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  • Low Standard FDA’s Fifty Percent MINIMUM: Good Enough For Government Work

     Hotspur updated 4 weeks, 1 day ago 2 Members · 2 Posts
  • TheRealRestoreInc.

    Member
    October 26, 2021 at 5:07 pm

    The vaccine question in the near future is this: Does the Pfizer booster alone make the immune system better able to avoid getting sick with any form of SARS-CoV-2 that might be around?

    “The FDA minimum level of efficacy is 50 percent, which is standard also for flu vaccines”

    https://www.cnbc.com › 2021 › 07 › 23 › delta-variant-pfizer-covid-vaccine-39percent-effective-in-israel-prevents-severe-illness.html

    Jul 23, 2021 Pfizer and BioNTech’s Covid-19 vaccine is just 39% effective in Israel where the delta variant is the dominant strain, according to a new report from the country’s Health Ministry

    IT DOES NOT PASS THE FDA’s MINIMUM REQUIREMENT FOR EFFICACY (WHEN APPLIED AGAINST DELTA VARIANT)

    https://www.npr.org › sections › health-shots › 2020 › 09 › 12 › 911987987 › a-covid-19-vaccine-may-be-only-50-effective-is-that-good-enough

    https://www.nbcnews.com

    But even if a Covid-19 vaccine is only 50 percent effective, it could make a difference, experts say, pointing out that the flu vaccine effectiveness can vary widely from year to year, anywhere …
    FDA will require 50% efficacy for COVID-19 vaccines. How …

    https://www.fiercepharma.com

    RELATED: FDA could approve ‘at least one’ COVID-19 vaccine before election: analyst. An efficacy figure of 50% would compare somewhat favorably to flu vaccine efficacy in the last decade, which …
    FDA issues COVID-19 vaccine guidance, setting 50% …

    https://www.raps.org

    FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold. In an immediately effective guidance issued Tuesday, the US Food and Drug Administration (FDA) sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and …
    FDA says it would clear a coronavirus vaccine so long as …

    https://www.cnbc.com

    Jul 30, 2020 The Food and Drug Administration would authorize a coronavirus vaccine so long as it is safe and at least 50% effective, the agency’s commissioner, Dr. Stephen Hahn, said Thursday.
    All COVID-19 Vaccines Will Have to Pass These FDA Requirements

    https://www.healthline.com

    The FDA is requiring COVID-19 vaccine candidates to show at least 50 percent efficacy in order to win approval. During a daylong meeting, experts advising the FDA on …

    What does COVID-19 vaccine efficacy mean? https://www.sciencenews.org

    The U.S. Food and Drug Administration recommends vaccines tested against COVID-19 reach an efficacy of 50 percent, at minimum. That means at least a 50 percent reduction in cases of COVID-19 …

    Why A COVID-19 Vaccine That’s Only 50% Effective Could … https://www.npr.org

    Sep 12, 2020 The Food and Drug Administration has said that once a vaccine is shown to be safe and at least 50% effective, it could be approved for use in the U.S. So what does 50% efficacy mean? Shots …

    So then, MOLNUPIRAVIR. It is TECHNICALLY BELOW FIFTY PERCENT EFFICACY.

    “Merck said an interim analysis of a phase 3 study showed its drug, known as molnupiravir, cut the risk of hospitalization or death by roughly 50% for patients with mild or moderate cases…”

    “ROUGHLY”? IT DID NOT REACH THE FIFTY PERCENT MARK THAT IS THE MINIMUM.

    ACCEPTABLE? NO.

    OK, SO FIFTY PERCENT PASSES FOR GOVERNMENT WORK. BUT THERE IS A FAMILIAR DEJA VU THAT TAKES US TO…

    “PIGGYBACKING”.

    Excerpt from a hamster study

    The COMBINATION [emphasis mine] of suboptimal doses of Molnupiravir and Favipiravir resulted in a marked antiviral activity in our hamster infection model. Infectious virus titers were reduced to undetectable levels in 10 out of 16 treated animals when the first dose was administered just before the infection. A median reduction of >4.5 log10 TCID50/mg lung tissue was achieved, which is markedly more pronounced than what could be expected from an additive activity of either Molnupiravir (1.3 log10) or Favipiravir (1.1 log10) when dosed alone. Even when start of treatment was delayed until 6h or 24h pi, a marked antiviral effect was achieved. Moreover, when sentinel animals were co-housed with treated infected hamsters, transmission of virus from the infected to the sentinel contact animals was nearly completely curbed. Consequently treatment of infected patients (e.g. soon after they have tested positive) may largely reduce the likelihood of transmission which could for example be important in post exposure household prophylaxis. – The Lancet https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(21)00388-1/fulltext

    WHERE WAS THE NEWS MEDIA REPORTING ON “PIGGYBACKING” HYDROXYCHLOROQUINE WITH ZINC?

    THE MEDIA USUALLY CONDEMNED HCQ USE WHEN IT WAS ADMINISTERED ALONE IN CLINICAL TRIALS AND REFUSED TO PRESENT THE “PIGGYBACK” EFFICACY WHEN HCQ WAS COMBINED WITH ZINC.

    NOT OFTEN REPORTED, THERE WAS GREAT COVID-19 MITIGATION SUCCESS WITH THE HCQ-ZN COMBINATION BY DR. ZELENKO:

    “As early as March 2020, Dr. Vladimir Zelenko boasted a near-100% success rate treating COVID-19 patients with hydroxychloroquine (HCQ), azithromycin and zinc sulfate for five days; Zelenko has now treated 3,000 patients with COVID-19 symptoms and only three high-risk patients have died; Misinformation and outright lies were spun about HCQ, including fabricated research”

    NY Doctor Proves Everyone Wrong About Hydroxychloroquine

    SO NOW TO IVERMECTIN…

    “PIGGYBACKING IVM WITH ZINC AND DOXYCYCLINE IS CALLED ZIVERDO. THE COMBINATION OF COMPOUNDS HAS AN EFFICACY MEASURED IN REAL WORLD DATA FROM UTTAR PRADESH, INDIA.

    Ziverdo Kit: Why you should consider them

    It STILL MAKES BETTER SENSE TO ALLOW HCQ-ZN AND ZIVERDO KITS TO FIGHT THIS VIRUS, INSTEAD OF JUST DEPENDING ON EMERGENCY USE AUTHORIZATION “FIFTY PERCENT MINIMUM EFFICACY” BOTTOM-LEVEL GOVERNMENT EFFORTS.

    THERE IS INSANITY IN 50% LEVEL MEDIOCRITY WHEN IT ALSO FORCES EFFICACIOUS THERAPEUTIC TREATMENTS OUT OF MEDIA’S CHEERLEADING EFFORTS…THAT ARE RESERVED FOR THE GOVERNMENT’S CONTRIBUTIONS.

    THE UNENUMERATED RIGHTS OF CITIZENS TO HAVE A PATIENT-PHYSICIAN RELATIONSHIP IS REQUIRING FDA TO REFORM. IT IS OUR MONEY PAYING FOR OUR COVID-19 SOLUTIONS, BUT THE USA IS THE BIGGEST EMBARRASSMENT IN THE WORLD IN HOW INNOVATION IS FUNNELED INTO FUTURIST POSSIBILITIES.

    WE HAVE SOLUTIONS THAT WORK

    NOW GIVE.

  • Hotspur

    Member
    November 9, 2021 at 1:23 pm

    Your point is made even more valid when you consider that the measure of ‘efficacy’ being used is the RELATIVE Risk Reduction (‘RRR’) and not the ABSOLUTE Risk Reduction (‘ARR’) – even though the latter is generally considered, including by the CDC, to be the more accurate measure of the effectiveness of a treatment.

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