A non-replicating smallpox vaccine, Imvanex was developed in partnership with the US Government.
The move to expand the marketing authorization for Imvanex to include protection from monkeypox and disease caused by the vaccinia virus comes after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion.
This latest approval is valid in all member states in the EU, Liechtenstein, Norway and Iceland.
In June, Bavarian Nordic submitted a rolling type-II variation application seeking label expansion for the vaccine usage in accordance with the company and Emergency Task Force (ETF) of the EMA, Rapporteurs and the European Health Emergency Preparedness and Response Authority (HERA).
The EC-approved full indication for Imvanex includes usage in adults for active immunisation against smallpox, monkeypox and disease caused by the vaccinia virus.
Bavarian Nordic president and CEO Paul Chaplin said: “We are pleased to receive the approval from the European Commission, broadening the label of our vaccine to include monkeypox.
“The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness.
“The development of Imvanex was made possible through significant investments from the US Government for the past two decades, leading the way for other governments to develop plans and prioritise for the future to protect their citizens against public health threats.”
In 2020, the company entered a final agreement with AdaptVac for licencing a capsid virus-like particle-based SARS-CoV-2 subunit vaccine.