Monkeypox Vaccine: FDA Recommends Giving Smaller Doses

OThe U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA), on August 9th, for a new method of administering Jynneos monkeypox vaccination. Doctors can now give smaller doses of the Jynneos monkeypox vaccine to their patients in an effort to quickly protect them and get more shots from each vial. It’s the latest step in the federal government’s response to the growing monkeypox outbreak, which it declared a public health emergency on August 4.

The government has already shipped 620,000 vaccines across the nation. However, the U.S. Centers for Disease Control and Prevention estimates that about 1.5 million Americans are high-risk and should be immunized with at least two doses. The U.S. is expecting an additional 750,000 doses of Jynneos from the manufacturer Bavarian Nordic, but they won’t arrive until September or later, said Robert Fenton, the White House monkeypox response coordinator, during an August 9 briefing.

FDA will allow doctors to obtain five doses from the one-dose Jynneos vials. The vaccine is administered between skin layers or intradermally, rather than subcutaneously. This allows people most susceptible to infection to be vaccinated. By being injected under the skin, the vaccine activates immune cells and can trigger strong immunity. It is comparable to subcutaneous injections of the full dose. The FDA commissioner, Dr. Robert Califf stated during the briefing that they had reviewed data from an earlier study which was done when Jynneos first became available for smallpox. This comparison compared both the administration methods. “The results of that study demonstrated that intradermal administration provided similar immune response to subcutaneous administration, meaning that individuals in both groups responded to vaccination in a similar way,” he said.

Dr. Rochelle Walsky, Director of the CDC, noted that some health care workers may not be familiar with intradermally administering vaccines. The majority of shots currently are given deeper into the fat layers under the skin. The skin test for tuberculosis is done intradermally. The CDC is launching an education campaign—through webinars, online instructional videos, and other materials—to help teach health care providers how to give Jynneos between the skin layers.

Children under 18 should be given the vaccine in a deeper dose. It may prove more difficult to administer a shot into skin layers for children who are younger than 18. Walensky said that only a tiny percentage of cases of monkeypox in America are still being reported by children.

Dawn O’Connell, assistant secretary for preparedness and response in the Department of Health and Human Services, said that the U.S. currently has 441,000 doses of Jynneos vaccine in the Strategic National Stockpile, which now translates to more than 2.2 million doses if given intradermally. Two doses of Jynneos vaccine must be administered 28 days apart in order to fully immunize a person. Already, five million more doses have been ordered by the United States. The revised intradermal administration strategies will allow for 25 million more doses.

Nearly 9,000 monkeypox cases have been confirmed in the United States. The government has sent more than 617k doses to the states and local health department.

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