The European Commission granted marketing authorization to Merck for a vaccine to immunize adults against Ebola Virus Disease (EVD) caused by the Zaire Ebola virus.
The vaccine, called ERVEBO, can be marketed in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein, and Norway. ERVEBO is currently under review with the U.S. Food and Drug Administration (FDA). The target date for a decision is March 14, 2020.
“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,” Kenneth Frazier, chairman and chief executive officer at Merck, said. “After recognizing the need and urgency for an Ebola Zaire vaccine, many came together across sectors to answer the global call for outbreak preparedness. We at Merck are honored 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 World Health Organization on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most.”
This approval allows Merck to begin the manufacturing of licensed doses in Germany, which are expected to be available in the third quarter of 2020. Merck is also working with the World Health Organization (WHO), the United States Government, and Gavi, the Vaccine Alliance, to ensure access to its investigational Ebola Zaire vaccine (V920) in support of international response efforts in the Congo. Merck has committed to manufacturing additional doses of V920 over the coming year. As part of its clinical development, Merck has donated more than 250,000 1.0mL doses of V920 to the WHO for use in outbreak response efforts occurring in the DRC since May 2018.
Merck has made a submission to the WHO seeking prequalification status for the vaccine. It has also made submissions to selected African country National Regulatory Authorities to allow the vaccine to be registered in several African countries.