EC extends vaccine label to tackle monkeypox

Words by GOLD newsdesk

An extension of the marketing authorisation for Bavarian Nordic’s smallpox vaccine, Imvanex has been granted by the European Commission, meaning it can now be used as a method of protection from monkeypox and disease caused by vaccinia virus in adults.


Typically, an indication extension such as this would take at least six to nine months to achieve, but given the recent declaration by the World Health Organization (WHO) that the multi-country outbreak of monkeypox constitutes a public health emergency of international concern (PHEIC), the approval was considered to be of high priority.


“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,” commented Paul Chaplin, President and CEO, Bavarian Nordic. “The development of Imvanex was made possible through significant investments from the U.S. government for the past two decades, leading the way for other governments to develop plans and prioritize for the future to protect their citizens against public health threats. With this approval, we look forward to working closer with the EU and its member states to solve this important task.”


The approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) and is valid across all EU Member States, plus Iceland, Liechtenstein, and Norway.


Following the PHEIC announcement, the WHO Director-General has issued a set of temporary recommendations, including advice on areas such as monkeypox surveillance, response and protection.