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Merck announced Thursday 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.

Image/Dr. Frederick Murphy,CDC

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.

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Ebola virus disease is a rapidly progressive, severe, potentially fatal and transmissible hemorrhagic illness caused by infection with one of the Ebola virus species. While there are six identified Ebola virus species, the Zaire ebolavirus strain has been the leading cause of outbreaks over the last 20 years. The average fatality rate for Ebola virus disease is approximately 50% but has ranged from 25% to 90% in previous outbreaks.

Human-to-human transmission can occur via blood or bodily fluids, objects (like needles and syringes), possibly from contact with semen from a man who has recovered from Ebola, or direct contact through broken skin or mucous membranes.