US health regulators have authorized the intradermal injection of a monkeypox vaccine in adults, meaning between the layers of the skin rather than under the skin, in an effort to extend low supplies of vaccines, the US Food and Drug Administration (FDA) announced this Tuesday.
The emergency use authorization for Bavarian Nordic’s Jynneos monkeypox vaccine will increase available doses by five times as it uses only a fraction of the dose but provides the same protection, officials said healthcare workers at a briefing at the White House.
The FDA’s authorization comes after the declaration of monkeypox as a public health emergency in the United States and the World Health Organization, to strengthen the response against the outbreak.
Jynneos was approved in 2019 for the prevention of smallpox and monkeypox in high-risk adults 18 years of age and older. Under its original approval it was to be administered under the skin, or subcutaneously, in two doses.
Two doses of the vaccine given four weeks apart with the intradermal method will still be needed, the agency said.
FDA approval also allows people under 18 to receive the vaccine by subcutaneous injection if they are determined to be at high risk for monkeypox infection. The FDA is sticking with this method for children because it is easier to administer and not as much data is available.
So far, 80 countries where the virus is not endemic have reported a total of 26,500 cases of monkeypox, according to a Reuters count. (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 reported on May 18, Health and Human Services Secretary Xavier Becerra said.
Administration of the vaccine requires a different type of needle than current vaccine administration and is similar to tuberculin skin testing (or PPD) or intradermal allergy testing. The US 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, CDC Director Rochelle Walensky said.
So far, the administration has made more than 1.1 million vaccine doses available for order and shipped more than 620,000 doses, Becerra said.
There are currently 441,000 vials in the national strategic stockpile, and therefore more than 2.2 million doses under the new method of administration, said Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services.
The UK will run out of smallpox vaccines in about two to three weeks as the country has just over 8,300 doses of the vaccine left, the Financial Times reported on Tuesday.