The Biden administration has decided to expand its limited supply of monkeypox vaccine by allowing a different injection method that uses one-fifth the amount per shot, according to people familiar with the discussions.
In order for the Food and Drug Administration to approve what is known as intradermal injection, in which one-fifth of the current dose is injected into the skin instead of a full dose into the underlying fat, the Department of Health and Human Services must issue a new emergency declaration, which allows regulators to invoke FDA’s emergency powers. That statement is expected as early as Tuesday afternoon.
The move would help alleviate a vaccine shortage that has become a growing political and public health issue for the administration.
The government has been heavily criticized for being too slow to ship ready-to-use vaccines from Denmark, where they were manufactured, to the United States and too slow to order large stockpiles of vaccines to be processed first in vials after the disease in mid-May in emerged in the US.
More than 8,900 cases of monkeypox were reported in less than three months. The virus spreads from person to person primarily through close physical contact with infectious lesions.
Despite investing more than $1 billion to develop the two-dose vaccine known as Jynneos, which works against both monkeypox and smallpox, the government has just 1.1 million shots on hand. It takes about three times that 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.
The vaccine is currently given in two 0.5-milliliter doses 28 days apart, with immune protection reaching its “maximum” 14 days after the second dose, according to the CDC.
The shot is recommended by the CDC for people who have been exposed to monkeypox and those who are likely to be affected. The latter category includes people identified as having been in contact with people with monkeypox, people who know a sexual partner has been diagnosed with the disease in the past 14 days, and people who have been in an area with “multiple” sexual partners during that period had “known monkeypox.”
Federal health officials said last week they have distributed about 600,000 doses of the vaccine to state and local jurisdictions so far.
The Department of Health and Human Services also issued a broader public emergency declaration last week, allowing the federal government to more easily allocate money and other resources to fight the virus.
Research on intradermal injection of monkeypox vaccine is essentially limited to one study. The vaccine, when injected between layers of skin, was shown to elicit an immune response comparable to that of a standard injection into the fat under the skin. Federal officials have been consulting with a variety of outside groups about moving 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 for being too sparse and narrowly focused. The government’s decision is heavily based on a 2015 study sponsored by the National Institutes of Health.
dr John Beigel, an NIH associate director of clinical research who has briefed federal health officials and the World Health Organization, said switching to the intradermal method is a better option for preserving the vaccine than administering just one of the two recommended doses, according to some jurisdictions do now. One shot doesn’t elicit nearly as strong an immune response as two, he said.
“The benefit is that you can stretch doses,” said John Moore, a virus expert at Weill Cornell Medicine. “The downside is if you cut too far or take too many liberties, you reduce effectiveness. And how do you know that? It’s an educated guess.”
The intradermal method can be complicated for vaccinees who need to insert a needle into a thin space. If a vaccinator goes too deep and introduces the dose in fat, the patient may not get enough vaccine, experts say. However, if the needle is not inserted far enough, some of the vaccine may leak out.
Such shots typically cause more redness and swelling but are less painful than a standard injection, the 2015 study showed.
They have previously been used in polio vaccination campaigns, rabies and tuberculosis skin tests.
The NIH had planned further studies into how well such vaccinations work with the monkeypox vaccine, but the results were not expected until late fall or early winter. Over the weekend, senior federal officials came to a consensus that the government must now embrace the approach.
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