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US Moves to Expand Supply of Monkeypox Vaccine

US Moves to Expand Supply of Monkeypox Vaccine

 


WASHINGTON—The Biden administration has decided to expand the limited supply of monkeypox vaccine, allowing a different injection method that uses one-fifth in a single injection, familiar with the debate. people said.

For the Food and Drug Administration to approve so-called intradermal injections, one-fifth of the current dose would have to be injected into the skin instead of the full dose into the subcutaneous fat. A new emergency declaration that allows regulators to exercise FDA’s emergency use authority. That declaration is expected as early as Tuesday afternoon.

This move shortage of vaccines It has become an increasingly serious political and public health issue for the administration.

In less than three months, more than 8,900 monkeypox cases were reported. The virus spreads from person to person primarily through close physical contact with an infected lesion.

Despite investing more than $1 billion in developing a two-dose vaccine known as Jynneos, monkeypox And smallpox, the government only has 1.1 million vaccinations on hand. About three times the dose is needed to cover her 1.7 million Americans from her 1.6 million who are at increased risk of getting monkeypox, according to the Centers for Disease Control and Prevention.

According to the CDC, the vaccine is currently given in two doses of 0.5 milliliters 28 days apart, with immune protection reaching “maximum” 14 days after the second dose.

the shot is Recommended by CDC For people who have had monkeypox or who may have it. The latter category included those with confirmed contact with a monkeypox case, those who knew a sexual partner who had been diagnosed with monkeypox in the previous 14 days, and those who had “multiple ” includes those who have had sexual partners. “Known monkeypox.”

Federal health officials said last week they had distributed so far About 600,000 times of vaccines to state and local jurisdictions.

Last week the Department of Health and Human Services also Broader public emergency declaration issued This allowed the federal government to more easily allocate funds and other resources to fight the virus.



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Studies on intradermal injection of monkeypox vaccine are essentially limited to one study. Injecting the vaccine between layers of the skin has been shown to induce an immune response comparable to standard injection into the fat under the skin. Federal officials are in discussions with various outside groups, including the Infectious Diseases Society of America, about switching to an intradermal injection approach, according to people familiar with the matter.

Some outside experts have criticized the data supporting the monkeypox method for being too thin and targeted. 2015 survey It was sponsored by the National Institutes of Health.

John Beigel, Ph.D., associate director for clinical research at the NIH, who briefed federal health officials and the World Health Organization, said that switching to the intradermal vaccine is more effective than administering only one of the two recommended doses. said to be a better option for storing . Jurisdictions are currently doing so. One injection doesn’t produce as strong an immune response as two, he said.

“The advantage is that you can extend the dose,” says John P. Moore, a virologist at Weill Cornell Medicine. “The downside is that if you cut too much or take too much liberty, it becomes less effective. And how are you going to know that? It’s educated guesswork.”

The intradermal method can be complicated for vaccinated persons who must guide the needle into tight spaces. If the vaccinated person goes too deep and inserts the dose into the fat, the patient may not receive enough vaccine, experts say. part of the may leak out.

Such injections usually cause redness and swelling, but a 2015 study showed that they were less painful than standard injections.

They have previously been used in polio vaccination campaigns, rabies and tuberculosis skin tests.

The National Institutes of Health had planned further research into how well such injections worked with the monkeypox vaccine, but results weren’t expected until late fall or early winter. Government officials have reached a consensus that the government needs to adopt this approach now.

Sources

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2/ https://www.nytimes.com/2022/08/08/us/politics/monkeypox-vaccine.html

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