Europe considers dose-sparing to scale up monkeypox vaccine, WHO aims for trials

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LONDON – Health officials in Europe are discussing whether to follow a move by the United States to expand scarce monkeypox vaccine supplies, with the World Health Organization calling for more data.

That year there were 27,800 cases of monkeypox worldwide — mostly in men who have sex with men — and 12 deaths.

According to the WHO and other state health officials, supplies of the key Bavarian Nordic Shot, the only vaccine approved to prevent monkeypox and a key part of the global public health response, are running low.

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On Tuesday, the US supported using a vial of the vaccine to give up to five separate doses – instead of a single dose – by injecting a smaller amount between layers of skin. The vaccine is designed to be injected into a layer of fat under the skin.

This so-called “dose-sparing” approach has been tried with other vaccines, including polio and yellow fever, but there’s limited evidence that it might work for monkeypox.

“The European Medicines Agency (EMA) will discuss the possibility of a dose-saving approach,” an EMA spokesman told Reuters, adding that the regulator will discuss the strategy with the manufacturer, Bavarian Nordic and European countries.

The company did not respond to repeated requests for comment.

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The WHO “encourages the use of vaccines in studies that will help gather relevant information for their use in this outbreak,” a spokesman told Reuters via email.

According to the US Food and Drug Administration, data collected in a 2015 clinical study https://www.sciencedirect.com/science/article/pii/S0264410X15008762?via%3Dihub showed that dose savings could work without compromising the safety and effectiveness of the vaccine.

Meanwhile, some governments in Europe are taking other steps to expand existing supplies. For example, the UK is only offering vaccination of the two-dose regimen to those most at risk as a temporary measure to provide at least some protection to a larger number of people.

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It is unclear whether either approach results in adequate protection against monkeypox, which is usually a mild to moderate infection resulting in flu-like symptoms and characteristic pus-filled skin lesions.

The viral disease has been endemic in parts of Africa for decades and was first reported outside those countries in May this year.

Adam Finn, a professor at the University of Bristol who is working with WHO Europe to provide advice on monkeypox vaccination campaigns, said it was “meaningful” to evaluate the dose-sparing approach “as vaccine stocks are a very real potential concern of the.” Monkeypox epidemic.” (Reporting by Jennifer Rigby and Natalie Grover; Editing by David Gregorio)