Bavarian Nordic's monkeypox vaccine gets EU approval

The manufacturer company hasn't turned down any orders from governments yet.
Deniz Yildiran
Monkeypox vaccine stock image.Diy13/iStock

Unfortunately, the world hasn't been freed of the ongoing COVID-19 pandemic for the last three years, with fluctuating death and case rates all over the globe. While countries are still dealing with the deadly effects of the virus, a recent announcement about another virus from the World Health Organization (WHO) hasn't been here to be something of a morale-boosting statement.

The WHO declared the outbreak of monkeypox, which has been recently reported in various countries, a public health emergency of international concern on Saturday and issued temporary recommendations for governments to consider while possibly trying to prevent the further spread.

Just two days after the WHO's statement, a Danish biotechnology firm called Bavarian Nordic revealed on Monday, July 25, that it's been granted permission by the European Commission to market its Imvanex vaccine for monkeypox. Currently, Bavarian Nordic's vaccine is the only approved one in the U.S. and Canada to protect against the newly spreading virus, Reuters reported.

"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," Bavarian Chief Executive Paul Chaplin told Reuters.

However, the firm has reportedly provided the vaccine to a few European Union countries during the outbreak for "off-label" use. European Union Member States, Iceland, Liechtenstein, and Norway, are on the list for approved use of the vaccine.

On the other hand, the U.S. government has funded the development of Imvanex throughout the past two decades, and the company's share price has risen by 122% in the last three months due to the demand for their product.

30 million doses a year 

Bavarian Nordic currently seems ambitious in achieving its plans to produce 30 million doses per year as the firm hasn't refused any orders from governments yet, Bloomberg reported

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"Whatever more demand we will face, we expect to meet it with our own resources," Rolf Sass Sorensen, Bavarian's head of investor relations, told Bloomberg. "One very straightforward solution is to run our production facility overnight and get more people into work shifts."

The company's vaccine is approved to be used against monkeypox as well as smallpox in Europe. According to some estimates by Peter Verdult, an analyst at Citigroup, at least half of the company's production capacity could be devoted to Imvanex, and the firm could charge about $100 per dose on average. 

On top of that, the company could contract different producers to manufacture the vaccine. However, it doesn't seem likely at the moment, according to Sorensen.

"The product is not something that easily can be copied, so it's highly unlikely that anyone but us would be able to quickly ramp up production of the vaccine," he added. "It's not a standard type of product that can be copied; you need a lot of expertise to get the vaccine to work. I would say it's an art form."

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