Smallpox vaccine for monkeys: FDA recommends smaller dose

On August 9, US Food and Drug Administration emergency use authorization (EUA) has been issued. on a novel method of administering the Jynneos monkeypox vaccine. The move allows doctors to inject patients in smaller doses to get more shots from each vial and protect more people quickly. This is the latest step in the federal government’s response to a growing monkeypox outbreak, which it declare a public health emergency on the 4th of August.

While the government has shipped nearly 620,000 doses of the vaccine around the country to date, the US Centers for Disease Control and Prevention (CDC) estimates that around 1.5 million people are at high risk and need to be treated. immunized with two doses. Robert Fenton, White House smallpox response coordinator, said the US was expecting an additional 750,000 doses of Jynneos from Bavarian manufacturer Nordic, but they won’t reach customers until September or later.

To ensure that those most at risk of infection get vaccinated in the meantime, the FDA allows physicians to inject 5 doses from current single-dose Jynneos vials by injecting the vaccine between layers of skin ( or intradermally) instead of subcutaneously (or subcutaneously). Being delivered into the layers of the skin allows the vaccine to activate immune cells that can induce a strong immune response, similar to the immune response produced by subcutaneous injection of a full dose. During the briefing, FDA commissioner Dr. Robert Califf said that the agency reviewed data from a study conducted when Jynneos was initially approved for smallpox and monkeypox in 2019, Compare different routes of administration. “The results of that study demonstrated that the intradermal injection provided a similar immune response to the subcutaneous injection, meaning that individuals in both groups responded to vaccination in a similar manner,” he said. on one’s own.

CDC Director Dr. Rochelle Walensky noted that many healthcare professionals may not have experience administering vaccines intradermally. Currently, most injections are injected deeper, into the subcutaneous fat layer. But skin tests for tuberculosis and rabies vaccine are injected into the skin. The CDC is launching an educational campaign — through webinars, video tutorials, and other materials — to help teach healthcare providers how to inject Jynneos between layers of the skin.

For children younger than 18, the FDA recommends that doctors continue to inject the vaccine deeper into the fat layer, as injections between skin layers can be more difficult in the youngest children. Walensky notes that children still make up a small percentage of monkeypox cases in the US

Dawn O’Connell, assistant secretary of preparedness and response for the Department of Health and Human Services, said the US currently has 441,000 doses of Jynneos vaccine in the Strategic National Stockpile, which now has more than 2.2 million. dose if injected intradermally. (To be fully immunized, people need two doses 28 days apart.) The US has ordered an additional five million doses, which will eventually provide the country with an additional 25 million doses under a revised intradermal injection strategy. .

To date, nearly 9,000 cases of monkeypox have been reported in the US, and the government has shipped more than 617,000 doses of the vaccine to states and local health departments.

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