J&J noted in its press release.

The regimen includes Ad26.ZEBOV, a vaccine based on Janssen’s proprietary AdVac viral vector technology, as the first dose, and MVA-BN-Filo, a vaccine based on the MVA-BN technology from biotechnology company Bavarian Nordic, as the second dose. The second does is administered approximately eight weeks after the first. This two-dose approach is intended to induce long-term immunity against Ebola virus disease. The AdVac technology, alongside Janssen’s PER.C6 production cell line, is also being used in J&J’s efforts to develop a preventive vaccine against COVID-19 and is the basis of the company’s investigational human immunodeficiency virus, respiratory syncytial virus, and Zika vaccine candidates.

The most recent Ebola outbreak, originating in the Democratic Republic of the Congo (DRC) in 2018, was the world’s second worst on record, causing more than 3000 cases and more than 2000 deaths, according to J&J in the press release.

“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,” said Paul Stoffels, MD, vice-chairman of the executive committee and chief scientific officer of Johnson & Johnson, in the press release. “We are pleased with the [c]ommittee’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.”

To date, approximately 60,000 people have been vaccinated with Janssen’s investigational preventive Ebola vaccine regimen in clinical studies and vaccination initiatives.

“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,” said Johan Van Hoof, MD, global therapeutic area head, Vaccines, and managing director, Janssen Pharmaceutica N.V., in the press release. “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 [v]irus [d]isease. 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.”

Source: Johnson & Johnson