Covid-19 News

  • FDA VRBPAC Vote Avoids Mass Booster Vaccine Scenario but Approves for Elderly, At Risk, & Immunocompromised on Weak Moderna Evidence


    FDA VRBPAC Vote Avoids Mass Booster Vaccine Scenario but Approves for Elderly, At Risk, & Immunocompromised on Weak Moderna Evidence
    Moderna sent a rosy message to investors that the U.S. Food and Drug Administration (FDA) Advisory Committee unanimously voted in support of Emergency Use
    trialsitenews.com


    Moderna sent a rosy message to investors that the U.S. Food and Drug Administration (FDA) Advisory Committee unanimously voted in support of Emergency Use Authorization for a booster dose of the company’s mRNA-based vaccine called mRNA-1273 for COVID-19. However, even though the company submitted limited data, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-9 that the overall benefits of the mRNA-1273 vaccine-based booster dose outweighs any prospective risks in population cohorts including those age 65 and up as well as younger people with high-risk medical conditions and those in cohorts deemed at risk due to occupation. What Moderna didn’t tout was that given the lack of a benefit and risk assessment, VRBPAC was not keen on recommending the greenlight of a vast mass booster campaign for all adults. This of course limits the number of vaccines the company can sell in America. The takeaway is that VRBPAC becomes much more discriminating in terms of who should receive a booster while some on the committee wondered aloud about the sponsor’s “thin” submission package. Moderna did inform investors that given the positive vote for the booster at the 50 ug level—assuming subsequent approval—could lead to an additional 1 billion doses available for distribution in 2022—of course this translates into significant revenue.


    The company noted in its press release that VRBPAC recommended that the FDA grant an EUA for the booster dose of mRNA-1273 at the 50 ug dose level for the following:


    People aged 65-up

    People 18 to 64 who are at a high risk of severe COVID-19 complications or severe illness

    The vote was unanimous in that all 19 VRBPAC members recommended the EUA under the above conditions. They recommended that the booster dose be administered at least six months after completion of the primary series.


    Thin’ Evidence

    Moderna shared that the VRBPAC recommendation was based on scientific evidence including analyzed data from a Phase 2 clinical study (P201) investigating mRNA-1273 booster dose at the 50-µg dose level boosting naturalizing titers significantly above the Phase 3 benchmark. They reported that after a booster dose, a comparable level of neutralizing titers was observed across age groups but particularly noticeable among those 65 and above. They reported that the safety profile for the booster was comparable for dose 2 of mRNA-1273.


    Not all were fully impressed with the data. Molly Walker writing for MedPage Today reported recently that while there were no safety concerns the recent Moderna Phase 2 study yielded a “small sample size” and “no efficacy data.”


    Of the 149 adults receiving the two-dose regimen, FDA staff went on the record “Immunobridging analyses against the D614G strain met with the pre-specified success criteria for the [geometric mean titers] ration.” Moreover, the staff noted that in association to seroresponse rates post the booster jab “the pre-specified success criteria was not.”


    MedPage Today’s Ms. Walker reported that Patrick Moore, MD with the University of Pittsburgh Cancer Institute shared his concern with the “poor quality data submitted by the sponsor. He was quoted “I’ve got real issues with this vote…[it’s] more of a gut feeling rather than truly serious data,” and declared “I think it’s very important that companies coming to VRBPAC…really take seriously that we need to see good, solid data, and it needs to be explained well.”


    Non-Binding Recommendation

    Advisory committees to the FDA, such as VRBPAC provide non-binding recommendations. This means the FDA takes the recommendation into consideration while they prepare to make a final decision on authorization of the booster. Once the FDA made its decision, the U.S. Centers for Disease Control, and the Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss a recommendation for the use of COVID-19 boosters.


    Separate Approval in August

    Moderna reported in their recent press release that on August 13, the FDA approved an update to the EUA for mRNA-1273 to include a third dose at the 100 ug dose level for immunocompromised people aged 18 years and up in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.


    Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S. | Moderna, Inc.
    Positive unanimous vote for mRNA-1273 booster at the 50 µg dose level for individuals aged 65 and older as well as individuals aged 18 through 64 at high risk…
    investors.modernatx.com

  • Needing a new kidney is not an elective procedure, so your analogies don't apply.

    Those are not analogies. They are actual examples from surgical medical procedures. Eye surgery is not elective either, when the patient has something like glaucoma and will go blind without surgery.


    This patient had Stage 5 disease and will probably die without a transplant.

    Then it is essential the patient follow doctors' orders! Why do you say the patient should be free to dictate to the doctor how to do the operation? Would you say that about any other aspect of the treatment? That violates many laws. Doctors are not allowed to ignore their own training, and ignore best practices. They can lose their licenses or be sued for malpractice if they do that.


    You want an analogy? This is as if a person comes into a restaurant with spoiled meat and demands the cooks prepare it for a meal. No restaurant would be allowed to do that, even if they wanted to. You cannot just ignore laws and health departments standards because your customer tells you to.


    The only way that makes sense is to look at it through the lens of ruthless political ideology, not medicine.

    There is nothing ideological about health standards, vaccinations, and best practices. There is nothing special about the COVID vaccine that sets it apart from any other vaccine, or from the drugs used before eye surgery. The doctor's decision to order the patient to take pretreatment for an operation is normal, non-ideological, and obligatory. People are not forced to follow a doctor's orders, but doctors cannot perform surgery on patients who refuse to cooperate, or who refuse essential pre-treatment. Doctors are not allowed to let the patient dictate unsafe procedures.


    Patients can always leave the hospital, even when they are at death's door, but they have to sign an AMA (against medical advice) form. If this woman insists on risking her life in an unsafe procedure, she must find another doctor. No doctor should be forced to go against medical training. It is illegal for a doctor to do that!

  • Not all were fully impressed with the data. Molly Walker writing for MedPage Today reported recently that while there were no safety concerns the recent Moderna Phase 2 study yielded a “small sample size” and “no efficacy data.”

    There is no need for Moderna boosters as it protects at least 5x better as Pfizer/Oxford crap.

    May be moderna boosters for Pfizer damaged people could be an idea!

  • You seem to really love your analogies. Eye drops for eye surgery - makes sense!, Antibiotics for infections - also logical standard practice! vaccine for surgery - illogical, irrelevant.

    That is not even slightly true. People often have to get vaccinations or other shots or medical treatment before surgery. A older person who is behind in vaccinations for tetanus or influenza will be told to get the vaccinations before surgery. (I was!) If you have a cold or influenza when you go in for surgery, they give you a shot and tell you to come back in two weeks. (Happened to me.) Any infection has to be cleared with a shot or pills. A patient with a serious case of diabetes may need injections to control it before surgery, no matter what kind of surgery it is. Anyone who undergoes cancer treatments may need preliminary injections and treatment before surgery.


    During a pandemic, when a vaccine is available, OBVIOUSLY every patient has to be vaccinated to prevent infection. That is the most basic medical imperative of all. George Washington insisted on it for his entire army in 1777. Any doctor would.


    You do not know much about medicine. I suggest you do some homework before commenting.

  • To clarify : I was referring to the data for people over 40, not people over 40.

    As far as I'm concerned, it's better for all of us if the healthy vaccinated get infected, and sooner rather than later.


    The data is not looking good for those who want to believe and promote the idea that getting vaccinated is stopping the spread of the virus.

    So - actually I'm not going to call that an unreasonable antivax meme, it is not antivax.


    That one ONS datapoint with its caveat about denominators (you ignore) and the two other issues, justifies what you say here as possibly true.


    However, I am much more cautious. This is one (known flaky - actually caveated as this) datapoint. A whole load of other data points a different way. Exactly because it is anomalous I'd like to spend more time with it, and test it.


    Note the difference between a mainstream viewpoint of these this (where when data looks against expectations you investigate) and an antivax-lite view of things, where you believe implicitly data in line with your expectations, and ignore as fake data against them. (I'm not counting antivax full-blown because the errors are so large and repetitive it gets boring).


    One that can be investigated - but it is a lot of effort to do this properly - is the distinction between infections and cases. The ONS infection survey data has both, subgrouping is possible, but its samples so you need a period of time to get better accuracy if you are subgrouping a lot.

    One thing that is tricky is the denominator issue. There is definitely an error, I don't know how to quantify it. But there must be information somewhere that can do that. the problem is to gte the right subgrouping, and also that the last census was 2018 and inflows/outflow from UK have been atypical since then due to Brexit.


    I'm aware of the possibility that most of the other data out there being used is not delta, or not > 6 months from vaccination. I'm also aware of the fact that there will be more care taken before publishing widely anything that makes vaccination look less good - because vaccination - and specifically high vaccination rates - is the only thing that can keep countries open (the health service overload thing - which we all know is the only reason governments such as the UK locked down).


    I'm suspicious of single data points, even without unquantified known sources of errors.


    here is the other information relating to this:

    We will get proper estimates of vaccination efficacy change over longer periods - say up to 8 months - shortly.

    We will eventually get proper estimates for covid-infection immunity efficacy chnage over time. This one difficult because very mild infections are not noticed, so you need sample-and-test techniques like ONS and then complex analysis of that data.

    We will also - and I'm interested as somone shortly to be triple-jabbed - get estimates for how efficacy after 3rd jabs compare over time with efficacy after 2nd. Initially, things are looking good because 3rd jab is better than 2nd.


    Over enough time the whole vax/antivax thing will go away because everyone will have caught covid. which will not make covid go away, but turn it into something much more like Flu. The antivax estimates of how much prior infection we now have are wrong, and the correct estimates show it will take longe rthan i'd like even with the Uk with the highest infection rate in Europe. We are now at (my approx guess) approx 25% (18% official estimate with errors up not down).


    THH

  • Lets repeat the facts. > 6 out of 7 people are immune for delta (recent African data) . So the group that could profit from a vaccination contains at most 13% of the population. If you take this as input for the UK Vaccine surveillance week 41 report then overall currently no people profit from vaccines. (was better for alpha where 25% was in the group.)

    This could only change when we would have the knowledge to find out who is not protected. But even then we would see no vaccine effect at all.

    So may be a tiny subgroup only could finally profit.


    Effectively statistics do show that 0.1..0.3% of the population is highly vulnerable.

    So you have to vaccinate (rape) between 333..1000 person to indirectly save one live....

  • How else is it that the Together, ACTIV-6, and COVID-OUT studies all use basically the same protocol, 3 days of ivermectin 0.4 mg/kg or less on an empty stomach? ACTIV-6 and COVID-OUT are giving a slightly lower dose than in the Together study after the higher dose of ivermectin failed to show statistical benefit in Together. That only makes sense if they are trying to make ivermectin fail. There were lots of problems with Together which appear intentional. Lead investigator, Edward Mills basically works for Bill Gates. Analysis of Ivermectin in Together


    NIH and FDA stand to be humiliated if the NIH-sponsored ACTIV-6 or the University of Minnesota COVID-OUT trial show significant benefit of ivermectin. Why would the University of Minnesota, who should be independent, choose to treat patients with about the same dose that failed in Together? No one knowledgeable about ivermectin would in real life use it that way for the delta variant.

    The UK trial card is here https://www.principletrial.org…cardv1-0_15-03-2021pn.pdf


    0.3 to 0.4 mg/kg/day for 3 days.


    I am quite sure that everyone is following this dose because it is the maximum they think safe. It is however significantly higher than what we know is safe. That is one dose (1 day) of 200ug/kg.


    In addition: empty stomach is as it is normally prescribed, and will make absorption less variable. It is (guess) not a question of what delivers most drug, because you can always up the dose, but what delivers the most consistent amount.


    ---------------------------------------------------------------------------------



    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For river blindness:
        • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 150 micrograms (mcg) per kilogram (kg) (68 mcg per pound) of body weight as a single dose. The treatment may be repeated every three to twelve months.
        • Children—Dose is based on body weight and must be determined by your doctor. For children weighing 15 kg (33 pounds) or more, the usual dose is 150 mcg per kg (68 mcg per pound) of body weight as a single dose. If necessary, the treatment may be repeated every three to twelve months. For children weighing less than 15 kg, use and dose must be determined by your doctor.
      • For strongyloidiasis:
        • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 200 micrograms (mcg) per kilogram (kg) (91 mcg per pound) of body weight as a single dose. Additional doses usually are not needed.
        • Children—Dose is based on body weight and must be determined by your doctor. For children weighing 15 kg (33 pounds) or more, the usual dose is 200 mcg per kg (91 mcg per pound) of body weight as a single dose. For children weighing less than 15 kg, use and dose must be determined by your doctor.


  • Effectively statistics do show that 0.1..0.3% of the population is highly vulnerable.

    Wyttenfact (except in some developing countries) if by highly vulnerable you mean will die - in developed countries. IFR (for unvaccinated) is 0.5% - 1%.


    in developing countries:

    (1) many have high rates of prior infection

    (2) all have young populations with lower IFR


    So this figure might be correct - for death. W will be glad to know that developing countries in general are not vaccinating now - no-on will give them enough vaccine.

  • Wide Reports of Italian Worker Protests against New Mandatory COVID-19 Health Pass


    Wide Reports of Italian Worker Protests against New Mandatory COVID-19 Health Pass
    In Italy protests around the country erupted in response to the passage of one of the world’s most rigid COVID-19 vaccine passport systems. Across the
    trialsitenews.com



    In Italy protests around the country erupted in response to the passage of one of the world’s most rigid COVID-19 vaccine passport systems. Across the country from ports to town squares, protestors amassed to make their sentiment about the situation known. Approximately 3 million workers face no pay if they don’t get vaccinated or cough up the money for COVID-19 tests every 2 to 3 days.


    For example, in the northeastern port city of Trieste, several thousand protestors showed up at the port to strike although regional president Massimiliano Fedriga reported “The port is working.” However, on the other side of the country, the northwestern port city of Genoa was the scene of a protest involving hundreds of protestors who blocked an entrance while several other protests surfaced across the country in anticipation of a mass protest later that day.


    Reports in Italian and English-speaking press such as the BBC and Reuters carry the story.


    Vaccination & COVID in Italy

    Italy was hit particularly hard upfront during its first spike in the pandemic but with four specific surges, other spikes were deadly as well. The nation with 60 million has recorded 4.7 million cases and 131.5K deaths.


    About 85% of Italians aged 12 and up have received at least one vaccine dose. A total of 70.6% are fully vaccinated while 77.3% have received at least one jab—much of the country has been vaccinated.


    The Unvaccinated

    A small number remain unvaccinated in the nation. While some are politically opposed to mandates and coercive measures such as vaccine passports others may have religious exemptions or are fearful of adverse events. In some cases, undocumented workers may seek inoculation but cannot secure access to care.


    Up to 3 million workers remain unvaccinated and most of them will not be able to work moving forward unless they cover the costs of their SARS-CoV-2 tests every 2 to 3 days which many consider a gross violation of equity.


    Green Pass Day

    The rebellious energy started today—the first official day commencing the Green Pass, a rule stating that workers must offer positive proof of COVID vaccination or conversely proof they recently recovered from infection or show a negative test. The consequence for violating this rule—the worker is classified as absent and docked pay.


    Growing numbers of the Italian working class are infuriated about this new rule. The tension has mounted since protests in Rome last weekend in anticipation of a massive protest today. The U.S. Embassy and Consulates Italy provides more information on implications for travel from America.


    Italy imposes mandatory COVID health pass for work amid protests
    Italy made COVID-19 health passes mandatory for all workers from Friday in a test case for Europe, with the measure being applied mostly peacefully across the…
    www.reuters.com

  • I just made an overview among different US and EU states about waves and deaths.


    States (NY, NJ, France) we high death rates for alpha had 50% lower death rate from gamma and 4x (8x) lower death rate from Delta versus (Alpha/gamma)

    States with early (AUS,UK) lockdown did see just the opposite. Double death rate from gamma or delta. States with no measures like Florida had no difference between alpha/gamma and double the death rate from delta (despite 50% vaxx)


    So what can we learn? Lockdowns do not help - these just delay the problem.

    We know mortality among PCR+ is not different for all 3 virus. thus the relation of death is just given by prior immunity plus recovered the number of vulnerables killed. This should finally agree with the virus spread & virality factor.

    From this Florida data is absolutely in line with the 3x alpha, 5x gamma 9x delta silent infection factor that also tells how many of the uninfected got it.

  • External Content youtu.be
    Content embedded from external sources will not be displayed without your consent.
    Through the activation of external content, you agree that personal data may be transferred to third party platforms. We have provided more information on this in our privacy policy.

  • New data from Israel (preprint) show significant decrease in infection rates after 3rd Pfizer booster shot across different age groups.


    Protection Across Age Groups of BNT162b2 Vaccine Booster against Covid-19
    BACKGROUND Following administration to persons 60+ years of age, the booster vaccination campaign in Israel was gradually expanded to younger age groups who…
    www.medrxiv.org


    Abstract

    BACKGROUND Following administration to persons 60+ years of age, the booster vaccination campaign in Israel was gradually expanded to younger age groups who received a second dose >5 months earlier. We study the booster effect on COVID-19 outcomes.


    METHODS We extracted data for the period July 30, 2021 to October 6, 2021 from the Israeli Ministry of Health database regarding 4,621,836 persons. We compared confirmed Covid-19 infections, severe illness, and death of those who received a booster ≥12 days earlier (booster group) with a nonbooster group. In a secondary analysis, we compared the rates 3-7 days with ≥12 days after receiving the booster dose. We used Poisson regressions to estimate rate ratios after adjusting for possible confounding factors.


    RESULTS Confirmed infection rates were ≈10-fold lower in the booster versus nonbooster group (ranging 8.8-17.6 across five age groups) and 4.8-11.2 fold lower in the secondary analysis. Severe illness rates in the primary and secondary analysis were 18.7-fold (95% CI, 15.7-22.4) and 6.5-fold (95% CI, 5.1-8.3) lower for ages 60+, and 22.0-fold (95% CI, 10.3-47.0) and 3.2-fold (95% CI, 1.1-9.6) lower for ages 40-60. For ages 60+, COVID-19 associated death rates were 14.7-fold (95% CI, 9.4-23.1) lower in the primary analysis and 4.8-fold (95% CI, 2.8-8.2) lower in the secondary analysis.


    CONCLUSIONS Across all age groups, rates of confirmed infection and severe illness were substantially lower among those who received a booster dose of the BNT162b2 vaccine.

  • Maine Health Care Workers Fight Back


    Maine Health Care Workers Fight Back
    By Laurie Dobson, Oct. 15, 2021UPDATE:  The judge is still considering the case. As of 11:30 A Kennebec County Court clerk said it remained under
    trialsitenews.com


    UPDATE: The judge is still considering the case. As of 11:30 A Kennebec County Court clerk said it remained under advisement.


    As leaked video testimony from an ongoing court case revealed this week, informed consent is missing in Maine. That is the fact that several deaths are not made publicly known and rather passed on to the U.S. Centers for Disease Control and Prevention (CDC) for investigation. In somewhat of a bombshell admission the Maine CDC Director Dr. Nirav Shah went on the record that the 661 Maine Covid-19 vaccine deaths in the first 28 days post the jab were not sufficiently researched.


    Ruling Forthcoming

    A ruling is set for Friday morning in a potential landmark case in Kennebec County Superior Court, Maine. Nationally known lawyer Ron Jenkins, of Portland, Maine is representing the Alliance Against Medical Mandates.


    The suit was brought against the State’s CDC Dir. Dr. Nivrah Shaw and DHHS Comm. Jeanne Lambrew, to bring light to the situation in the State where health care workers in Maine expect to be terminated if they are not “in compliance” with what is known as “covid vaccine mandates.”


    The Alliance’s lawsuit was filed August 26 with a ruling set for Friday, October 15. If lost, it will likely be appealed up to the Maine Supreme Court.


    Maine’s Legislature gave power to the CDC and the DHHS to decide on extending rules regarding the emergency rulemaking. This has put Maine CDC Director Dr. Shah in a position of power which plaintiffs argue is excessive and unjustified.


    The Mandate

    These agencies, under the direction of Gov. Janet Mills, are requiring health care workers to be inoculated or lose their jobs by the 15th with enforcement starting Oct. 29.


    It has been reported that FEMA nurses are filling positions where local nurses are being forced out. FEMA workers are exempt from vaccine mandates. Of course, this presents an ironic twist to the whole affair.


    Health care workers are banding together under organizations, such as “Maine Stands Up”, to look for continuing ways of providing care.


    Large-Scale Walk-Off

    A nurse at Mount Desert Hospital reported that, before this announcement, a third of all nurses in her ward had recently walked off the job, due to covid-related concerns, and that she expected further loss due to the ruling.


    Expert Witnesses Include Dr. Peter McCullough

    The two expert witnesses on vaccines in the case are Dr. Peter McCullough and Maine’s own Dr. Meryl Nass. McCullough is a nationally recognized Covid treatment specialist. Nass is also an anthrax vaccine expert who has testified and helped to win previously against the FDA in a court ruling on the anthrax vaccine.


    State CDC Director Admission

    The State’s CDC Director, Dr. Nirav Shah, admitted in his testimony that the 661 Maine Covid deaths in the first 28 days following taking the Covid “vaccine shot” were not sufficiently researched. Only the 23 cases of myopericarditis were studied by Shah and his team. The rest were sent to the US CDC to investigate.


    Maine’s Ongoing Saga in Age of COVID

    Another lawsuit lost this week in Maine, which attempted to succeed in making the case for religious exemptions to taking the vaccine and is being appealed.


    The Maine State Legislature is also effectively on trial in this case as they gave authority to do this rulemaking to the DHHS, which began the rulemaking procedure in late August, calling it routine emergency procedure.


    This case reveals a “pattern of suppression of the severity of the problem,” according to a lawyer working with the case. “Knowlton, the defense attorney, claimed that there is a health care worker shortage. They crushed this claim, and this lawsuit is forcing them to admit to the fact that they have not communicated (with) the public.”


    Gail Geraghty, with the Butterfly_Effect_Group, which publicly released videos of court proceedings, said


    “The media has gone virtually dark on covering this all-important case, which has national ramifications, whichever way it goes.” Silence is broken as more residents become aware of this dire health care situation regarding loss of workers due to the State’s intrusion. This case may break open the need to resist and oppose these unethical rules.


    State argues CDC vaccine mandate 'routine', healthcare workers's 'aren't being forced'
    Timestamps: 4:30 -State Deputy Attorney General says CDC emergency rules routine; 6:04 DHHS considered "all relevant data; 8:00 '"There is no fundamental…
    www.bitchute.com

  • For those who might be interested in this and can read German, here is a comment from a different perspective. There is a high probability that this report and website might be sponsored by the FM/R/J/B mafia.. 😉


    "Ärzte für Aufklärung" verbreiten irreführende Behauptungen über Covid-19
    Die Gruppierung „Ärzte für Aufklärung“ verbreitet in einem Video irreführende Behauptungen zu Masken, PCR-Tests und möglichen Impfstoffen.
    correctiv.org