J&J’s Ebola vaccine approved in EU

The European Commission has approved Johnson & Johnson’s Ebola vaccine, developed by its Janssen pharmaceuticals unit and Bavarian Nordic.

This is the first major regulatory approval of the vaccine developed by Janssen and Bavarian Nordic, which produces the second part of the two-dose jab. 

The vaccine is designed to induce long-term immunity against the Ebola virus in adults and children aged one year and above. 

It will be used to support preventive vaccination in countries most at risk of outbreaks, as well as for other at-risk groups such as healthcare workers, biosafety laboratory workers, military personnel deployed in the affected regions, airport staff and visitors to high-risk countries.

The vaccine involves a first dose based around Janssen’s Zebov administered with the company’s AdVac viral vector technology and a second dose known as Mvabea developed by Bavarian Nordic. 

Based in Copenhagen, Bavarian Nordic is set to receive a milestone payment of $10 million under a license agreement with Janssen dating back to 2014. 

The approval follows a positive opinion by the CHMP of the European Medicines Agency (EMA) in May. The vaccine regimen is indicated for active immunisation for prevention of disease caused by Ebola virus in individuals aged one year and above. 

Janssen supported vaccination initiatives in the Democratic Republic of Congo and neighbouring Rwanda, with the goal of preventing Ebola’s geographic spread beyond the outbreak zone.  

This followed a recommendation in May 2019 from the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on immunisation, which backed the use of the Janssen Ebola vaccine regimen. 

Including clinical studies and vaccination initiatives, approximately 60,000 people have been vaccinated with Janssen’s regimen to date. 

This is the second Ebola vaccine approved by the European Commission: in November it granted a marketing authorisation to MSD’s vaccine known as Ervebo. 

This vaccine has been shown to produce effective protection against onset of the virus with a single dose. 

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