The US Food and Drug Administration (FDA) has granted approval for an expanded indication of Merck’s (MSD) Ebola vaccine, Ervebo, for usage in paediatric populations aged 12 months and above.
The vaccine prevents Zaire ebolavirus-caused Ebola disease. The company noted that the vaccine does not offer protection against other ebolavirus or Marburgvirus species.
Ervebo initially received approval in December 2019 for its usage in those aged 18 and above.
Merck Research Laboratories global clinical development head, senior vice-president and chief medical officer Dr Eliav Barr stated: “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.”
In July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended granting expanded approval to the vaccine for usage in children aged one year and above.
The vaccine has already received marketing authorisation in the European Union for use in people aged 18 years and above.
The European Commission will take into account the opinion of the CHMP. Its final decision is anticipated in the third quarter of 2023.
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