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Move to dose sparing and new delivery method would change Monkeypox vaccine status from FDA-approved to Emergency Use Authorization

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  • Move to dose sparing and new delivery method would change Monkeypox vaccine status from FDA-approved to Emergency Use Authorization
    Monkeypox officially a public health emergency, HHS chief Becerra says
    The emergency declaration makes available more tools to combat the virus, which is spreading across the country and the world

    By Lois M. Collins
    Dr. Robert Califf, U.S. Food and Drug Administration commissioner, said the goal has always been to vaccinate as many people as possible and his agency is considering and will decide within a few days whether to change the way the Jynneos smallpox/monkeypox vaccine is delivered to allow more people to receive it.

    Right now, the vaccine is given as a subcutaneous shot. But FDA experts believe that a bottle of vaccine could instead deliver five doses by intradermal injection, which essentially amounts to creating a little pocket of vaccine just below the skin surface. That would not sacrifice efficacy or safety, he said. That would effectively quintuple the vaccine dose supply.

    If that decision is made, the intradermal injections would be allowed under an emergency use authorization, he added....
    By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs
    What’s the difference between an EUA and a BLA?

    A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines. A company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. A company receiving a BLA for their product can introduce the product into interstate commerce and market it for its approved uses. A BLA also has no defined end date — assuming no significant problems emerge, the product can stay on the market indefinitely.

    By contrast, an Emergency Use Authorization, or EUA, is just that — an authorization to distribute an otherwise unapproved product (or an approved product for an unapproved use) during an emergency formally declared by the Secretary of Health & Human Services. Both the substantive and procedural rules surrounding an EUA differ from those surrounding a BLA (or the BLA counterpart for small-molecule drugs, a New Drug Application or NDA). Substantively, the standard for granting an EUA is whether, “based on the totality of scientific evidence available,” “it is reasonable to believe that the product may be effective” and that the “known and potential benefits… outweigh the known and potential risks.” Procedurally, an EUA lasts only as long as the underlying emergency. Further, the FDA may “revise or revoke” an EUA if the substantive evidence for granting it no longer exists...

    Ask Congress to Investigate COVID Origins and Government Response to Pandemic H.R. 834

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