Covid-19 News

  • Follow the money: Big Pharma, Dr. Fauci and the death of hydroxychloroquine

    The $2.45 million Gilead spent in the first quarter of 2020 lobbying the federal government was well spent


    https://amp.washingtontimes.co…a-dr-fauci-and-the-death/


    ANALYSIS/OPINION:


    To better understand how using hydroxychloroquine (HCQ) to treat COVID-19 patients last year became a scientific quagmire, it’s always best to follow the money.


    HCQ is cheap (costing under $10 for the course of a COVID-19 treatment), well-understood by physicians having been prescribed for more than 80 years, and can be taken orally. Yet, Dr. Anthony Fauci and others at the National Health Institute of Allergy and Infectious Diseases preferred remdesivir, a proprietary, intravenous drug manufactured by Gilead Sciences, costing about $3,500 per treatment, with unknown side effects. And as to not make Big Pharma mad — and possibly threaten invites to cocktail parties, board seats and threaten grant monies — Dr. Fauci and his cohorts did everything possible to promote remdesivir and downplay HCQ, possibly costing millions of lives around the globe.

    Although, many doctors around the world were finding success with HCQ, in February 2020 NIH started enrolling patients for a remdesivir COVID-19 trial, with Dr. Fauci overseeing its progress. He had the final say on all the press releases, and presumably was working closely with Gilead. On April 16 something funny happened with the trial — the endpoints of it were quietly changed and updated on the clinicaltrials.gov website. Instead of evaluating remdesivir’s ability to prevent death from COVID-19, the study was redesigned to evaluate how fast a patient recovered from remdesivir.

    It was an interesting change because a leaked World Health Organization study of remdesivir showed there was no statistically significant clinical benefits in using the drug on COVID-19 patients and that it had severe side effects. However, it did show some promise in reducing recovery time. When the news broke of this study to the public, on April 23, Gilead shares fell.


    Drs. Dennis Bier at the Baylor College of Medicine and Arne Astrup, from the University of Copenhagen wrote in the BMJ Medical Trade Journal, NIH’s decision to move its study’s endpoints in the middle of the trial is generally frowned upon because the trial design is not drafted to focus on secondary endpoints, can produce data that’s unreliable, and can “introduce bias into a trial and creates opportunities for manipulation.”

    Yet, on April 29, the NIH enthusiastically rolled out its results. During an appearance alongside former President Donald J. Trump in the Oval Office, Dr. Fauci said there was reason for optimism, the study achieved its primary goal, which was to improve the time to recovery, which was reduced by four days for patients on remdesivir. He failed to mention the study’s endpoint was changed mid-way through the trial. Still, the media tour was started, with Dr. Fauci at the lead, praising remdesivir and simultaneously bashing HCQ for its lack of a similar clinical trial. Gilead’s stock soared.


    On May 1, the NIH’s COVID-19 Treatment Guidelines panel members granted emergency use of remdesivir and stated HCQ could only be used in hospitals or in studies. Investigative journalist Sharyl Attkisson found 11 members of that panel had financial ties to Gilead. Two were on Gilead’s advisory board, others were paid consultants or received research support and honoraria. None of the members, however, had ties to HCQ, which is made by numerous generic manufacturers, and “is so cheap, analysts say even a spike in sales would not be a financial driver for the companies,” Ms. Attkisson reported.

    Ms. Attkisson also found one of the authors of a small Veterans Administration trial that claimed HCQ caused increased deaths received a $247,000 grant from Gilead in 2018.


    On May 22, a fraudulent paper published by Lancet put the nail in HCQ’s coffin, claiming to show HCQ was not effective and was dangerous. The lead author of the now-debunked and retracted study was Dr. Mandeep Mehra, a Harvard professor, who attended a conference co-sponsored by Gilead a month before to discuss COVID-19. Many have speculated whether Gilead ghostwrote the study, as Surgisphere the company that spearheaded the effort, had only a handful of recently hired staff that reportedly included a science fiction writer and an adult-content model.

    Yet, the damage was done. On June 11, the NIH updated its COVID-19 guidelines recommending against the use of HCQ except for in clinical trials. Days later, on June 15, the Food and Drug Administration revoked emergency use of HCQ, with remdesivir being the only officially U.S. endorsed drug to treat COVID-19.


    The $2.45 million Gilead spent in the first quarter of 2020 lobbying the federal government was well spent. Meanwhile, a new, not yet peer-reviewed study of HCQ released this month found it, taken with azithromycin, improved COVID-19 survival by nearly 200% in ventilated patients.

    If only there were money in the drug. Imagine the lives that could’ve been saved.

  • Finnish firm earns US patent for Covid drug containing ivermectin and hydroxychloroquine

    The Turku company says its nasal spray delivers low, safe doses of hydroxychloroquine, ivermectin and aprotinin


    https://yle.fi/uutiset/osasto/…droxychloroquine/11946611.


    A coronavirus drug developed by Therapeutica Borealis, a pharmaceutical firm in Turku, has been granted a patent by the United States Patent and Trademark Office (USPTO). The nasal spray contains hydroxychloroquine, among other ingredients.


    Earlier in May, the company said it had received approval for a patent application, based on which it expected a final patent this month.


    “The final patent is an important milestone for us on our way to the market. Our next goal is to find an established pharmaceutical industry company with an international business scale,” says Professor Kalervo Väänänen, one of the three inventors and founders of Therapeutica Borealis, in a press release on Monday. Väänänen is a cell biologist and former rector of the University of Turku.

    The co-inventors of the drug and co-founders of Therapeutica Borealis are Lauri Kangas, an adjunct professor of science at the University of Turku, and Matti Rihko, a psychologist, and board chair of the Turku Chamber of Commerce and of the University of Turku. He is also a former CEO of the Raisio food corporation, known for its cholesterol-lowering Benecol products.


    According to the company, the nasal spray acts on cell function in nasal mucous in three ways, impairing the ability of the virus to penetrate the body and multiply, thus reducing the risk of serious illness.


    Another Finnish pharmaceutical company, Rokote Laboratories, has been developing a coronavirus vaccine in nasal spray form, but has struggled to gain financing.


    “Tackling the pandemic probably requires, in addition to a vaccine, a preventive or early-acting drug. This drug also helps especially in a situation where vaccine coverage threatens to remain too low for herd immunity,” said Väänänen.


    WHO warned against ivermectin use except in clinical trials

    The firm said that the drug's active ingredients – aprotinin, hydroxychloroquine and ivermectin – are well-known and widely used drugs, but in this product are used in a new, targeted manner on the upper respiratory mucous membrane.


    All the drug molecules covered by the patent are approved for the treatment of other diseases, but if used systemically, for instance as pills or infusions swallowed by patients, the amounts of drugs would be high and potentially harmful.


    For topical use, as in a nasal spray, the concentrations of the active ingredients throughout the body remain very low but are sufficient locally to prevent the passage and replication of the virus, making the drug safer and more effective, says Therapeutica Borealis.


    Aprotinin is a protease inhibitor while ivermectin is an antiparasitic and hydroxychloroquine has been used against malaria – and has been touted as a Covid-19 treatment by Brazilian President Jair Bolsonaro and former US President Donald Trump among others.


    Earlier this year ivermectin manufacturer Merck said there was “no scientific basis for a potential therapeutic effect against Covid-19” and “no meaningful evidence for clinical activity or clinical efficacy in patients with Covid-19.”


    In March, the World Health Organisation (WHO) recommended against using ivermectin in patients with Covid-19 except for clinical trials, because of a lack of data demonstrating its benefits. The European Medicines Agency and the US Food and Drug Administration issued similar warnings. It has however been used for Covid patients in countries including South Africa and India

  • Renowned Doctor Says Feds Deliberately Avoiding Affordable COVID-19 Treatment To Promote Experimental Vaccines


    http://www.christianitydaily.c…experimental-vaccines.htm


    A renowned Dallas cardiologist is challenging the federal government's push for experimental vaccines versus affordable COVID-19 treatment that is already available to many.


    Cardiologist Dr. Peter McCullough is challenging the way the U.S. healthcare system is treating COVID-19 patients. The renowned doctor from Baylor University Medical Center in Dallas is questioning why U.S. doctors have failed to come up with an official treatment protocol for COVID-19.


    Dr. McCullough said "something has gone off the rails in the world" in the "irregular response" the federal government has towards the global pandemic.


    In a recent appearance in "Tucker Carlson Today," Dr. McCullough clarified that while he has no agenda, he is "deeply concerned" that the federal government's response to the COVID-19 pandemic has been "in fear, in isolation and despair."


    FOX News reported that the renowned doctor from Dallas wanted to know why the FDA and pharmaceutical companies "strictly excluded" several groups from their clinical trials of the COVID-19 vaccine.


    These groups include persons who were suspected to have recovered from COVID-19, persons with antibodies, pregnant women, and women who were capable of reproduction but who could not assure contraception. Dr. McCullough believes that this "huge group of exclusions'' is a "giant part of the healthcare workforce."


    Dr. McCullough further cast doubt on why these groups were not eligible for randomized trials. He theorized that the FDA and sponsors may have thought there was a safety problem in the COVID-19 vaccines.


    Insisting that the COVID-19 response has been "fear driven," the renowned doctor warned that he does not recommend experimental vaccines to pregnant women because "We have no information on safety...It violates a simple medical practice principle, we don't use things where we don't have a signal of benefit or acceptable safety. We don't do it."


    Dr. McCullough also argued that in other countries, doctors have encountered success in using affordable COVID-19 treatments such as hydroxychloroquine and ivermectin. However, in the U.S. those two drugs have been shunned and rejected as viable COVID-19 treatments in favor of experimental vaccines.


    According to WND, Dr. McCullough was one of the several physicians in a Senate testimony who condemned the politicization of hydroxychloroquine, ivermectin, and other affordable COVID-19 treatment. The renowned doctor argued, "I have seen things in the last year that I cannot explain as a doctor. Why are other doctors not helping, with a simple [treatment] these patients avoid hospitalization and death?"


    In January, Daily Mail reported how the U.S. journal Frontiers of Pharmacology published a peer-reviewed study on how ivermectin can decrease COVID-19 infections and hospitalizations by up to 75%. Over 30 trials around the world showed ivermectin causes "repeated, consistent, large magnitude improvements in clinical outcomes."


    However, in March, The Scientist reported that the editors at Frontiers in Pharmacology took down the paper, which was written by Front Line COVID-19 Critical Care Alliance (FLCCC) members, citing that the article "contained unsubstantiated claims and violated the journal's editorial policies." FLCCC condemned the move, saying it was "censorship" and that their paper had passed through several reviews before publishing.

  • FLCCC Statement on the Irregular Actions of Public Health Agencies & the Disinformation Campaign Against Ivermectin


    https://www.newswise.com/coron…mpaign-against-ivermectin


    WASHINGTON DC, USA, May 13, 2021- The FLCCC Alliance has issued the following statement regarding the posting of its new white paper:



    "For too long the World Health Organization (WHO) and other public health authorities have ignored effective treatments like Ivermectin and the peer-reviewed science that supports it to help end this pandemic. We, the FLCCC Alliance, felt compelled to tell the public, our peers and our colleagues the reasons why this is happening and what they can do about it.


    We have posted a white paper in which the list of irregular activities of the recent review of the evidence by WHO and the impact it is having on our ability to treat patients is presented. We also show the compelling evidence of what appears to be a deliberate disinformation campaign that is meant to mislead the public and silence doctors who do not follow the guidance from the WHO.


    We hope that all citizens of the world will take the time to read this paper and share it with friends and colleagues. The current actions by the WHO to ignore some of the most published and well-respected physicians in world will have long lasting effects on our ability to give the public access to the best possible treatments now and in the future.


    We cannot let this go on without acting to inform as many as possible.


    Please join us in spreading the word.


    The FLCCC Alliance

    Dr. Pierre Kory

    Chief Medical Officer




    The FLCCC Alliance is a nonprofit, humanitarian organization made up of renowned, highly published, world-expert clinician-researchers whose sole mission over the past year has been to develop and disseminate the most effective treatment protocols for COVID-19. In the past six months, much of this effort has been centered on disseminating knowledge of our identification of significant randomized, observational, and epidemiologic studies consistently demonstrating the powerful efficacy of ivermectin in the prevention and treatment of COVID-19. Our manuscript detailing the depth and breadth of this evidence passed a rigorous peer review by senior scientists at the U.S Food and Drug Administration and Defense Threat Reduction Agency. Recently published, our study concludes that, based on the totality of the evidence of efficacy and safety, ivermectin should be immediately deployed to prevent and treat COVID-19 worldwide.

  • Horowitz: The censorship of ivermectin is the biggest story of COVID


    https://www.theblaze.com/amp/h…story-of-covid-2653291134


    Last week, Manitoba Premier Brian Pallister launched a $1 million grant to convince "hesitant" communities to get themselves vaccinated with one of the experimental shots on the market. But if people are hesitant about an experimental gene therapy that has already racked up a record number of serious adverse events on the CDC's Vaccine Adverse Event Reporting System (VAERS), why not spend the money persuading people to get ivermectin, a safe and effective early and prophylactic COVID treatment that has been approved by the FDA and the WHO for other uses for years?


    In a recent video clip from one of his forums, Pallister was asked by a caller about another kind of hesitancy – not hesitancy to vaccinate, but "hesitancy to talk about ivermectin" and other early treatments. The caller cited the evidence about this drug, which "does no harm" and causes no risk to try it. The female caller completed her thought by asking him, "Are we doing anything with that, and if not, why not?"

    As if to illustrate the caller's point, Pallister responded to her question about hesitancy to talk about ivermectin by ... refusing to talk about ivermectin! Like a programmed robot, Pallister blinked his eyes during her question, then proceeded to answer by discussing more about the vaccine! "We're pursuing domestic research that we hope can lead to better vaccine availability in the future, perhaps not during this wave, but when we need boosters in coming years," answered the Manitoban premier. He then quickly finished the discussion, put on his mask (even though he is vaccinated), and concluded the session.


    This video embodies the criminal behavior of the political class in censoring lifesaving, cheap treatments like ivermectin. Even in vaccine-crazed Israel, they found in a small study of 30 patients that all of them recovered with the use of ivermectin, 29 of them within 3-5 days. In India, which was a hot spot until recently, much of the country began using ivermectin. Delhi saw a 99% decline in cases after beginning universal use of ivermectin. While cases were going down everywhere after reaching some level of immunity, a 99% reduction from April 24 to June 7 is remarkable and much steeper than anywhere else in the world following a big wave.

    A similar dynamic played out in the state of Uttar Pradesh, which is now 98% off its peak of COVID cases in late April. India's overall reduction since its peak five weeks ago was 76%, more in line with what we saw in the U.S. and Europe, once the peak wave passed and a modicum of herd immunity kicked in.

    Despite Fauci warning about the Indian "Delta" variant being more deadly and continuing to push vaccines as the only solution, in reality, India's death rate from COVID — even after achieving what appears to be herd immunity — is just one-seventh of our COVID death rate and that of other European countries! India's death rate is even lower than Israel's and fairly close to that of Finland, which largely escaped the worst of the virus so far.

    And no, the secret sauce is not the vaccine, because fewer than 15% of Indians have received at least one dose, while over 50% of Americans and 60% of British citizens have already had one shot.

    The secret sauce is natural immunity, which is much stronger than the vaccine, along with arming people with early, cheap treatments to obtain that natural immunity as risk-free as possible.


    In a remarkable contrast from the legal establishment in the U.S., the Indian Bar Association served Dr. Soumya Swaminathan, an Indian pediatrician who is the chief scientist at the World Health Organization (WHO), with a legal notice for spreading disinformation about ivermectin. Dr. Swaminathan recently tweeted that the WHO advises against use of ivermectin outside clinical trials:

    Some Indian states have taken this guidance to heart. In the southern state of Tamil Nadu, the newly elected governor, M.K. Stalin, excluded ivermectin from the treatment protocol and opted instead for the expensive and ineffective remdesivir. The result? Just the opposite of Delhi. The virus continued to peak for an extra month and only recently began to recede at a much slower rate.

    The state of Goa, which is also in the south, began offering ivermectin to all adults on May 11. The 87% drop in four weeks is remarkable

    Ditto for Karnataka, another southern state neighboring Tamil Nadu, that sanctioned the use of ivermectin

    In Uttarakhand, another ivermectin state in the north, cases dropped by 95% since the peak.

    The point is that, while herd immunity seems to be the major factor, the states that used ivermectin seemed to experience an earlier peak and a steeper decline in cases than those that shunned ivermectin. The troubling question is what these curves would have looked like had the WHO recommended ivermectin before the virus began to spread and if it had used at the first sign of trouble with the same religious fervor as vaccines, remdesivir, and masks. We will never know, but we can surmise that the curves would have been milder based on the results we are seeing from those countries that used it once they were in a world of trouble.


    Mexico experienced a sharp increase in cases during the winter, but enjoyed much success in the regions that used ivermectin. Last month, Mexico City Mayor Claudia Sheinbaum held a press conference where she claimed a study showed ivermectin decreased the likelihood of hospitalization in her large metropolis by between 52% and 76%.


    The question everyone needs to answer is this: With all of the adverse reporting from the experimental vaccines, why do the global authorities continue to push them like candy without further study, when they refuse to greenlight ivermectin, with 29 randomized controlled trials vouching for its efficacy with no side effects and 4 billion doses dispensed over decades?

  • Delayed Antibody and T-Cell Response to BNT162b2 Vaccination in the Elderly, Germany


    https://wwwnc.cdc.gov/eid/arti…article#suggestedcitation


    Abstract

    We detected delayed and reduced antibody and T-cell responses after BNT162b2 vaccination in 71 elderly persons (median age 81 years) compared with 123 healthcare workers (median age 34 years) in Germany. These data emphasize that nonpharmaceutical interventions for coronavirus disease remain crucial and that additional immunizations for the elderly might become necessary.


    The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has led to an urgent need for vaccines, particularly among persons at high risk for severe disease and death, such as the elderly (1). Efficacy against severe coronavirus disease (COVID-19) of mRNA vaccine BNT162b2 (Pfizer-BioNTech, https://www.pfizer.comExternal Link) is reported to be >90% starting 7 days after the second vaccination; robust antibody and T-cell response has been demonstrated consistently across age groups (2–4). However, only 4.3% of participants in the BNT162b2 efficacy trial were >75 years of age (4). Given the elderly generally have weaker immune responses after vaccination, more detailed investigation is necessary (4,5).


    The Study

    In a prospective observational cohort study, we investigated SARS-CoV-2–specific antibodies, maturation of IgG avidity, and interferon-γ (IFN-γ) release of SARS-CoV-2–specific T cells in 2 cohorts of young and elderly BNT162b2-vaccinated persons (Table). Participants were recruited from 2 studies conducted at Charité–Universitätsmedizin Berlin, both conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (https://www.ema.europa.eu/en/d…ice-step-5_en.pdfExternal Link) and approved by the local ethics committee (EA4/244/20 and EA4/245/20)


    The first cohort consisted of 123 healthcare workers; median age was 34 (interquartile range [IQR] 20–64) years. The second cohort consisted of 71 elderly residents of an assisted living facility; median age was 81 (IQR 70–96) years. Blood samples were taken before the first vaccination (week 0), just before the second vaccination (week 3), and 4 weeks after the second vaccination (week 7). To discriminate between vaccine-induced antibody response and convalescent SARS-CoV-2 infection, we used the SeraSpot Anti-SARS-CoV-2 IgG microarray-based immunoassay including nucleocapsid and spike as antigens (Seramun Diagnostica GmbH, https://www.seramun.comExternal Link) (Appendix). Ten of 123 healthcare workers and 1 of 71 elderly participants showed reactive anti-nucleocapsid or anti-spike IgG before the first vaccination and were excluded from further analyses.


    Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–specific antibody and T-cell response after vaccination with BNT162b2 (Pfizer-BioNTech, https://www.pfizer.com) in the elderly, Germany. A) SARS-CoV-2 RBD IgG measured in serum of BNT162b2-vaccinated younger participants (healthcare workers) before the first vaccination (n = 100, week 0), 3 weeks after the first vaccination (n = 107, week 3), and 4 weeks after the second vaccination (n = 113, week 7) and from elderly participants at week 0 (n = 70), week 3 (n = 52), and week 7 (n = 70) using the SeraSpot Anti-SARS-CoV-2 IgG assay (Seramun Diagnostica GmbH, https://www.seramun.com). B) Neutralizing capacity of antibodies measured at week 3 and 7 in the young and elderly cohorts using the ELISA-based surrogate virus neutralization test (sVNT) cPass (medac GmbH, https://international.medac.de). C) SARS-CoV-2 spike IgG avidity analyzed in the healthcare workers cohort (n = 30) and elderly cohort (n = 16) at week 3 and 7. D) At week 7, whole blood from vaccinated elderly participants (n = 43) and young participants (n = 71) was stimulated ex vivo with components of the S1 domain of the spike protein for 24 h, and IFN-γ concentration in the supernatant was detected by ELISA. Dotted lines indicate the manufacturer’s specified threshold for RBD IgG >1 S/Co, for sVNT >30%, and for avidity 40–60% borderline avidity and >60% high avidity. For IGRA, we defined an arbitrary threshold at 334.2 mIU/mL. p value was calculated by the nonparametric Mann Whitney U test, and the median and interquartile range are depicted. ACE2, angiotensin-converting enzyme 2; IFN-γ, interferon-γ; IU, international units; NS, not significant; RBD, receptor-binding domain; S/CO, signal-to-cutoff ratio; sVNT, surrogate virus neutralization test.

    Figure. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–specific antibody and T-cell response after vaccination with BNT162b2 (Pfizer-BioNTech, https://www.pfizer.comExternal Link) in the elderly, Germany. A) SARS-CoV-2 RBD IgG measured in serum...


    At week 3, in the younger cohort, 93/107 (86.9%, 95% CI 79.2%–92.0%) participants showed reactive SARS-CoV-2 receptor-binding domain (RBD) IgG, compared with only 16/52 elderly participants (30.8%, 95% CI 19.9%–44.3%). At week 7, the antibody response rate had increased in both cohorts, to 112/113 in younger participants (99.1%, 95% CI 95.2%–100.0%) and 64/70 in the elderly cohort (91.4%, 95% CI 82.5%–96.0%) (Figure, panel A; Appendix Table). The comparison of SARS-CoV-2 RBD IgG levels demonstrated a significant difference in the 2 cohorts at both week 3 (p<0.0001) and week 7 (p = 0.0003) (Appendix Table), indicating a substantial delay and overall reduced antibody response in elderly participants. We observed similar kinetics and differences between cohorts for antibody responses to 2 further SARS-CoV-2 spike antigens: the S1 subdomain and the full spike protein (Appendix Table, Figure).


    We further confirmed the delayed and reduced antibody response in the elderly by measurement of the functional neutralization capacity using the surrogate virus neutralization test (sVNT) cPass (medac GmbH, https://international.medac.deExternal Link) (Appendix) (6). At week 3, only 24/52 elderly participants (46.2%, 95% CI 33.3%–59.5%) had neutralizing capacity in serum, compared with 97/107 younger participants (90.7%, 95% CI 83.7%–94.8%; p<0.0001 (Figure). In addition, the median sVNT titer for elderly participants was significantly lower than the young cohort (26.4% [IQR 6.8%–40.9%] vs. 60.2% [IQR 45.0%–76.4%]; p<0.0001) (Appendix Table). Although the neutralizing antibody response rate increased to 63/70 (90.0%, 95% CI 80.8%–95.1%) in elderly participants by week 7, the median sVNT titer remained significantly lower than in the younger cohort (89.6% [IQR 70.9%–95.2%] vs. 96.7% [IQR 95.6%–97.2%]; p<0.0001) (Appendix Table).


    To characterize the maturation of IgG avidity in all 16 elderly and 30 randomly selected younger participants who were seroreactive at week 3, we applied a modified SARS-CoV-2 S1 IgG ELISA (Euroimmun, https://www.euroimmun.comExternal Link) (Appendix Figure 2). The delayed antibody response in the elderly is reflected in results: at week 7, only 8/16 elderly (50.0%, 95% CI 28.0%–72.0%) exhibited high S1 IgG avidity indices (>60) compared with 28/30 young participants (93.3%, 95% CI 78.7%–98.8%) (Figure, panel C). Consequently, the median relative avidity index of IgG was significantly higher in the younger cohort than the elderly cohort (76.2% [IQR 67.6%–82.9%] vs. 59.3% [IQR 55.3%–68.9%]; p = 0.0002) (Figure, panel C).


    In addition to antibody responses, we assessed SARS-CoV-2 spike-specific T cell responses by an IFN-γ release assay (IGRA) (Euroimmun) (Appendix) of S1 peptide-stimulated T cells at week 7. The proportion of persons with IGRA results above the defined threshold (Appendix) was significantly lower in the elderly than in younger participants (51.2% [95% CI 36.8%–65.4%] vs. 84.5% [95% CI 74.4%–91.1%]; p = 0.0002). Accordingly, median S1-induced IFN-γ release was significantly decreased in the elderly compared to younger participants (707.3 mIU/mL [IQR 216–1,392] vs. 2184 mIU/mL [IQR 1,274–2,484]; p<0.0001) (Figure, panel D). In contrast, we detected no significant difference in IFN-γ release after mitogen stimulation between the 2 cohorts, indicating no general impairment of IFN-γ responses in the elderly (p = 0.77) (Figure, panel D; Appendix Table).


    In summary, vaccination with BNT162b2 induces both arms of adaptive immunity: SARS-CoV-2–specific antibodies and SARS-CoV-2–specific T cells. However, we observed delayed and less robust cellular and humoral immune response among the elderly than among younger adults. A limitation of our study is the lack of data on other COVID-19 vaccines. Furthermore, we cannot exclude that underlying diseases or medications, which are more common in the elderly (Table), might impair the vaccine-induced immune response. For example, patients on dialysis have significantly lower antibody response than vaccinated same-age patients not on dialysis (E. Schrezenmeier et al., unpub. data, http://medrxiv.org/lookup/doi/…21.03.31.21254683External Link).


    Our data are supported by other real-world observations suggesting a delayed and reduced immunogenicity of BNT162b2 in the elderly (5,7; D.A. Collier et al., unpub. data, http://medrxiv.org/lookup/doi/…21.02.03.21251054External Link). In line with our observations for BNT162b2, an effect of age-dependent decrease of immune function, referred to as immunosenescence, is well known and contributes to increased prevalence of infectious disease and vaccine failure in the elderly (8). A lower vaccine-induced immune response to influenza and hepatitis B viruses is well documented (9,10); however, such data are scarce for mRNA vaccines.


    Of note, vaccination with 2 doses of BNT162b2 might not fully prevent SARS-CoV-2 outbreaks among elderly persons in congregate settings, such as long-term care facilities, possibly because of delayed and reduced immune response. However, vaccination protects against severe disease (11–13).



    Conclusions

    Although the immune response of elderly participants 4 weeks after the second dose of BNT162b2 nearly reached the level of younger participants, a small fraction of elderly participants did not demonstrate robust antibody and T-cell response. However, the immunologic correlates of protection remain unknown, and identification of persons with no or incomplete protection after vaccination remains challenging. Therefore, strategies focused solely on vaccination of high-risk groups might be insufficient to protect those at risk for severe disease. For the elderly, vaccination of caregivers and close contacts should be prioritized. Moreover, a booster vaccination, altered vaccine dose, or different COVID-19 vaccines should be considered for the elderly if further evidence demonstrates high rates of breakthrough infections despite 2-dose BNT162b2 vaccination.


    These results are particularly relevant for vaccination strategies focused on broad administration of the first dose of a 2-dose vaccine while postponing the second vaccination. This practice might leave a relevant proportion of elderly with comparatively low levels of immunity for a prolonged period, emphasizing the need for nonpharmaceutical interventions, such as mask use and regular testing.

  • Did your phase 1, 2 or 3 show these vaccine drawbacks and if so please point them out to me as I have not read any papers pertaining to blood clots or any bleeding disorders before vaccination begun specific to oxford vaccine


    The whole point is that even phase 3 studies are not large enough to detect very uncommon side effects - which is why vaccines are monitored. The same is true for drugs used at levels not previously tested etc. RCTs are important because they show efficacy and in the case of a drug for people with disease they can show that the outcomes with drug are better than those without on a fairly small sample - if the disease is a bad one. That is because the good the drug does will easily predominate over any low frequency side effects.


    With a prophylatic, or vaccine, that is given to everyone the equation is different - and very low frequency side effects at levels lower than the risk of crossing the road become significant.


    You still need RCTs to determine efficacy - but ultimate safety is discovered only when very large numbers of patients are treated / immunised. however at this point the risks are known low and for example with COVID vaccines the vaccine risks are much lower than the COVID risks without vaccine. Those blood clot risks are for example lower than the risks of COVID blood clots (it does that).


    COVID is not going away, the delta variant is (we now learn) 100% more deadly and 60% more transmissable than alpha. Further future variants may be even worse - we just don't know how it will evolve.


    So the personal equation of safety to take / not take a COVID vaccine that is effective is a no-brainer.


    Alas there are many people in the world with no brains - or with brains full of false anti-vax propaganda.

  • This business damaging paper has been unlinked...


    Except it seems that CDC - which many US citizens seem to view as part of this worldwide conspiracy* has put it on its website?


    https://wwwnc.cdc.gov/eid/article/27/8/21-1145_article


    The paper is saying what everyone expected would be the case - that old people's immune systems, being less good, respond less well to vaccines.


    But they still respond.



    *disclaimer - I think all these conspiracy theories are nuts - am happy for those who believe them to sound off as long as I have a chance to give the opposite - sane - viewpoint

  • Except it seems that CDC - which many US citizens seem to view as part of this worldwide conspiracy* has put it on its website?

    More FUD from THHuxleynew ::

    This is not the original paper: Just a CDC edited summary: The original has disappeared.

    RCTs are important because they show efficacy and in the case of a drug for people with disease they can show that the outcomes with drug are better than those without on a fairly small sample - if the disease is a bad one.

    Yes: Only goal of RCT. Exclude small companies from market. Get a blueprint for making tons of money. Typical RCT size 100:100 e.g Lucentis versus Avastin. Both exactly behave the same. ----> new licence (Lucentis) to make tons of money.

    You can never see any side effects > 1 year in an RCT study that usually is closed after 1 year. Pfizer RNA phase III after silly 3 months with illegal setup. In reality the Pfizer vaccine did not protect better than placebo. (200 additional people kicked out of vaccine arm...

    Same for viox, contargan, statines, opioides, pandermix, ...

    RCT are a 100% failed method for giving any guarantee because humans cannot be normed !!!!! We have 4 major genome groups - not reflected in most RCT's. We have at least 20 very distinct subgroups given e.g. by age <20 > 65 Sex state of sex )hormon production, fitness (sports) skin type, exposition to radiation,pollution, smoke (various degrees), food intake, hygienic standards,...

    most not reflected in RCT's.

  • Bad news from UK: 8000 cases/day. Vaccines seem not to work against India variant. We know this from the Cell paper already!


    Good news from India especially Delhi. Cases now 100x lower 231/day magnitudes better than Germany/Switzerland only with IVERMECTIN. (After about 6 weeks ...)


    Larger, "poor" states seem to run into challenges now as the stay stable at the "bottom" of cases with a tiny uptick now. May be they should use Ivermectin also for late treatment.

  • Here a link to a summary of the mask effect(s):

    Contains references to original papers: Not JedRothwell 's fairy tales from his grand father...


    https://swprs.org/face-masks-evidence/


    Summary: Masks help nothing. In my view just a mean of oppression and an expression of state terror by fascist capitalist minded individuals.

    Real masks = FP98 really help!! That's what I used in critical locations during high incidence times. Now gone again.

  • Hydroxychloroquine study further erodes credibility of health 'experts'


    https://www.washingtonexaminer…-health-experts?_amp=true


    Trump Derangement Syndrome might be a silly term, but the phenomenon itself was real. Almost every time the former president opened his mouth, members of the media and expert class would run forward with their list of reasons why he was wrong — before actually checking to see if he was.


    The immediate condemnation of hydroxychloroquine, an antimalarial drug touted by Trump during the early days of the pandemic, is a great example. Trump claimed that the drug could be used as an effective treatment against COVID-19, and within minutes, there were dozens of headlines slamming him for pushing an “unproven” and “disproved” medication. The health experts agreed and warned the public that hydroxychloroquine, a drug that had been in common use for more than 60 years, could be “dangerous.”

    As a result, the Food and Drug Administration pulled its emergency use authorization for the drug and suspended trials testing its effectiveness. The World Health Organization urged the international community to abandon using hydroxychloroquine. And Twitter even restricted the account of Trump’s son, Donald Trump Jr., because he posted a video of several doctors touting the effectiveness of the drug, which amounted to “spreading misleading and potentially harmful misinformation,” according to the social media giant.


    Well, a new study suggests they were wrong and that Trump was right. Research published by medRxiv this week found that hydroxychloroquine, when paired with zinc, could increase the coronavirus survival rate by nearly 200% in ventilated patients who have a severe version of COVID-19.

    We found that when the cumulative doses of two drugs, HCQ and AZM, were above a certain level, patients had a survival rate 2.9 times the other patients,” the study’s conclusion reads.


    It is true that hydroxychloroquine was unproven against the coronavirus at the time Trump was pushing its use, and there is a strong argument to be made that Trump should have been more restrained when touting a potential therapeutic for a virus about which we knew very little. But there was plenty of evidence last year that Trump was on to something, evidence that should have prevented the experts from dismissing his claims outright.

    In early April, a French study showed that hydroxychloroquine was safe and effective in lowering the virus count at times when used in combination with zinc. A few months later, the Henry Ford Health System published a study that showed hydroxychloroquine helped its severely ill coronavirus patients recover. Dr. Marcus Zervos, the division head of infectious disease for the hospital, said 26% of those not given hydroxychloroquine died, compared to 13% of those who got the drug. Zervos also said patients treated with hydroxychloroquine experienced very few adverse side effects, such as heart problems, which was one of the scientific community’s biggest concerns.


    And in June, another study, this one claiming that hydroxychloroquine was both dangerous and ineffective, was retracted and slammed as a “monumental fraud.”

    We still don’t know for sure whether hydroxychloroquine really works against COVID-19 because there’s a lot of contradictory information out there. But this uncertainty should have forced the media and the scientific community to approach the subject with a bit more nuance. Instead, they ran with the narrative that was opposite Trump’s and ignored all of the data pointing in his direction.


    This irresponsibility has further undermined the credibility of the crowd of experts we once trusted. Even worse, if this latest study is right and hydroxychloroquine can actually make a difference, their negligence may have also cost people their lives. There’s nothing silly about that.

  • There must be millions of different variants of the original Bat virus cooked up by the Chinese - they have been at this form of germ or biological warfare for centuries - this bio-weapon approach to World Politics is nothing new to them. It is a common denominator of all EXPANDING EMPIRES. Including the BRITISH EMPIRE and so for the Chinese it is simply putting into practice what all other EMPIRES have done in the PAST. So to them its fair game. No???.Well Remember GenGHIS KAHN or Attila the HUN????..How much of their military success was due to sheer FORCE OF ARMS or other more sneaky biological use of NATURAL POISONS or BIOLOGICAL AGENTS???? The VIKINGS also used to use Amanita Sp mushrooms to fuel BERSERKERS and GIANTS in Battle Formations as used by the GOTHS and VISIGOTHS to route the ROMAN EMPIRE????!!!!. PUT it all INTO the PERSPECTIVE of HISTORY.and there aint anything new here. EXCEPT viruses like HIV, microchip technology and a slew of ignorant uneducated young peasant children in the WEST who think they know it all because of their new hand-held glossy new mobile phones working on 5G.....made by who...guess who....THE CHINESE!!!!. Working alongside that LAP-DOG KIM JONG UN???? And Don't mention his sociopathic little sister who runs the ROYAL HOUSEHOLD in PEKING (sorry they changed the name to Beiging to make it harder to hit with a nuclear cruise missile perhaps?????) Come on GUYS THIS IS WORLD WAR 111 no matter how you dress it all up with your CIVILIZED WORDS....Because it is all just HOT AIR FROM START to FINISH.... :) :) :)

  • The CDC will discuss heart inflammation , now I really feel safe sending my grandkids for a vaccine???



    CDC to discuss rare potential heart inflammation linked to mRNA vaccines

    226 cases of myocarditis or pericarditis reported as authorities continue to recommend vaccines for all eligible Americans


    https://amp.theguardian.com/us…eart-inflammation-reports



    An advisory committee with the Centers for Disease Control and Prevention (CDC) is meeting next week to discuss several reports of heart inflammation, particularly in young men, following them receiving doses of the Moderna and Pfzier/BioNtech Covid-19 messenger RNA (mRNA) vaccines, the agency said.


    Instances are extremely rare, accounting for 226 cases of myocarditis or pericarditis among 141 million fully vaccinated people in the US. Myocarditis is a type of inflammation of the heart muscle, pericarditis is inflammation of the outer lining of the heart. Fewer than 100 cases of heart inflammation would be typical for this age group.

    A potential link between the conditions and vaccines using innovative mRNA technology were confirmed by Tom Shimabukuro, deputy director of the CDC’s immunization safety office, during a meeting with an advisory committee for the Food and Drug Administration (FDA).

    We clearly have an imbalance there,” said Shimabukuro during the meeting. Of the 221 cases the CDC had recovery information on, a majority have fully recovered.


    A total of 41 patients are still experiencing some symptoms and 15 are still hospitalized. Three patients are being treated in intensive care units, two of whom had existing co-morbid health conditions.


    While the instances of heart inflammation occurred typically a few days after vaccination in people under the age of 30, scientists are still investigating the potential link.


    The reports on the heart inflammation are also only preliminary. “Not all these will turn out to be true myocarditis or pericarditis reports,” said Shimabukuro to CBS.


    The CDC had been investigating previous reports of heart inflammation following reported cases and has put some information on its website.



    Israel’s health ministry also investigated cases of heart inflammation in young men who received mRNA vaccines. The ministry confirmed a link between rare instances of heart inflammation and the Pfizer Covid-19 vaccine.


    Of the more than 141 million people who have been vaccinated in the US, people between 12-24 represent just 9% of vaccinations. The CDC and public health officials still recommend anyone over the age of 12 get their vaccinations, because the risk of severe outcomes from Covid-19 outweighs that of rare potential side-effects.

  • AND IF YOU ALL THINK I AM INSANE (and I am sure alan smith does-by the way)----well just listen to our new KONSTRUKTIVISTS album WORLD WAR 111 eXtinction Rebellion. WHICH is designed to shake you out of your complacancy and see life for what it is rather than all the conspiracy-fuelled bullshit that is circulating about the TRUTH. CONSPIRACY THEORIES like Q-anon are only that....same as BITCOIN which is FRAUD on a massive SCALE designed to prevent INFLATION of the dollar and other fiat currencies which now have no inherent value after abandoning the GOLD STANDARD. QE (quantative easing) has now reared the ugly head of RAMPANT INFLATION. I predict as soon as this probabilistic FRAUD is universally recognized for what it really all is ie they are just very very long pin codes....that is all....and they are so long NOBODY CAN REMEMBER where their money has gone---only the main players like ELON MUSK and other CEO's make on it because it is just one massive great gambling house and as everybody from gambler's anonymous knows--the HOUSE AlWAYS WINS. BUT this time once everybody knows of the fraud BITCOIN will tend to ZERO. SO GET your money out now before th :) is happens and you are all left high and DRY!!£££$$$ REMEMBER THE BILLY FURY SONG WHITE WEDDING---THERE IS NOTHING SAFE IN THIS LIFE. :) :) :) Post Script I do have BIPOLAR DISORDER so take or leave my crazy advice......but use SCIENCE FACTS not PROBABILITiES and then we will see real advances both in MEDICINE and NUCLEAR PHYSICS. :) :)

  • Navarro accuses Fauci and CNN of having 'blood' on their hands after study shows effectiveness of hydroxycholorquine


    https://www.washingtonexaminer…-blood-on-hands?_amp=true


    Former Trump adviser Peter Navarro slammed Dr. Anthony Fauci and the media after a new study showed the effectiveness of hydroxychloroquine against the coronavirus, accusing the immunologist and journalists of costing people's lives by opposing the drug.


    “I had 60 million tablets of HCQ that Tony Fauci and @cc wouldn't allow the American public to use because of their Hydroxy Hysteria,” Navarro tweeted Thursday. “Blood on @JohnBerman @cnn and Saint Fauci's hands. More than 50,000 Americans would be alive today.”

    Attached to the tweet was an article from the Daily Mail that outlined a new study showing that the drug, when paired with zinc, increased the survival rate of coronavirus patients by almost three times.


    Last summer, Navarro attempted to distribute 60 million tablets of hydroxychloroquine that were stored in the Strategic National Stockpile, but he couldn’t do so without an emergency authorization from the Food and Drug Administration.

    The Trump administration was ultimately unable to acquire that authorization and received harsh pushback from CNN anchors, including John Berman, and medical experts such as Fauci.

    Berman and Navarro clashed during a television interview in July of last year and had an argument about the effectiveness of the drug in which Berman questioned its effectiveness and Navarro said, “There are two sides to this.”

    Around the same time of that interview, Fauci, a member of Trump’s White House coronavirus response team, definitively stated that all “valid” scientific data showed that hydroxychloroquine was not effective at treating the coronavirus.

    Several studies, including a study in early July 2020 from the Henry Ford Health System, showed positive signs regarding the effectiveness of the drug in treating the coronavirus.

    Some medical experts continue to downplay the effectiveness of hydroxychloroquine and cite its potential negative side effects. Earlier this year, the World Health Organization warned against using the drug.