Biden administration authorizes new injection method for monkeypox vaccine

WASHINGTON – The Biden administration has decided to expand the limited supply of monkeypox vaccine by allowing a different injection method that uses a fifth of the dose per shot, according to senior administration officials familiar with the matter. with the plan.

In order for the Food and Drug Administration to authorize so-called intradermal injections, i.e. injecting one-fifth of the current dose into the skin instead of the entire dose into the underlying fat, the Department of Health and Human Services will needed to issue a new emergency declaration allowing regulators to invoke the FDA’s emergency use authority. That statement is expected as early as Tuesday afternoon.

The move will help alleviate vaccine shortages that have become a growing political and public health issue for the administration.

The administration has faced a barrage of criticism that it has been too slow to ship the ready-to-use vaccine to the United States from Denmark, where it is manufactured, and too slow to order large quantities of the vaccine. Please reserve is processed into jars after the previous epidemic. emerged here in mid-May.

In less than three months, more than 8,900 cases of monkeypox were reported. The disease is spread mainly through skin-to-skin contact during sex between gay and bisexual men. Federal officials are concerned about both the current infection rate and the risk that the disease could spread to other segments of the population.

Despite investing more than $1 billion to develop a two-dose vaccine called Jynneos that works against both monkeypox and smallpox, the government only has 1.1 million shots on hand. According to the Centers for Disease Control and Prevention, it needs three times the dose to cover 1.6 million to 1.7 million Americans, who are at high risk for monkeypox.

Federal health officials said last week that so far, they have about 600,000 doses of vaccines for state and local jurisdictions.

The Department of Health and Human Services last week issued a more widely publicized emergency declaration allowing the federal government to more easily allocate money and other resources to fight the virus.

Research on intradermal monkeypox vaccination was essentially limited to one study. It showed that when the vaccine was injected between layers of skin, it produced an immune response comparable to that from a standard injection into the subcutaneous fat layer. Federal officials have consulted with multiple outside groups about switching to intradermal injections, including the Infectious Diseases Society of America, according to people familiar with the negotiations.

Some outside experts have criticized the methodological backup data for monkeypox as being too thin and narrowly focused. The government’s decision to implement it is based on Research 2015 sponsored by the National Institutes of Health.

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Dr. John Beigel, NIH’s deputy director of clinical research who informed federal health officials and the World Health Organization, says that switching to intradermal injections is a better option. to preserve vaccines rather than using only one of the two recommended doses, as some jurisdictions currently do. One shot doesn’t produce as strong an immune response as two shots, he said.

“The advantage of it is that you can increase the dose,” says John P. Moore, a virologist at Weill Cornell Medicine. “The downside is, if you cut too far or too much free, you will reduce efficiency. And how will you know that? That’s educated guesswork. “

The intradermal injection method can be complicated for the injector, who must aim the needle into a thin space. If a person vaccinates too deeply and inserts the dose into the fat, the patient may not receive enough vaccine, experts say. But if the needle is not inserted far enough, part of the vaccine can leak out.

A 2015 study found that such injections typically cause more redness and swelling, but less pain, than conventional injections.

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

The National Institutes of Health has planned further studies on how effective such shots are with the monkeypox vaccine, but results are not expected until late fall or early winter. Over the weekend, top federal officials came to a consensus that the government needs to take an approach now.

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