This week the European Commission issued preliminary marketing approval for Merck’s Ebola immunization vaccine Ervebo. This vaccine has been developed as an active immunization for the Zaire strain of the Ebola virus. The European Medicines Agency’s Committee for Medicinal Product for Human Use has also issued a positive recommendation for Ervebo; and the vaccine is under United States FDA priority review, with anticipated decision mid-March 2020.

Merck states that EU approval was validated by data submitted for priority European medical expert review. Ervebo is already in active marketplace use, engaged in protocol to protect healthcare workers at risk of infection who may be subject to exposure of infected individuals. Merck notes the company has made a donation to the World Health Organization of more than 250,000 doses of the Ervebo vaccine for use in the Ebola outbreak response in Democtactic Republic of Congo.   

Now with EU approval, Merck plans to begin manufacturing Ervebo in Germany and plans for the vaccine to be available for EU marketplace inoculations third quarter 2020. Merck noted further intentions to ramp up additional Ervebo supply over the next year to support Ebola eradication efforts.

Merck CEO, Kenneth Frazier, commented “[We are] continuing to work with FDA and African countries on their regulatory reviews over the coming months and with WHO on vaccine prequalification, which will help broaden access … for those who need it most.

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