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Biden Administration to Allow New Injection Method for Monkeypox Vaccine

WASHINGTON — The Biden administration has decided to expand its limited supply of monkeypox vaccine by allowing another injection method that consumes one-fifth per injection, according to senior officials familiar with the schedule.

In order for the Food and Drug Administration to authorize the so-called intradermal injection, in which one-fifth of the current dose is injected into the skin rather than a full dose into the underlying fat, the Department of Health and Human Services must issue a new emergency statement. allowing regulators to rely on the powers of the FDA for emergency use. That statement is expected on Tuesday afternoon.

The move would help reduce a vaccine shortage that has become a growing political and public health problem for the government.

The government has faced a barrage of criticism that it was too slow to ship a ready-to-use vaccine to the United States from Denmark, where it was manufactured, and too slow to order that the post-disease bulk vaccine stocks were first processed in vials. emerged here in mid-May.

More than 8,900 cases of monkey pox have been reported in less than three months. The disease mainly spreads through skin-to-skin contact during sex among gay and bisexual men. Federal officials are concerned about both the current infection rate and the risk of the disease spreading to other parts of the population.

Although it has invested more than $1 billion in developing the two-dose vaccine known as Jynneos that works against monkey pox, the government only has 1.1 million injections on hand. It takes about three times as many doses to cover the 1.6 million to 1.7 million Americans who are at high risk of contracting monkeypox, according to the Centers for Disease Control and Prevention.

Federal health officials last week said they have spread so far about 600,000 doses of the vaccine to state and local jurisdictions.

The Department of Health and Human Services issued a broader public emergency statement last week that made it easier for the federal government to allocate money and other resources to fight the virus.

Research on intradermal injection of the monkeypox vaccine is limited to one study. It showed that when the vaccine was injected between the skin layers, it elicited an immune response similar to that of a standard injection into the fat under the skin. Federal officials have consulted with several outside groups about switching to the intradermal injection approach, including the Infectious Diseases Society of America, according to people familiar with the talks.

Some outside experts have criticized the data supporting the monkeypox method as being too thin and narrowly focused. The government’s decision to participate is strongly based on a 2015 study that was sponsored by the National Institutes of Health.

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dr. John Beigel, an NIH associate director of clinical research who informed federal health officials and the World Health Organization, said switching to the intradermal method was a better option for preserving the vaccine than administering just one of the two recommended doses, as some jurisdictions do. do now. One shot doesn’t elicit nearly as strong an immune response as two, he said.

“The advantage is that you can stretch doses,” says John P. Moore, a virologist at Weill Cornell Medicine. “The downside is that if you go too far or take too many liberties, you reduce efficacy. And how are you going to know? It’s guesswork.”

The intradermal method can be complicated for vaccinators, who must pass a needle into a thin space. If a vaccinator goes too deep and inserts the dose in fat, the patient may not get enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could leak back out.

Such injections typically cause more redness and swelling, but are less painful than a standard injection, the 2015 study found.

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

The National Institutes of Health had planned further studies on how well such injections work with the monkeypox vaccine, but results weren’t expected until late fall or early winter. Over the weekend, top federal officials came to a consensus that the government should now embrace the approach.

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