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Reuters
Ahmed Abulenin and Ankur Banerjee
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WASHINGTON — U.S. health regulators have authorized intradermal injection of monkeypox vaccine in adults, meaning between the layers of the skin rather than under the skin, in an effort to expand low vaccine supplies, the U.S. Food and Drug Administration (FDA) said Tuesday. .
The emergency use authorization of Bavarian Nordic’s Jynneos monkeypox vaccine will increase available doses fivefold because it uses only a fraction of the dose but provides the same protection, health officials said at a White House briefing.
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The FDA’s approval comes after the United States and the World Health Organization declared monkeypox a public health emergency to aid the response to the outbreak.
Jynneos was approved in 2019 for the prevention of smallpox and monkeypox in high-risk adults 18 years of age and older. According to the original approval, it was to be administered subcutaneously under the skin or subcutaneously as two doses.
Two doses of the vaccine given four weeks apart would still be required with the intradermal method, the agency said.
FDA approval also allows people under 18 to receive the vaccine by subcutaneous injection if they are found to be at high risk of monkeypox infection. The FDA is sticking with this method for children because it is easier to administer and there is not as much data available.
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So far, 80 countries where the virus is not endemic have reported a total of 26,500 cases of monkeypox, according to Reuters data.
(Monkeypox Tracking and Map:
There have been 8,900 cases of monkeypox in the United States since the first case was reported on May 18, Health and Human Services Secretary Xavier Becerra said.
Administering the vaccine requires a different type of needle than current vaccine administration and is similar to tuberculin skin tests (or PPD) or intradermal allergy tests.
The U.S. Centers for Disease Control and Prevention will provide information and educational materials aimed at teaching healthcare workers and providers how to administer the vaccine intradermally, CDC Director Rochelle Walensky said.
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So far, the administration has placed more than 1.1 million vaccine doses on order and shipped more than 620,000 doses, Becerra said.
There are currently 441,000 vials in the strategic national stockpile, and therefore more than 2.2 million doses under the new administration method, said Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services.
Britain will run out of monkeypox vaccines in about two to three weeks, with just over 8,300 doses of the vaccine left in the country, the Financial Times reported on Tuesday.
(Reporting by Ahmed Abulenin in Washington and Ankur Banerjee in Bengaluru; Additional reporting by Rami Ayub in Washington; Editing by Aditya Soni and Josie Kao)
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