EUROPE – The European Medicines Agency (EMA) has extended the approved indications of Bavarian Nordic’s smallpox vaccine Imvanex for monkeypox, which has now infected tens of thousands of people across dozens of countries worldwide.

Imvanex has been approved in the EU since 2013 for smallpox, a virus related to monkeypox, and according to the CHMP should not be approved to protect adults from monkeypox disease.

The World Health Organization (WHO) has just taken the step of declaring monkeypox a “public health emergency of international concern” – its highest level of alert – two years after taking the same step with COVID-19.

The WHO’s declaration signals a public health risk requiring a coordinated international response. The designation can lead member countries to invest significant resources in controlling an outbreak, draw more funding to the response, and encourage nations to share vaccines, treatments and other key resources for containing the outbreak.

With the WHO declaring the outbreak a public health emergency, Bavarian Nordic’s vaccine is a hot commodity.

Since monkeypox cases started to rise two months ago there have been more than 16,000 cases recorded from 75 countries, with more than two thirds found in Europe, a scale of outbreak never before encountered with the virus.

WHO director general Tedros Adhanom Ghebreyesus took the unusual step of over-ruling the agency’s expert advisors in declaring the emergency, after they were unable to come to a consensus position on the threat.

The WHO’s declaration signals a public health risk requiring a coordinated international response. The designation can lead member countries to invest significant resources in controlling an outbreak, draw more funding to the response, and encourage nations to share vaccines, treatments and other key resources for containing the outbreak.

He said the rapid spread of the virus, with new modes of transmission that were poorly understood, underpinned the decision, which activates mechanisms requiring a coordinated, international response to the outbreak.

Having an approved vaccine “can significantly improve nations’ readiness to fight emerging diseases,” said Paul Chaplin, chief executive of Bavarian Nordic.

The Danish biotech said that the shot benefited from two decades of support from the US government, showing the importance of “investments and structured planning” for biological preparedness.

In June said it had received orders for 1.5 million doses of the shot from an unidentified European country and was scheduled to start deliveries in the fourth quarter.

It had previously agreed supply deals with the US and Canada where the vaccine is called Jynneos – for almost 7 million doses, with around 1 million doses expected to be delivered this year.

The EMA’s human medicines committee, the CHMP, recommended approval of the vaccine after reviewing data from several animal studies which showed protection against the monkeypox virus in non-human primates vaccinated with Imvanex.

European regulators approved it to prevent monkeypox much faster than their usual 6- to 9-month review timeline.

Six events were declared public health emergencies of international concern (PHEIC) between 2007 and 2020.

They include the 2009 H1N1 influenza pandemic, Ebola (West African outbreak 2013–2015, outbreak in Democratic Republic of Congo 2018–2020), poliomyelitis (2014 to present), Zika (2016) and COVID-19 (2020 to present).

Monkeypox is the seventh public health emergency since 2007.Poliomyelitis is the longest PHEIC. Zika was the first PHEIC for an arboviral disease.

There are only two other current WHO-designated public health emergencies, COVID-19 and polio.

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