Merck’s ERVEBO? [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Granted Conditional Approval in the European Union

發(fā)布時(shí)間： 2019-11-13 閱讀：682次

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November 11, 2019, Merck, today announced that 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 (EVD) caused by Zaire Ebola virus. ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration (FDA) 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 (WHO), the United States Government, and Gavi, the Vaccine Alliance, to ensure uninterrupted access of its investigational Ebola Zaire vaccine (V920) 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.