The Playground

    You yourself has questioned Mercks lastest and greatest. Would you take it?

    Quote from THHuxleynew

    One of the things not talked about is when do we expect to get better vaccines. It is not clear. There is nothing technically impossible about making them - it comes down to politics and money.

    I read somewhere that the CDC experts and the people at Pfizer discussed this a few weeks ago. They decided that it is better to keep making the same vaccines now, rather than improving the formula. It would take time to shut down the production lines and prepare to make an improved formula. The time lost and the doses they fail to make would have a larger negative impact than the positive impact of an improved vaccine. So, it is not politics or money; it is a calculated decision about the most medically effective course of action. Production costs would be the same with a new formula vaccine.


    Maybe by now they rethinking that? I would, if I were them. Decisions like this have to be reevaluated frequently as new data comes in. COVID is a moving target.


    I gather they are working on an improved version, with different RNA. They said it will take about 3 months. Maybe 2 more months to go. Perhaps by the time they have an improved one, they will decide to suspend production and make a new vaccine that works better against omicron.

    France puts pressure on the unvaccinated as it again breaks its COVID-19 case record

    France puts pressure on the unvaccinated as it again breaks its COVID-19 case record
    France's government is forging ahead with efforts to increase pressure on unvaccinated people to get coronavirus jabs.
    www.pbs.org


    QUOTE:


    PARIS (AP) — France’s government is forging ahead with efforts to increase pressure on unvaccinated people to get coronavirus shots, as the country reported 208,000 new COVID-19 cases Wednesday — a record fueled by the omicron variant.


    Health Minister Olivier Veran on Wednesday defended a government plan to allow only the fully vaccinated to enjoy continued access to places such as restaurants, cinemas, theaters, museums, and sports arenas. The pass will also be required on long-distance trains and domestic flights. . . .


    Speaking to those not vaccinated, he said: “There is really little chance that this time you can escape (COVID-19): The virus is spreading too fast.” Veran said that in Paris public hospitals, 70% of people hospitalized in intensive care units aren’t vaccinated. . . .


    The speeded-up introduction of the so-called vaccine pass forms part of a government strategy to use vaccinations, rather than new lockdowns, to try to soften the impact of the fast-spreading omicron variant on already overburdened hospitals.


    France has vaccinated 77% of its population and is rushing out booster shots, again to combat omicron. But more than 4 million adults remain unvaccinated, including more than 1 million people over age 65.



    [Note that the unvaccinated 23% of the population have 70% of the hospitalized cases. Probably those 23% tend to be younger people. The vaccines reduce serious cases by a factor of ~7.5. Probably more, when you account for the average age of the unvaccinated.]

    Australia with 50'000/day Omicron cases still believes foreigners area a danger...

    Weltnummer 1 abgewiesen - Keine Einreise: Djokovic muss Australien verlassen
    Nun ist es offiziell: Novak Djokovic darf nicht nach Australien einreisen. Dem Serben fehlt das nötige Visum.
    www.srf.ch


    Vaccine terror also rule sports. The world now seems to be an Auschwitz camp with strict rules for prisoners. Numbered/stamped by vaccine passes.


    Next event:: Winter Olympics in level III fascist camp China. The Chinese destroyed a national nature preservation territory and use a water a far distant water pipeline to bring it up hill to the snow machines...


    Next winter Olympics possible under water! In large submarine park...

    Quote from JedRothwell

    PARIS (AP) — France’s government is forging ahead with efforts to increase pressure on unvaccinated people to get coronavirus shots, as the country reported 208,000 new COVID-19 cases Wednesday — a record fueled by the omicron variant.

    Irrational (guided by $$$$$$$$$) leaders like to beef up their post gov. income... Vaccinated do spread CoV-19 more often than unvaxx. But luckily Omicron is a free vaccination! As said 100x less impact than delta!


    But the real problem is a large percentage of dumb folks believes this state spread nonsense. Gene therapy (vaccination) is only about personal protection. It has zero = "0" = nada influence on the pandemics!

    Japanese Pharmaceutical Conducts 1,000 Patient Phase 3 Clinical Trial Targeting Ivermectin for COVID-19


    Japanese Pharmaceutical Conducts 1,000 Patient Phase 3 Clinical Trial Targeting Ivermectin for COVID-19
    TrialSite has reported multiple times on the ivermectin clinical trial targeting COVID-19 in Japan. Reports over the summer indicated that the
    trialsitenews.com


    TrialSite has reported multiple times on the ivermectin clinical trial targeting COVID-19 in Japan. Reports over the summer indicated that the investigator-initiated clinical trial (e.g., doctor led) at Kitasato University was behind schedule, possibly due to common challenges involving patient enrollment. Japanese media recently showcased another commercial pharmaceutical company entering the COVID-19 antiviral market in the research stage using ivermectin. A specialized pharmaceutical company, Kowa Co. Ltd. (Kowa) based in Nagoya City, is part of an umbrella conglomerate that dates to 1894. Kowa commenced a clinical trial in Q4 of 2021 to investigate the therapeutic effect of ivermectin against SARS-CoV-2, the virus behind COVID-19. Called K-237 (an ivermectin-based product), successful study results could shake up the COVID-19 medicine landscape. The world seeks a low cost, effective, and safe orally administered treatment for mild-to-moderate COVID-19, which represents about 90%+ of all cases worldwide—a vast market.


    TrialSite reminds all that ivermectin was discovered in Japan and that Kitasato University has been a hub of research interest for the therapy as applied to COVID-19. But this university’s efforts have been largely ignored by the West. Now, a company has launched a major Phase 3 clinical trial targeting the low-cost, safe, and currently approved antiparasitic drug targeting SARS-CoV-2. A company in France called MedinCell also is developing an ivermectin-based treatment for COVID-19, as reported by TrialSite on multiple occasions. In April 2021, MedinCell reported on a successful safety trial involving their ivermectin-based product targeting COVID-19.


    Japanese Conglomerate Investigates Ivermectin

    Kowa reports that their ivermectin-based clinical trial is the first company sponsored study in this Asian nation targeting COVID-19. Initiating a Phase 3 clinical trial (the final stage in the clinical trials process) in November, the industry sponsor continues to seek about 1,000 COVID-19 patients with mild symptoms to take the study drug (ivermectin) or control placebo to compare the progress and investigate whether ivermectin can help accelerate recovery. With ambitious plans initially to complete the study by end of 2021, as reported in the Japanese press, and apply for approval in early 2022, TrialSite questioned the feasibility of such an aggressive timeline. Their formal target study end date is now March 2022.


    What does the company have to say?

    Kowa’s Research and Development division includes two primary centers, including their Tokyo New Drug Research Laboratories and Fuji Research Laboratories for all R&D activity in Japan. Working to progress and advance intellectual property for commercialization around the world, core therapeutic areas include:



    Life-style related diseases

    Immunity Inflammation

    Sensory Organ diseases

    The company’s pipeline validates the ivermectin strategy now in pivotal Phase 3 clinical trials. Their pipeline can be reviewed here.


    The Clinical Trial

    Kowa Company Ltd. disclosed the Phase 3 ivermectin-based study in the U.S. clinical trials registry. A Phase 3 confirmatory study of their ivermectin investigational product called K-237, the multicenter, placebo controlled, randomized, double-blind, parallel-group controlled trial with up to 1,000 patients with mild COVID-19 started late last year and is planned to end March 31, 2022.


    The study drug arm includes 0.3-0.4 mg/kg once daily (Ivermectin 3mg) with one key endpoint: monitoring patients from start of study to 168 hours until clinical symptoms approve with a window of effectiveness between day 1 to 14 of study drug administration.


    Secondary endpoints for the study include A) time of improvement in clinical symptoms (headache, abdominal pain, nasal) in the day 1–14-time range and B) time to reach a temperature less than 37.5 ˚C without the use of antipyretics (acetaminophen) in the day 1–14-time range of the study.


    The study’s primary trial site, Tokyo Medical University Hachioji Medical Center is a 621-bed hospital with nearly 1,000 medical professionals. The Hachioji Medical Center, an authorized tertiary emergency center, is designated as a specialized infectious disease center with an emphasis on AIDS/HIV as well as a Japan Organ Transplantation Network/Transplantation Center by the Ministry of Health and Welfare. A scientist with Kowa, Yuji Yoshikawa is listed as the study contact. TrialSite News has reached out for comment and study status.


    The Company

    Owned by umbrella holding company Kowa Group, this conglomerate owns multiple assets from medicine and health care products to high tech equipment and consumer products. The history of this venture goes back in time to its founding in 1894 as a cotton fabric wholesaler in Japan. Employing 6,316, Kowa Company Ltd (the pharmaceutical subsidiary) is financially backed by the parent company.


    Satoshi Hata leads the U.S. operation for the holding company


    A Phase III Confirmatory Study of K-237 - Full Text View - ClinicalTrials.gov
    A Phase III Confirmatory Study of K-237 - Full Text View.
    www.clinicaltrials.gov

    Population-wide Observational Study in Brazil: Prophylactic Use of Ivermectin Reduces COVID-19 Mortality, Hospitalization & Infection


    Population-wide Observational Study in Brazil: Prophylactic Use of Ivermectin Reduces COVID-19 Mortality, Hospitalization & Infection
    Lucy Kerr, a Brazilian physician, participated in an Ivermectin summit hosted by TrialSite. Kerr and four other medical researchers, two affiliated with
    trialsitenews.com



    Lucy Kerr, a Brazilian physician, participated in an Ivermectin summit hosted by TrialSite. Kerr and four other medical researchers, two affiliated with Brazilian academic medical centers and one from a Cuban biotech institute were involved in the study of the efficacy of the generic, regulatory approved antiparasitic drug in three different municipalities in Brazil covered by TrialSite back in September 2020. Most recently, Dr. Kerr and colleagues posted the results of a citywide prevention program using ivermectin, implemented in Itajai in the south of Brazil. The prospective, observational study analyzed citywide COVID-19 data between July 2020 to December 2002. The study logistics of instructional review board approval and registry data analysis occurred retrospectively due to the urgent pandemic conditions at the time.


    TrialSite emphasizes this research hasn’t been peer-reviewed yet and shouldn’t be cited as medical evidence. This media platform focuses on medical research and these results require further verification. The study data derives from a public health program in response to COVID-19 in the municipality of Itajai in Santa Catarina, Brazil. This city has nearly 285,000 residents.


    The Study

    As reported in the group’s manuscript posted on ResearchGate, the Brazilian observational retrospective study centered on population-level data associated with the Brazilian municipality’s public health program. A total of 220,517 subjects were included in the analysis including:


    Group %

    133,051 regular ivermectin users 60.3%

    87,466 non-ivermectin users 39.7%

    Study Hypothesis

    Did ivermectin have a positive impact on subsequent COVID-19 infection and mortality rates?



    Results

    Setting up various categories for analysis, the study team compared ivermectin use with nonuse based on several cohorts (e.g., age, sex, comorbidities, etc.) while both employing, in some cases, patient propensity score matching or “PSM,” a statistical matching technique that attempts to estimate the effect of a treatment or other intervention by accounting for the covariates that predict receiving the treatment. This method is used in a bid to reduce bias in observational studies associated with confounding variables that are present in results.


    The study team reports in what is still non-reviewed data the following:


    Out of two study cohorts of 3,034 COVID-19 infected patients, the regular use of ivermectin led to a 68% reduction in COVID-19 mortality 25 (0.8%) versus 79 (2.6%) among ivermectin non-users—mortality rates were analyzed both with and without PSM. The reported risk ratio (RR) equaled 0.32; 95% confidence interval, 0.20-0.49; p < 0.0001.

    Adjusting for residual variables, Kerr and team report a mortality reduction at 79% (RR, 0.30; 95%CI 0.19 – 0.46; p < 0.0001).

    A 56% reduction in hospitalization rate (44 versus 99 hospitalizations among ivermectin users and non-users respectively—RR, 0.44; 95% CI, 0.31-0.63; p < 0.0001).

    Adjusting for residual variable s they reported a reduction in hospitalization at 67% (RR, 0.33; 95%CI 023 – 0.66; p < 0.0001 ).

    Conclusion

    Dr. Kerr and colleagues report that based on their data, the large, propensity-matched study verifies that regular use of ivermectin as a prophylactic agent was associated with a significant reduction in COVID-19 infection, hospitalization, and mortality rates.


    Limitation

    This study isn’t yet peer-reviewed, and hence, shouldn’t be used to cite medicinal evidence. Moreover, observational studies done retrospectively carry less weight than randomized, controlled studies.


    Comment

    TrialSite notes that over 70 ivermectin studies have been concluded around the world, with a great majority of them evidencing some positive impact. In the West, (e.g., North America, Europe, Australia, etc.) medical establishments have discounted the numerous ivermectin studies and focused more on a couple of the studies that either generated neutral findings or in one case had what looked to be improper data manipulation.


    It’s astounding, however, that the positive data is uniformly discounted as not relevant.


    Lead Research/Investigator

    Lucy Kerr, Instituto Kerr

    Fernando Baldi, Ph.D. Sao Paulo State University

    Cadegiani Flavio, MD, MSc, Ph.D. Applied Biology

    Raysildo Barbosa Lobo, Center for Genetic Engineering and Biotechnology,

    Call to Action: Check out the manuscript here.

    Quote from Fm1

    TrialSite notes that over 70 ivermectin studies have been concluded around the world, with a great majority of them evidencing some positive impact. In the West, (e.g., North America, Europe, Australia, etc.) medical establishments have discounted the numerous ivermectin studies and focused more on a couple of the studies that either generated neutral findings or in one case had what looked to be improper data manipulation.

    Trialsite needs a permanent set of footnotes.


    This comment is misleading. As I have read the negative meta-studies are negative because they filter out:

    (1) all the observational studies (including this one) it is muhc too easy to miss out confounding factors, or have ones that are nonlinear, or quantise discrete factors too corsely, all of which will give false signals.

    (2) the RCTs that have unclear or bad methodology, poor randomisation. etc, etc.


    They are left with still quite a few high quality RCTs with neutral results, easily enouigh to be statistically significant though not enough to detect small results.

    Remdesivir-Resistant COVID Strains Emerging


    Remdesivir-Resistant COVID Strains Emerging
    With the new Omicron variant of COVID-19 driving a new wave of cases around the globe, news that the virus is becoming resistant to the first approved
    trialsitenews.com


    With the new Omicron variant of COVID-19 driving a new wave of cases around the globe, news that the virus is becoming resistant to the first approved anti-COVID drug is adding to concerns. While several treatments have Emergency Use Authorization (EUA), Remdesivir is currently the only FDA-approved antiviral drug to treat COVID-19 in hospitals. But lab tests and case studies have shown that SARS-CoV-2, the virus that causes COVID-19, is developing resistance against the drug. This adds to the deep controversy surrounding remdesivir, which TrialSite has been following. The World Health Organization (WHO) previously declared the drug to have no effect on mortality in COVID-19 patients, and a separate French study also found it to show little benefit to hospitalized patients.


    Assessing the Risk of SARS-CoV-2 Remdesivir Resistance

    The Center for Pathogen Genomics and Microbial Evolution set out in 2020 to determine if SARS-CoV-2 had mutated to become resistant to remdesivir. The study was conducted by collecting diagnostic samples from the Northwestern Memorial Hospital, and sequencing SARS-CoV-2. “So far, none of the mutations we have found, as far as we can tell, are driving remdesivir resistance,” said Dr. Judd Hultquist, assistant professor of medicine at the Northwestern University Feinberg School of Medicine.


    However, that study was conducted in 2020, and it appears the situation may have changed. New evidence of mutations in SARS-CoV-2 is emerging, resulting in remdesivir resistance. Mutations in viruses are well-studied and are a mechanism to escape drug inhibition, especially monotherapy where only one drug is used for treatment.


    In Vitro Resistance of SARS-CoV-2 to Remdesivir

    A pre-print paper from February 2021 that has yet to be peer-reviewed, titled In vitro evolution of Remdesivir resistance reveals genome plasticity of SARS-CoV-2, looked at the emergence of mutations in the SARS-CoV-2 virus – and how they allowed it to escape the effects of remdesivir. This drug is a broad-spectrum nucleoside analog, and remdesivir has shown an impressive ability to inhibit viral activity in vitro.



    In the study, Szemiel and colleagues, affiliated with the MRC University of Glasgow Centre for Virus Research, the Institute of Technology from the University of Tartu, and the Institut fur Medizinische Virologie in Switzerland, looked at the virus’ genomic sequences to discover if any mutations would make the virus resistant to remdesivir.


    They found that a mutation in the RNA polymerase enzyme resulted in decreased sensitivity to remdesivir, meaning the virus was able to continue replicating despite the presence of remdesivir. The researchers looked at more than 200,000 sequences of globally circulating SARS-CoV-2 variants, and concluded that there appeared to be no widespread or concerning transmissions of remdesivir-resistant mutations. However, they did find that mutations that can help SARS-CoV-2 evade remdesivir, as well as key mutations associated with emerging strains, occurred in vitro without any selective pressure.


    The authors of the pre-print paper concluded that their observations demonstrate the plasticity of SARS-CoV-2.


    Remdesivir Resistance in an Immunocompromised Patient

    The study by Szemiel et al. is not the only occurrence or study into a remdesivir resistance mutation. A team of scientists from Yale observed a SARS-CoV-2 mutation resistant to remdesivir after an immunocompromised patient was treated with the drug at Yale New Haven Hospital in CT, USA.


    The case study, still awaiting peer review, identified a mutation resistant to remdesivir following a 10-day remdesivir treatment. This mutation had only previously been identified in a lab setting and had never been observed in a patient.


    According to Dr. Shiv Gandhi, lead author of the study, the patient was admitted to the hospital after having fevers for 150 days and continuously testing positive for SARS-CoV-2. “She was pretty profoundly immunocompromised as a consequence of having a malignancy and then chemotherapy,” said Dr. Gandhi. This meant that the patient did not really have a strong enough immune system to fight the virus.


    As her case was consistent with a SARS-CoV-2 persistent infection, the medical team treated the patient with administered remdesivir – the only FDA-approved COVID-19 drug for hospitalized patients at the time. Within one day of taking remdesivir, the patient’s fever subsided and did not return, and there was an observed decline in the patient’s viral load.


    Despite the medical team believing they were helping the patient, the viral load started to increase as treatment with remdesivir continued. Despite a marked improvement in the patient, her COVID-19 tests continued to show live remnants of the virus. “The team was concerned that the remdesivir treatment was not enough to clear the virus completely,” Gandhi said.


    As there were no other approved COVID-19 treatments available at the time, the medical team sought approval from the FDA to use monoclonal antibodies. Monoclonal antibodies can target two different parts of the SARS-CoV-2 virus, and the researchers hoped it would be more effective than the remdesivir treatment. Once the patient started treatment with monoclonal antibodies, her COVID-19 tests came back negative.


    After the immunocompromised patient recovered, the team investigated the ineffectiveness of the remdesivir and if any resistant mutations had developed. They sequenced viral samples taken from the patient during her remdesivir treatment period. According to Professor Albert Ko, a co-author of the paper, the researchers found a mutation that had previously only been found in a lab.


    Implications of Resistance to Remdesivir

    The authors of the case study emphasized how important it is to monitor how often this mutation may occur, especially in countries where remdesivir and other monotherapies are widely used. “It’s a good documentation of something that we need to be aware of and something that we need to keep our eye on”, said Ko.


    While examining the mutant variants, Mario Peña-Hernández, co-author of the case study, found that they replicated slower than the wild type. This suggests that if one of these remdesivir-resistant mutations were to arise in a virus in the general population, it would not replicate as fast as the existing variants, and would therefore not become a dominant strain.


    The authors of the case study recommend that scientists should identify more mutations that might be resistant to other antivirals. The team did check if the mutations were resistant to other antivirals, like molnupiravir, but found that they were not. But other different mutations may still arise.


    Dr. Maha Farhat, assistant professor of biomedical informatics at Harvard Medical School, recently said in an interview with The Harvard Gazette in December 2021, “We’re going to start to see the use of the new pills against COVID that have better activity than remdesivir.” Dr. Farhat indicated that patients who were not responding to the usual therapy would be tested to see if they had developed resistance to remdesivir, so that their treatment plan could be changed accordingly. “It’s the combination of reaching for additional drugs that are now available and testing and surveying for the presence of resistance mutations.”


    As treatment with remdesivir and other antiviral drugs continue to be the main therapy in hospitals, it can be speculated that new mutations may occur. “The main takeaway (from the case study) is to pay a little more attention to immunocompromised patients and be on the lookout for these kinds of mutations,” said Professor Ko.


    TrialSite will continue to monitor the mutations and new variants of SARS-CoV-2, as well as report on alternatives to remdesivir in the fight against COVID-19

    Omicrom did not mutate from delta. Did it jump from mice?


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    Maybe your math is different….

    The text in the cited source you are referring to tells this (did you read it at all…?). Other posters here were already trying to get the Swiss numbers for you right…


    „Over the 4 weeks to 14 December 2021, 525 Covid-19 deaths were recorded in Switzerland. These were split roughly equally between the vaccinated and unvaccinated. However, to make sense of these numbers it is essential to look at the number of people in each group. Once this is factored in the life-saving power of vaccines is clear.

    Nearly all of those dying were 60 or over2. Among this age group, 88% were fully vaccinated, 1% partially vaccinated and 11% unvaccinated. This means that roughly half of Switzerland’s Covid deaths over the last 4 weeks have occurred among a relatively small number of unvaccinated people. In fact, the unvaccinated in this age group (60+) have been dying at a rate 7.53 times higher than the vaccinated, essentially because the vaccinated now outnumber the unvaccinated by 7.5 to 1.“

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