FDA approves expanded indication for Ervebo in Zaire ebolavirus – Merck Inc

Merck Inc announced that the 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.