NewsWorldFDA authorizes change in how monkeypox vaccine is administered,...

FDA authorizes change in how monkeypox vaccine is administered, expanding supply amid high demand


How do I know if I have monkeypox? 1:38 (CNN) — The US Food and Drug Administration (FDA) issued an emergency use authorization Tuesday that allows health care providers to change the way they Jynneos monkeypox vaccine is administered, extending supply amid high demand. The vaccine can now be administered to high-risk adults intradermally, that is, between the layers of the skin, instead of subcutaneously or under the skin, as it has been administered until now. This will allow providers to obtain five doses from a standard one-dose vial. The new emergency use authorization also allows subcutaneous vaccination in people under the age of 18 who are at high risk of infection. “In recent weeks, the monkeypox virus has continued to spread at a rate that has made it clear that our current supply of vaccines will not meet current demand,” FDA Commissioner Dr. Robert said in a statement. M. Califf. “FDA quickly explored other scientifically sound options to make the vaccine more accessible to all affected individuals. By increasing the number of doses available, more people who want to be vaccinated against monkeypox will now have the opportunity to do so.” The move comes less than a week after the Biden administration declared monkeypox a public health emergency, giving the FDA and other government health agencies more flexibility to combat the spread of the virus. A man in Spain recounts how he lived with monkeypox 4:09 Earlier Tuesday, US Department of Health and Human Services Secretary Xavier Becerra issued a determination to pave the way for the FDA move . “Last week, I declared monkeypox a public health emergency to unlock additional tools that will help us contain and end this outbreak and to signal to the American people that we are taking our response to the next level,” Becerra said. it’s a statement. “Today’s action will allow the FDA to exercise additional authority that may increase the availability of vaccines to prevent monkeypox while continuing to ensure that the vaccine meets high standards for safety, efficacy, and manufacturing quality.” As of Monday, the US government shipped 617,693 doses of Jynneos to states and jurisdictions. The US Centers for Disease Control and Prevention (CDC) has estimated that at least 1.5 million people in the US are eligible for monkeypox vaccination . As of Monday night, the CDC reported 8,934 probable or confirmed cases of monkeypox in 49 states, Puerto Rico and the District of Columbia. With an intradermal vaccine, “basically, you stay on the skin; you don’t go through the skin,” said Dr. Daniel Griffin, an infectious disease specialist at Columbia University. A smaller dose with intradermal injection has been used with flu and rabies vaccines, epidemiologist Dr. Jay Varma told CNN in an email. “The skin has special cells that are very good at helping a vaccine stimulate the body’s immune system,” he wrote. These cells, called dendritic cells, are better able to mount an immune response, Griffin said. “They live on the skin and are better at teaching the immune system what to respond to,” he said. “If you can give the monkeypox vaccine intradermally, you can give a smaller dose … They would just need to have some kind of demonstration that you get the same immune response,” he said. CNN’s Jeremy Diamond, Brenda Goodman and Virginia Langmaid contributed to this report.


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