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Move to dose sparing and new delivery method would change Monkeypox vaccine status from FDA-approved to Emergency Use Authorization - Critics called the plan “unscientific.”

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  • Move to dose sparing and new delivery method would change Monkeypox vaccine status from FDA-approved to Emergency Use Authorization - Critics called the plan “unscientific.”

    https://www.deseret.com/2022/8/4/232...o-fenton-biden
    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....

    https://blog.petrieflom.law.harvard....orization-eua/
    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

    i love myself. the quietest. simplest. most powerful. revolution ever. ---- nayyirah waheed
    Governments don't have or own souls.

    (My posts are not intended as advice or professional assessments of any kind.)
    Never forget Excalibur.

  • #2
    https://www.yahoo.com/entertainment/...194002471.html
    Monkeypox Vaccine Maker Warns of FDA Dosing and Administration Change
    Christopher Wiggins
    Thu, August 11, 2022 at 2:40 PM

    In private, the company that manufactures the only monkeypox vaccine approved by the Food and Drug Administration expressed concerns to the Biden administration about the FDA’s plans to dilute a vial’s dose into five doses and change the way the shot is administered.

    The CEO of Bavarian Nordic, Paul Chaplin, wrote of his concerns to the Department of Health and Human Services in a letter obtained by the Washington Post Tuesday, the paper reports.

    “Bavarian Nordic...is dedicated to assisting Governments around the globe to control the current monkeypox outbreak and is fully supportive of dose-sparing approaches, such as delaying the second vaccination,” Chaplin wrote. “However, we do have some reservations on the [new injection] approach, due to the very limited safety data available..., the higher [rates of expected adverse reactions] compared to the JYNNEOS standard dose and route..., and the fact that there was a relatively high percentage of subjects...that failed to receive the second vaccination during a controlled clinical study.”

    The letter continues, “We have been made aware of some additional analysis of the [intradermal] study data, but essentially this does not change the overall picture that the [intradermal] administration results in increased [adverse reactions] compared to [the current route of administration] and this may have a negative impact on vaccine uptake and coverage.”

    For the manufacturer to present valid data concerning its product and untested protocols, Chaplin urges the administration to gather data from the rollout of the government’s new dosage and administration option.

    “It is our understanding that it is the United States Government position that there is no time to prepare or conduct such a protocol,” Chaplin writes. “Therefore, as the manufacturer of JYNNEOS, we have already begun discussions with investigators on the feasibility of how to conduct a study to provide more safety information to help govern future vaccination policies.”

    Biden administration officials said they were aware of Bavarian Nordic’s concerns, but that they would not change the vaccine strategy, according to the Post.

    “We’ve had conversations with them about this, and so has FDA,” Becerra said. “We wouldn’t have moved forward unless we thought it was safe and effective, and if FDA hadn’t dotted its I’s and crossed its T’s.”

    The Post also reports that some in the administration feel that the company's worries are actually from concerns that it will suffer from a loss in profit if countries extend their current supply.

    A representative for Bavarian Nordic told the paper that the company's concerns were over safety....
    _____________________________________________

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

    i love myself. the quietest. simplest. most powerful. revolution ever. ---- nayyirah waheed
    Governments don't have or own souls.

    (My posts are not intended as advice or professional assessments of any kind.)
    Never forget Excalibur.

    Comment


    • #3
      August 18, 20225:59 PM ET

      PIEN HUANG
      MICHAELEEN DOUCLEFF

      The U.S. is facing a shortage of the monkeypox vaccine as the outbreak grows rapidly. The White House is pursuing a controversial strategy where each person only gets a fraction of the full dose.

      Transcript

      MARY LOUISE KELLY, HOST:

      It was about three months ago that the first case of monkeypox was discovered in the U.S. Now, there are well over 13,000 cases. That is more than any other country in the world. The U.S. government's plan to get the disease in check is largely based on a vaccine, but there are a lot of questions about how well that plan might work. So here to take on those questions are two of our NPR health correspondents, Pien Huang and Michaeleen Doucleff.

      ... MARK DEL BECCARO: That - the federal announcement of five doses per vial was, I think, incredibly optimistic. And what we're seeing in real life is three to four doses per vial.

      HUANG: In reality, this dose-splitting strategy is not yielding as much as federal officials had hoped. And yet, Del Beccaro says it seems like the government is already using this new math when they count how many doses they're sending to health departments.

      ... DOUCLEFF: Yeah. So here's another reason why cutting the dose, as Pien's been talking about, is a bit concerning. Right now, we don't know how well the vaccine works. It clearly offers some protection, but at what level, we don't know. And that's because there has never been a clinical trial to measure its efficacy. In fact, there has been very little testing of this vaccine against monkeypox in people. Most of the studies have been in animals. I was talking to Dr. Boghuma Titanji about this. She's an infectious disease specialist at Emory University, and she's been immunizing people at her clinic. And here's how she counsels people about the vaccine.

      BOGHUMA TITANJI: I tell them, you know, we do know that you're going to get some protection from this. Some protection is better than no protection. We also do know that it can reduce the severity of the disease if you do develop the disease. But we don't know for a fact that you would be completely protected from getting monkeypox.

      DOUCLEFF: And to be clear, she's talking about protection with the full vial. If we cut the dose, she says, it could lower that protection further. ...

      https://www.npr.org/2022/08/18/11182...osing-strategy




      Comment


      • #4
        https://www.nytimes.com/2022/08/18/u...rmal-dose.html
        Monkeypox Vaccine Plan Prods Cities and States to Adopt New Dosing Regimen

        The Biden administration will distribute monkeypox vaccine to jurisdictions that adopt a new protocol using one-fifth the regular dose. Critics called the plan “unscientific.”

        By Sheryl Gay Stolberg, Sharon Otterman and Apoorva Mandavilli

        Aug. 18, 2022

        “More shots in arms is how we get the outbreak under control,” Robert J. Fenton Jr., the White House monkeypox response coordinator, told reporters on Thursday.

        But not all jurisdictions have switched to intradermal dosing — New York City, the epicenter of the U.S. outbreak, has yet to begin such a change. And the protocol has raised concerns from some scientists, activists and the vaccine’s manufacturer, Bavarian Nordic.
        ...

        The administration’s vaccine distribution plan drew criticism from activists, who said that the better response would be to work with cities and states on a more flexible plan for mixed dosing. In that proposed regimen, some shots would be given into the skin — most likely by major health centers that were equipped to do so — and some would be given in the more traditional way, by providers who were not trained or equipped to switch.

        “What they are doing now, first and foremost, is unscientific,” said Joseph Osmundson, a virologist at New York University. “To pretend that 100 percent of doses will be given intradermally is incorrect.”

        James Krellenstein, a founder of PrEP4All, an advocacy group for H.I.V. patient care, called Thursday’s announcement about the distribution of vaccine doses “a complete accounting trick.” Activists also say the new protocol could exacerbate existing racial disparities and signal to people of color that they might be getting a lesser dose, despite health officials’ approval.

        “Once it starts becoming equitable, now it’s not, ‘We’ll give you the dosage that everyone was getting prior,’ it’s, ‘We’ll give you the shorter doses,’” said Jennifer Barnes-Balenciaga, a Black transgender woman who is helping to lead RESPND-MI, an epidemiological study on monkeypox.
        ...

        There is limited data on whether Jynneos is safe and effective. The vaccine was approved at its current dose based on small studies showing that it appears to produce an immune response comparable to that of an older smallpox vaccine. Even less evidence supports the use of one-fifth intradermal doses of Jynneos to prevent monkeypox.

        Only one study has been conducted directly on intradermal dosing of Jynneos, and while it did not note a decrease in efficacy, it noted more localized side effects like swelling and redness. Dr. Peter Hotez, a vaccine expert at the Baylor School of Medicine in Houston, said he would have preferred the government to do an additional pilot study on intradermal dosing before switching vaccination strategies midstream.

        “Collect more data on a few thousand individuals, not only for the immunological parameters, but safety, to confirm the safety effects are not worse than we thought,” he said. But overall, he felt intradermal dosing was an “innovative approach” to address the problem of supply...
        _____________________________________________

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

        i love myself. the quietest. simplest. most powerful. revolution ever. ---- nayyirah waheed
        Governments don't have or own souls.

        (My posts are not intended as advice or professional assessments of any kind.)
        Never forget Excalibur.

        Comment

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