Janssen’s Ebola vaccine secures European regulatory approval

Johnson & Johnson unit Janssen Pharmaceutical Companies has received marketing authorisation from the European Commission (EC) for its vaccine regimen designed to prevent Ebola Virus Disease.

Currently, Janssen is working with the World Health Organization (WHO) to obtain vaccine pre-qualification in order to expedite registration of the Ebola vaccine regimen in African countries.

The company filed two marketing authorisation applications (MAAs) with the European Medicines Agency (EMA) for the vaccines consisting of the two-dose, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), regimen.

Ad26.ZEBOV, the first dose, is based on Janssen’s AdVac viral vector technology while the second MVA-BN-Filo dose derives from Bavarian Nordic’s MVA-BN technology, administered about eight weeks apart.

The MAAs include results from eleven Phase I, II and III clinical trials assessing the safety and immunogenicity of the vaccine regimen in more than 6,500 participants across the US, Europe and Africa, preclinical studies, and immunobridging analyses.

EC granted marketing authorisation under exceptional situation after accelerated review of the MAAs, noted the company.

The Ebola vaccine regimen is indicated for active immunisation to prevent Ebola Virus Disease caused by the Zaire ebolavirus species in people aged one year and above.

Janssen Research & Development global head Mathai Mammen said: “Not only is it the first vaccine to emerge from our vaccines pipeline, it is also the first approved vaccine to be developed using Janssen’s AdVac technology.

“The same technology is being used to develop vaccines candidates to protect against SARS-CoV-2, as well as Zika, RSV and HIV.”

Janssen’s Ebola vaccine regimen is specifically designed to trigger long-term immunity against the Ebola virus, intended to support preventive vaccination in countries at risk of outbreaks and for other at-risk groups such as healthcare workers.

As part of clinical studies and vaccination initiatives, nearly 60,000 individuals have been vaccinated with Janssen’s preventive Ebola vaccine regimen so far.

Last November, Merck (MSD) secured conditional approval from the EC to market its Ervebo vaccine for active immunisation against Ebola Virus Disease caused by the Zaire Ebola virus.