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European countries can extend the limited supply of monkeypox vaccines with smaller doses of the vaccine, the European Medicines Agency (EMA) said on Friday.
The agency’s recommendations are in line with the so-called fractionated-dose approach, endorsed by U.S. regulators, in which a vial of vaccine can be used to administer up to five separate doses — rather than a single dose — by injecting smaller amounts of skin (intradermally) between layers injection).
The vaccines, known as Jynneos, Imvanex and Imvamune, depending on geographic location, are designed to be injected into a layer of fat under the skin, known as a subcutaneous injection.
As an interim measure, national authorities may decide to use the vaccine as an intradermal injection during the current monkeypox outbreak to protect at-risk groups, while vaccine supplies remain limited, the EMA said.
The recommendation is based on a study involving about 500 adults that compared the performance of vaccines given either intradermally or subcutaneously, with two doses given about a month apart.
Those who received the intradermal injection received one-fifth the subcutaneous dose, but produced antibody levels similar to those who received the original subcutaneous dose, the EMA said.
However, the agency warns that there is a higher risk of local reactions after intradermal injections, such as redness, skin thickening or discoloration.
Since early May, more than 40,000 confirmed cases of monkeypox, including a handful of deaths, have been reported in more than 80 countries where the virus is not endemic.
The World Health Organization has declared the outbreak a global health emergency. Vaccines made by Nordic in Bavaria are in short supply.
Some countries are expanding available doses, with unknown results, to make the most of existing supplies.
The UK, Canada and Germany are getting one dose each instead of two, allowing them to vaccinate more people, even though each of them may have more or less lasting protection.
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