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EU supports split-dose monkeypox vaccine

The EU drug regulator has backed the implementation of a new monkeypox vaccine strategy that involves administering smaller doses, a move aimed at expanding limited stocks as cases continue to rise around the world.

The European Medicines Agency approved the approach, commonly known as fractionated dosing, as a temporary measure on Friday. And British authorities are also finalizing the approach, according to people familiar with the matter.

The only available monkeypox vaccine, Bavarian Nordic’s Imvanex, is “only approved for injection under the skin,” the EMA said. However, when given just under the top layer of skin, a lower dose of the vaccine can be used.

“Given the current limited supply of the vaccine, this means more people can be vaccinated,” it said.

The approach aims to help Europe’s healthcare systems increase coverage by up to fivefold, according to people familiar with the matter. One of them said the recommendation was more likely to allow four doses of extraction.

The fractionated dosing has drawn criticism from Bavarian Nordic, the Denmark-based manufacturer of the vaccine, and some public health experts after the US approved a similar strategy earlier this month. The criticism is that there is limited data on the effectiveness of lower doses in protecting against monkeypox, although the approach has been used successfully for other vaccines.

The World Health Organization last month declared the monkeypox outbreak a public health emergency of international concern. More than 40,000 cases have been registered around the world since May, according to research group Our World in Data.

The Financial Times reported last week that the UK was almost out of vaccine stocks and that it would not receive any more supplies until the end of September. The shortage is also serious in Europe, with people who push boundaries get vaccinated, as doses are often unavailable.

Claire Dewsnap, head of the British Association for Sexual Health and HIV, said they hope fractional dosing will be approved in the UK in the next few days.

“I understand it is now with ministers. We all really hope that this will be possible,” she said.

According to people familiar with the matter, there was dissatisfaction within the UKHSA and among campaign groups at how the agency initially underestimated the number of people eligible for vaccination.

The UK’s vaccination strategy is “continuously reviewed to ensure doses of the smallpox vaccine are reaching as many people at high risk of exposure as possible,” UKHSA’s head of vaccinations, Mary Ramsay, said when asked.

“If there are any changes, they will be announced as decisions are made,” she said, adding that global supplies are limited and that the agency “acted early to secure the maximum possible number of doses available from the sole global manufacturer.” to get “.

Fractional dosing is used for other vaccines because it allows for an increase in supply and has been shown to be as effective as other routes of administration.

Bavarian Nordic announced late Thursday that it has reached an agreement to expand production with US company Grand River Aseptic Manufacturing amid rising demand.

https://www.ft.com/content/8d23eb83-fa7c-4bd8-9ad9-0e600568022c EU supports split-dose monkeypox vaccine

Adam Bradshaw

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