Policy & Regulation
Merck's ERVEBO Ebola Zaire Vaccine Granted Conditional Approval in the European Union
14 November 2019 - - The European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease caused by Zaire Ebola virus, US-based pharmaceutical company Merck (NYSE: MRK).
The use of ERVEBO should be in accordance with official recommendations.
The approval is based on data submitted to the European Medicines Agency for accelerated assessment in March 2019.
With this approval, the European Commission will grant a centralised marketing authorization with unified labeling that is valid 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 Priority Review with the US Food and Drug Administration with a target action date of March 14, 2020.
Given the unique manufacturing requirements for ERVEBO, this approval allows Merck to initiate manufacturing of licensed doses in Germany, which are expected to start becoming available in the third quarter of 2020.
Merck is also working closely with the World Health Organization, the United States government, and Gavi, the Vaccine Alliance, to ensure uninterrupted access of its investigational Ebola Zaire vaccine in support of ongoing international response efforts in the DRC.
As previously announced, Merck has committed to manufacture additional doses of investigational V920 over the coming year.
As part of its clinical development, and in response to requests from the WHO, Merck has, to date, 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, as well as submissions to selected African country National Regulatory Authorities in collaboration with the African Vaccine Regulatory Forum (AVAREF), which, if approved, will allow the vaccine to be registered in several African countries.
V920 was initially engineered by scientists from the Public Health Agency of Canada's National Microbiology Laboratory and the technology was subsequently obtained by a subsidiary of NewLink Genetics Corp.
In late 2014, when the Ebola outbreak in western Africa was at its peak, and with the goal of applying its capabilities in process research, clinical development, and manufacturing to an important global effort, Merck acquired the rights to develop V920 from NewLink Genetics.
Since that time, the company has worked closely with a number of external collaborators to enable a broad clinical development programme with partial funding from the US government, including the Department of Health and Human Service's Biomedical Advanced Research Development Authority (BARDA) and the Department of Defense's Defense Threat Reduction Program and Joint Vaccination acquisition Program, among others. Merck's V920 vaccine supply replenishment activities are supported by partial Federal funding from BARDA under Contract No. HHSO100201700012C.
Merck has been responsible for the research, development, manufacturing and regulatory efforts in support of V920. The company has committed to working closely with other stakeholders to accelerate the continued development, production and distribution of the vaccine.
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