Merck Ervebo gets European Commission expanded indication approval for active immunization of individuals 1 year of age or older to protect against EVD

Merck, known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved an expanded indication for Ervebo for active immunization of individuals 1 year of age or older to protect against Ebola virus disease (EVD) caused by Zaire ebolavirus. The EC’s decision follows the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) received on July 20, 2023. The vaccine was previously approved for use in the European Union (EU) for individuals 18 years of age or older. The use of Ervebo should be in accordance with official recommendations.

“Ebola virus disease is severe and potentially life-threatening for both children and adults. The European Commission’s expanded approval of Ervebo for children 1 year of age and older is an important milestone for the prevention of disease caused by Zaire ebolavirus,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “When outbreaks of Ebola virus disease occur, they can quickly become a public health crisis. We are proud to play a role, alongside the global public health community, in helping to prepare for potential outbreaks of Zaire ebolavirus.”

In January 2021, Merck confirmed an agreement with UNICEF to establish the world’s first global Ebola vaccine stockpile with Ervebo to support future Zaire ebolavirus outbreak preparedness and response efforts. To date, over 500,000 doses of the licensed vaccine have been delivered to the stockpile, which is administered by the International Coordinating Group on Vaccine Provision.

Ervebo is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older. Ervebo is a live recombinant viral vaccine consisting of a vesicular stomatitis virus (VSV) backbone deleted for the VSV envelope glycoprotein and substituted with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain).

Ervebo was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and the technology was subsequently licensed by a subsidiary of NewLink Genetics Corporation now known as Lumos Pharma, Inc. Merck licensed the vaccine in 2014 and led research and development efforts in collaboration with a number of public health organizations to enable a broad clinical development program. This project has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201700012C.

The National Institute of Allergy and Infectious Diseases (NIAID), L’institut National de la Santé et de la Recherche Médicale (INSERM), and the London School of Hygiene and Tropical Medicine (LSHTM) sponsored the PREVAC study, designed to evaluate the safety and immunogenicity of two Ebola virus disease vaccine candidates, including Ervebo, in adults and children aged 12 months and older.

Ervebo is approved in the European Union, United Kingdom, United States, Canada, Switzerland, and 10 countries in Africa.

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