Merck’s Ervebo [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Receives EC’s Conditional Approval to Prevent Ebola Virus Disease

Shots:

• The EC has granted conditional marketing authorization to Ervebo for active immunization of individuals aged ≥ 18yrs. to protect against Ebola virus disease (EVD) caused by Zaire Ebola virus
• The approval allows Merck to initiate the manufacturing of licensed doses in Germany with its anticipated availability in Q3’20. Additionally, Merck has submitted prequalification status of the vaccine to the WHO and selected African country National Regulatory Authorities in collaboration with AVAREF, which if approved allow the vaccine to registered in African countries
• Ervebo has received EC’s centralized marketing authorization with unified labeling, valid in all 28 EU countries including European Economic Area members, Iceland, Liechtenstein and Norway and is under priority review with the US FDA with PDUFA date as Mar 14, 2020

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