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FDA authorizes altered monkeypox dosing regimen to increase doses five-fold

The Food and Drug Administration on Tuesday authorized healthcare workers to change how the monkeypox vaccine is administered to increase available doses. Photo by Terry Schmitt/UPI | <a href="/News_Photos/lp/9bf99ec62d405bd2c387cd2780b1989a/" target="_blank">License Photo</a>
The Food and Drug Administration on Tuesday authorized healthcare workers to change how the monkeypox vaccine is administered to increase available doses. Photo by Terry Schmitt/UPI | License Photo

Aug. 10 (UPI) -- The U.S. Food and Drug Administration has authorized an alternative dosing regimen of the monkeypox vaccine that will increase the total number of doses available five-fold amid a nationwide shortage of the medicine.

The authorization issued Tuesday approves doctors to administer the Jynneos vaccine to those 18 years of age or older who are determined to be at high risk of infection intradermally, which means between layers of the skin.

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The two-dose Jynneos vaccine regimen that was first approved by the FDA in 2019 calls for it to be administered subcutaneously, meaning under the skin.

The federal regulator permitted the change citing studies that found one-fifth of the volume of a vaccine dose when administered intradermally produces "a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way," it said.

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The White House said in a statement that the change instantly increases the number of doses from 400,000 in the Strategic National Stockpile to upward of 2 million.

The administration added that in order to expedite the change it is launching a "robust effort" to train healthcare workers on the new dosing regimen.

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"In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand," FDA Commissioner Robert Califf said in a statement. "The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals."

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The change was made by the Biden administration as it comes under criticism for its handling of the outbreak.

The first cases were diagnosed in the country mid-May, and the outbreak has since grown to nearly 9,500 confirmed cases who are mostly men who have sex with other men.

However, despite efforts by the administration to increase vaccine shots, the nation continues to face a shortage of the vaccine.

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The Biden administration has ordered some 7 million doses of the vaccine, but they are to be delivered in batches until mid-next year.

According to the Department of Health and Human Services, some 617,000 vaccine doses have been shipped nationwide.

"By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so," Califf said.

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