WASHINGTON — The Biden administration has moved to expand its limited monkeypox vaccine supply by authorizing a different injection method that uses one-fifth more per injection, according to senior administration officials familiar with the planning. .
In order for the Food and Drug Administration to authorize the so-called intradermal injection, which would involve injecting one-fifth of the current dose into the skin instead of a full dose into the underlying fat, the Department of Health and Human Services Social media will have to issue a new emergency declaration allowing regulators to invoke the FDA’s emergency use powers. This statement is expected on Tuesday afternoon.
The move would help alleviate a vaccine shortage that has turned into a growing political and public health issue for the administration.
The administration has faced a barrage of criticism that it was too slow to ship the ready-to-use vaccine to the United States from Denmark, where it was manufactured, and too slow to order that vaccine stocks in bulk are processed into vials after illness. surfaced here in mid-May.
In less than three months, more than 8,900 cases of monkeypox have been reported. The disease is spread primarily through skin-to-skin contact during sex in gay and bisexual men. Federal officials are worried about both the current infection rate and the risk of the disease spreading to other parts of the population.
What to know about the 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 outbreaks occurred in monkeys kept for research. The virus was primarily found in parts of central and western Africa, but has recently spread to dozens of countries and infected tens of thousands of people, mostly men who have sex with men.
Although it has invested more than a billion dollars in the development of the two-dose vaccine known as Jynneos which works against both monkeypox and smallpox, the government has only 1.1 million vaccines on hand. It takes about three times as many doses to cover the 1.6 to 1.7 million Americans who the Centers for Disease Control and Prevention say 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 also issued a broader public emergency declaration that made it easier for the federal government to allocate money and other resources to fight the virus.
Research on intradermal injection of monkeypox vaccine is essentially limited to one study. She showed that when the vaccine was injected between the layers of the skin, it induced an immune response comparable to that of a standard injection into the fat under the skin. Federal officials have consulted with various outside groups on the shift 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 method for monkeypox as being too thin and narrowly focused. The government’s decision to move forward is heavily based on a 2015 study that was sponsored by the National Institutes of Health.
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Dr. John Beigel, the NIH 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 conserving the vaccine than d Administer only one of the two recommended doses, as some jurisdictions now do. One hit doesn’t elicit as strong an immune response as two, he said.
“The advantage is that you can extend the doses,” said John P. Moore, virologist at Weill Cornell Medicine. “The downside is that if you cut it too far or take too many liberties, you reduce efficiency. And how are you going to find out? It’s an educated guess.
The intradermal method can be complicated for vaccinators, who must guide a needle through a thin space. If a vaccinator goes too far and inserts the dose into the fat, the patient might not get enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could flow back.
These injections typically cause more redness and swelling, but are less painful than a standard injection, the 2015 study showed.
They have already been used in vaccination campaigns against polio, against rabies and with skin tests for tuberculosis.
The National Institutes of Health had planned further studies on the effectiveness of these injections with the monkeypox vaccine, but results were not expected until late fall or early winter. Over the weekend, senior federal officials reached a consensus that the government must take the approach now.