Source – Merck
Merck announced that the US Food and Drug Administration (FDA) has granted expanded approval for Ervebo. The vaccine is now indicated for preventing disease caused by Zaire ebolavirus in individuals aged 12 months and older. Previously, Ervebo was approved for use in individuals aged 18 years and older. It is essential to note that Ervebo does not protect against other types of Ebolavirus or Marburgvirus, and the duration of its protection is currently unknown. Furthermore, the effectiveness of Ervebo when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is not yet established. A contraindication exists for individuals with a history of severe allergic reactions, including anaphylaxis, to any component of the vaccine, including rice protein.
โEbola virus disease is contagious and potentially deadly in both children and adults. Weโre 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.โ
– 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, (rVSVฮG-ZEBOV-GP) live] for active immunization of individuals aged 1 year or older, providing protection against Ebola Virus Disease (EVD) caused by Zaire ebolavirus. Currently, Ervebo is authorized for use in the European Union (EU) for individuals aged 18 years and older. The CHMP’s opinion will be considered by the European Commission to amend the marketing authorization, with a final decision expected in the third quarter of 2023.
In January 2021, Merck established an agreement with UNICEF to create the world’s first global Ebola vaccine stockpile using Ervebo to support future preparedness and response efforts for Zaire ebolavirus outbreaks. As of March 2023, over 500,000 doses of the licensed vaccine have been delivered to the stockpile, managed by the International Coordinating Group on Vaccine Provision.
