Fm1 Member
  • Member since Mar 28th 2016
  • Last Activity:
  • Forum

Posts by Fm1

    The BMJ Demands More Vaccine Trial Data from Pharma and its Regulators


    The BMJ Demands More Vaccine Trial Data from Pharma and its Regulators
    A prominent international medical journal has renewed demands for more transparency by coronavirus vaccine manufacturers, who have repeatedly delayed
    trialsitenews.com


    A prominent international medical journal has renewed demands for more transparency by coronavirus vaccine manufacturers, who have repeatedly delayed disclosing critical information about clinical trials and study results.


    The BMJ, a weekly peer-reviewed United Kingdom-based medical journal, published an article this week calling on vaccine makers Pfizer, Moderna, and AstraZeneca, and also therapeutics manufacturers like Regeneron, which makes monoclonal antibodies and Gilead Sciences, maker of remdesivir to make their drug data public.


    Pharma and Government Regulators Failing to Release Trial Data

    The article’s author, Peter Doshi, an associate professor of pharmaceutical health services research in the School of Pharmacy and associate editor at The BMJ, also criticized medical journals for failing to hold pharmaceutical companies to account for missing data and government regulators at the U.S. Food and Drug Administration for being complicit in data secrecy.


    “Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process,” Doshi wrote.



    Doshi has been a critic of the government’s pandemic response and testified about his concerns at a hearing organized by U.S. Senator Ron Johnson (R-Wisconsin) as recently as November.


    FDA Complicit in Pharma Secrecy

    Doshi cited a recent Freedom of Information lawsuit against the FDA, which initially argued that it could only manage to release 500 pages per month of Pfizer’s mRNA vaccine data, which meant that the complete files would be hidden for decades.


    “Among regulators, the U.S. Food and Drug Administration is believed to receive the most raw data but does not proactively release them,” Doshi said.


    After a federal court ordered the agency to speed up disclosure the FDA agreed to release 55,000 pages per month, a development that calls into question the agency’s complicity with companies it claims to regulate.


    The article cites company statements from Moderna, AstraZeneca, and Johnson & Johnson that suggest neither company will prioritize timely disclosure of trial data.


    COVID Therapeutical Data Is Also Being Withheld

    Doshi also noted that published reports of Regeneron’s phase III trial results for REGEN-COV lack participant level data. And in another example of government abetment, the U.S. National Institutes of Health, which funded clinical trials and runs a research portal for remdesivir that acknowledges that “longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”


    EMA and Health Canada Slightly More Transparent

    Doshi praised Health Canada and the European Medical Agency for releasing far more COVID vaccine and therapeutics clinical trial data than its American counterpart but remained critical of those agencies for delays in producing documents with copious redactions, missing appendices and omissions of participant level data.


    Doshi argues that pharmaceutical companies, which have made billions of dollars from public financed vaccine contracts, and governments, which have mandated these drugs and instituted draconian public health policies based on these companies data, have an obligation to be more transparent.


    “The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations,” Doshi wrote. “We need complete data transparency for all studies, we need it in the public interest, and we need it now.”


    The BMJ is a Long-Standing Critical Voice on Health Policy

    Previously known as the British Medical Journal, The BMJ is one of the world’s oldest continuously published medical research publications. The journal made headlines last year with its report of clinical trial errors and fraudulent practices by Pfizer’s clinical research contractor Ventavia Research Group.


    The journal reported that Ventavia, the largest privately owned medical research company in Texas suffered from poor laboratory management, patient safety concerns, and data integrity issues. The journal also reported the company fired a whistleblower who brought the problems to the attention of federal regulators

    You just continue to deny the science!

    Perfect Storm: Vaccine Booster ‘Fatigue’ + Antiviral & mAb Shortages = Push to Introduce State Laws Ensuring Ivermectin Access


    Perfect Storm: Vaccine Booster ‘Fatigue’ + Antiviral & mAb Shortages = Push to Introduce State Laws Ensuring Ivermectin Access
    While TrialSite reported that a Brazilian rural state recently passed a law allowing the use of ivermectin and hydroxychloroquine for COVID-19, now in the
    trialsitenews.com


    While TrialSite reported that a Brazilian rural state recently passed a law allowing the use of ivermectin and hydroxychloroquine for COVID-19, now in the United States, Republican lawmakers from New Hampshire, Kansas, and Indiana push to ensure access to such repurposed drugs in those states, despite a stance by the U.S. Food and Drug Administration (FDA) that such drugs should only be used for COVID-19 in clinical trials. In Concord, New Hampshire, some politicians seek to make it easier for patients to access ivermectin as an early-onset treatment for COVID-19. In the ‘Live Free or Die’ state, House Bill 1022 would enable pharmacists to dispense ivermectin via what’s known as a standing order, reports local media WMUR 9, despite the FDA’s declaration on the drug for off-label use against COVID-19. In Kansas, a growing Republican-led movement calls for a similar bill for early treatment to include ivermectin and hydroxychloroquine, while similar calls are heard in Indiana. Will 2022 be the year of the push for repurposed therapies at the state level? Prominent U.S. government-backed clinical trials that include ivermectin may help or hinder the momentum for state-level initiatives. Meanwhile, with record COVID-19 infection counts, health authorities become more intent on educating people about the benefits of vaccination versus the risks of COVID-19. A lack of early treatments combined with the concern that monoclonal antibodies may not work as well against Omicron leaves the sick fewer choices, as it appears only Sotrovimab works well against the latest variant of concern, according to some critical care doctors.


    What to do?

    With an explosion of Omicron COVID-19 cases across America, concerns grow that vaccination does not stop viral transmission, as observed with mounting breakthrough infections. TrialSite covered the recent study from Denmark’s Statens Serum Institut which reported in an uploaded preprint study that the second doses of Pfizer and Moderna mRNA-based vaccines may actually increase the likelihood of SARS-CoV-2 infection after 90 to 150 days.


    It would be misleading to declare that the vaccines are not effective against Omicron. Rather, the investigators from Denmark found them to be effective, but the durability of the vaccines raised concerns. The study authors declared, “In light of the exponential rise in Omicron cases, the findings highlight the need for a massive rollout of vaccinations and booster vaccinations.” The latter was emphasized with the Pfizer vaccine, due to waning effectiveness but an identified rebound in positive efficacy with a booster.


    Regardless, “booster fatigue” becomes a growing topic, as a confluence of forces increasingly indicate countries such as the USA, the UK, and perhaps soon Israel’s health authorities will signify a transition to an endemic stage of COVID-19.


    Authorized Treatments in Short Supply

    While both Pfizer and Merck have antiviral-like medications now coming to market there are still limited supplies amidst the historic rises in new infections due to the highly transmissible nature of Omicron.


    Concerns with Merck’s Molnupiravir are mounting in some parts of the world—so much so that in the world’s second most populated nation, India, the apex research organization ICRM has cautioned against the use of the drug.


    The antivirals, key for many as a tool to end the pandemic, are hard to come by in many locations. With Omicron raging, the timing of the shortages couldn’t be worse.


    In the meantime, although monoclonal antibodies have helped infected Americans fight off COVID-19, a crisis emerged with this class of treatment as well. A confluence of factors, including product shortages in part due to federal meddling of the supply chain combined with the fact that only one of the mAb products appears to work well with the new mutant version of SARS-CoV-2 (GSK and Vir’s Sotrovimab), makes access to these products exceedingly elusive.


    Meanwhile, with vaccinated persons becoming infected all over America due to the highly transmissible mutant, concern and fear associated with breakthrough hospitalizations become a daily fear. Yes, it appears that the vaccines still protect people from more severe Omicron-based disease, but again, the effectiveness wanes and booster fatigue become a growing reality. What about other treatments?


    Moves to Ivermectin?

    Despite the incredible controversy surrounding ivermectin, TrialSite reports that elected officials are proposing bills to ensure access to this FDA-approved repurposed drug. Even though the FDA recommends only in clinical trials, a medical freedom movement thrusts forward with what is supposed to culminate in a large march in the nation’s capital Sunday, January 23. TrialSite follows proposed legislation involving ivermectin, and the even more controversial hydroxychloroquine.


    New Hampshire’s Move

    The medical freedom movement takes on steam in anticipation of a forthcoming march in Washington, DC (January 23), as several groups testified against the proposed New Hampshire Bill while others “say there should be more research.”


    Recently tracked on local media, New Hampshire Republicans seek to guarantee access to the repurposed drug. Recently showcased on WMUR 9, a Hearst Media-owned station, Dr. Nick Perencevich, a retired surgeon was filmed on television declaring, “I would like to think that the standard of care in New Hampshire is that a patient can certainly have ivermectin prescribed off-label if that patient, ideally, gets put into some clinical trial, whether it’s a drug company, or whether it’s an academic institution like Dartmouth.”


    Now before the House Health and Human Services Committee, the WMUR 9 report shared [the Bill] is expected to make it to the House floor for a vote in the weeks ahead. The broadcast ended with a segment on ivermectin indicated for horses. TrialSite notes that the media didn’t bother to interview the proponents of the bill nor hear their argument, indicating the possibility of bias.


    Kansas Callings

    Meanwhile, In Kansas, Sen Mark Steffan recently announced forthcoming bills to promote off-label use of approved FDA prescription drugs including hydroxychloroquine and ivermectin for COVID-19 patients.


    The bill was introduced in a special session, however, has not yet been acted upon in a recent Kansas Senate committee resolution, reports the Kansas Reflector, an independent non-profit-based media.


    In the recent report, reporter Noah Taborda referred to the proponents of the forthcoming bill as driven to appease “anti-vaxxers,” and that would “undermine local health officials and promote off-label use of prescription drugs.”


    An anesthesiologist, Sen. Steffen has been critical of the medical establishment’s efforts to block use of off-label early care treatments such as ivermectin and hydroxychloroquine. Taborda writes that “the Hutchinson Republican advocated for more avenues to use these treatments,” even though the FDA is on the record that ivermectin, for example, should only be used for COVID-19 in clinical trials. TrialSite reports a couple of sizable clinical trials including ivermectin have been underway in the United States.


    Meanwhile, COVID-19 continues to rage in Kansas, breaking new daily case counts. The issue of off-label drug use continues to be positioned as an “anti-vaxxer” issue, yet this clearly isn’t the case for all proponents. In the case of Steffen, he is on the record that the risk-benefit analysis associated with the COVID-19 vaccine products favors avoidance for children who rarely end up hospitalized. Yet, according to the Kansas Reflector, while the movement for medical freedom gains momentum in parts of this plains state, there has been an explosion of cases, many of which are either Delta or Omicron-based, with a total of 7,162 deaths in a state with a population of 2.93 million residents.


    Tragically, Tim Carpenter writing for the local media reported child deaths—three children under ten years old and three additional adolescents between the age of 10 and 17. Hence, medical establishment proponents argue the risks of hospitalization and death are too high, justifying universal vaccination.


    Hoosier Hope?

    In the meantime, in the midwestern state of Indiana, Rep. Curt Nisly, R-Goshen, authored a bill that would allow for use of ivermectin to treat COVID-19. Like Kansas, this agricultural state has more access to the animal variety of the drug. Nisly went on the record for the Indy Star in an email declaring, “Why wouldn’t we make this available, especially if we want Hoosiers to stop using horse paste. Hoosiers should be able to care for their health safely and effectively.”


    The proposed House Bill 1372 allows for a physician or advanced practice registered nurse to write a standing order for ivermectin ensuring the pharmacist would dispense the drug while stipulating that the pharmacist couldn’t try to dissuade the patent from accessing the drug.


    Conclusion

    The surge in Omicron cases, in a way, is the perfect bad storm, as a combination of vaccine booster fatigue and antiviral and monoclonal antibody shortages along with the rising medical freedom movement lead to state legislatures pushing for new bills to make economical repurposed drugs like ivermectin available on demand.


    An imminent march on Washington this Sunday, January 23 possibly intensifies the medical freedom movement which very well may influence midterm elections. TrialSite predicts within a couple of weeks more proposed off-label bills will contribute to a growing clash of interests. Luckily, thus far, omicron infections appear milder but exponential numbers of cases, hospitalization rates, and deaths move higher, regardless

    Preventive Ivermectin: international scientific review confirms 68% efficacy in SUS study


    Preventive Ivermectin: international scientific review confirms 68% efficacy in SUS study
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite by Filipe Rafaeli Dr Flávio
    trialsitenews.com


    by Filipe Rafaeli



    Dr Flávio Cadegiani, one of the authors of the study, presenting the pre-print at the World Congress – World Council for Health – Doctors for Life, held in Brasilia in December.

    Over the weekend, after reviewing the data by three independent groups of scientists, the 68% efficacy of the preventive ivermectin against deaths caused by COVID-19 was confirmed. The final results of the study were published in the prestigious scientific journal Cureus, based in San Francisco, USA, and with a chapter in Munich, Germany.


    Cureus has two esteemed editors-in-chief in the scientific community: Dr John Adler Jr, Professor of Neurosurgery and Radiation Oncology (Emeritus) at Stanford University in California, and Dr Alexander Muacevic, the medical director of the European Radiosurgery Center in Munich, Germany and a professor at the University of Munich Hospitals.



    The medical research took place in Itajaí, a port city in Santa Catarina, in the southern region of Brazil, between July and December 2020. The lead scientist of the study is the Brazilian medical doctor Lucy Kerr. Other important scientists collaborated with the scientific article and co-signed the research. Among them are Jennifer Hibberd, from the University of Toronto, Canada, Fernando Baldi, professor at the State University of São Paulo (UNESP), Dr Pierre Kory, North American medical professor and one of the world’s leading experts in intensive care, among several others.


    The largest ivermectin study in the world only occurred because of the excellence of SUS


    UBS – Basic Health Unit Promonar was one of several health points used to distribute ivermectin, record data on comorbidities, previous diseases, perform COVID tests, and serve the population of Itajaí during the study. Photo: Google Street View.

    The study was only possible due to the excellence of the Brazilian public health system. “The National Health System (SUS) functions as full healthcare support to the entire population allowed the city to establish a non-restricted population program,” the scientists explained in the study.


    Only people over the age of 18 participated. “Children were excluded. And also people who have had COVID before,” Lucy Kerr explained.


    Thus, of the 223,128 citizens of Itajaí considered for the study, a total of 159,561 individuals were included in the analysis: 113,845 (71.3%) ivermectin users and 45,716 (28.7%) non-users.


    The drug was offered by the municipal government to all citizens and only those residents who wanted it participated. “Patient preferences and medical autonomy were preserved,” the scientists explained.


    SUS professionals in Itajaí monitored and recorded the data of both patients who took ivermectin and those who did not take the drugs. “The whole city had digital registration at SUS and it was being updated with the new consultations as people went to get their medication,” Kerr said.


    The scientist praises the health professionals in Itajai. “They all collaborated very, very much,” said Dr. Lucy. “It wasn’t just data if they took it or didn’t take it. It was also knowledge of all people’s previous comorbidities and illnesses. Whether they had asthma, diabetes, cancer.”


    “I don’t know if this would be possible in other countries, since Brazil, through SUS, is one of the most digitalized countries, and with accurate data, in the health system,” said Dr Flavio Cadegiani, one of the scientists involved in the data analysis.


    Result: 44% reduction in chance of getting COVID-19, study concludes


    The study was published in the journal Cureus (link)

    Among all citizens over the age of 18 with no history of COVID, 113,845 volunteered to take Ivermectin every two weeks. Among those who did not volunteer, there were 45,716 people.


    Over the next six months, among those taking ivermectin, 3.7% became infected with the virus. Among non-users, 6.6%. There was a 44% reduction, therefore, in the chance of being infected with Sars-Cov-2, the virus that causes COVID-19.


    Once infected, 56% reduction in chance of being hospitalized

    Among the 113,845 who took ivermectin, 4,197 had Covid. Among the 45,716 who did not take it, 3,034 had Covid.


    In the study, from this point on, there was an advanced statistical technique called Propensity Score Matching, where two groups were balanced to be similar with regard to age and risk factors, such as previous diseases and sex. Thus 3,034 citizens using ivermectin were matched and compared with 3,034 non-users.


    The hospitalization rate among users of the preventive medicine was 1.6%. Among non-users, it was 3.3%. Therefore, ivermectin reduced the need for hospitalizations by 56%.


    A 68% reduction in mortality among ivermectin users

    Among the 3,034 with COVID not users of preventive ivermectin, 79 people (2.6%), died. Among the 3,034 in the comparison group, ivermectin users, 25 people (0.8%) died. So there was a 68% reduction in mortality.


    “There was no early treatment established by the municipality, so there was no interference in the study regarding hospitalization and death. It’s just the effect of prophylaxis. With treatment after infection, the numbers tend to improve,” says Dr Flavio Cadegiani.


    “The statistical technique used, the PSM, allows us to affirm that the study has the power close to a randomized clinical trial,” he added.


    How peer review happened

    Peer review, when other scientists review and attest to the scientific quality of articles, is an essential scientific process. In the case of this study, three independent groups had access to all the data and the manuscript. Subsequently, they contacted the authors anonymously via the Cureus journal communication system. Each group of reviewers was classified with a letter of the Greek alphabet: Alpha, Beta, and Gamma.


    “In addition to peer review, the study goes through three editorial stages. And all three need to accept the work. In our case, due to the relevance of the study, we didn’t even have the opportunity to appoint reviewers. All were completely independent”, says Dr. Flavio Cadegiani.


    Transparent and available data for the scientific community


    Aerial photo of Itajaí. Photo by Eduardo Marquetti, under Creative Commons license, published in Wikipedia.

    “Health status was assessed and data were entered prospectively throughout the period of the program, in a fully digitized system provided by the National Health System (SUS),” the scientists stated in the study.


    “Since the system existed prior to the pandemic, a significant number of the population were already registered with their health information, including past and current diseases, use of medications, and other characteristics.,” they added.


    Soon, in about two weeks, with the objective of total transparency with the national and international community, the raw data extracted from the SUS system of Itajaí, containing all the characteristics of the residents, preserving their identities, will be made available. The data will be publicly available on a platform. The electronic address will be announced on the blog of the journal Cureus.


    “Unlike studies with vaccines and patent medicines, this is a unique opportunity in the pandemic where scientists from around the world will be able to analyze the data. To our knowledge this is unprecedented for a study of this level and importance in Covid-19,” said Cadegiani.


    This was a decision of the team that produced the study. It comes at the same time as an editorial in the BMJ (British Medical Journal), one of the world’s most respected medical journals, published yesterday, calling for all raw data on vaccines and new treatments for COVID to be made public.


    Official data from the epidemiological bulletin confirm the drop in mortality throughout Itajaí

    Of the more than 220 thousand inhabitants of Itajaí, only a little more than 114 thousand volunteered to use ivermectin every two weeks. Even so, the impact on the entire city was quite significant, compared to the other cities in the state.



    One of the study’s results tables shows a dramatic drop in mortality before and during the study, even with much of it not using the drug. Deaths dropped from 3.5% of those infected to 1.4%.


    “The most basic confirmation that there can be of this whole result is to do an analysis on all the epidemiological bulletins of the state of Santa Catarina. The difference between hospitalizations and mortality, before and during the ivermectin program, was striking. Anyone can check this at any time with official numbers,” says Cadegiani.


    Doses used

    ivermectin was offered in biweekly doses of 0.2mg per kg per day for two days. In other words, a person weighing between 60 and 90 kg was given 3 ivermectin tablets a day every two weeks for two consecutive days. If the weight was greater than 90 kg, 4 tablets a day for two consecutive days were offered.


    “I believe the results could be even better if the use was weekly, in the same amount, while maintaining the same unquestionable level of safety,” Cadegiani explained.


    Other possible uses of ivermectin

    In addition to having identified no relevant side effects from the use of ivermectin citywide, the scientists wrote about promising data found: “Prophylactic use of ivermectin can be particularly impactful in older subjects. In addition, ivermectin seemed to reduce the exceeding risk of hypertension, T2D, and other diseases.,” they wrote in the study.


    Dr Flavio Cadegiani, one of the authors, is excited about the possibility of other uses of the drug besides COVID-19. “Preliminary data surprised us. It helped for liver, kidney and inflammatory issues. In other words, ivermectin may help reduce fat in the liver, kidney problems, prevent inflammatory disease, and other potential metabolic benefits. It may work to control cholesterol and diabetes,” he says. “It would be a crime not to study it for those diseases,” he exclaimed.


    Press attacked the action, but there was good reception among the citizens

    The prophylactic action of ivermectin against COVID was proposed by Dr Volnei Morastoni, a medical doctor and mayor of the city of Itajaí. Soon after, he came under attack.


    Among the various aggressions at the time, Dr Volnei was called a “witch doctor” by a local newspaper, the NCS total. In the newspaper O Estado de S. Paulo, one of the most important in the country, biologist Natália Pasternak wrote an article with the following title: “Analysis: the case of Itajaí shows how the fight against the pandemic is marked by science denialism”.


    “The mayor of Itajaí seems to build public health policies based on social network fads and conspiracy theories,” she stated in the article. In her twitter, she classified the action concluded now as effective as “Itajaí madness.”


    However, even at that time, the population was already suspicious of the excessive aggressiveness of the press. The positive result was felt by the population during the action, and they gave their answer in the ballot box. In October 2020, Marastoni was re-elected mayor of the city for another four-year term.


    So far, four days after the international review confirming that lives were saved, there has been no apology to the mayor for the offenses. “The denialism came exactly at the person who colored himself as a defender of science. This is a great example of the catastrophe that occurs when science and political passions mix,” says Cadegiani.


    “How many lives would be here today if it weren’t for the attacks devoid of logic and valid arguments?” he questions. “Vanity will never allow people to turn back. It would be to confess that they killed in the name of a false science.”


    “It is important to make it clear that I did not believe in the effectiveness of ivermectin as a preventative. That doesn’t mean to say that I was against using it, because, after all, any scientist with the least humanity, knowing that there were no theurapeutic alternatives and the drug is safer than any medicine we use for headache, I would never smear or contraindicate it in a pandemic of intubated people,” Cadegiani said. “I was wrong in my bet of ineffectiveness and I assume it. That’s science.”


    Journalists and science communicators got everything wrong, even the speculation that ivermectin would relax other measures

    At the time, journalists and science communicators bet that the use of the drug would lead to the loosening of other measures to contain the pandemic. “The narrative that using preventive and early treatment therapies will have people relax their caution of remaining socially and physically distanced to allow more COVID-19-related infections is not supported here,” the scientists concluded in the study.


    “These study data demonstrate that the use of preventive ivermectin significantly lowers the infection rate and that benefits outweigh the speculated increased risk of changes in social behaviors. Hence, we can speculate that the prophylactic use of ivermectin could play an important role in the reduction of the pandemic burden.,” they added.


    Other studies on the same data from Itajaí will be coming out soon

    This study aimed to evaluate the impact of the whole preventive program in the city during five months. However, many residents who started with ivermectin, discontinued after some time of use and did not complete the five months.


    Now, in a phase two analysis of the data collected by the SUS, efficacy calculations are being done only on those residents who kept using the drug for the full five months. “At first, looking at the data, those who used more than 75% of the doses had zero deaths. That’s surprising. Too bad it was a minority. We are calculating the data to hand over to reviewers,” Cadegiani said.


    “In the third month, of the more than 100,000 who volunteered to take ivermectin, only a little more than 8,000 continued, and even then we had this 68% reduction in deaths. Even the most optimistic were shocked.”


    Daughter of a fish, a little fish is (a Brazilian saying, when sons follow their fathers)


    Dr Lucy Kerr, during the World Council for Health

    The father of Lucy Kerr, the main scientist of the Itajaí study, was Warwick Stevam Kerr, a Brazilian scientist who died in 2018, at age 96, in the city of Ribeirão Preto, where he developed most of his brilliant career.


    Warnick, with a worldwide career, besides several Brazilian universities, lectured in North American universities (Louisiana, California, Wisconsin and Columbia University in New York.). In Brazil he held important positions, such as Scientific Director of FAPESP. He was also president of the prestigious Brazilian Society for the Advancement of Science.


    With relevant scientific productions, he was a member of the “National Academy of Sciences”, in the USA, besides being admitted by President Itamar Franco in the National Order of Scientific Merit in the “Grã-Cruz” class in 1994.


    Lucy confesses to be inspired by her father: “I used to accompany him whenever I could. He didn’t bother to help”, she says.


    There are 15 other studies on ivermectin prophylaxis. All are unanimously positive.

    The Itajaí study is the largest in the world with ivermectin. Besides it, there are 15 other studies on prophylaxis, all finding positive effects of the drug against COVID-19. However, because it was with a large number of patients and uses the statistical technique PSM – Propensity Score Matching, due to the data having great precision, there is a greater weight in this study as scientific evidence. That is, Itajai only confirmed other studies.



    Check out the complete list here.

    Final note: Nostradamus against anxious fact-checkers

    Hello, fact-checker. You are now going after some expert to refute the study, right? I know. Your goal is to say that the study proves nothing. There is one thing left for your expert to say: that the study is not randomized and double blind. He is in the mood to shout: “observational studies do not prove effectiveness”.


    If he says that, throw in his lap the Anglemeyer study, published in Cochrane in 2014, and watch him have a sudden malady. This study says that there are no significant differences between observational studies with “gold standard” RCT study, especially when the difference is greater than 8% efficacy, as is the case. In other words. It says that observational studies do prove efficacy.


    Was that not enough? Show Kjell Benson’s study, published in 2000 in the New England Journal of Medicine, where the author reached the same conclusions. He will run out of answers. He will have a stroke.


    Don’t even make up an answer, think that you are refuting the study with two or three sentences, without mentioning Anglemeyer and Benson. Are we agreed?


    Ivermectin Prophylaxis Used for COVID-19: A Citywide, Prospective, Observational Study of 223,128 Subjects Using Propensity Score Matching


    Ivermectin Prophylaxis Used for COVID-19: A Citywide, Prospective, Observational Study of 223,128 Subjects Using Propensity Score Matching
    Background: Ivermectin has demonstrated different mechanisms of action that potentially protect from both coronavirus disease 2019 (COVID-19) infection and…
    www.cureus.com


    The Cureus Blog
    Medical publishing powered by community
    blog.cureus.com


    Covid-19 vaccines and treatments: we must have raw data, now
    Data should be fully and immediately available for public scrutiny In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to…
    www.bmj.com


    COVID-19 / CORONAVIRUS


    Ivermectin for COVID-19: real-time meta analysis of 63 studies
    Ivermectin for COVID-19. Early treatment - 72% improvement, p < 0.0001. All studies - 68% improvement, p < 0.0001. 1 in 1 trillion probability results of the…
    ivmmeta.com


    https://www.nejm.org/doi/full/10.1056/NEJM200006223422506

    Physician on a Mission: Sues Houston Hospital Seeking to Compel COVID-19 Financial Ties to Feds & Pharma


    Physician on a Mission: Sues Houston Hospital Seeking to Compel COVID-19 Financial Ties to Feds & Pharma
    Times have changed for physicians in this age of medicine, marked by large, often monopolistic desirous health systems leading to the practice of medicine
    trialsitenews.com


    Times have changed for physicians in this age of medicine, marked by large, often monopolistic desirous health systems leading to the practice of medicine by administration and bureaucracy, not to mention the drive for revenue capture over the sacrosanct physician and patient relationship. With ever less leverage in the domain called big medicine, physicians, once highly revered, now increasingly face a “system” that ultimately supersedes individuals, including both doctors and patients. This evolving dynamic is catalyzed by a rapidly federalized model—one where nearly 150 million Americans gain access to medicine via federal insurance (Medicare, Medicaid, VA, DOD, etc.). Meanwhile, the COVID-19 pandemic led to ongoing federal orchestration and direction of all treatment protocols. Federal dollars poured into hospitals and health systems and accepted strict protocols for how to treat patients infected with SARS-CoV-2 ensued. Thus, regardless of what the physician calls for at the point of care, even if potentially beneficial to the patient based on the doctor’s best judgment, a higher authority makes the call—one far away from the traditional local health care transaction. Doctors that don’t line up and align with this hierarchy find trouble—fast. Of the approximately one million physicians in the United States, emerges a small number of restless, energetic, angry, patient-centric, independently-minded firebrands. One such case covered by TrialSite is that of Doctor Mary Bowden, the Houston, Texas-based physician at the sprawling Houston Methodist Hospital who found herself in trouble with the administration that suspended her for public opposition to the COVID-19 vaccine mandate. In today’s climate, such public sentiment, along with the treating of patients with repurposed therapies such as ivermectin get doctors into trouble–quickly.


    Resigning in protest due to suspended privileges for “spreading dangerous misinformation,” (20) Houston Methodist on Twitter: “Dr. Bowden, who has never admitted a patient at Houston Methodist Hospital, is spreading dangerous misinformation which is not based in science. (4/5)” / Twitter Dr. Bowden filed a lawsuit against Houston Methodist in the 5th circuit court for not complying with state non-profit corporation transparency laws. Specifically, the activist-plaintiff seeks to compel the large health system with a 2,500-bed hospital and over 300 clinics and satellite locations to share data about COVID-19 patients and associated payments from the federal government.


    The doctor went on the record Monday, January 17 disavowing her interest in any pecuniary gain declaring, “I want to make this clear, I’m not seeking any financial gains from this or personal gain, I’m simply seeking the truth, which we all deserve,” said Bowden.


    The Team

    Dr. Bowden has teamed up with a group of individuals with like-minded interests in what could likely be a David and Goliath-level legal battle. But nonetheless, the group brings fire, passion, and frankly, channeled anger that just might spell trouble for the hospital assuming sound legal arguments. The Houston-based physician has a team including the following:



    Attorney Steve Mitby

    Sylvia Anderson, one of Bowden’s patients who was successfully treated for COVID-19 using a combination regimen of steroids, Vitamin C, and high doses of ivermectin

    Jennifer Bridges, a former nurse at Houston Methodist who was terminated for failure to comply with the health system’s universal employee vaccine mandate. Bridges is part of a lawsuit against the vaccine mandates now pending appeal before the 5th Circuit Court

    Wayne Dolcefino, an investigative reporter

    The Plaintiff’s Target: ‘Secrecy’

    As reported recently in The Texan, the University of Texas and Stanford University-trained ear, nose, and throat (ENT) specialist now strikes back at what some doctors consider “The Empire,” a large health system, exemplifying for other doctors a toughness, resolve, and dedication to ideals perhaps higher than one’s own self-interests. At a recent Houston-based press conference, Bowden declared the target of “secrecy” was taken on because “Medical freedom has been hijacked by hospitals, big pharma, insurance companies, and the federal agencies.”


    The Issue

    Is Houston Methodist complying with the transparency provisions included in Texas state law applying to non-profit tax-exempt corporations? According to the physician-plaintiff, the health system has thus far failed to provide hospital financial data required since November and December to the plaintiff side, reports Holly Hansen, writing for The Texan.


    Specifically, the litigants’ claim filed Monday of this week in state district court states that the hospital needs to share financial data associated with COVID-19 reimbursements and other payments from the government, payers, and patients. Also, the plaintiff pursues to understand relevant ties between the health system and pharmaceutical companies for COVID-19 treatments. For example, this might include information associated with clinical trial deals. TrialSite has learned from multiple hospitals/health systems that entered contracts with Pfizer, for example, to conduct COVID-19 vaccine trials with contractual restrictions potentially inhibiting the hospital from seeking alternative, potentially competitive treatments.


    Data Transparency

    Among other things, the plaintiff seeks to understand if Houston Methodist benefitted financially from including remdesivir in its COVID-19 protocol. This antiviral was embraced early by the National Institutes of Health (NIH) in clinical trials, first granted Emergency Use Authorization (EUA) in May of 2020 then gained formal approval by October of that year. Mrs. Hansen reminds the reader that the drug failed to produce clinically relevant results in the World Health Organization’s Solidarity trial leading to that agency’s elimination of the product from its COVID-19 recommendations. While the drug is known to carry risks for kidney and liver damage not to mention renal failure, it continues to still be heavily relied upon in American hospitals.


    The plaintiff also seeks to understand just how many of the hospital’s patients and employees were involved with so-called breakthrough infections: those fully vaccinated persons that still became infected with SARS-COV-2 and how many of “the 2,879 patients who have died of COVID-19 at the system were denied early treatment protocols,” according to The Texan.


    Conclusion

    Have hospitals and health systems become more significantly entangled with federal payers and pharmaceutical companies during the pandemic? If so, is this trend to the detriment of physician flexibility and patient choice? For example, is remdesivir overprescribed in acute settings while federal COVID-19 guidelines unreasonably restrict physicians from considering other off-label approaches? How many of the infections and acute cases as well as deaths involved vaccinated patients at Houston Methodist? Are there patterns associated with the COVID-19 deaths (e.g., remdesivir associated with failure to improve)? What does the Medicare and Medicaid payment scheme look like for SARS-CoV-2 infected patients? Is the hospital receiving fixed payments for SARS-CoV-2 acute and then again ICU-housed patients? These are just some of the questions that may be addressed in this lawsuit.


    Plaintiff’s counsel Steve Mitby remains upbeat, declaring he expects victory in the courts: “I expect we will get these records. It’s state law.” Meanwhile, Houston Methodist’s spokesperson wouldn’t provide any comment to the local Texas newspaper, rather instructing them to refer to past statements. ‘Personally offended’: Houston Methodist Hospital CEO on doctor who made controversial claims about COVID-19 treatments (click2houston.com)


    Note, Dr. Bowden joins fellow Texan Dr. Peter McCullough and other physicians and health care workers from around the USA and beyond at the forthcoming Medical Freedom march on Sunday, January 23 in Washington, DC


    Doctor Mary Bowden Sues Houston Methodist Hospital for COVID-19 Data, Financials
    After sparring with the healthcare giant over COVID-19 treatments, Bowden says Houston Methodist is not complying with transparency laws for non-profit…
    thetexan.news

    Without a freedom of information act, would we be getting real data from authorities?


    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.

    Another CDC narrative proved wrong!!!


    Natural Immunity More Potent Than Vaccines During Delta Wave In US: Study


    Natural Immunity More Potent Than Vaccines During Delta Wave In US: Study
    During America's last surge of the coronavirus driven by the Delta variant, people who were unvaccinated but survived Covid were better protected than those…
    www.ndtv.com


    During America's last surge of the coronavirus driven by the Delta variant, people who were unvaccinated but survived Covid were better protected than those who were vaccinated and not previously infected, a new study said Wednesday.

    The finding is the latest to weigh in on a debate on the relative strengths of natural versus vaccine-acquired immunity against SARS-CoV-2, but comes this time with the imprimatur of the US Centers for Disease Control and Prevention (CDC).


    The authors of the paper warned, however, against depending on infection as a strategy, given the higher risks to unvaccinated persons of hospitalization, long term impacts, and death, compared to vaccinated people.


    "Viruses are constantly changing, including the virus that causes Covid-19," the CDC said in a statement.


    "The level of protection offered by vaccination and surviving a previous infection changed during the study period. Vaccination remains the safest strategy for protecting against Covid-19," it added.


    The analysis was also carried out before the emergence of the Omicron variant, for which both vaccine and infection-derived immunity appear diminished, and before boosters were made widely available.


    The new study involved patients in New York and California between May 30 to November 30, 2021.


    Prior to Delta becoming dominant, vaccination conferred greater immunity than infection. But the relationship shifted when the variant became predominant in late June and July.


    By the week of October 3, case rates among vaccinated people without prior Covid were around six times lower in California and five times lower in New York compared to those who were unvaccinated and without prior Covid.

    But the rates were substantially lower among people with previous Covid, including around 29 times (California) and 15 times lower (New York) among unvaccinated persons with a previous diagnosis, compared to those who were unvaccinated and without prior Covid.


    Protection was highest among those who had both vaccination and prior Covid.


    Hospitalizations followed a similar pattern.


    Other research, including a notable paper from Israel in August, have similarly found that natural immunity was more potent than vaccines during the Delta surge.


    But the US CDC had previously taken the opposite position, based on pre-Delta data.


    "Further studies are needed to establish duration of protection from previous infection by variant type, severity, and symptomatology, including for the Omicron variant," the paper concluded

    Id like to see that trial . I believe it took place in a hospital setting well into the infection. I posted two studies a year ago, that had been held back from publication for over 9 months the showed early treatment with hydroxychloroquine, zinc were affective if given within first 3 days of symptoms. Your hospital study waited till almost a week after symptoms started. You probably missed reading those because if I remember correctly you had no response to these postings. Hydroxychloroquine works when used early !


    HCQ COVID-19 studies. 371 studies, 276 peer reviewed, 305 comparing treatment and control groups. HCQ is not effective when used very late with high dosages over a long period (RECOVERY/SOLIDARITY), effectiveness improves with earlier usage and improved dosing. Early treatment consistently shows positive effects. Negative evaluations typically ignore treatment time, often focusing on a subset of late stage studies. In Vitro evidence made some believe that therapeutic levels would not be attained, however that was incorrect, e.g. see [Ruiz]. Recently added: Juneja Tyson Atipornwanich McKinnon. HCQ or CQ has been officially adopted for early treatment in all or part of 36 countries (53 including non-government medical organizations). Submit updates/corrections.


    HCQ for COVID-19: real-time analysis of all 371 studies
    HCQ for COVID-19: real-time analysis of all 371 studies
    c19hcq.com

    When Japan's latest surge ends, and it will once the virus has reached a saturation point of around 40%, it surely will not be because of vaccination!


    Japan's daily COVID cases top 46,000, new record for 3rd straight day



    Japan's daily COVID cases top 46,000, new record for 3rd straight day
    Japan's confirmed daily coronavirus cases top 42,000, setting a new record for the third day in a row as the highly transmissible Omicron variant spreads…
    english.kyodonews.net


    Japan's confirmed daily coronavirus cases on Thursday topped 46,000, setting a new record for the third consecutive day as the rapid spread of the highly transmissible Omicron variant has left the country struggling with what has become the "sixth wave" of infections.


    Japan's cumulative total of COVID-19 cases has also topped 2 million since the government confirmed the nation's first COVID-19 case in January 2020.


    On Thursday, Tokyo confirmed 8,638 daily coronavirus cases, eclipsing the previous record high of 7,377 registered Wednesday. The seven-day rolling average of new infections stood at 5,386.1 per day in the capital

    In an effort to curb the further spread of infections, Prime Minister Fumio Kishida's government decided Wednesday to expand a quasi-state of emergency to Tokyo and other regions.


    Japan logged a cumulative total of over 1 million COVID-19 cases in August last year when it was reeling from the "fifth wave" of infections.


    Although infection numbers started falling afterward with the progress in vaccination against the virus, there has been another surge in Japan since cases of community transmission of Omicron were confirmed in late December.

    time to dump the present vaccines!!!!!


    Breakthrough infections with SARS-CoV-2 omicron despite mRNA vaccine booster dose


    DEFINE_ME


    The most recent SARS-CoV-2 variant of concern to emerge has been named omicron.1 Its immune evasion potential was predicted by genomic data and has been preliminarily confirmed by observations of an increased incidence of reinfections and breakthrough infections.2 This has triggered calls to intensify vaccination programmes including provision of vaccine booster doses.3

    A group of German visitors who had received three doses of SARS-CoV-2 vaccines, including at least two doses of an mRNA vaccine, experienced breakthrough infections with omicron between late November and early December, 2021, while in Cape Town, South Africa. The group consisted of five White women and two White men) with an average age of 27·7 years (range 25–39) and a mean body-mass index of 22·2 kg/m2 (range 17·9–29·4), with no relevant medical history. Four of the individuals were participating in clinical elective training at different hospitals in Cape Town, whereas the others were on vacation. The individuals were members of two unlinked social groups and participated in regular social life in Cape Town, in compliance with applicable COVID-19 protocols. Upon arrival during the first half of November, 2021, each individual tested negative for SARS-CoV-2 by PCR and provided records of complete vaccination, including booster or third, doses administered via intramuscular injection using homologous (n=5) and heterologous (n=2) vaccination courses (appendix p 3).4

    • View related content for this article


    Six individuals were fully vaccinated with BNT162b2 (Comirnaty, Pfizer–BioNTech, Mainz, Germany), five of whom received a third (booster) dose of BNT162b2 in October or early November, 2021. One individual had received a full dose of CX-024414 (Spikevax, Moderna, Cambridge, MA, USA) in early October, 2021; this was not in line with the European Medicines Agency recommendations at that time, which suggested a half dose to boost healthy individuals.5 The seventh individual received an initial dose of ChAdOx1-S (Vaxzevria, AstraZeneca, Cambridge, UK), followed by a dose of BNT162b2 for completion of primary immunisation, and a booster dose of the same vaccine. Except for the CX-024414 booster, all vaccinations were in accordance with European recommendations.4, 5 The early timepoints of some individuals' primary and booster vaccinations were due to their occupation in the medical field. Nobody reported a history of SARS-CoV-2 infection.

    During a marked increase in incidence of SARS-CoV-2 infections in the Western Cape province, these individuals observed onset of respiratory symptoms between Nov 30 and Dec 2, 2021. SARS-CoV-2 infections were diagnosed by ISO 15189-accredited diagnostic laboratories using molecular assays approved by the national regulator.

    The investigation was approved by the Health Research Ethics Committees of Stellenbosch University (C21/12/004_COVID-19) and the University of Cape Town (279/2021) and all participants provided informed consent.

    We obtained swab and serum samples 2–4 days after onset of symptoms. Futher details of how samples were processed are provided in the appendix (p 2). All patients were placed in domestic isolation and used a daily symptom diary to document the course of disease during the observation period of 21 days.

    Illness was classified as mild (n=4) or moderate (n=3; shortness of breath) according to National Institutes of Health COVID-19 Treatment Guidelines. Two individuals were asymptomatic by the end of the observation period (day 21). Blood oxygenation levels (SPO2) remained in the normal range (>94%) without exception and none of the patients required hospitalisation. Prevalence of symptoms over time is provided in the appendix (p 4).

    All seven individuals were infected with omicron (PANGO lineage B.1.1.529, Nextstrain clade 21K). Viral loads ranged from 4·07 to 8·22 (mean 6·38) log10 viral RNA copies per mL of swab eluate. Anti-spike antibody levels ranged from 15 000 arbitrary units (AU) per mL to more than 40 000 AU/mL, with a mean of approximately 22 000 AU/mL of serum (appendix p 3).

    Robust CD4 and CD8 T-cell responses to SARS-CoV-2 spike, nucleocapsid, and membrane proteins were detected in six of the participants tested after a minimum of 2 weeks after onset of symptoms (appendix p 5), at frequencies of 0·011–0·192% for CD4+ and 0·004–0·079% for CD8+ T cells.

    These were the first documented breakthrough infections with the omicron variant in fully vaccinated individuals after receipt of booster vaccine doses. Some of these individuals had received heterologous vaccine doses, in line with emerging global practice. Booster doses were administered 21–37 weeks after the second vaccine doses, and breakthrough infections occurred 22–59 days thereafter. At the onset of their breakthrough infections, all individuals had high levels of viral spike protein binding antibodies, similar to levels reported 4 weeks following second vaccine doses6 and as expected after receipt of booster vaccine doses.7

    Viral RNA loads in omicron variant infections have yet to be reported. It remains unknown whether the viral loads observed in our group are different from those in unvaccinated, or differently vaccinated, individuals. During wild-type SARS-CoV-2 infection, an average viral RNA load of 5·83 log10 viral RNA copies per swab was found in samples taken up to day after onset of symptoms,8 with a maximum of 8·85 log10 viral RNA copies per swab. In this group of individuals, an average of 6·38 log10 viral RNA copies per mL of eluted swab was detected, with the highest viral load (8·22 log10) detected on day 4 after onset of symptoms. This suggests that the individuals were infectious, in keeping with the occurrence of infection clusters sparing none of the members of the two groups.

    Specific T-cell responses were detected in all participants tested at least 2 weeks after symptom onset, in the range reported after vaccination,9 with additional T-cell responses to the viral nucleocapsid and membrane proteins.

    The mild to moderate course of illness suggests that full vaccination followed by a booster dose still provides good protection against severe disease caused by omicron. However, we cannot exclude long-term sequelae of COVID-19. Furthermore, our findings are limited to a low number of individuals in relatively young and otherwise healthy individuals (n=7). This case series adds further evidence that, as predicted, omicron is able to evade immunity induced by mRNA vaccines in vivo. South Africa only recently introduced booster vaccinations for individuals immunised with two doses of BNT162b2, so the presence of this group from Germany presented a unique opportunity to study omicron breakthrough infections in individuals with mRNA vaccine boosters.

    In-vitro data suggest lower titres of neutralising antibodies against omicron compared to other SARS-CoV-2 lineages following BNT162b2 vaccination but increased titres after a third dose,10, 11, 12 supporting calls for booster doses while the omicron variant appears to be spreading globally. Our study, however, demonstrates insufficient prevention of symptomatic infection in otherwise healthy individuals who had received three doses of COVID-19 mRNA vaccines.

    These findings support the need for updated vaccines to provide better protection against symptomatic infection with omicron13 and emphasise that non-pharmaceutical measures should be maintained. Encouragingly, early data from South Africa suggest maintained if reduced effectiveness of the BNT162b2 vaccine against hospital admission.14

    While the world waits for these very easy to tweak mRNA vaccines, some companies are actually moving forward,


    Swiss researchers launch trial for COVID "patch" vaccine


    Swiss researchers launch trial for COVID &quot;patch&quot; vaccine
    HEALTH-CORONAVIRUS/VACCINE-PATCH (TV, PIX):Swiss researchers launch trial for COVID "patch" vaccine
    news.trust.org


    LAUSANNE, Switzerland, Jan 19 (Reuters) - Swiss medical researchers said on Wednesday they have launched an early-stage study to test a next-generation COVID-19 vaccine candidate which would be administered via an arm patch, the latest to look at alternative methods of giving injections.


    Unlike conventional vaccines that stimulate antibody production, the new PepGNP-Covid19 vaccine candidate focuses on T-cells, which are responsible for cellular immunity, to eliminate cells infected by the virus and prevent it from replicating.


    British company Emergex Vaccines Holding Ltd developed the potential vaccine, while Unisanté medical research centre in Lausanne in collaboration with the city's CHUV hospital will run the trial, which started on Jan. 10.


    Professor Blaise Genton, head of the study, said this cellular immunity generates so-called "memory cells", which could make the vaccine more durable and could be better than others at protecting against potential variants of the virus.


    The possible vaccine will be administered via micro-needles in the patch that are less than one millimetre deep that they hope will provide long-term immunity from COVID-19 and do away with the need for seasonal booster shots.


    "With this new vaccine that generates this cellular immunity we hope to have a longer period of protection ... we don't know yet, but it could be one year, two years, three years," Genton told Reuters.


    To administer the vaccine, the patch will be pressed against the skin briefly and then removed.


    The study is the first in the world with the new candidate and follows the start last year of another study in Lausanne to assess the safety of a new-generation dengue vaccine that uses the same technology.


    Emergex Vaccines Holding Ltd announced in November it would begin the trial of the COVID-19 vaccine. The company did not immediately respond to a request for comment.


    Drug companies are developing other ways of delivering vaccines. India's Bharat Biotech and partners Codagenix Inc and India's Serum Instituteis are each testing a nasal COVID-19 vaccine candidate.


    The PepGNP-Covid19 researchers started vaccinating 26 volunteers last week and plan to give them two doses each - a base dose and a slightly stronger one. They will follow the volunteers for six months. (Reporting by Cecile Mantovani Writing by Paul Carrel; Editing by Frank Jack Daniel)

    Interesting, was not really aware of how this "nocebo-effect" can affect a persons perception and feelings on a corona vaccination...


    https://www.newscientist.com/a…ms-down-to-nocebo-effect/

    You might want to send that article to Kyle. I bet he will disagree with 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.

    How does Omicron spread so fast? A high viral load isn’t the answer

    Data on viral levels point to immune evasion as a cause of the variant’s transmissibility.


    How does Omicron spread so fast? A high viral load isn’t the answer
    Data on viral levels point to immune evasion as a cause of the variant’s transmissibility.
    www.nature.com


    In countries around the world, Omicron has rapidly surged past other variants to become the dominant SARS-CoV-2 strain. Now, two studies show that the variant has achieved success despite causing viral levels in the body that are similar to — or lower than — those of its main competitor, the Delta variant1,2.


    The results suggest that Omicron’s hyper-transmissibility does not stem from the release of large amounts of virus from infected people. Instead, the best explanation for its lightning-fast spread is its ability to evade SARS-CoV-2 immunity caused by either vaccination or past infection, says Emily Bruce, a virologist at the University of Vermont in Burlington.


    The studies have not yet been peer reviewed.


    Heavy load

    Previous research has hinted that, compared with infections earlier in the pandemic, Delta-variant infections lead to a higher ‘viral load’, the amount of virus in an infected person. This is often measured using a polymerase chain reaction (PCR) test, which provides an index of the quantity of viral RNA in the body.


    To compare the viral loads linked to the ever-changing cast of SARS-CoV-2 variants, Yonatan Grad, an infectious-disease specialist at the Harvard T. H. Chan School of Public Health in Boston, Massachusetts, and his co-authors drew on data from the National Basketball Association, the organization responsible for professional basketball in North America1. The league conducts frequent COVID-19 testing of its players and personnel.


    The researchers studied PCR-test results of nose and throat swabs collected from infected individuals and found that those who had Delta had a slightly higher peak viral load than did those with Omicron. “I was really not expecting to see that,” says Grad. After all, in only two months, Omicron replaced Delta as the dominant cause of US COVID-19 cases.



    Beyond Omicron: what’s next for COVID’s viral evolution


    Benjamin Meyer, a virologist at the University of Geneva in Switzerland, says he too was stunned by Grad’s results. “Naturally, you’d think that higher transmissibility must cause a higher viral load,” he says.


    Meyer and his colleagues took the study a step farther: rather than measuring only viral RNA, they also measured the number of infectious virus particles on swabs collected from a separate group of almost 150 infected people2. This more stringent method found no significant difference between the viral loads of vaccinated individuals infected with Omicron and those infected with Delta.


    Isolation exit

    The findings have implications for government policies on isolation after infection. Meyer’s team examined samples from people who had been vaccinated but nonetheless became infected with Delta. They found that about half of the samples still held infectious virus five days after the individuals tested positive. Grad and his colleagues found that five days after an initial positive test for Omicron, about half of tested individuals had viral loads high enough that they were probably still infectious.


    Such results are concerning, Grad says, because guidelines published by the US Centers for Disease Control and Prevention (CDC) allow people infected with the virus to end their isolation five days after either testing positive or experiencing their first symptoms. The guidelines specify that people who have exited isolation must continue to wear a mask around others for five more days, but do not require a negative COVID-19 test to end isolation. The CDC did not respond to Nature with any comment by press time.


    Omicron has made public-health decisions all the more difficult, Grad says. He and his colleagues also found more variability in viral load in individuals infected with Omicron than in people infected with Delta. “That means there’s no clear ‘one size fits all’ approach,” he says.


    doi: https://doi.org/10.1038/d41586-022-00129-z

    No Evidence to Give COVID-19 Booster Dose to Healthy Children & Adolescents: WHO Chief Science Scientist Soumya Swaminathan


    No Evidence to Give COVID-19 Booster Dose to Healthy Children & Adolescents: WHO Chief Science Scientist Soumya Swaminathan
    Soumya Swaminathan, chief scientist for the World Health Organization (WHO), went on the record yesterday downplaying any indication that healthy
    trialsitenews.com



    Soumya Swaminathan, chief scientist for the World Health Organization (WHO), went on the record yesterday downplaying any indication that healthy adolescents or children are targets for the COVID-19 booster doses suggesting a possible divergence of opinion between the medical establishment in some of the richer nations and the global health agency charged with implementing a mass COVID-19 vaccination scheme targeting at least 70% of eligible populations by mid-2022.


    During a brief press briefing the WHO head scientist declared, “There is no evidence right now that healthy children or healthy adolescents need boosters. No evidence at all.”


    While in select wealthy countries such as the United States, England and Israel medical establishments simply recommend boosters the WHO’s mandate and point of view necessitates a different paradigm. For example, in much of sub-Saharan Africa less than 10% of entire populations are vaccinated against COVID-19. Why not send surplus doses to these nations the WHO head might contemplate.


    On the other hand, pharmaceutical company manufactures may have financial incentives to see more consumption of doses in wealthy countries because that would lead to a higher probability of new orders, satisfying investor sentiment, goes the thinking.


    More Research Necessary

    Based on the WHO mandate the heads of the organization suggest more evidence is needed before even third boosts are suggested in healthy young populations. IN the meantime, Israel is already moving to a fourth booster dose in just over twelve months since the first vaccine dose targeting the wildtype version of SARS-CoV-2. Since then, a couple problematic variants emerged including Delta and now Omicron which seems to evade all the vaccines more easily. Highly transmissible thus far accumulating data points to a less severe disease with less death. Of course, this could change quickly. The WHO chief scientist reminded all the group likes to follow “science” in a signal they would like to keep away from other political or economic considerations.


    Booster Central

    In the land of the Pharma lobby, from the USA to the UK boosters are handed out far more easily. For example, the FDA recently gave the greenlight that youngsters aged 12 and up can receive the Pfizer booster timed five months after the last jab. This changed from the previous six month duration required.


    The U.S. Centers for Disease Control and Prevention (CDC) reported CDC COVID Data Tracker recently that 81 million eligible people in the United States have already received a booster. TrialSite reported recently that over 50% of the entire Israel population has already received a third boost. While infection rates skyrocket in both America and Israel luckily thus far the death rates remain far lower than previous surges. The hope is that this trend will continue

    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.

    Brazilian State of Rondônia Establishes Law: Use of ivermectin & Hydroxychloroquine Authorized Off Label Targeting COVID-19


    Brazilian State of Rondônia Establishes Law: Use of ivermectin & Hydroxychloroquine Authorized Off Label Targeting COVID-19
    The northwest Brazilian state of Rondônia, heavily dependent on agriculture and situated south of Amazonas and west of Mato Grasso, appears to be bucking
    trialsitenews.com


    The northwest Brazilian state of Rondônia, heavily dependent on agriculture and situated south of Amazonas and west of Mato Grasso, appears to be bucking the trend of many other states and accepting repurposed generic drugs for the early-onset treatment of SARS-CoV-2, the virus behind COVID-19. With about 1.6 million people, recently the state’s Legislative Assembly published a new law enacted by January 13, 2022, authorizing the use of hydroxychloroquine, chloroquine, azithromycin, and ivermectin in the treatment COVID-19.


    Published recently in the media Journal Electronico Floresta, Rudinei Sbalchiero reports that while there is “no scientific proof” that these repurposed drugs effectively treat COVID-19, the state’s legislative assembly approved the law anyway. TrialSite, with a team in Brazil, reported that the key law’s sponsor isn’t a physician.


    Authored by Deputy Chiquinho da Emater, the law was approved by the House of Laws, then forwarded to Governor Marcos Rocha, who held back from any sanctioning of the rule, thus leaving the Assembly to act and convert to law.


    Informed Consent Key

    Moving forward, physicians in the State of Rondônia can treat their patients with early-onset COVID-19 with hydroxychloroquine, chloroquine, azithromycin, and ivermectin. A fundamental requirement, however: the physician must inform the patient that these treatments are not indicated for SARS-CoV-2, thus the treatment is done off label and the patient must consent.



    This type of process is typical and occurs frequently in medicine in North America until COVID-19—since then, there has been far more federal oversight and influence over the doctor and patient relationship


    https://www.florestanoticias.com/2022/01/18/assembleia-legislativa-promulga-lei-autorizando-uso-da-cloroquina-e-ivermectina-em-rondonia/

    Judge blocks hospital from turning off ventilator of severely ill COVID-19 patient

    The order prohibited Mercy Hospital from turning off ventilation support.


    Judge blocks hospital from turning off ventilator of severely ill COVID-19 patient
    The order prohibited Mercy Hospital from turning off ventilation support to the patient.
    abcnews.go.com


    A Minnesota man with COVID who had been fighting for his life for months was transferred to a new hospital days after a judge blocked another hospital from taking him off a ventilator.


    The decision allowed Scott Quiner, 55, of Buffalo, Minnesota, to be moved to a hospital in Texas, where he is being treated.



    Quiner was initially admitted to Waconia Hospital, and then transferred to the ICU at Mercy Hospital, in Coon Rapids, on Nov. 6, after he tested positive for the virus in late October, according to a GoFundMe page in support of Quiner’s family, and the StarTribune, which was first to report this story.


    Anne Quiner, Scott's wife, was granted a temporary restraining order last Thursday against Mercy Hospital, after doctors informed her that day that they would be disconnecting her husband from the ventilator that had been supporting him since the late fall.


    The order, from an Anoka County judge, prohibited the hospital from turning off ventilation support, while Anne Quiner searched for a new facility to care for her husband.



    According to the court order, Anne Quiner told doctors that as her husband’s health care proxy, she “vehemently disagree[d]” with these actions and did not want her husband’s ventilator turned off.




    Over the weekend, Scott Quiner was moved to a facility in Texas for treatment, Marjorie J. Holsten, the Quiner family's attorney, told ABC News in a statement on Monday.



    “A doctor evaluated him and determined that he was severely undernourished. Scott has been receiving much-needed nourishment and hydration and medications that were not given by Mercy,” Holsten said. “He is being weaned off of the sedating drugs and has already been able to follow with his eyes movements the doctor made with his hands. He is making progress in the right direction, though he has a long road ahead of him and continued prayers are appreciated.”


    Quiner remains on a ventilator but the oxygen level has been lowered, the family's lawyer said.


    Representatives from Allina Health, which operates Mercy Hospital, told ABC News that they wish the patient and the family well, and have "great confidence" in their team's work.


    “Allina Health has great confidence in the exceptional care provided to our patients, which is administered according to evidence-based practices by our talented and compassionate medical teams. Due to patient privacy, we cannot comment on care provided to specific patients,” the health system wrote. “Allina Health continues to wish the patient and family well. Any information regarding the patient’s on-going care should be directed to his current medical provider.”

    https://www.haaretz.com/israel…-serious-cases-1.10530817


    Clowns are back referencing fake studies about Israel and IVR. I wonder whether it is a joy to kill people or whether here is the only space where they can fully live out their fascist nature.


    Fact is most new serious Israel cases are among boostered. Most deaths currently are among 2xx/3xx/4xx vaccinated. And 30% are not vaccinated in Israel not as the Haaretz fake claims 15%... Studies older than one week won't help here for Omicron actual situation....

    Israel’s Vaccine Chief on the Record: COVID-19 mRNA Vaccines Failed to Protect Israel by providing ‘Sterilizing Immunity’


    Israel’s Vaccine Chief on the Record: COVID-19 mRNA Vaccines Failed to Protect Israel by providing ‘Sterilizing Immunity’
    Israel served as a sort of canary in the mine for the United States, Britain, and other nations in the “West” during the COVID-19 pandemic. Rapidly
    trialsitenews.com


    Israel served as a sort of canary in the mine for the United States, Britain, and other nations in the “West” during the COVID-19 pandemic. Rapidly adopting the novel COVID-19 mRNA-based vaccines, Israel used its small, condensed population and strong government in an unprecedented rapid mass vaccination program. With the highest booster rates in the world, Israel now embraces the fourth booster jab in just over a year. While the vaccines have, according to the Israeli Ministry of Health, reduced rates of hospitalization and death, TrialSite chronicled major waves of breakthrough infections there, including so-called breakthrough hospitalizations and death during the Delta variant-driven surge and now again with record numbers of new infections with the Omicron surge. Cyrille Cohen’s voice carries significant influence in Israel in all matters of COVID-19 as the professor and head of Immunology at Bar Ilan University, not to mention a member of the government’s advisory committee for vaccines. Cohen declared in a recent interview with a British conservative upstart media that Israel’s COVID-19 vaccine passport program probably won’t be relevant soon given challenges with Omicron, suggesting the program could be phased out. Predicting that the Israeli government will, in fact, eliminate such improper policies sooner rather than later, the top immunologist shared in this interview that he and colleagues are of the opinion that the COVID-19 vaccines fell far short of their purported goal of stopping SARS-CoV-2 transmission. The thought leader went on the record, questioning their approach—such as shutting down schools, business, and the like—along with other measures that shook up Israeli society in a desperate attempt to avoid mass infection as well as the dangers of hospitalization and death associated COVID-19. Cohen now acknowledges that “widespread infection is now an inevitable part of future immunity,” also known as “herd immunity.”


    The Expert

    A notable key opinion leader, Professor Cyrille Cohen currently works as Principal Investigator with the title of Head of the Laboratory of Tumor Immunology and Immunotherapy at Bar Ilan University.


    Educated at Israel Institute of Technology, Cohen earned his BSc, MSc, and Ph.D. in Immunology and Biology. Dr. Cohen runs a lab named after him which centers on investigations into immunology associated with cancer.


    The Interview

    Recently interviewed on the conservative new media startup UnHerd, interviewer Freddie Sayers took in a recognition by one of Israel’s top immunologists that “mistakes were made” in Israel.



    With nearly 70% of the population fully vaccinated and over 50% boosted with the mRNA vaccine, the government now initiates a fourth booster dose.


    Sayers pointed out Israel’s importance in the global pandemic response in the West. America and many countries in Europe, such as the UK, look to Israel as “an example to follow,” given they were a fist to implement stringent travel restrictions. Israel also boasted the fastest COVID-19 mass vaccination implementation all backed by a “muscular” government believing the “virus could be controlled.”


    Of course, with Omicron-based cases raging the opposite is very much the case. Dr. Cohen, starting with what was most certainly guarded language, offered what some could interpret as bombshell admissions.


    In the first part of the interview, Cohen declared:


    “Today we are in a different phase of the pandemic. We are in a different stage of what we call COVID-19.


    Israel, where we were the first to immunize massively, exactly a year ago in January and February, enabled us to actually end lockdowns since March. Even before that, from February on, we started to open our economy, our society. And then we were confronted. We were the first to notice a decrease in the waning of the immunity following the second shot, and that’s when we had to decide, and believe me, it wasn’t an easy decision to decide that we needed a third shot, a booster shot. And we did that, and it helped us minimize the consequences of what we call here the fourth wave. And then Omicron happened.


    And Israel, I would say quite intelligently, closed its border again, which enabled us to get prepared during a month, where we had almost no cases of Omicron here. But again, we cannot delay that indefinitely. And now, we have Omicron.”


    What have they learned according to the top Israeli immunologist?


    The COVID-19 vaccines are excellent at preventing severe SARS-CoV-2

    Unfortunately, the durability of the vaccines are a real problem—their effectiveness against infection wanes or reduces in a short period of time—a major lesson for the world

    When asked by Sayers if the durability issue was a surprise, the Israeli scientist responded with a resounding “yes.” Cohen shared that scientists and health experts in Israel were quite bullish about the vaccine’s effectiveness after dealing with a deadly month last January, thanks to the initial vaccination push: not only did cases rapidly decline but society opened back up. Many of his colleagues thought the pandemic was “over” thanks to the Pfizer vaccine, and the situation unfolded from April through part of summer 2020.


    On the assumption that the mRNA vaccine stopped viral transmission, Cohen shared, “We did believe at that time [spring of 2021] that vaccines can prevent transmission.”


    But Cohen qualified this blocking of transmission was short-lived, and “not over a long period of time.” Thus, going on the record, he reported that they were surprised by the Pfizer vaccine’s questionable durability.


    Several studies emerged in summer 2021 that indicated that the Pfizer vaccine’s effectiveness waned in a matter of a few months, which is by no means long in duration.


    Cohen and colleagues were most certainly surprised as to the durability challenges stating, “at the end of the day the vaccines are not protecting us, they are not causing what we call sterilizing immunity.”


    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.

    Or perhaps not! Thousands if not millions say YOU are wrong. Ask the citizens of India who have no Covid.