Covid-19 News

  • China Passes Law Granting Doctors the Right to use Off-Label Drugs


    China Passes Law Granting Doctors the Right to use Off-Label Drugs
    A new law in China grants physicians explicit rights to prescribe or try out off-label drugs in a bid to bring greater opportunity to drug makers in the
    trialsitenews.com


    A new law in China grants physicians explicit rights to prescribe or try out off-label drugs in a bid to bring greater opportunity to drug makers in the world’s most populous nation and second-largest economy. Starting March 1, 2022, physicians may use off-label drugs that can benefit both patients and pharmaceutical companies. Patients will have new options to potentially treat any number of conditions, while drug makers could benefit from the expanded use of their drugs. While American physicians have long had the right to prescribe off-label drugs during the pandemic, government health agencies, regulators, and medical licensing societies have put increasing pressure on physicians to not prescribe ivermectin, for example, pointing to a centralization of control over local physicians.


    Recently, China’s Pharma DJ reported on the new law based on the Chinese Pharmacological Society definition of an off-label drug as in the “use of drugs for an unapproved indication or in an unapproved dosage, treatment course, route of administration and patient group.” In reality, the State in China is merely codifying what physicians have long done anyway, writes Minhua Chu. That’s because Chinese drug law has lagged other nations, thus slowing down drug approvals and associated label updates.


    The Crux of the Law

    Ms. Chu informs that the law “stipulates that when no effective treatments are available, physicians may upon patient consent, use drugs in a way that is not indicated in the package insert but is supported by medical evidence.” Based on Article 29 of the new law, physicians must adhere to several principles behind the law.


    Hospital Practice in China

    A recent survey by the Chinese Pharmacological Society reveals that 24 hospitals, representing half of the respondents, support off-label prescribing. According to Ms. Chu, 24 hospitals recorded 1,652 off-label uses of 998 drugs, mostly indicated for oncology, immunomodulatory, cardiovascular, digestive, endocrine, and infectious disease.


    China—A Rising Drug Market Powerhouse but Still Small

    China recently updated its drug development laws to become more competitive in the global market for clinical trials. Perhaps not known to many, China now represents the second-largest pharmaceutical market in the world next to the United States.


    Of course, the difference between America’s drug market and China is orders of magnitude in size and amount of revenue. America controls just under 50% of the world’s market, while China has emerged with 8%.

  • Dr. Tom Frieden on COVID-19 Pandemic: Eradication via Vaccination Not Possible


    Dr. Tom Frieden on COVID-19 Pandemic: Eradication via Vaccination Not Possible
    As TrialSite has reported, an independent U.S. Food and Drug Administration (FDA) Advisory Panel voted overwhelmingly against the mass booster program at
    trialsitenews.com



    As TrialSite has reported, an independent U.S. Food and Drug Administration (FDA) Advisory Panel voted overwhelmingly against the mass booster program at this point. The independent advisory panel put a screeching halt on an imminent mass booster access and rather elected that the third jabs should only be available for a far more narrow subsection of the population, from the elderly to severely ill, and select occupations facing higher risks of exposure. On this point, Dr. Tom Frieden shares his thoughts via Twitter, “…an FDA committee voted to recommend booster doses of Covid vaccines for people ages 65 and older and those at high risk of severe disease. Unlike Israel, they decided there is currently insufficient evidence of the need or benefit for everyone to get boosters.”


    Moving forward, he suggests, “Given what we know and don’t know at this point, a sensible way forward is becoming clearer based on filling our knowledge gaps, protecting the most vulnerable, and reducing the risk of new dangerous variants emerging.


    No one knows what will happen next in the pandemic. Longer-term predictions are just guesses. But we do know the endgame has shifted. Eradication is not possible. Even control will be difficult. We can reduce transmission and severe disease, but we can’t eliminate them.”


    Regarding booster shots, he states, “I agree with the FDA group that a third dose makes sense for people 65+ and at high risk. Though we aren’t certain it will be necessary or effective, it’s reasonable to conclude that it will be. Even more important is to increase vaccine uptake among these groups.”


    In a similar sentiment to those of TrialSite, Frieden says, “We can’t rely on vaccination alone to contain Covid. Masks, testing, and other measures are also necessary. But we must still increase vaccinations—our most powerful tool—around the world to prevent deaths, preserve health care, and reduce spread as much as we can.”


    Frieden concludes, “Finally, we must learn this lesson and act accordingly: Health protection and public health matter. Microbes outnumber us, we must work together to outsmart them.” What about low-cost treatment options? In the developing world, at least 20 countries use ivermectin; however, in America, a coordinated effort to vilify what has been a safe and effective drug for other indications suggests material forces dedicated to intensive monetization of the space for early-onset care—representing about 90% of all COVID-19 cases.

  • Big gap between Pfizer, Moderna vaccines seen for preventing COVID-19 hospitalizations


    https://www.post-gazette.com/news/health/2021/09/18/Big-gap-between-Pfizer-Moderna-vaccines-seen-for-preventing-COVID-19-hospitalizations/stories/2021091800

    Big gap between Pfizer, Moderna vaccines seen for preventing COVID-19 hospitalizations


    Los Angeles Times

    SEP 18, 2021 3:43 PM

    LOS ANGELES — Amid persistent concerns that the protection offered by COVID-19 vaccines may be waning, a report released Friday by the Centers for Disease Control and Prevention finds that America’s workhorse shot is significantly less effective at preventing severe cases of disease over the long term than many experts had realized.


    Data collected from 18 states between March and August suggest the Pfizer-BioNTech vaccine reduces the risk of being hospitalized with COVID-19 by 91% in the first four months after receiving the second dose. Beyond 120 days, however, that vaccine efficacy drops to 77%.


    Meanwhile, Moderna’s vaccine was 93% effective at reducing the short-term risk of COVID-19 hospitalization and remained 92% effective after 120 days.


    Overall, 54% of fully vaccinated Americans have been immunized with the Pfizer shot.


    A vaccine provider prepares a dose of the COVID-19 vaccine at a clinic run by the Allegheny County Health Department at Casa San Jose, a non-profit serving Latino immigrants, Tuesday, September 14, 2021, in Beechview.

    PETER SMITH

    Many faith leaders say no to endorsing vaccine exemptions

    The surprising findings came as a Food and Drug Administration advisory panel recommended against offering booster doses of the Pfizer vaccine to all Americans ages 16 and older. In a striking rebuke, 16 of 18 experts told the agency it had not mustered enough data to make a third shot the norm.


    In lengthy briefings to the panel, representatives from Pfizer pointed to clinical trial results involving 306 mostly healthy participants to argue that a booster “restores” the 95% vaccine effectiveness rate seen earlier in the pandemic.


    Company officials also touted evidence from Israel, which rolled out boosters after seeing a rise in hospitalizations among people who were fully vaccinated. Those hospitalizations dropped dramatically after third doses were given, Israeli scientists have said.


    But panel members made clear that despite Pfizer’s aggressive stance, it had not gathered enough evidence that a third shot was safe for young people and for those at lesser risk of becoming severely ill with COVID-19.


    “We need age-specific data” on the safety and protective benefits of a further booster, said Dr. Ofer Levy, a panel member who directs the Precision Vaccines program at Boston Children’s Hospital.


    FDA clearance for booster shots for everyone 16 and older would be seen as something “close to a mandate,” said Dr. Eric Rubin, a panel member and infectious-disease expert at the Harvard T.H. Chan School of Public Health. Rubin worried that such a move could redefine what it takes to be considered fully vaccinated against COVID-19.


    “None of us are there yet,” he said.


    But others apparently are. Dr. Anthony Fauci, President Joe Biden’s top adviser on vaccines, has come out strongly in favor of booster shots, saying before Friday’s vote that a failure to endorse the shots “would be a mistake.”


    And in mid-August, Biden himself said his administration would begin making booster shots available the week of Sept. 20 to those vaccinated for at least eight months.


    Biden cautioned at the time that his plan was contingent on FDA approval. But his announcement stoked concerns of political meddling in a matter that required the unhindered evaluation of scientists.


    “This should demonstrate to the public that the members of this committee are independent of the FDA,” Dr. Archana Chatterjee, dean of the Chicago Medical School, said after the vote. “In fact, we do bring our voices to the table when we are asked to serve on this committee.”


    The panel unanimously agreed that a third shot of the vaccine now sold under the brand name Comirnaty should be offered to select groups: individuals 65 and older, people at risk of developing severe disease, and those, including health-care workers, whose occupations put them at high risk of infection.


    Dr. Peter Marks, who leads the FDA’s evaluation of drugs and vaccines, told panel members that the agency could give its blessing to booster shots with an emergency use authorization — a regulatory step that falls short of the full approval Pfizer had sought.


    The company issued no statement Friday in response to the panel’s vote.


    Researchers in the United States have been warning for months that the immunity afforded by COVID-19 vaccines might be waning. The CDC reported that in late July, close to three-quarters of the 469 people swept up in a Massachusetts outbreak were fully vaccinated. And the agency has launched several studies aimed at detecting changes in vaccine effectiveness in healthcare workers and others who were vaccinated early.


    But virtually all of those infections appeared to be mild. And health officials eager to induce vaccine skeptics to step up for their shot — including Fauci and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention — have repeatedly praised the vaccines for keeping most fully vaccinated people out of hospitals.


    The new report on waning vaccine efficacy challenges that expectation.


    Researchers from around the country found striking differences between two mRNA vaccines long thought to be interchangeable.


    When the Moderna vaccine received emergency use authorization in December, the company reported that 30 people in its clinical trial developed severe cases of COVID-19, including nine who required hospitalization. All 30 patients were in the placebo group, resulting in a vaccine efficacy against severe disease of 100%.


    Ten people in Pfizer’s initial clinical trial developed severe cases of COVID-19. Nine of them was in the placebo group, including seven who were hospitalized, resulting in a vaccine efficacy against severe disease of 88.9%.


    Once the Moderna and Pfizer vaccines were rolled out to the public, their records of preventing COVID-19 hospitalizations in the first four months were neck and neck — 93% and 91% effective, respectively. But the degree of protection diverged after that.


    When they focused specifically on the period 120 days beyond the second dose, the study authors found that the Moderna vaccine remained 92% effective at preventing COVID-19 hospitalizations. But the equivalent figure for the Pfizer vaccine was 77%.


    The results were published in the CDC’s Morbidity and Mortality Weekly Report.


    Both the Pfizer and Moderna vaccines are based on mRNA technology, which delivers temporary instructions to the body’s muscle cells that help it learn to recognize the spike protein, a key part of the coronavirus’ structure. But “they’re actually not necessarily interchangeable,” said Dr. Timothy Brewer, a professor of medicine and epidemiology at UCLA.


    Each vaccine is formulated and administered differently, Brewer said, and those differences could affect the strength and duration of the two vaccines’ protection.


    Moderna’s shot contains 100 micrograms of vaccine, more than three times the 30 micrograms in the Pfizer shot. And Pfizer’s two doses are given three weeks apart, while Moderna’s two-shot regimen is administered with a four-week gap.


    Brewer also pointed to evidence that the Moderna vaccine seemed to elicit higher levels of a key antibody than the Pfizer vaccine.


    “We know from other studies the neutralizing antibody levels will decay over time, so starting at a higher level will mean that you have farther to go before you decay to a point where efficacy drops off,” he said.


    Dr. Robert Murphy, who directs Northwestern University’s Institute for Global Health, said the Pfizer vaccine’s reduced protection against severe disease may bolster the case for boosters for all who got the vaccine, not just the specific groups identified by the FDA advisory panel.


    “Based on the data I have seen, persons who received the Pfizer vaccine would benefit from a booster dose at this time,” he said. “I don’t see why we have to wait until the younger people get sick and become hospitalized.”


    But Dr. Arnold Monto, who chairs the FDA advisory panel, applauded the agency’s willingness to withhold a full-throated call for boosters until a stronger case can be made. And he suggested that as more evidence accumulates, boosters for all might still get the nod.


    “That’s the beauty of the emergency use authorization,” said Monto, an epidemiologist at University of Michigan. “It can be changed based on changing data.”


    ©2021 Los Angeles Times. Visit latimes.com. Distributed by Tribune Content Agency, LLC.


    Overall, 54% of fully vaccinated Americans have been immunized with the Pfizer shot.

  • however, in America, a coordinated effort to vilify what has been a safe and effective drug for other indications suggests material forces dedicated to intensive monetization

    Your conspiracy theory would have to include independent-minded regulators in UK, Sweden, etc, none of whom recommend ivermectin at the moment bbased on the totality of data seen so far.


    Admittedly were it not for the unscientific campaign to push ivermectin from FLCC etc I think there would be less specifically "don't take ivermectin - you are not a cow" counter-propaganda. But the decision not to recommend it based on negative evidence so far would remain for any science-based regulatory system.

  • Your conspiracy theory would have to include independent-minded regulators in UK, Sweden, etc, none of whom recommend ivermectin at the moment bbased on the totality of data seen so far.


    Admittedly were it not for the unscientific campaign to push ivermectin from FLCC etc I think there would be less specifically "don't take ivermectin - you are not a cow" counter-propaganda. But the decision not to recommend it based on negative evidence so far would remain for any science-based regulatory system.

    Remdesivir !!!!

  • -Scientists are getting closer to classifying long COVID as an autoimmune disease


    Long COVID could be an autoimmune disease, new research suggests
    New research may finally answer why long COVID patients are still sick, suggesting one "auto-antibody" may be responsible for harmful inflammation.
    www.businessinsider.com


    Long COVID patients may finally get an answer as to why they're still sick.


    The National Institutes of Health announced Wednesday that it's kicking off a $470 million study to figure out why COVID-19 symptoms persist for so long among many patients.


    Already, research has started to coalesce around a theory: The virus may set off an autoimmune reaction that causes lingering symptoms such as fatigue, shortness of breath, loss of smell, muscle aches, or brain fog.


    "We can't say for sure that it's an autoimmune disease now, but it's really starting to look like it," John Arthur, a researcher at the University of Arkansas for Medical Sciences, told Insider.



    Development of ACE2 autoantibodies after SARS-CoV-2 infection


    Development of ACE2 autoantibodies after SARS-CoV-2 infection
    Background Activation of the immune system is implicated in the Post-Acute Sequelae after SARS-CoV-2 infection (PASC) but the mechanisms remain unknown.…
    journals.plos.org


    Abstract

    Background

    Activation of the immune system is implicated in the Post-Acute Sequelae after SARS-CoV-2 infection (PASC) but the mechanisms remain unknown. Angiotensin-converting enzyme 2 (ACE2) cleaves angiotensin II (Ang II) resulting in decreased activation of the AT1 receptor and decreased immune system activation. We hypothesized that autoantibodies against ACE2 may develop after SARS-CoV-2 infection, as anti-idiotypic antibodies to anti-spike protein antibodies.


    Methods and findings

    We tested plasma or serum for ACE2 antibodies in 67 patients with known SARS-CoV-2 infection and 13 with no history of infection. None of the 13 patients without history of SARS-CoV-2 infection and 1 of the 20 outpatients that had a positive PCR test for SARS-CoV-2 had levels of ACE2 antibodies above the cutoff threshold. In contrast, 26/32 (81%) in the convalescent group and 14/15 (93%) of patients acutely hospitalized had detectable ACE2 antibodies. Plasma from patients with antibodies against ACE2 had less soluble ACE2 activity in plasma but similar amounts of ACE2 protein compared to patients without ACE2 antibodies. We measured the capacity of the samples to inhibit ACE2 enzyme activity. Addition of plasma from patients with ACE2 antibodies led to decreased activity of an exogenous preparation of ACE2 compared to patients that did not have antibodies.


    Conclusions

    Many patients with a history of SARS-CoV-2 infection have antibodies specific for ACE2. Patients with ACE2 antibodies have lower activity of soluble ACE2 in plasma. Plasma from these patients also inhibits exogenous ACE2 activity. These findings are consistent with the hypothesis that ACE2 antibodies develop after SARS-CoV-2 infection and decrease ACE2 activity. This could lead to an increase in the abundance of Ang II, which causes a proinflammatory state that triggers symptoms of PASC.

  • To be fair, that article is likely above the reading age of the typical FUDER -like our children that post here.

    You are not even able to read what google writes in the head line.. Goes away without permanent complications. Once you have a scar in your heart tissue there is no longer any complication until you stress your heart to much. Seen twice recently in professional football. Yes the Danish player that collapsed during Euro has been vaccinated! (His Italy league team has been fully vaccinated)...

    Only children believe google is a medical encyclopedia ...

  • U.S. concerned about "superspreader event" at U.N. as diplomats challenge New York City vaccine requirement


    U.S. concerned about "superspreader event" at U.N. as diplomats challenge New York City vaccine requirement
    The Biden administration worries that this year's U.N. General Assembly could become a COVID-19 "superspreader event" as world leaders descend on New York City.
    www.cbsnews.com


    United Nations – The Biden administration worries that this year's U.N. General Assembly could become a COVID-19 "superspreader event" as world leaders descend on New York City without necessarily abiding by local vaccine requirements. On Friday, President Biden's U.N. Ambassador, Linda Thomas-Greenfield, told CBS News at a press conference, "We are concerned about the U.N. event being a superspreader event, and that we need to take all measures to ensure that it does not become a superspreader event."


    Unlike last year, when COVID-19 pandemic forced the largest annual gathering of world leaders to go virtual, this year, a hybrid format means that heads of state can either send in a video or appear in person.


    Despite a note from Thomas-Greenfield urging diplomats to send in videos, more than 100 presidents, prime ministers and others are set to give in-person speeches at the two-week event. Mr. Biden will be attending with a scaled-down White House entourage.

    Brazil's President Jair Bolsonaro, who says he is unvaccinated but has antibodies from a COVID-19 infection last year, announced he would attend in person, defying the New York City vaccine requirement.

    In a letter on September 9, New York City Mayor Bill de Blasio's Office for International Affairs and the city health commissioner informed the president-elect of the General Assembly, Abdulla Shahid, that the gathering would be covered by a local law requiring proof of vaccination for indoor venues like dining and entertainment.


    "Indoor entertainment also includes 'convention centers,' and the U.N. General Assembly Hall qualifies as a convention center," the letter said.


    Shahid wrote to all U.N. member states "strongly" supporting the measure and pledging to implement it. But then, in a diplomatic accommodation, Shahid sent a new letter Thursday saying, "I would like to advise delegations that the honour system related to vaccinations … remains in place."

    The decision to invoke the "honour system" came after Russian Ambassador Vassily Nebenzia weighed in, saying he was "surprised and disappointed" by the idea of requiring proof of vaccination to enter the General Assembly Hall. Nebenzia called it "discriminatory" and contrary to the 1947 agreement between the U.S. and the U.N. that establishes the world body's international status.


    Asked about the Russian opposition to the requirement on Thursday at his press conference, the mayor was defiant.


    "My simple statement to begin is if the Russian ambassador is against it, I'm for it," de Blasio said.


    "I spoke to Secretary General Guterres two weeks ago, and we had a very good conversation. He's been outstanding in trying to push the highest health standards for the General Assembly," de Blasio said, adding, "We understand the United Nations is a particular organization, has its own rules and its own jurisdiction."


    The honor system, the Secretary General's spokesperson Stephane Dujarric said Friday, means that "by swiping a badge to enter the General Assembly Hall, delegates attest that they are fully vaccinated, that they have not tested positive for COVID‑19 in the last 10 days [and] have no symptoms."

    The mayor also announced that the city would be opening a pop-up testing and vaccination site at U.N. headquarters to provide free COVID-19 tests as well as the single-dose Johnson & Johnson vaccine.


    Thomas-Greenfield said she'll be getting a test there herself Monday morning.


    Asked by CBS News about the risk of so many people coming into New York from so many countries, she said, "Leaders have to be responsible, and they have to take responsibility for their actions and ensure that their actions do not lead to jeopardizing the health and safety of the people of New York, of all of the participants here at the United Nations, and that they don't take COVID back to their home countries."


    The General Assembly meeting comes after a rough year at U.N. Headquarters, where COVID-19 has taken a toll. Hundreds of staff, diplomats, and members of the press were infected, and meetings and other work went remote for months. Contact tracing was voluntary, and a confidential WhatsApp group, seen by CBS News, was the main way that many diplomats found out about colleagues who were infected with COVID.

  • Cardiologists typically recommend a resting period of three to six months after viral myocarditis to allow the heart tissue to heal without intense physical exercise.

    Yes! If you detect it. Unluckily only a small fraction of the cases gets detected. It's all a matter of the damage on point of detection. Children still have a lot of active stem cells in the heart - not so grown up.

    For me parents that apply Pfizer, Moderna, Astra-Oxford gene therapy to children are monsters and a sign of how broken today people already are.

  • You have to be weird to think that the scientists doing a (Cochrane) systematic meta-analysis of ivermetin would be biassed against it working!

    You must be a FUD'er to believe that Lancet, Nature, Cochrane support other science that contradicts the ruling mafia business targets. The Cochrane fake review is one other brick of a monumental tombstone of the classic science publishing circus...

  • But the decision not to recommend it based on negative evidence so far would remain for any science-based regulatory system.

    For our free mason trumpet I once more link a stringent scientific proof about how fast Ivermectin clears the CoV-19 virus.


    In this double-blind, randomized trial with mild COVID-19 patients, ivermectin significantly reduced time of viral shedding and affected viral viability when initiated at the first week after evidence of infection.

    Favorable outcome on viral load and culture viability using Ivermectin in early treatment 1of non-hospitalized patients with mild COVID-19 –A double-blind, randomized placebo.pdf


    In India all full Ivermectin treatment & prophylaxis states see no reoccurrence of CoV-19.


    Kerala the only India vaccine terror state sees the same problems as USA,Israel,UK,France,Italy,.... and still delivers 2/3 of all India CoV-19 cases and about 50% of India's CoV-19 deaths.

    Uttar Pradesh is stable since 4 months now with in average <20 cases for 235 Million people during teh last 2 months.


    Compared with the vaccine and treatement terror state USA Uttar Pradesh + IVERMECTIN is running 1000x better least!

  • Italy now requires you to have a vaccination to be able to do work.


    The president of Italy is a former partner of Goldman Sachs, the X-mafia center company that most likely, indirectly also is the sponsor of the Auschwitz Mengele Pfizer trial in Israel.


    Just for people that miss some connections along the finance fascists!


    So Italy left humanity and all human rights and is already a step ahead of the Mussolini state. Fascism reemerges faster than people ever can dream!

  • Once you have a scar in your heart tissue there is no longer any complication

    What an ridiculous statement. And funnily enough, completely at odds with the original wyttenfact:

    Myocarditis (always live long damage)


    So I think we have the first case of a wyttenfact being confirmed by wyttenbach himself. Does that count as progress? I'm not sure.


    Anyway, this seems as good place as any to provide the fourth (fifth, if we include the above idiocy) refutation of the original wyttenfact.


    Myocarditis is an acute inflammatory disease of the heart and a precursor of dilated cardiomyopathy18. Myocarditis is often characterized by a cellular infiltrate, and if inflammation of the myocardium does not resolve during the acute stage, the heart may be compromised due to necrosis and direct loss of myocytes9, injury from granulomatous inflammation10, 11, or fibrosis due to proliferation of fibroblasts and collagen deposition12, 13.


    TURNING POINT IN MYOCARDITIS
    www.ncbi.nlm.nih.gov


    N.B. Wyttenbach-encouragers: 'Necrosis' and 'fibrosis' are doctor words describing the processes that form scar tissue.

  • MSN Showcases the Amazing Uttar Pradesh Turnaround—The Ivermectin-based Home Medicine Kits


    MSN Showcases the Amazing Uttar Pradesh Turnaround—The Ivermectin-based Home Medicine Kits
    Recently Indian press touted that Uttar Pradesh, India’s most populous state with about 230 million people was nearly COVID-19 free. An amazing
    trialsitenews.com


    Recently Indian press touted that Uttar Pradesh, India’s most populous state with about 230 million people was nearly COVID-19 free. An amazing accomplishment chronicled by TrialSite—a heroic public health story demonstrating how organized, proactive testing, early care, and quarantines contributed to overcoming an outright scary Delta variant-based surge from April to May of this year. The proactive use of Ivermectin, included in a home health care kit, showed to be instrumental in combating the incredibly virulent and transmissible strain of SARS-CoV-2. Public health workers made continuous visits to homes in villages and districts across the state, proactively testing and treating the condition immediately, including household contacts. Even the World Health Organization (WHO) praised the effort, yet omitted the use of Ivermectin—a scandal. Now Microsoft News (MSN) posted the story for the world to read, digest and hopefully understand.


    MSN appears to be the first mainstream news source to recognize the amazing feat accomplished by the health agencies in India’s most populous state. The state experienced a massive spike in infections by April, but just two months later, the turnaround was well on its way, and what ensued should have been the story of the year.


    The Outbreak

    TrialSite provided in detail data associated with the Delta outbreak in India. The Delta variant of concern emerged from the State of Maharashtra and the Punjab regions by way of Lahore in Pakistan, locations where the AstraZeneca vaccine had been administered. Maps associated with the first outbreaks can be found here. Any correlation with vaccination, however, cannot be proven however and may be coincidental.


    The outbreak that started in the east of Maharashtra in early February moved slowly to neighboring states. But once it arrived in Mumbai, cases exploded, and the virus rapidly spread to other states. Mumbai played a huge role in the expansion of the Delta variant. A huge concentration of migrant workers are present in this giant metropolis, and upon the surge, many people fled, fearing imminent lockdown, job loss, and the like. Traveling in trains and buses, migrant workers brought Delta back to hometowns, including those in Uttar Pradesh.


    Ivermectin Incorporated in State Protocol in 2020

    TrialSite reported last year that the findings at Monash University (Ivermectin inhibits SARS-CoV-2 in a lab cell culture), research results in Bangladesh (see Dr. Tarek Alam et al.), and other places influenced health officials in Uttar Pradesh.


    Now Microsoft News becomes the first mainstream media to introduce the Uttar Pradesh story—and for that, they should be commended. MSN shared that last August 6, 2020, a committee led by the Director-General, Medical and Health Services for the state gave the go-ahead to use the drug as a prophylactic.


    MSN reposed that Vikssendu Agrawal, Uttar Pradesh State Surveillance Officer declared, “Uttar Pradesh was the first state in the country to introduce large-scale prophylactic and therapeutic use of Ivermectin. In May-June 2020, a team at Agra, led by Dr. Anshul Pareek, administered Ivermectin to all RRT team members in the district on an experimental basis. It was observed that none of them developed Covid-19 despite being in daily contact with patients who had tested positive for the virus.”


    The Turnaround

    On May 30, TrialSite reported an “unprecedented turnaround in Uttar Pradesh” was indeed a reality marked by a “dramatic decline in cases.” TrialSite suggested to world health leaders it was “time to smell the coffee.”


    But just how severe was the problem? By March 19, 2021, the state, with a population larger than Brazil, reported 380 cases—however, by April 24, the number of COVID-19 cases skyrocketed to 37,944. By April, India included Ivermectin on its national guidelines, much to the chagrin of the World Health Organization (WHO) and the Directorate of Medical & Health Services, Uttar Pradesh went into full throttle in an unprecedented home health outreach campaign.


    Health department teams of two, organized by area, proactively visited homes, conducted tests, and provided medication kits in what was probably the largest home prophylactic delivery program worldwide. Led by Dr. Anshul Pareek, General Medical and Health Services for the state, Uttar Pradesh became the first state across India to declare Ivermectin in a large-scale prophylactic program emphasizing 1) close contacts of COVID-19 patients, 2) health workers, and 3) general care of COVID-19 patients.


    WHO Praises the Effort—but Omits Use of Ivermectin

    WHO reported on the amazing health agency effort via its website, titled “Going the Last Mile to Stop COVID-19” the agency acknowledged government health teams were “moving across 97,941 villages, 75 districts over five days for this activity.”


    WHO emphasized that public health teams of two crisscrossed the state home to 230 million, “visiting homes in villages and remote hamlets to test everyone with symptoms of COVID-19 using Rapid Antigen Tests (RAT) kits.” Anyone that was tested positive WHO reported was immediately“…given a medicine kit with advice on disease management” accompanied with quarantines.


    As TrialSite reported, local media such as the Hindustan Times reported that Uttar Pradesh accounted for nearly 75% of all COVID-19 recoveries nationwide. Yet severe press censorship was in effect. No Western media at the time covered the unfolding activity at the time (except TrialSite), while coverage in India was guarded. Few newspapers and online journals uttered the word—Ivermectin—but some media managed to do so.


    Merck & WHO Cabal

    WHO went on the offense once India established Ivermectin on its national protocol. WHO’s chief scientist Soumya Swaminathan tweeted that Ivermectin should not be used, referencing Merck’s warning about the drug. See TrialSite’s entry on the Merck-Ivermectin warning topic. Of course, this tweet triggered the Indian bar association lawsuit against WHO. Indirectly including Merck in her tweet, WHO’s Dr. Swaminathan insulted not only millions of people but also evidenced her true naivety.


    Of course, Merck was paid $356 million in December to develop a COVID-19 therapeutic—Molnupiravir.


    Since then, the Biden administration has awarded Merck a $1.2 billion guaranteed procurement contract should the drug become either authorized on an emergency use basis or approved. Any data that indicates some ivermectin benefit represented an inconvenient truth for Merck. Ivermectin had to be banished from the public discussion.


    Most certainly, that’s why over the past few months, an intense and particularly vile smear campaign emerged in mainstream media. Various medical establishment organizations now vilified Ivermectin and anyone discussing positive benefits. Elite academicians and physician society and board leadership to mainstream media writers found it paid to trash talk the drug—it was the start of hunting season, and Ivermectin was the target. Notably, the drug has become fondly referred to across mainstream media as the deworming agent for horses.


    Social media had already systematically censored any content mentioning the drug for months previous. For example, when TrialSite reported in January 2021 that Slovakia authorized the use of the drug for the pandemic, Facebook immediately censored that article, despite the fact that it was the truth—and not misinformation.


    Much of the media over the past couple of months exploited a reference made by the FDA and CDC to data from the Association of Poison Control Centers (AAPCC) indicating a three-fold increase in Ivermectin-related calls to one of their 55 poison control centers.


    TrialSite was able to secure that data. Our analysts found that the number of calls increased from 435 to 1,143 and that only 1% of the calls involved anything serious (11 incidents). There were no deaths despite legitimate physician prescriptions increasing from a few thousand per month to nearly 90,000. TrialSite determined, based on the data hand sanitizer (4 deaths), was more dangerous. We also noted that the media was confusing legitimate physician-to-patient prescriptions versus the illicit use of the veterinary version of the drug.


    MSN posted a summary of the amazing Uttar Pradesh turnaround. An amazing accomplishment that should have been chronicled by every major media, rather a media blackout for all things Ivermectin helped suppress the pathbreaking public health accomplishment. But the truth has a way of finding the light.


    Call to Action: Follow the link to the MSN story—the first mainstream media account of the amazing Uttar Pradesh story.

  • What an ridiculous statement. And funnily enough, completely at odds with the original wyttenfact:

    You are a silly child: Damage is damage! Whether it harms is not included in the word damage. So your understanding of speech and semantics are underground. Or as I say just silly. At least you did try to teach yourself some medical terms...


    WHO reported on the amazing health agency effort via its website, titled “Going the Last Mile to Stop COVID-19” the agency acknowledged government health teams were “moving across 97,941 villages, 75 districts over five days for this activity.”


    I guess THHuxleynew will teach us this have been clandestine Gates teams that healed Uttar Pradesh by spending chips ....and free vaccines..

  • University of Ottawa Heart Institute Retrospective Study Finds 1 in 1,000 mRNA Vaccinations Leads to Myopericarditis


    University of Ottawa Heart Institute Retrospective Study Finds 1 in 1,000 mRNA Vaccinations Leads to Myopericarditis
    A research team from the University of Ottawa Heart Institute in Canada recently concluded and uploaded study results investigating the relationship
    trialsitenews.com


    A research team from the University of Ottawa Heart Institute in Canada recently concluded and uploaded study results investigating the relationship between mRNA COVID-19 vaccinations (Pfizer-BioNTech and Moderna) and heart-related conditions of myocarditis/pericarditis diagnosis over a two-month period from June 1, 2021, to July 31, 2021. A prospective study, the Ottawa-based study team, studied the records of patients that received an mRNA vaccine within a month prior to symptom presentation. The study subjects were admitted into the hospital with heart and chest-related symptoms. With data obtained from the Public Health Agency of Ottawa, the study team was able to compare data sets, declaring that this study effort represented the largest case series relating temporal relationship between mRNA COVID vaccination, symptoms, and findings. Study subjects were patients at the Heart Institute. Summarizing the study results, the study authors found that among the subjects, typically, symptom onset commenced during the first few days post-vaccination. Study investigators identified 32 patients during the study period fitting the study inclusion criteria, with 18 patients diagnosed with myocarditis. They concluded that in this part of Ottawa, Canada, during the study term that approximately one out of every 1,000 inoculations led to myopericarditis. While the Ottawa team cannot provide causation, they most certainly declared a tight temporal association between jab and myocarditis-related hospitalization.


    In this health catchment area, the investigators found that during the study period, 32 patients met the study inclusion criteria. Of that group, 18 were diagnosed with myocarditis, 12 with myopericarditis, and 2 with pericarditis alone. At a median age of 33, the majority of subjects were males (29 out of 32).


    The study team found that in five cases, symptoms emerged after the first mRNA vaccine dose. While 27 of the subjects developed symptoms after the second dose. The investigators observed that the median time from vaccine dose and symptom onset equaled 1.5 days. As far as symptoms associated with the adverse events, chest pain was most common, but investigators identified numerous other conditions.


    The authors, led by Andrew M. Crean with the University of Ottawa Heart Institute, found that the median LV ejection fraction (EF) equaled 57% (44-66%) while investigators observed nine patients with an LVEF under the normal baseline of 55%.


    Again this still non-reviewed study represents the “largest series in the literature to clearly relate the temporal relationship between mRNA COVID vaccination, symptoms and CMR findings.”


    Cases Settled

    Luckily the investigators reported that for the study group, “symptoms settled quickly with standard therapy, and patients were discharged within a few days.” The Canada-based team reported “no major adverse cardiac events and no significant arrhythmias” during the patient’s time in the hospital.


    Limitations

    The investigators declare that these study results don’t necessarily indicate evidence of causation—yet what they refer to as “the tight temporal coupling between vaccination and symptom onset represents a strong causal signal,” which they note are replicated in other reports. Moreover, they benefited from a central referral process, yet they cannot be certain of complete case capture. The study team acknowledged that they didn’t routinely test for other causes of myocarditis.


    With limited short-term outcome data, and acknowledge that the basis for the incidence numbers are based on imperfect public health data. They could not distinguish incidents associated with the first or second dose, so consequently report more generalized data.


    Of course, the study has not been peer-reviewed, and consequently, these results shouldn’t be interpreted until the data is further scrutinized.


    Risk Factors

    According to one recent research paper, the incidence of myocarditis equals between 10 to 20 persons per 100,000 worldwide. The authors from the University of California, Riverside, suggest that a majority of these patients are young and healthy.


    While no conclusions can be made from the present data, the Ottawa study indicates that incidence of myocarditis is more frequent post mRNA COVID-19 vaccination than the normal risk for an average young person. To better understand risks associated with vaccination and COVID-19, it would be important to understand what is the probability of a healthy young person to become infected with a severe case of SARS-CoV-2, leading to serious adverse events and hospitalization.


    University of Ottawa Heart Institute

    The University of Ottawa Heart Institute, located in Ottawa, Canada, originated as a department in The Ottawa Hospital and since then evolved into Canada’s only comprehensive cardiac center, encompassing prevention, diagnosis, treatment, rehabilitation, research, and education.


    The center cares for over 100,000 patients annually and reports very high patient satisfaction. The center is affiliated with the Ottawa Hospital and the University of Ottawa, Faculty of Medicine. The center includes 60 principal investigators leading $65 million worth of research studies per year.


    Lead Research/Investigator

    Andrew M. Crean, BSc, BM, MRCP, FRCR, MPhil, MPH


    Call to Action: Researchers declared additional follow-up is necessary to better understand long-term outcomes for the study group.

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