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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