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New US strategy to develop monkeypox vaccine continues – Health and Lifestyle News – Report by AFR

U.S. health officials on Tuesday approved a new method for injecting the monkeypox vaccine that should allow more people to be vaccinated with the same amount of the drug when doses run low in the country.

The Food and Drug Administration also approved the vaccine for people under the age of 18 who are at high risk of infection.

For people over the age of 18, health workers can now give the vaccine differently, via an intradermal injection – meaning between the top layers of the skin – rather than a deeper, subcutaneous injection.

The new method will “increase the total number of doses available by up to five-fold,” the FDA said in a statement.

Two injections four weeks apart are still required.

The FDA said it relied on data from a 2015 clinical trial that showed a similar immune response in people given a subcutaneous injection compared to people given a fifth of the dose via an intradermal injection.

About 620,000 doses of the vaccine, which is manufactured by Bavarian Nordic and marketed in the US under the name Jynneos, have now been distributed nationwide.

Another 440,000 additional doses have yet to be distributed, which could allow for up to 2.2 million injections under the new strategy.

The government has also ordered an additional five million doses, which will arrive from September and will run through 2023, offering the potential to deliver 25 million doses.

The decisions came after the FDA granted an emergency use authorization for the vaccine, a move that itself followed last week’s declaration of a public health emergency.

For approval in minors, the FDA said it reviewed safety data for the vaccine, as well as data for another vaccine given to children against smallpox.

“We’re very comfortable with the safety of the approach,” the FDA’s Peter Marks said at a news conference, noting that the number of children exposed to potentially infected individuals has increased recently.

The United States has recorded nearly 9,000 cases of monkeypox, a fifth of them in upstate New York. The vast majority of cases involve men who have had sex with men.

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