Merck receives EU CHMP positive opinion for investigational V920 Ebola Zaire vaccine for protection against Ebola virus disease

Merck/MSD

18 October 2019 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending a conditional marketing authorisation for V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live). 

If affirmed by the European Commission, the vaccine will be authorized under the brand name Ervebo (pronounced UR-VEE-BOH) and indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The use of Ervebo should be in accordance with official recommendations.

In September 2019, the U.S. FDA accepted the biologics license application and granted priority review for V920. The PDUFA, or target action date, is set for 14 March 2020. In parallel, and in close collaboration with FDA and EMA, submissions have also been made to the World Health Organisation to achieve pre-qualification status and to African health authorities in collaboration with the African Vaccine Regulatory Forum.

Read Merck press release

Michael Wonder

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Michael Wonder

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Outcome , Europe , Vaccine