First monkeypox vaccine approved as WHO declares emergency

The World Health Organization (WHO) has officially declared the monkeypox outbreak to be a global health emergency.

Monkeypox is a zoonotic disease, occurring when it is transmitted from animals to humans. The disease occurs primarily in tropical rainforest areas of central and west Africa where it is endemic, however since May this year there has been a surge in cases in other parts of the world.

This is the first time a multinational outbreak of monkeypox has taken place. There are currently more than 17,000 cases globally, reported in 75 countries – this represents a 50 percent increase since the previous week commencing July 18th.

The latest global health emergency

The rapid surge in transmission has prompted the WHO to label it a public health emergency of international concern (PHEIC), the strongest call to action the agency can make. In a public address, the WHO’s Director-General Tedros Adhanom Ghebreyesus, said: “I have decided that the global monkeypox outbreak represents a public health emergency of international concern.

“The risk of monkeypox is moderate globally, except in the European region where we assess the risk as high. Although I am declaring a public health emergency of international concern for the moment, this is an outbreak that's concentrated among men who have sex with men, especially those with multiple sexual partners. That means that this is an outbreak that can be stopped with the right strategies in the right groups.”

A PHEIC is defined by the WHO as “an extraordinary event which is determined to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response”.

It is the seventh time the WHO has declared a PHEIC, the most recent being for the Covid-19 pandemic.

The first monkeypox vaccine

In May, Pharma IQ reported that Bavarian Nordic A/S had secured a contract with an undisclosed European country to supply Imvanex, its smallpox vaccine, in response to the outbreak.

Today the Danish pharma manufacturer has announced it has received permission from the European Commission to officially label Imvanex as a treatment for monkeypox in the European Union as well as Iceland, Liechtenstein and Norway. It was previously approved for use in Canada and the US under the commercial names Jynneos and Imvamune respectively.

Bavarian Nordic is currently the only organization to have a vaccine approved for monkeypox. Imvanex is a Modified Vaccinia Ankara (MVA) vaccine that contains a virus that has been modified so that it cannot grow in the human body. After two doses, most people develop enough antibodies to protect them against monkeypox.

Containing the monkeypox outbreak

Some countries have started inviting people most at risk of the disease for vaccination. For patients who are already infected, treatment of depends on symptoms. In the US, the antiviral tecovirimat is being administered in some cases, however it is currently only approved for the treatment of smallpox and therefor can only be administered with patients’ informed consent.

The WHO recommends avoiding contact with infected people, wearing personal protective clothing while taking care of people who are sick, and raising awareness to prevent infection and stop transmission.

Paul Chaplin, President and CEO of Bavarian Nordic, said: “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.”

Quick links: 

• Pharma prepares to fight global monkeypox outbreak
• Keeping tabs on Covid-19: Living with the virus
• Why R&D must digitalize and become data-centric

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