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MSD secures EU approval for its Zaire Ebola vaccine Ervebo

Published on 12/11/19 at 12:03pm

MSD has scored approval from the European Commission for Ervebo, the company’s Zaire Ebola vaccine, for the prevention of Ebola virus disease (EVD) in patients at least 18 years old, it has emerged.              

The decision follows a positive recommendation from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in October. The vaccine is currently under review in the US under the FDA’s priority review pathway, with a final decision due by 14 March 2020.

The ruling enables MSD to begin manufacture of Ervebo in Germany with the goal of making the first doses available by the third quarter of 2020

In order to ensure continuous and consistent access to the vaccine in the Democratic Republic of the Congo, MSD also confirmed it has partnered with the World Health Organization (WHO), the US Government and Gavi, the Vaccine Alliance. To this end, the company has donated over 250,000 1.0mL doses of the vaccine to the WHO since May 2018 for use in fighting the nation’s ongoing Ebola crisis.

“The European Commission’s marketing authorization of Ervebo is the result of an unprecedented collaboration for which the entire world should be proud. It is a historic milestone and a testament to the power of science, innovation and public-private partnership,” commented Kenneth C Frazier, Chairman and CEO.

“After recognising the need and urgency for an Ebola Zaire vaccine, many came together across sectors to answer the global call for outbreak preparedness,” he continued. “We at MSD are honoured to play a part in Ebola outbreak response efforts and we remain committed to our partners and the people we serve. We also look forward to continuing to work with the FDA and the African countries on their regulatory reviews over the coming months and with the WHO on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most.”

Matt Fellows

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