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Crucial step towards EC regulatory approval of IMI-funded J&J Ebola vaccine

Studies indicate that the vaccine regimen is well tolerated, with robust and durable immune responses to the Zaire ebolavirus strain.

A volunteer is administered a vaccine. Photo courtesy of University of Geneva


Johnson & Johnson announced that its Janssen Pharmaceutical Companies received a positive opinion from 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.

Two Marketing Authorisation Applications (MAAs) were submitted to the EMA in support of the vaccines in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). Janssen’s investigational Ebola vaccine regimen is designed to support preventive vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers, Biosafety Level 4 (BSL-4) lab workers, military deployed from other countries, airport staff and visitors to high-risk countries.

Read the full Janssen press release 

A number of organisations contributed to the development of the vaccine regimen, including IMI through the Ebola+ programme. Specifically, IMI granted in total over 130 million to the projects EBOVAC1 (58.3 million IMI funding), EBOVAC2 (2.8 million) and EBOVAC3 (29.4 million), that have conducted numerous clinical trials of the vaccine regimen in Africa and Europe, while EBOMAN (1 million) supported its manufacture. Finally, the EBODAC project (20.3 million) successfully developed supporting tools to promote the acceptance and uptake of new Ebola vaccines as well as facilitated the engagement of local communities.

Read  "Trial of second Ebola vaccine to start in Democratic Republic of the Congo" (31/10/2019)

To date, approximately 60,000 people have been vaccinated with Janssen’s investigational preventive Ebola vaccine regimen in clinical studies and vaccination initiatives. Studies indicate that the vaccine regimen is well tolerated, inducing robust and durable immune responses to the Zaire ebolavirus strain.

Janssen is collaborating with the World Health Organization (WHO) on vaccine pre-qualification to broaden access of its investigational Ebola vaccine regimen to those most in need and enable registration in African countries; European Commission (EC) approval of this regimen may help accelerate this process. The most recent Ebola outbreak, which started in the Democratic Republic of the Congo (DRC) in 2018 was the world’s second worst on record. It has caused more than 3,000 cases and over 2,000 deaths.

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Read the full Janssen press release 


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