MSD's Ebola Vaccine Ervebo Receives FDA Approval for Use in Individuals Aged 12 Months and Older

On August 3, MSD announced that its Ebola vaccine Ervebo (V920) received FDA approval for an expanded indication, now applicable for active immunization in individuals aged 12 months and above to prevent Ebola virus disease caused by the Zaire ebolavirus.

The vaccine was approved by the European Commission in November 2019 and by the FDA in December 2019 for use in individuals aged 18 and above. It is the world's first approved Ebola vaccine.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended on July 20, 2023, to expand the approval of Ervebo for active immunization in individuals aged 1 year and older. The European Commission will now consider the CHMP's opinion, with a final decision expected in the third quarter of 2023.

Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer of MSD, said: "Ebola virus disease is contagious and can be fatal to both children and adults. We are proud that Ervebo has been approved for use in pediatric populations, marking another milestone in our ongoing commitment to helping address the global health threat posed by the Zaire ebolavirus."

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