Posted by Michael Wonder on 12 Nov 2019
Merck’s Ervebo [Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP) live] granted conditional approval in the European Union
12 November 2019 - Authorisation represents significant advancement in the global response to Ebola.
Merck today announced that the European Commission has granted a conditional marketing authorisation to Ervebo for active immunisation of individuals 18 years of age or older to protect against Ebola virus disease caused by Zaire Ebola virus. The use of Ervebo should be in accordance with official recommendations.
The approval is based on data submitted to the European Medicines Agency for accelerated assessment in March 2019. With this approval, the European Commission will grant a centralised marketing authorisation with unified labelling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Ervebo is currently under priority review with the U.S. FDA with a target action date of 14 March 2020.
