EC expands indication approval for Merck’s Ebola vaccine
2023-09-08
上市批准疫苗
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来源: Pharmaceutical Technology
Ervebois is indicated for active immunisation of the paediatric population against Zaire ebolavirus-caused Ebola virus disease. Credit: Novikov Aleksey / Shutterstock.com.
The European Commission (EC) has granted expanded indication approval for Merck’s Ebola Zaire vaccine, Ervebo, to include children aged one year or above.
Ervebois is indicated for active immunisation of the paediatric population against the Zaire ebolavirus-caused Ebola virus disease.
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The live recombinant viral vaccine comprises a vesicular stomatitis virus (VSV) backbone with the VSV envelope glycoprotein removed and replaced with the Zaire ebolavirus’s (Kikwit 1995 strain) envelope glycoprotein.
The latest approval comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency gave its approval in July 2023.
The vaccine is currently approved in the European Union for active immunisation in those aged 18 years or above.
Merck Research Laboratories global clinical development senior vice-president and chief medical officer Dr Eliav Barr stated: “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 US Food and Drug Administration approved the expanded indication of Ervebo for usage in children aged 12 months and above in August 2023.
In a bid to support planning and response activities for future outbreaks, the company signed an agreement with the United Nations International Children’s Emergency Fund in January 2021, under which a global Ebola vaccine stockpile is being created using Ervebo.
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