The U.S. Food and Drug Administration (FDA) has approved an expanded indication for ERVEBO, which is now indicated for the prevention of disease brought on by the Zaire ebolavirus in people 12 months of age and older, according to Merck (NYSE: MRK), also known as MSD outside of the United States and Canada. The vaccination was previously authorised for use in anyone aged 18 and over. The duration of the protection offered by ERVEBO is uncertain, and it does not offer protection against other Ebolavirus or Marburgvirus species. It is unknown whether the vaccination works well when given along with immune globulin (IG), blood or plasma transfusions, antiviral drugs, or both. For those who have experienced a history of a severe allergic reaction (such as anaphylaxis), ERVEBO includes a contraindication.
“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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended that ERVEBO® [Ebola Zaire Vaccine, (rVSV-G-ZEBOV-GP) live] be given expanded approval for the active immunisation of people 1 years of age and older in order to protect against Ebola Virus Disease (EVD) brought on by the Zaire ebolavirus. The use of ERVEBO is currently permitted in the European Union (EU) for people who are 18 years of age and older. The European Commission will now take the CHMP position into consideration when modifying the marketing authorization; a final decision is anticipated in the third quarter of 2023.
In order to support future Zaire ebolavirus outbreak preparedness, Merck and UNICEF announced their agreement in January 2021 to develop the world’s first global Ebola vaccine stockpile with ERVEBO. By March 2023, the International Coordinating Group on Vaccine Provision, which oversees the stockpile, had received approximately 500,000 doses of the licenced vaccine.
Selected Safety Information for ERVEBO
CONTRAINDICATIONS
If a person has experienced a severe allergic reaction, such as anaphylaxis, to any vaccine component, including rice protein, they should not be given ERVEBO.
