Industry Spotlight  |

European Approval for Monkeypox Vaccine

Edited by Tia Byer |
29 July 2022
The European Commission (EC) has approved Bavarian Nordic’s Imvanex vaccine which protects against monkeypox, and diseases caused by the vaccinia virus.

Last week the World Health Organization (WHO) declared the monkeypox virus a global health emergency. The news came after Dr Tedros Adhanom Ghebreyesus, WHO’s Director General, insisted on a call to action stronger than that against COVID-19.

His justification read: “We have an outbreak that has spread around the world rapidly, through new modes of transmission, about which we understand too little, and which meets the criteria in the international health regulations.”   

So far, 16,016 monkeypox cases have been identified globally, with a total of five deaths, according to WHO data. The virus has now spread to 75 countries, with Europe exhibiting the highest number of cases, at 11,865.

However, the EC has now approved use of the Imvanex vaccine, a non-replicating smallpox treatment which also provides protection against monkeypox, and diseases caused by the vaccinia virus. The decision came after the Danish company, Bavarian Nordic also received encouragement from the Committee for Medicinal Products for Human Use (CHMP).

In an official press release published on July 25, 2022, Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, commented: “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. With this approval, we look forward to working closer with the EU and its Member States to solve this important task,” he added.

“The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases”

The label extension of Imvanex was approved following submission of a rolling type-2 variation application in June 2022. This was proposed as a joint venture between Bavarian Nordic and the European Medicines Agency’s Emergency Task Force.

An indication extension of this kind usually takes six to nine months to approve. However, the rapid monkeypox approval attests to the cooperation between Bavarian Nordic and the European regulators.

Monkeypox is an infectious disease that can be caught via rodents (rats, mice, squirrels etc.) in western and central Africa. Transmission occurs when bitten by an infected animal or when touching its blood, bodily fluids, spots, blisters, or scabs.

Human transmission occurs through touching either the body, clothing, bedding, or towels of an individual infected by monkeypox. Coughing and sneezing likewise spread the disease.

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