WASHINGTON — The Biden administration has decided to expand the limited supply of the monkeypox vaccine, according to administration officials familiar with the plan.
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.
The move will help alleviate a vaccine shortage that has become a political and public health problem for the administration.
The administration said it was too slow to ship a ready-to-use vaccine to the United States from Denmark, where it was manufactured, and that it was too late to order bulk vaccine stocks to be processed into vials after the illness first. Faced with a barrage of criticism for being too slow. Showed up here in mid-May.
In less than three months, more than 8,900 monkeypox cases were reported. The disease is spread through skin-to-skin contact during sex, primarily among gay and bisexual men. Federal officials are concerned both about current infection rates and the risk of the disease spreading to other parts of the population.
What you need to know about the monkeypox virus
What is monkeypox? Monkeypox is a virus similar to smallpox, but less severe. It was discovered in 1958 after an outbreak in monkeys kept for research. The virus was found primarily in parts of Central and West Africa, but has recently spread to dozens of countries, infecting tens of thousands of people, predominantly men who have sex with men.
Despite investing more than $1 billion in developing a two-dose vaccine known as Jinneos, which works against both monkeypox and smallpox, the government only has 1.1 million injections on hand. According to the Centers for Disease Control and Prevention, he needs about three times the dose to cover the 1.7 million Americans from her 1.6 million who are at increased risk of contracting monkeypox.
Federal health officials said last week they had distributed so far About 600,000 times of vaccines to state and local jurisdictions.
The Department of Health and Human Services last week also issued a broader public emergency declaration that would allow the federal government to more easily allocate funds and other resources to fight the virus.
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.
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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.