WASHINGTON — The Biden administration has decided to increase its limited supply of monkeypox vaccine by authorizing a different injection method that uses one-fifth less of a shot, according to senior administration officials familiar with the plan.
For the Food and Drug Administration to authorize the so-called intradermal injection, which involves injecting one-fifth of the current dose into the skin instead of the full dose into underlying fat, the Department of Health and Human Services would have to issue a new emergency declaration , which allows regulators to use the FDA’s emergency use authority. This declaration is expected already on Tuesday afternoon.
The move will help reduce the vaccine shortage, which has become a growing political and public health issue for the administration.
The administration has faced a flurry of criticism that it was too slow to ship the ready-to-use vaccine to the US from Denmark, where it was made, and too slow to order bulk vaccine stockpiles into vials after the first illness. appeared 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 among gay and bisexual men. Federal officials are concerned about both the current level of infection and the risk of the disease spreading to other parts of the population.
What you need to know about monkeypox virus
What is monkey pox? Monkeypox is a virus similar to smallpox, but the symptoms are less severe. It was discovered in 1958 after an outbreak of the disease in monkeys that were kept for research. The virus was first found in parts of Central and West Africa, but it has recently spread to dozens of countries and infected tens of thousands of people, mostly men who have sex with men.
Despite investing more than $1 billion to develop a two-dose vaccine known as Jynneos that works against both monkeypox and wild pox, the government only has 1.1 million shots. About three times as many doses are needed to cover the 1.6 to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of contracting monkeypox.
Federal health officials said last week that so far they have distributed about 600,000 doses of the vaccine to state and local jurisdictions.
Last week, the Department of Health and Human Services issued a broader emergency declaration that made it easier for the federal government to allocate money and other resources to fight the virus.
The study of intradermal administration of monkeypox vaccine is essentially limited to one study. It showed that when the vaccine was injected between the layers of the skin, it produced an immune response comparable to a standard injection into the fat under the skin. Federal officials have consulted with various outside groups about switching to the subcutaneous injection approach, including the Infectious Diseases Society of America, according to people familiar with the negotiations.
Some outside experts have criticized the data supporting the monkeypox control method as too thin and narrowly focused. The government’s decision to go ahead is largely based on a 2015 study that was funded by the National Institutes of Health.
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Dr. John Beigel, the NIH’s associate director of clinical research, who briefed federal health officials and the World Health Organization, said switching to the intradermal method was a better option for preserving the vaccine than giving only one of the two recommended doses, as some jurisdictions now do. . He said that one shot does not produce as strong an immune response as two.
“The advantage is that you can increase the doses,” said John P. Moore, a virologist at Weill Cornell Medicine. “The downside is that if you cut it too far or take too much leeway, you reduce efficiency. And how do you know that? This is educated guesswork.”
The intradermal method can be difficult for vaccinators, who must insert the needle into a thin space. Experts say that if the vaccinator digs too deep and injects the dose into the fat, the patient may not receive enough vaccine. But if the needle is not inserted far enough, some of the vaccine can leak back.
Such injections usually cause more redness and swelling but are less painful than a standard injection, a 2015 study found.
In the past, they were used in polio vaccination campaigns, against rabies and in tuberculosis skin tests.
The National Institutes of Health has planned further studies on how well such shots work with the monkeypox vaccine, but results are not expected until late fall or early winter. Last weekend, top federal officials came to a consensus that the government should adopt this approach now.
