FDA approves Merck’s Ervebo vaccine for under 18s

Betsy Goodfellow | August 4, 2023 | News story | Research and Development FDA, Immunology, Vaccine, ebolavirus 

On 3 August 2023, the US Food and Drug Administration (FDA) approved Merck’s Ervebo vaccine for children over 12 months. The Ebola Zaire vaccine was approved for over 18s in December 2019 initially, however the Committee for Medicinal Products for Human Use (CHMP) recommended granting further approval to allow children to receive the vaccine.

The duration of protection that the vaccine provides for Zaire Ebolavirus is unknown but will be determined with time, along with its effectiveness. Developers of the vaccine have confirmed that it does not protect against any other species of Ebolavirus, and should not be given to individuals with a history of severe reactions to any of its components.

In January 2021, Merck made a deal with UNICEF to establish the first global Ebola vaccine stockpile to protect against any Zaire Ebolavirus breakouts in the future and response efforts. In March 2023, over 500,000 doses of the vaccine were delivered to the stockpile, administered by the International Coordinating Group on Vaccine Provision.

Dr Eliav Barr, senior vice president at Merck Research Laboratories, commented: “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.”

Rebecca Lee

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