Based on the CHMP recommendation, the European Commission (EC) will grant the final approval soon, which will be valid in all the Member States of the European Union (EU) along with Iceland, Liechtenstein, and Norway
Bavarian Nordic has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for its smallpox vaccine Imvanex.
The committee recommended the extended marketing authorisation for Imvanex in Europe, to include active immunisation to protect people from monkeypox disease.
The Danish biotechnology company has submitted the data supporting the positive opinion, upon request from EMA’s Emergency Task Force (ETF) amid the current monkeypox outbreak.
Based on the CHMP recommendation, the European Commission (EC) is expected to grant the final approval soon.
The potential EC extended marketing authorisation will be valid in all the Member States of the European Union (EU) along with Iceland, Liechtenstein, and Norway.
Bavarian Nordic president and CEO Paul Chaplin said: “We applaud the expedited review by the Committee for Medicinal Products for Human Use and the recommendation to extend the approval of our vaccine to include protection against monkeypox, thus aligning with the approvals from the US FDA and Health Canada.
“While we have already supplied our vaccine to many European countries during the current monkeypox outbreak, including supplies to the joint EU stockpile facilitated by the European Health Emergency Preparedness and Response Authority (HERA), the extension of the label will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox.”
Imvanex is a non-replicating smallpox vaccine, distributed in liquid-frozen formulation, and contains a live modified form of the vaccinia virus, dubbed vaccinia Ankara.
Bavarian Nordic is currently developing the vaccine in collaboration with the US government to supply the smallpox vaccine to all, including immunocompromised people.
The vaccine has been approved in several countries, including in the EU, Canada (Imvamune), and the US (Jynneos), among others, for immunisation against smallpox in adults.
Bavarian Nordic has supply contracts in place with US and Canada and has delivered the vaccine to several undisclosed countries worldwide.
Last month, EMA’s CHMP commenced the review of Bavarian Nordic’s smallpox vaccine, to extend its use to prevent monkeypox disease.