Daily Newsletter

08 September 2023

Daily Newsletter

08 September 2023

EC expands indication approval for Merck’s Ebola vaccine

The vaccine is currently approved in the European Union for active immunisation in those aged 18 years or above.

Vishnu Priyan September 08 2023

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.

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.

M&A in the Contract Manufacturing Industry

Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent and Recipharm were particularly active in acquiring companies during this period, and these acquisitions had a focus on advanced biologic capabilities related to cell and gene therapies. CMOs are increasingly targeting companies with sophisticated (biologic and specialized) capabilities to manufacture modern drugs and seek high-value contracts.

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