FDA Approves Merck’s ERVEBO (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older

Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ERVEBO, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older. The vaccine was previously approved for use in individuals 18 years of age and older. ERVEBO does not protect against other species of Ebolavirus or Marburgvirus and the duration of protection conferred by ERVEBO is unknown. The effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown. ERVEBO includes a contraindication for individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein.

“Ebola virus disease is contagious and potentially deadly in both children and adults. We’re proud of the approval of ERVEBO for the prevention of disease caused by Zaire ebolavirus in children as young as 12 months old, which is another milestone in our continued commitment to help address the global health threat caused by Zaire ebolavirus,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

Separately, on July 20, 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the expanded approval of ERVEBO [Ebola Zaire Vaccine, (rVSVΔG-ZEBOV-GP) live], for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. ERVEBO is currently authorized for use in the European Union (EU) for individuals 18 years of age and older. The CHMP opinion will now be considered by the European Commission for amending the marketing authorization, and a final decision is expected in the third quarter of 2023.

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. As of March 2023, 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.