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EU regulators approve plans to expand supply of monkeypox vaccine

Monkeypox vaccine is effective even in small doses and could increase current supplies fivefold, the European Medicines Agency said on Friday, reflecting recommendations. said. It was created by the U.S. Food and Drug Administration earlier this month.

In a statement, the EU medicines regulator said that injecting people with one-fifth the usual dose of the smallpox vaccine produced by Bayern Nordic would produce levels similar to the full dose against monkeypox. of antibodies appeared to be produced.

This approach requires Bavarian Nordic's vaccine to be injected just under the skin rather than in deeper tissues, which may enhance the immune response. A patient should be vaccinated twice, about four weeks apart.

EMA decides national authorities will use lower doses of vaccine "as a temporary measure" to protect vulnerable populations during ongoing monkeypox epidemic I said it is possible.

EU Health Commissioner Stella Kyriakides said the decision would allow vaccinations to be five times the continent's current supply. More vaccines will be available to at-risk citizens and health workers," she said in a statement.

Earlier this month, the US FDA approved a similar plan to expand the country's monkeypox vaccine inventory. The technology has previously been used to expand vaccine supplies during other outbreaks such as yellow fever and polio.

Unusual recommendations from both regulatory agencies acknowledge that the global supply of the Jynneos vaccine, originally developed against smallpox, is very limited. Bavarian Nordic is the only company producing it, and about 16 million doses are expected to be available this year. On Thursday, the U.S. also announced a new agreement with manufacturers in Michigan to accelerate production of the 5.5 million vials of vaccine recently ordered by the government. approved the vaccine in July, based on experimental data suggesting that The World Health Organization estimates that this shot is about 85% effective in preventing monkeypox.

Globally, monkeypox cases have exceeded her 40,000, about half of them in Europe. Earlier this week, WHO Director-General Tedros Adhanom Ghebreyesus said there had been a 20% increase in reported cases in the past two weeks, with almost all infections in men who were gay, bisexual, or had sex with other men.

Tedros said the WHO is in talks with vaccine manufacturers and countries to see if they are willing to share doses. Africa has the highest number of reported deaths from suspected monkeypox, which has been endemic for decades in parts of central and western Africa, but vaccines used as part of research studies supply is negligible.

Approximately 98% of monkeypox cases outside Africa are reported in men who are homosexual, bisexual, or have sex with other men. The WHO said a small number of women and children also contract the disease, but there is no evidence of persistent infection outside of men who have sex with men. It spreads through close physical contact with the affected area, clothing, or bed sheets. Most people recover without needing treatment, but the lesions can be extremely painful and in more severe cases can lead to complications such as brain inflammation and death.[29] }

In the United Kingdom, which at one point had the largest outbreak outside of Africa, officials said earlier this week they had seen signs the outbreak was slowing.