Ebola Zaire Vaccine Approved for Young Children

Merck today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for the ERVEBO® vaccine, which is now indicated for preventing disease caused by Zaire ebolavirus in individuals 12 months of age and older.

ERVEBO was previously approved for use in individuals 18 and older.

This Ebolavirus vaccine does not protect against other species of Ebolavirus (Sudan) or Marburgvirus.

As of March 2023, over 500,000 doses of ERVEBO had been delivered to a stockpile administered by the International Coordinating Group on Vaccine Provision.

"Ebola virus disease is contagious and potentially deadly in 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, in a press release on August 3, 2023.

The vaccine's effectiveness when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions is unknown, and the duration of protection conferred by ERVEBO is unknown. 

ERVEBO includes a contraindication for individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein.

The initial Ebola virus disease case first appeared in 1976 in Africa. Since then, numerous outbreaks of Zaire and Sudan have been confirmed.

As of August 3, 2023, the FDA and European Medicines Agency have approved other ebola prevention and treatment products.