Ervebo is a live recombinant viral vaccine that has a VSV backbone removed for the VSV envelope glycoprotein and replaced with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain)
Merck gets expanded approval for its Ervebo vaccine in the EU. (Credit: Montgomery County Planning Commission/Wikimedia Commons)
Merck has received expanded indication approval for Ervebo (Ebola Zaire Vaccine, Live) from the European Commission (EC) for active immunisuation of individuals one year of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire ebolavirus.
Ervebo is a live recombinant viral vaccine. It has a vesicular stomatitis virus (VSV) backbone removed for the VSV envelope glycoprotein and replaced with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain).
The European Commission’s decision comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a favourable opinion for Ervebo in July 2023.
The vaccine has already been authorised for use in people aged 18 and older in the European Union (EU).
Merck, which is known as MSD outside of the US and Canada, said that the use of Ervebo has to be aligned with official recommendations.
Merck Research Laboratories chief medical officer and global clinical development head Eliav Barr said: “Ebola virus disease is severe and potentially life-threatening for both children and adults.
“The European Commission’s expanded approval of Ervebo for children one year of age and older is an important milestone for the prevention of disease caused by Zaire ebolavirus.
“When outbreaks of Ebola virus disease occur, they can quickly become a public health crisis. We are proud to play a role, alongside the global public health community, in helping to prepare for potential outbreaks of Zaire ebolavirus.”
The American pharmaceutical company and UNICEF announced an agreement in January 2021 to set up the first worldwide stockpile of Ebola vaccines with Ervebo to support future planning and response activities for the Zaire ebolavirus outbreak.
Over 500,000 doses of the licensed vaccine have already been delivered to the stockpile, which is overseen by the International Coordinating Group on Vaccine Provision.
Last month, the company secured approval from the US Food and Drug Administration (FDA) for Ervebo to be used in patients of age 12 months and older for the prevention of EVD.