Regulatory Bavarian Nordic’s Imvanex receives European approval

Bavarian Nordic’s Imvanex receives European approval

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European Commission (EC) has approved Imvanex, the smallpox vaccine from Bavarian Nordic. The drug can also be used against monkeypox and vaccinia virus.

The drug was given a positive opinion by the CHMP (Committee for Medicinal Products for Human Use), which played a major part in the approval. This approval is valid in Liechtenstein, Norway, Iceland, and all EU Member States.

Bavarian Nordic is a biotechnology organization whose key strength is to manufacture, develop and commercialize vaccines for multiple diseases and immunotherapies for cancer. Founded in 1994, Bavarian Nordic is a Danish company that is headquartered in Tuborg Havn, Hellerup, Denmark.

Monkeypox is a rare viral disease that was detected in the United Kingdom in May 2022 after having been found in the region of Africa many years prior. It is from the family of variola virus, which also is the cause of smallpox. It can be categorized as a milder version of smallpox and is seldom fatal. WHO (World Health Organization) declared the eruption of monkeypox a worldwide health emergency on Saturday. According to the World Health Organization, since the first case in May, monkeypox has affected over 16,000 people in over 75 countries.

The virus’ human-to-human spread is limited. However, it can be transmitted through contact with bodily fluids, abrasions on the skin, throat, mouth, respiratory droplets, or objects that are unclean/contaminated. 

In collaboration with the United States government, Imvanex, which is a vaccine for smallpox, was developed in hopes to guarantee a consistent supply for the whole population. This population includes people who have a compromised immune system and are suggested to not use the traditional smallpox vaccines.

Rolling type-2 variation application was submitted in 2022 June in an agreement between European Medicines Agency’s Emergency Task Force and Bavarian Nordic, after which the approval was received.

The monkeypox indication did not take a lot of time to be approved, and this swift approval is an indication of the collaboration between European regulators and Bavarian Nordic. Indication of similar nature usually gets approved in a time frame of six to nine months, while the Europeans Medicines Agency’s review of Imvanex was initiated in late June, roughly a month ago, which makes this approval six to nine times quicker than the average. 

The said review began after the non-clinical data signified that the vaccine activates the production of antibodies that specifically aim for the monkeypox virus.

Chief Executive Officer and President of Bavarian Nordic, 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 biological preparedness. With this approval, we look forward to working closer with the EU and its Member States to solve this important task.”

He further mentioned that one of the major aid in the development of Imvanex was the substantial investments from the government of the United States over the last two decades. This led to other governments following by example and giving priority to the citizens’ protection against health concerns. 

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