On May 29, 2020, Johnson & Johnson announced that its Janssen Pharmaceutical subsidiary 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. Two Marketing Authorisation Applications (MAAs) were submitted to the EMA in support of the vaccines in the two-dose regimen.

Janssen’s investigational Ebola vaccine regimen is specifically 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. 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 – a mortality rate of 65 percent.

To date, approximately 60,000 people have been vaccinated with Janssen’s investigational preventive Ebola vaccine regimen in clinical studies and vaccination initiatives. Janssen-sponsored Phase 1 studies have been reported in peer-reviewed journals including JAMA and the Journal of Infectious Diseases, and Phase 1, 2 and 3 data were recently presented at the 2019 European Congress of Clinical Microbiology & Infectious Disease (ECCMID). These studies indicate that the vaccine regimen is well tolerated, inducing robust and durable immune responses to the Zaire ebolavirus strain. In May 2019, the WHO’s Strategic Advisory Group of Experts (SAGE) on immunization recommended the use of the Janssen investigational Ebola vaccine regimen as part of efforts to contain the DRC outbreak¹⁰ and more than 50,000 people in the DRC and Rwanda were vaccinated.

The regimen includes Ad26.ZEBOV as the first dose, based on Janssen’s proprietary AdVac^® viral vector technology, and MVA-BN-Filo as the second dose, based on Bavarian Nordic’s MVA-BN^® technology, administered approximately eight weeks later. The goal of this two-dose approach is to induce long-term immunity against Ebola Virus Disease. The AdVac^® technology, alongside the company’s PER.C6^® production cell line, is also being used in Johnson & Johnson’s efforts to develop a preventive vaccine against COVID-19 disease, and is the basis of the company’s investigational HIV, RSV and Zika vaccine candidates.