London, Aug. 10 (BUS) – European health officials are debating whether to follow the United States’ move to expand supplies of a rare monkeypox vaccine, as the World Health Organization has called for more data.
Reuters reported that there have been 27,800 cases of monkeypox – mostly among men who have sex with men – and 12 deaths worldwide this year.
According to the World Health Organization and other government health agencies, supplies of the North Bavarian flagship vaccine, the only authorized vaccine to prevent monkeypox and a key part of the global public health response, are scarce.
On Tuesday, the United States backed the use of a single vial of the vaccine to give up to five separate doses – instead of a single dose – by injecting a smaller amount between layers of the skin. The vaccine is designed to be injected into a layer of subcutaneous fat.
This so-called “dose-sparing” approach has been tried before with other vaccines, including polio and yellow fever vaccines, but evidence is limited about whether it can work with monkeypox.
“The European Medicines Agency (EMA) will discuss the possibility of a dose-sparing approach,” an EMA spokesperson said, adding that the regulator would discuss the strategy with the manufacturer, Northern Bavarian, and European countries.
The company did not respond to repeated requests for comment.
A WHO spokesperson told Reuters by email that the WHO “encourages the use of vaccines in trials that will help gather relevant information for use in the outbreak.”
According to the U.S. Food and Drug Administration, data collected in a 2015 clinical study showed that dose-sparing can work without compromising the safety and efficacy of the vaccine.
Meanwhile, some governments in Europe are taking further steps to expand existing supplies. For example, Britain is offering only one injection of the two-dose regimen to people most at risk as a temporary measure to provide at least some protection to more people.
It is not clear whether either approach would result in adequate protection against monkeypox, which is usually a mild to moderate infection that results in flu-like symptoms and pus-filled skin lesions.
The viral disease has been endemic in parts of Africa for decades, and was first reported this year outside of those countries in May.
Adam Fane, a professor at the University of Bristol who works with the World Health Organization in Europe to advise on monkeypox immunization campaigns, said it “makes sense” to “evaluate a dose-reduction approach” where vaccine run-out is a very real potential concern with monkeypox epidemics.
MI