U.S. expands monkeypox vaccine supply

WASHINGTON — The Biden administration has decided to expand its limited supply of the monkeypox vaccine to allow a different injection method, one-fifth of the dose per shot, according to people familiar with the matter.

In order for the FDA to approve so-called intradermal injections, which would involve injecting one-fifth of the current dose into the skin, rather than injecting the full dose into the underlying fat, the Department of Health and Human Services would need to release A new emergency declaration that allows regulators to invoke the FDA’s emergency use rights. The announcement is expected to be released as early as Tuesday afternoon.

The move will help ease a vaccine shortage that has become a growing political and public health problem for the government.

In less than three months, more than 8,900 cases of monkeypox have been reported. The virus is mainly transmitted from person to person through close physical contact with infectious lesions.

Although it has invested more than $1 billion to develop a two-dose vaccine called Jynneos, which is effective against both monkeypox and smallpox, the government has only 1.1 million doses on hand. According to the Centers for Disease Control and Prevention, it would take about three times the dose to cover the 1.6 million to 1.7 million Americans who are at high risk of contracting monkeypox.

According to the CDC, the vaccine is currently offered in two 0.5-milliliter doses 28 days apart, with immune protection reaching “maximum” 14 days after the second dose

The CDC recommends this vaccine to people who have been exposed to monkeypox and those who may be infected with monkeypox. The latter category includes people who have been identified as having been in contact with a monkeypox patient, those who know that a sexual partner in the past 14 days has been diagnosed with monkeypox, and who have had “multiple” of monkeypox-infected areas during that time period. sexual partners. “Monkeypox is known.”

Federal health officials said last week that they have so far distributed about 600,000 doses of the vaccine to states and local jurisdictions.

The Department of Health and Human Services also issued a broader public emergency declaration last week, allowing the federal government to more easily allocate funds and other resources to fight the virus.

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Studies of intradermal monkeypox vaccine have been largely limited to one study. The results showed that when the vaccine was injected between the layers of the skin, it elicited an immune response comparable to that of a standard injection into the subcutaneous fat. Federal officials have consulted with various outside groups, including the Infectious Diseases Society of America, about switching to the intradermal method, according to people familiar with the matter.

Some outside experts have criticized the data supporting the monkeypox approach as being thin and narrowly focused. The government’s decision was largely based on a 2015 study sponsored by the National Institutes of Health.

Briefing federal health officials and the World Health Organization, Dr. John Berger, associate director of clinical research at the NIH, said switching to the intradermal method preserves the vaccine compared to using only one of the two recommended doses. Better option, as some jurisdictions do now. One shot doesn’t elicit as strong an immune response as two, he said.

“The advantage is that you can prolong the dose,” says John P. Moore, a virologist at Weill Cornell Medicine. “The downside is that if you cut it too far or too casually, it reduces efficacy. How do you know? It’s an educated guess.”

The intradermal injection method can be complicated for vaccinators who must guide the needle into tight spaces. If the injector goes too deep and inserts the dose into the fat, patients may not get enough vaccine, experts say. But if the needle is not inserted far enough, some vaccines could leak out.

A 2015 study showed that such injections generally cause more redness and swelling, but are less painful than standard injections.

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

The NIH plans to further study how well this vaccine works with the monkeypox vaccine, but results won’t be available until late fall or early winter. Senior federal officials reached a consensus over the weekend that the government now needs to embrace that approach.

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