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The Highwire with Del Bigtree | February 4, 2023

Updated boosters and annual Covid shots mirroring session flu shots are the orders coming out of the recent FDA VRBPAC meeting. What data is supporting these ideas? Was this the plan all along? The HighWire gives their analysis.

February 8, 2023 - Posted by | Corruption, Science and Pseudo-Science, Timeless or most popular, Video | , ,


    Read on and learn what this MORON says in the video:

    “The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, Dr. Pamela McInnes said.

    FDA Panel Backs Shift Toward One-Dose COVID Shot
    Written by Kerry Dooley Young

    Jan. 26, 2023 – A panel of advisers to the FDA unanimously supported an effort today to simplify COVID-19 vaccinations, with the aim of developing a one-dose approach — perhaps annually — for the general population.

    The FDA is looking to give clearer direction to vaccine makers about future development of COVID-19 vaccines. The plan is to narrow down the complex landscape of options for vaccinations and increase use of these shots.

    COVID remains a serious threat, causing about 4,000 deaths a week recently, according to the CDC.

    The 21 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted “yes” on a single question posed by the FDA:

    “Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the U.S. to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

    In other words, would it be better to have one vaccine potentially combining multiple strains of the virus, instead of multiple vaccines – such as a two-shot primary series then a booster containing different combinations of viral strains.
    How Do COVID-19 mRNA Vaccines Work?

    Some of the COVID-19 vaccines are known as mRNA shots. How are they different from traditional vaccines? And do they contain the real virus?

    The FDA will consider the panel’s advice as it outlines new strategies for keeping ahead of the evolving virus.

    In explaining their support for the FDA plan, panel members said they hoped that a simpler regime would aid in persuading more people to get COVID vaccines.

    Pamela McInnes, DDS, noted that it’s difficult to explain to many people that the vaccine worked to protect them from more severe illness if they contract COVID after getting vaccinated.

    “That is a real challenge,” said McInness, a former deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

    “The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, she said.

    The Plan

    In the briefing document for the meeting, the FDA outlined a plan for transitioning from the current complex landscape of COVID-19 vaccines to a single vaccine composition for the primary series and booster vaccination.

    This would require:

    Harmonizing the strain composition of all COVID-19 vaccines
    Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children and in older adults and persons with compromised immunity, and only one dose in all others
    Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September

    During the discussion, questions arose about the June target date. Given the production schedule for some vaccines, that date might need to shift, said Jerry Weir, PhD, director of the Division of Viral Products at FDA’s Center for Biologics Evaluation and Research.

    “We’re all just going to have to maintain flexibility,” Weir said, adding that there is not yet a “good pattern” established for updating these vaccines.

    Increasing Vaccination Rates

    There was broad consensus about the need to boost public support for COVID-19 vaccinations. While about 81% of the U.S. population has had at least one dose of this vaccine, only 15.3% have had an updated bivalent booster dose, according to the CDC.

    “Anything that results in better public communication would be extremely valuable,” said committee member Henry H. Bernstein, DO, of the Zucker School of Medicine at Hofstra/Northwell Health in Hempstead, NY.

    But it’s unclear what expectations will be prioritized for the COVID vaccine program, he said.

    “Realistically, I don’t think we can have it all — less infection, less transmission, less severe disease, and less long COVID,” Bernstein said. “And that seems to be a major challenge for public messaging.”

    Panelists Press for More Data

    Other committee members also pressed for clearer targets in evaluating the goals for COVID vaccines and for more robust data.

    Like his fellow VRBPAC members, Cody Meissner, MD, of Dartmouth’s Geisel School of Medicine, supported a move toward harmonizing the strains used in different companies’ vaccines. But he added that it wasn’t clear how frequently they should be administered.

    “We need to see what happens with disease burden,” Meissner said. “We may or may not need annual vaccination. It’s just awfully early, it seems to me, in this process to answer that question.”

    Among those serving on VRBPAC Thursday was one of the FDA’s more vocal critics on these points, Paul A. Offit, MD, a vaccine expert from Children’s Hospital of Philadelphia. Offit, for example, joined former FDA officials in writing a November opinion article for the Washington Post, arguing that the evidence for boosters for healthy younger adults was not strong.

    At Thursday’s meeting, he supported the drive toward simplification of COVID vaccine schedules while arguing for more data about how well these products are working.

    “This virus is going to be with us for years, if not decades, and there will always be vulnerable groups who are going to be hospitalized and killed by the virus,” Offit said.

    The CDC needs to provide more information about the characteristics of people being hospitalized with COVID infections, including their ages and comorbidities as well as details about their vaccine history, he said. In addition, academic researchers should provide a clearer picture of what immunological predictors are at play in increasing people’s risk from COVID.

    “Then and only then can we really best make the decision about who gets vaccinated with what and when,” Offit said.

    VRBPAC member Ofer Levy, MD, PhD, also urged the FDA to press for a collection of more robust and detailed information about the immune response to COVID-19 vaccinations, such as a deeper look at what’s happening with antibodies.

    “I hope FDA will continue to reflect on how to best take this information forward, and encourage — or require — sponsors to gather more information in a standardized way across these different arms of the human immune system,” Levy said. “So we keep learning and keep doing this better.”

    In recapping the panel’s suggestions at the end of the meeting, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, addressed the requests made during the day’s meeting about better data on how the vaccines work.

    “We heard loud and clear that we need to use a data-driven approach to get to the simplest possible scheme that we can for vaccination,” Marks said. “And it should be as simple as possible but not oversimplified, a little bit like they say about Mozart’s music.”
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    Vaccines and Related Biological Products Advisory Committee meeting, Jan. 26, 2023.


    Comment by Pip | February 8, 2023 | Reply

  2. There is more than enough evidence from around the World (and sudden deaths attributed to these vaccines) for people to decide for themselves whether to get an annual vaccination.
    I personally will NOT get one of these vaccines, and when I did recently have a covid diagnosis, I treated myself with Ivermectin, and was well again in 3 days.

    No one is going to force me to have an annual covid vaccination, and anyone, anywhere on Earth who blindly accepts this annual “shot” will get what they deserve, for their stupidity.


    Comment by brianharryaustralia | February 8, 2023 | Reply

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