European regulator OK plans to increase supply of monkeypox vaccines

LONDON (AP) — A lower dose of the monkeypox vaccine still appears to be effective and can be used to increase the current supply fivefold, the European Medicines Agency said on Friday, echoing a recommendation made earlier this month. by the US Food and Drug Administration.

The EU medicines regulator said in a statement that injecting people with just a fifth of the regular dose of the smallpox vaccine made by Bavarian Nordic appeared to produce similar levels of antibodies against the virus. full dose monkeypox.

The approach calls for administering Bavarian Nordic’s vaccine with an injection just under the skin rather than deeper tissue, a practice that can stimulate a better immune response. People still need to get two doses, about four weeks apart.

The EMA said national authorities may decide, “as a temporary measure”, to use smaller doses of the vaccine to protect vulnerable people during the ongoing monkeypox outbreak.

EU Health Commissioner Stella Kyriakides said the decision would allow five times as many people to be vaccinated with the continent’s current supply.

“This ensures greater access to vaccination for at-risk citizens and healthcare workers,” she said in a statement.

Earlier this month, the US FDA authorized a similar plan to expand the country’s monkeypox vaccine stockpiles. The technique has already been used to stretch the supply of vaccines during other outbreaks, including yellow fever and polio.

The unusual recommendations from the two regulators acknowledge the extremely limited global supplies of the Jynneos vaccine, originally developed against smallpox. Bavarian Nordic is the only company making it and expects to have about 16 million doses this year. On Thursday, the United States also announced a new agreement with a Michigan manufacturer to help ramp up production of 5.5 million vaccine vials recently ordered by the government.

The EMA authorized the vaccine in July based on experimental data suggesting it would work; the World Health Organization has estimated that the vaccine is about 85% effective in preventing monkeypox.

Globally, there are more than 40,000 cases of monkeypox, around half of them in Europe. Earlier this week, WHO chief Tedros Adhanom Ghebreyesus said there had been a 20% increase in reported cases over the past two weeks and almost all infections were reported in men. homosexual, bisexual or having sex with other men.

Tedros said the WHO was in talks with vaccine makers and countries to see if some would be willing to share doses. Africa has reported the highest number of suspected monkeypox deaths and although the disease has been endemic in parts of West and Central Africa for decades, it has only a small supply of vaccines used as part of it. of a research study.

About 98% of monkeypox cases beyond Africa have been reported in men who are gay, bisexual, or have sex with men. The WHO said there were no signs of sustained transmission beyond men who have sex with men, although a small number of women and children have also been infected with the disease.

Monkeypox is spread when people have close physical contact with an infected person’s lesions, clothing, or bedding. Most people recover without needing treatment, but the lesions can be extremely painful and more severe cases can lead to complications including brain inflammation and death.

In the UK, which at one point had the biggest outbreak outside Africa, officials said earlier this week they had seen signs the outbreak was slowing.