ERVEBO is a live recombinant viral vaccine that includes a vesicular stomatitis virus backbone deleted for the VSV envelope glycoprotein and replaced with the envelope glycoprotein of the Zaire ebolavirus
Merck headquarters in Rahway, New Jersey. (Credit: Merck & Co., Inc.)
Merck has secured expanded approval from the US Food and Drug Administration (FDA) for ERVEBO (Ebola Zaire Vaccine, Live) to be used in patients of age 12 months and older for the prevention of Ebola Virus Disease (EVD) caused by the Zaire ebolavirus.
ERVEBO is a live recombinant viral vaccine that includes a vesicular stomatitis virus (VSV) backbone deleted for the VSV envelope glycoprotein and replaced with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain).
The vaccine was previously authorised for use in those aged 18 and over.
Merck said that the duration of the protection offered by ERVEBO is uncertain, and it does not offer protection against other Ebolavirus or Marburgvirus species.
It is also unknown whether the vaccination works well when given along with immune globulin (IG), blood or plasma transfusions, antiviral drugs, or both.
People who have experienced a severe allergic reaction to any vaccine component, including rice protein, are contraindicated from receiving ERVEBO.
Merck Research Laboratories global clinical development head, SVP, and chief medical officer Eliav Barr said: “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.”
Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended that ERVEBO be given expanded approval for the active immunisation of people one year of age and older for protection against Ebola Virus Disease.
The use of the live recombinant viral vaccine is currently approved in the European Union (EU) for people who are 18 years of age and older.
The European Commission will now consider the CHMP’s opinion for amending the marketing authorisation. The final decision is anticipated in the third quarter of this year.
In early 2021, Merck reached an agreement with UNICEF to develop the world’s first global Ebola vaccine stockpile with ERVEBO to bolster preparedness and response measures for future outbreaks of the Zaire ebolavirus.