EU extends indication to children aged 1 year and over

by time news

2023-09-15 17:23:05

The European Commission has approved the extension of indication for the live recombinant vaccine for protection against Ebola virus disease Zaire, in children aged 1 year and older. The EU decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), received on 20 July 2023. The vaccine – explains MSD (known as Merck & Co. in the United States United States and Canada) – was previously approved for use in the European Union for individuals 18 years of age and older. The use of the live recombinant Ebola Zaire vaccine must comply with official recommendations.

“Ebola virus disease is serious and potentially life-threatening for both children and adults,” said Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. The extended approval of the MSD vaccine from part of the European Commission for children aged 1 year and older represents an important milestone for the prevention of the disease caused by the Ebola virus Zaire. When epidemics of the Ebola virus disease occur – he emphasizes – they can quickly turn into a crisis of public health. We are proud to play a role, together with the global public health community, in helping prepare for potential Ebola Zaire virus outbreaks.”

In January 2021, MSD confirmed an agreement with Unicef ​​to build the world’s first Ebola vaccine stockpile with its live recombinant vaccine to support preparedness and response efforts for future Ebolavirus Zaire outbreaks, the company recalls in a press release. Note. To date, over 500 thousand doses of the authorized vaccine have been delivered and supplies are managed by the International Coordinating Group on Vaccine Provision.

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