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U.S. allows alternative monkeypox vaccine injections to boost supply

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U.S. health regulators have authorized injections monkeypox The U.S. Food and Drug Administration (FDA) announced Tuesday that the vaccine is being administered intradermally in adults, that is, between the layers of the skin rather than under the skin, in an effort to prolong vaccine shortages.​​​

Health officials told a White House briefing that the emergency use authorization for the Bavarian Nordic Jynneos monkeypox vaccine would increase the available dose by five times because it uses only a fraction of the dose but provides the same protection.

The FDA authorization comes after the United States and the World Health Organization declared monkeypox a public health emergency to intensify its response to the outbreak.

Jynneos was approved in 2019 for smallpox and monkeypox prophylaxis in high-risk adults 18 years of age and older. According to its original approval, it will be administered as two doses under the skin or under the skin.

The intradermal method still requires two doses of the vaccine four weeks apart, the agency said.

The FDA approval also allows people under the age of 18 to receive the vaccine by subcutaneous injection if they are determined to be at high risk for monkeypox infection. The FDA has been using this approach for children because it’s easier to administer and doesn’t have as much data available.

A total of 26,500 monkeypox cases have been reported so far in 80 countries where the virus is not endemic, according to a Reuters tally. (Monkeypox tracker and map: https://tmsnrt.rs/3QrYODa)

As many as 8,900 cases of monkeypox have been reported in the United States since the first case was recorded on May 18, Health and Human Services Secretary Xavier Becerra said.

Vaccination requires a different type of needle than current injections and is similar to the tuberculin skin test (or PPD) or intradermal allergy test. CDC Director Rochelle Walensky said the Centers for Disease Control and Prevention will provide information and educational materials aimed at training health care workers and providers on how to administer the vaccine intradermally.

So far, the government has ordered more than 1.1 million doses of the vaccine and shipped more than 620,000 doses, Becerra said.

There are currently 441,000 vials in the Strategic National Stockpile, so there are more than 2.2 million doses under the new management approach, 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 as the country has just over 8,300 doses left, the Financial Times reported on Tuesday.



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