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    From Shots to Clots: Science shows COVID vaccines cause blood clots.


    From Shots to Clots: Science shows COVID vaccines cause blood clots.
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Joel S. Hirschhorn Americans who
    trialsitenews.com


    Joel S. Hirschhorn


    Americans who have taken COVID vaccine shots and those who have refused to capitulate to the coercion and propaganda are ill-informed about blood clots. This article provides summaries of key recently published research on two types of observed blood clots – microscopic and relatively large size – that merit serious attention and concern. One inevitable conclusion is that the FDA with support from big media is not doing its job to ensure truly informed consent by those taking vaccine shots.


    Canadian physician reports high levels of clots

    Dr Charles Hoffe has been practicing medicine for 28 years in a small, rural town in British Columbia, Canada, and recently gave a long interview. He has given about 900 doses of the Moderna experimental mRNA vaccine to his patients. So, contrary to some critics, he is no anti-vaccine doctor.


    The core problem he has seen are microscopic clots in his patients’ tiniest capillaries. He said “Blood clots occurring at a capillary level. This has never before been seen. This is not a rare disease. This is an absolutely new phenomenon.”


    Most importantly, he has emphasized these micro-clots are too small to show up on CT scans, MRI, and other conventional tests, such as angiograms, and can only be detected using the D-dimer blood test. Using the latter, he found that 62% of his patients injected with an mRNA shot are positive for clotting. He has explained what is happening in bodies. The spike proteins in the vaccine become “part of the cell wall of your vascular endothelium. This means that these cells which line your blood vessels, which are supposed to be smooth so that your blood flows smoothly now have these little spikey bits sticking out. … when the platelet comes through the capillary it suddenly hits all these COVID spikes and it becomes absolutely inevitable that blood clots will form to block that vessel.”


    He made an important distinction: “The blood clots we hear about which the media claim are very rare are the big blood clots which are the ones that cause strokes and show up on CT scans, MRI, etc. The clots I’m talking about are microscopic and too small to find on any scan. They can thus only be detected using the D-dimer test…The most alarming part of this is that there are some parts of the body like the brain, spinal cord, heart and lungs which cannot re-generate. When those tissues are damaged by blood clots they are permanently damaged.”


    This is his pessimistic, scientific view: “blood vessels in their lungs are now blocked up. In turn, this causes the heart to need to work harder to try to keep up against a much greater resistance trying to get the blood through your lungs. This is called pulmonary artery hypertension – high blood pressure in the lungs because the blood simply cannot get through effectively. People with this condition usually die of heart failure within a few short years.”


    All these medical views have been suppressed by big media., but it was covered well in another alternative news site. And the doctor got some attention by submitting an open letter to the provincial Ministry of Health. A key point in that is this: “It must be emphasised, that these people were not sick people, being treated for some devastating disease. These were previously healthy people, who were offered an experimental therapy, with unknown long-term side-effects, to protect them against an illness that has the same mortality rate as the flu. Sadly, their lives have now been ruined.”


    The concept of micro blood clots has also been invoked for the serious impacts of COVID itself. The eminent Dr. Peter McCullough noted “So, this is a very different type of blood clotting that we would see with major blood clots in the arteries and veins. For instance, blood clots involved in stroke and heart attack. Blood clots involved in major blood vessels in the legs. This was a different type of clotting and in fact the Italians courageously did some autopsies and found micro blood clots in the lungs. And so, we understood in the end, the reason why the lungs fail is not because the virus is there. It is because micro blood clots are there. … When People can’t breathe, the problem is micro-blood clotting in the lungs. …The spicule on the ball of the of the virus itself which damages blood vessels that causes blood clotting.” He has also openly stated that none of the COVID vaccines are safe for most people at little risk from COVID.


    If spike protein is the cause of micro blood clots in COVID it is also reasonable to see the same phenomenon in vaccinated people impregnated with spike proteins, as Dr. Hoffe as explained.


    As to the Canadian situation, The Public Health Agency of Canada (PHAC) in July estimated the rate of vaccine-related blood clotting in Canadians who have received the AstraZeneca vaccine and said there have been 27 confirmed cases to date in Canada, with five deaths among those cases, a rather high death rate.


    But this is consistent with 6 out of 28 blood clot cases reported by Yale University for the J&J vaccine in the US Also noted was that these were a particularly rare and dangerous blood clot in the brain, known as cerebral venous sinus thrombosis (CVST), because it appears in the brain’s venous sinuses Also noted that there were abnormally low platelet levels in their blood, an unusual situation also found for those impacted by the AstraZeneca vaccine.


    Wall Street Journal and Nature Journal

    To its credit, the Wall Street Journal published a long article in July on the COVID vaccine blood clot issue. Here are highlights from it.


    “Canadian researchers say they have pinpointed a handful of amino acids targeted by key antibodies in the blood of some people who received the AstraZeneca Covid-19 vaccine, offering fresh clues to what causes rare blood clots associated with the shot.”


    “The peer-reviewed findings, by a team of researchers from McMaster University in Ontario, were published …by the science journal Nature. They could help doctors rapidly test for and treat the unusual clotting, arising from an immune-driven mix of coagulation and loss of platelets that stop bleeding.”


    “The blood clotting, which some scientists have named vaccine-induced immune thrombotic thrombocytopenia, or VITT, has also been linked to Johnson & Johnson’s Covid-19 shot, though incidents have occurred less frequently with that shot than with AstraZeneca.”


    “Though rare, the condition has proven deadly in more than 170 adults post-vaccination in the U.K., Europe and U.S., according to government tallies. Many were younger adults who appeared healthy before vaccination, researchers and drug regulators say.”


    “The total number of cases after first or second doses in the U.K. was 395 through June 23…Of the 395, 70 people have died. European officials said this month that they have seen 479 potential cases of VITT out of 51.4 million AstraZeneca vaccinations…Far fewer potential cases—21 …followed J&J vaccinations in Europe. Of those cases, 100 deaths occurred after AstraZeneca vaccination and four after Johnson & Johnson, European regulators said.”


    “U.S. health officials said in late June that they have identified 38 confirmed cases of the blood-clotting syndrome out of more than 12.3 million people who received the J&J vaccine…The Centers for Disease Control and Prevention said in May that three cases had been fatal and evidence ‘suggests a plausible causal association’ between the combination of low platelets and clotting and the vaccine.”


    As to what is going on inside the body: “[In] rare cases, vaccinated people have experienced an autoimmune reaction in which antibodies bind with unusual strength to a blood component called platelet factor 4, or PF4, forming distinct clusters resembling a bunch of grapes. This so-called immune complex, a molecular formation in the blood, activates more platelets, ‘like putting a match to gasoline,’ said John Kelton, an author of the Nature paper and researcher at McMaster University. The process accelerates, he and other researchers say, triggering simultaneous bleeding and clotting, sometimes in the brain, stomach and other areas that can in rare cases be deadly. ‘We think these antibodies are incredible amplifiers, in a bad way, of the normal coagulation system,’ says Dr. Kelton”


    Interestingly, this article did not mention at all the previously discussed case of the Canadian doctor and his findings about microscopic blood clotting.


    New York Times

    In April, there was limited coverage of stoppages of some vaccines: “First it was AstraZeneca. Now Johnson & Johnson. Last week, British regulators and the European Union’s medical agency said they had established a possible link between AstraZeneca’s Covid-19 vaccine and very rare, though sometimes fatal, blood clots. The pause in the use of Johnson & Johnson’s vaccine in Europe over similar concerns threatens to hurt a sluggish rollout that was just starting to gain momentum.” Also noted was that states paused use of the J&J vaccine after a US advisory.


    “Regulators have asked vaccine recipients and doctors to look out for certain symptoms, including severe and persistent headaches and tiny blood spots under the skin.”


    New England Journal of Medicine

    In April this journal published three research articles on blood clotting related to COVID vaccines and a long editorial by two physicians reviewing all the work. Here are highlights from the latter.


    “The Journal has now highlighted three independent descriptions of 39 persons with a newly described syndrome characterized by thrombosis and thrombocytopenia that developed 5 to 24 days after initial vaccination with [the AstraZeneca vaccine]. … These persons were healthy or in medically stable condition, and very few were known to have had previous thrombosis or a preexisting prothrombotic condition. Most of the patients included in these reports were women younger than 50 years of age, some of whom were receiving estrogen-replacement therapy or oral contraceptives. A remarkably high percentage of the patients had thromboses at unusual sites — specifically, cerebral venous sinus thrombosis or thrombosis in the portal, splanchnic, or hepatic veins. Other patients presented with deep venous thrombi, pulmonary emboli, or acute arterial thromboses. … High levels of d-dimers and low levels of fibrinogen were common and suggest systemic activation of coagulation. Approximately 40% of the patients died, some from ischemic brain injury, superimposed hemorrhage, or both conditions, often after anticoagulation.”


    “Better understanding of how the vaccine induces these platelet-activating antibodies might also provide insight into the duration of antigen exposure and the risk of reoccurrence of thrombosis, which will inform the need for extended anticoagulation and might lead to improvements in vaccine design.”


    “Additional cases have now been reported to the European Medicines Agency, including at least 169 possible cases of cerebral venous sinus thrombosis and 53 possible cases of splanchnic vein thrombosis among 34 million recipients of the [AstraZeneca] vaccine, 35 possible cases of central nervous system thrombosis among 54 million recipients of the Pfizer–BioNTech mRNA vaccine, and 5 possible (but unvetted) cases of cerebral venous sinus thrombosis among 4 million recipients of the Moderna mRNA vaccine. Six possible cases of cerebral venous sinus thrombosis (with or without splanchnic vein thrombosis) have been reported among the more than 7 million recipients of the Johnson & Johnson/Janssen vaccine.”


    Here is the final conclusion; “The questions of whether certain populations can be identified as more suitable candidates for one or another vaccine and who and how to monitor for this rare potential complication will require additional study.”


    Salk Institute

    In April, the Salk Institute promoted coverage of research conducted by a number of people associated with it. The chief finding was that the spike protein associated with the COVID virus and with vaccines was connected to strokes, heart attacks and blood clots.


    “The paper, published in Circulation Research, also shows conclusively that COVID-19 is a vascular disease, demonstrating exactly how the SARS-CoV-2 virus damages and attacks the vascular system on a cellular level. … the paper provides clear confirmation and a detailed explanation of the mechanism through which the [spike] protein damages vascular cells.”


    A subsequent article in May examined this work and made several important observations. Here is its perspective, as relevant to the COVID vaccines. “The prestigious Salk Institute…has authored and published the bombshell scientific study revealing that the SARS-CoV-2 spike protein used in the Covid jabs is what’s actually causing vascular damage. Critically, all three of the experimental Covid vaccines currently under emergency use authorisation in the UK either inject patients with the spike protein or, via mRNA technology, instruct the patient’s own body to manufacture the spike protein and release them into the blood system.”


    “The Salk Institute study proves the assumption made by the vaccine industry, that the spike protein is inert and harmless, to be false and dangerously inaccurate.”


    “The research proves that the Covid vaccines are capable of inducing vascular disease and directly causing injuries and deaths stemming to blood clots and other vascular reactions. This is all caused by the spike protein that’s engineered into the vaccines.”


    Report by 57 Medical Experts

    This May report was prepared by nearly five dozen highly respected doctors, scientists, and public policy experts from across the globe. It went public and was urgently sent to world leaders as well as all who are associated with the production and distribution of the various Covid-19 vaccines in circulation today. The report demanded an immediate stop to COVID vaccinations. Dr. McCullough was one of the signatories.


    “Despite calls for caution, the risks of SARS-CoV-2 vaccination have been minimized or ignored by health organizations and government authorities,” said the experts.


    On the issue of blood clotting in vaccinated people the report said this:


    “Some adverse reactions, including blood-clotting disorders, have already been reported in healthy and young vaccinated people. These cases led to the suspension or cancellation of the use of adenoviral vectorized [AstraZeneca] and [J&J] vaccines in some countries. It has now been proposed that vaccination with ChAdOx1-nCov-19 can result in immune thrombotic thrombocytopenia (VITT) mediated by platelet-activating antibodies against Platelet factor-4, which clinically mimics autoimmune heparin-induced thrombocytopenia. Unfortunately, the risk was overlooked when authorizing these vaccines, although adenovirus-induced thrombocytopenia has been known for more than a decade, and has been a consistent event with adenoviral vectors. The risk of VITT would presumably be higher in those already at risk of blood clots, including women who use oral contraceptives, making it imperative for clinicians to advise their patients accordingly.”


    Conclusions

    Supporters of the COVID vaccines are quick to emphasize that relatively few recipients have experienced post-vaccination blood clotting. True, except for the findings of the Canadian physician about microscopic blood clots in most of his patients that major news media have ignored. Also ignored are the findings from the Salk Institute which provide a rationale for seeing spike proteins as causing clots. Even vaccines not directly including spike proteins – the AstraZeneca and J&J adenovirus vector vaccines – pose a problem because they send genetic instructions into cells to produce the spike protein of the coronavirus.


    Even a June case study of one patient who died from clotting after taking the second dose of the Moderna vaccine and not related to anything else stressed the use of “safe” COVID vaccines. This was also stressed in an accompanying editorial that mentioned: “The highest reported incidence is 5 cases among about 130,000 Norwegian recipients of the [AstraZeneca] vaccine.” This statistical view of the medical establishment was expressed as: “any potential risks of vaccination must be interpreted in the context of the overall morbidity and mortality of COVID-19 itself.” It also stressed blood clots in hospitalized COVID patients. It cannot be emphasized enough that the vast majority of COVID victims could have been saved through early home/outpatient treatment as detailed in Pandemic Blunder. The proven treatments can stop COVID infection in its early virus replication phase and, therefore, prevent blood clots.


    The public also needs strong information about the many advantages of natural immunity, from prior COVID infection or life exposure to various coronaviruses. This is far better than vaccine induced artificial immunity that does less to protect against COVID variants and makes people susceptible to breakthrough infections. For most people the benefits of COVID vaccination do not outweigh the risks.


    On the issue of whether all COVID vaccines pose a blood clot threat consider an April study by Oxford University that found the number of people who receive blood clots after getting vaccinated with a coronavirus vaccine are about the same for those who get Pfizer and Moderna vaccines as they are for the AstraZeneca vaccine. And as already cited the J&J vaccine has also been implicated for clots.


    What needs attention by FDA, CDC and NIH is the need to do more testing of vaccine victims to discover through blood testing or autopsies the nature and extent of blood clotting.


    For those wanting to see many examples of COVID vaccine negative health impacts this website is recommended. The mission is: “This website is dedicated to sharing the truth about these people and their testimonials. Watch for yourself and make up your own mind. Is it worth it to risk life-changing and even fatal side effects from a vaccine for a disease that is survived by 99.98% of people under 70?”


    Of course, the risk of getting serious blood clots is much higher for those who get a serious case COVID-19 then it is for those who get vaccinated. They tend to be acute, near-term impacts amenable to various treatments, though sadly not lifesaving in all cases.


    More insidious, in the longer run, however, perhaps years after the shots, are the microscopic blood clots noted by Dr. Hoffe and Dr. McCollough that may impact the lives of many people, perhaps millions.


    Dr. Joel S. Hirschhorn, author of Pandemic Blunder and many articles on the pandemic, worked on health issues for decades. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers. He has served as an executive volunteer at a major hospital for more than 10 years. He is a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.

    .Chart of the day: COVID-19 virus found in sewage and blood samples in 2019


    Chart of the day: COVID-19 virus found in sewage and blood samples in 2019
    Through screening of past cases, tests on blood samples and even wastewater, multiple studies found the existence of the virus elsewhere before China reported…
    news.cgtn.com


    A recent research paper indicated that COVID-19 could have circulated in Italy in late 2019, weeks before it was formally identified in China, raising more questions about the origins of the virus.


    Since the start of the COVID-19 pandemic, scientists from all over the world have been researching SARS-CoV-2, the virus that causes the disease.


    Through screening of past cases, tests on blood samples and even wastewater, multiple studies found the existence of the virus elsewhere before China reported its first case


    It's Time For NIH Transparency on Wuhan Research Funding | Opinion


    It's time for NIH transparency on Wuhan research funding | Opinion
    While everyone in Washington loves a good debate, we need less finger wagging and more facts.
    www.newsweek.com


    The recent spats between Dr. Anthony Fauci and Sen. Rand Paul (R-Ky.) about how the coronavirus pandemic started made for good television. The head of the National Institute of Allergy and Infectious Diseases wagged his finger at a United States senator and called him a liar. Dr. Fauci rejected the premise of tough, evidence-based questions about our government's support of risky "gain-of-function" research at the Wuhan Institute of Virology (WIV) on his watch

    While everyone in Washington loves a good debate, we need less finger wagging and more facts.


    The public deserves access to documents from both the Chinese government and the National Institutes of Health (NIH). Communist China's secrecy is to be expected, of course, but the U.S. government ought to be more transparent and stop hiding what it knows about the virus research in Wuhan.

    Public health experts agree that to stop the next pandemic, we must find out how the COVID-19 virus—which has killed more than 4 million people worldwide and 600,000 Americans—began in China. Some argue the pandemic started because of a natural virus spillover from bats or other animals to humans, while others posit that it could have started through a leak from a lab in Wuhan, China, where scientists have been collecting and studying similar viruses for years.

    Members of both the House and Senate have sent multiple requests to the NIH demanding to see documents about the money American taxpayers provided to the virus lab in Wuhan, and to view reports that explain specifics about this research. By refusing to release these documents, Dr. Fauci and other NIH officials have made it impossible to learn what the NIH has funded, and what it knows about research at Wuhan.

    House members recently sent the NIH a second letter, demanding transparency on documents requested months ago about funding and reports of this research at the WIV. Meanwhile, the Washington Post editorial board reiterated its call for transparency on the WIV's risky gain-of-function research.


    In a recent editorial, Columbia University professor Jeffrey Sachs laid out what we know: the NIH funded U.S. and Chinese scientists to collect SARS viruses and study them at the Wuhan Institute of Virology. As Dr. Sachs explained, this research "included the creation of chimeric genetic recombinants of SARS-like viruses to study their capacity to infect human cells and to cause disease." In short, American taxpayers funded research at the WIV that many scientists call "gain of function," meaning it can increase the ability of an animal virus to infect and harm humans. Dr. Sachs leads a commission by a medical journal called The Lancet to investigate how the pandemic began.Last year, Newsweek reported that Dr. Fauci provided grant money that ended up supporting risky research at the WIV. In March, the Washington Post called for an independent investigation into how the pandemic started, pointing out that the Wuhan Institute of Virology had done gain-of-function experiments and had been working on viruses very similar to COVID-19. And last April, Politico reported that former acting CIA director Michael Morell noted that if the virus leaked from a Wuhan lab, the U.S. would shoulder some of the blame since it funded research at that lab through government grants from 2014 to 2019.

    The NIH released thousands of pages of internal documents that the Washington Post and Buzzfeed sought through the Freedom of Information Act. But the agency heavily redacted these documents, as the government often does to hide embarrassing details.


    Yet NIH director Francis Collins is on record demanding transparency from others. "I do think we should be calling on China to make an expert-driven transparent investigation possible, because there are way too many unanswered questions," he told the Washington Post. Dr. Collins also told the Post that the Wuhan researchers need to open their lab notebooks to be examined by outside experts. "If they really want to be exonerated from this claim of culpability, then they have got to be transparent."


    Agreed, but the NIH should be transparent too. How can Dr. Collins demand that researchers in Wuhan open their lab notebooks when the institute he leads will not do the same? Does Collins think that the public is not smart enough to see this hypocrisy?

    The NIH released thousands of pages of internal documents that the Washington Post and Buzzfeed sought through the Freedom of Information Act. But the agency heavily redacted these documents, as the government often does to hide embarrassing details.

    While everyone in Washington loves a good debate, we need less finger wagging and more facts.


    The public deserves access to documents from both the Chinese government and the National Institutes of Health (NIH). Communist China's secrecy is to be expected, of course, but the U.S. government ought to be more transparent and stop hiding what it knows about the virus research in Wuhan.



    Public health experts agree that to stop the next pandemic, we must find out how the COVID-19 virus—which has killed more than 4 million people worldwide and 600,000 Americans—began in China. Some argue the pandemic started because of a natural virus spillover from bats or other animals to humans, while others posit that it could have started through a leak from a lab in Wuhan, China, where scientists have been collecting and studying similar viruses for years.

    Members of both the House and Senate have sent multiple requests to the NIH demanding to see documents about the money American taxpayers provided to the virus lab in Wuhan, and to view reports that explain specifics about this research. By refusing to release these documents, Dr. Fauci and other NIH officials have made it impossible to learn what the NIH has funded, and what it knows about research at Wuhan.



    House members recently sent the NIH a second letter, demanding transparency on documents requested months ago about funding and reports of this research at the WIV. Meanwhile, the Washington Post editorial board reiterated its call for transparency on the WIV's risky gain-of-function research.


    In a recent editorial, Columbia University professor Jeffrey Sachs laid out what we know: the NIH funded U.S. and Chinese scientists to collect SARS viruses and study them at the Wuhan Institute of Virology. As Dr. Sachs explained, this research "included the creation of chimeric genetic recombinants of SARS-like viruses to study their capacity to infect human cells and to cause disease." In short, American taxpayers funded research at the WIV that many scientists call "gain of function," meaning it can increase the ability of an animal virus to infect and harm humans. Dr. Sachs leads a commission by a medical journal called The Lancet to investigate how the pandemic began.


    Last year, Newsweek reported that Dr. Fauci provided grant money that ended up supporting risky research at the WIV. In March, the Washington Post called for an independent investigation into how the pandemic started, pointing out that the Wuhan Institute of Virology had done gain-of-function experiments and had been working on viruses very similar to COVID-19. And last April, Politico reported that former acting CIA director Michael Morell noted that if the virus leaked from a Wuhan lab, the U.S. would shoulder some of the blame since it funded research at that lab through government grants from 2014 to 2019.



    The NIH released thousands of pages of internal documents that the Washington Post and Buzzfeed sought through the Freedom of Information Act. But the agency heavily redacted these documents, as the government often does to hide embarrassing details.


    Yet NIH director Francis Collins is on record demanding transparency from others. "I do think we should be calling on China to make an expert-driven transparent investigation possible, because there are way too many unanswered questions," he told the Washington Post. Dr. Collins also told the Post that the Wuhan researchers need to open their lab notebooks to be examined by outside experts. "If they really want to be exonerated from this claim of culpability, then they have got to be transparent."


    Agreed, but the NIH should be transparent too. How can Dr. Collins demand that researchers in Wuhan open their lab notebooks when the institute he leads will not do the same? Does Collins think that the public is not smart enough to see this hypocrisy?



    "It is in fact common knowledge in the US scientific community that NIH has indeed supported genetic recombinant research on SARS-like viruses that many scientists describe as [gain of function research]," wrote Dr. Sachs in his recent editorial. He added that the process for oversight of this research is weak, limiting access for outside experts to inspect virus labs, review safety reports and scrutinize funding approvals.


    "All laboratory notebooks and other relevant information should be opened by the Chinese and U.S. scientists working on this project for detailed scrutiny by independent experts," Dr. Sachs wrote.


    To get to the bottom of how this pandemic—which has demolished economies and destroyed millions of lives—began, we cannot rely on half measures and debates driven by politics rather than facts.



    Americans funded research in Wuhan. We have a right to know what we paid for and whether it went horribly wrong. The Chinese government needs to be more transparent and cooperate with world leaders to get to the bottom of what happened in those labs. And Americans need to hold our own government accountable to an even higher standard of transparency.


    Jason Foster is Founder & President of Empower Oversight Whistleblowers & Research, and former Chief Investigative Counsel to the Senate Judiciary Committee.

    COVID: 90% of patients treated with new Israeli drug discharged in 5 days


    COVID: 90% of patients treated with new Israeli drug discharged in 5 days
    The Phase II trial for an Israeli COVID drug saw some 29 out of 30 patients, moderate to serious, recover within days.
    m.jpost.com


    The Phase II trial for an Israeli COVID drug saw some 29 out of 30 patients, moderate to serious, recover within days.

    Some 93% of 90 coronavirus serious patients treated in several Greek hospitals with a new drug developed by a team at Tel Aviv’s Sourasky Medical Center as part of the Phase II trial of the treatment were discharged in five days or fewer.

    The Phase II trial confirmed the results of Phase I, which was conducted in Israel last winter and saw 29 out of 30 patients in moderate to serious condition recover within days.

    The main goal of this study was to verify that the drug is safe,” Prof. Nadir Arber said. “To this day we have not registered any significant side effect in any patient from both groups.”

    The trial was conducted in Athens because Israel did not have enough relevant patients. The principal investigator was Greece’s coronavirus commissioner, Prof. Sotiris Tsiodras.

    Arber and his team, including Dr. Shiran Shapira, developed the drug based on a molecule that the professor has been studying for 25 years called CD24, which is naturally present in the body.

    “It is important to remember that 19 out of 20 COVID-19 patients do not need any therapy,” Arber said. “After a window of five to 12 days, some 5% of the patients start to deteriorate.”

    The main cause of the clinical deterioration is an over activation of the immune system, also known as a cytokine storm. In case of COVID-19 patients, the system starts attacking healthy cells in the lungs.

    “This is exactly the problem that our drug targets,” he said.

    CD24 is a small protein that is anchored to the membrane of the cells and it serves many functions including regulating the mechanism responsible for the cytokine storm.

    Arber stressed that their treatment, EXO-CD24, does not affect the immune system as a whole, but only targets this specific mechanism, helping find again its correct balance.

    “This is precision medicine,” he said. “We are very happy that we have found a tool to tackle the physiology of the disease.”

    “Steroids for example shut down the entire immune system,” he further explained. “We are balancing the part responsible for the cytokine storms using the endogenous mechanism of the body, meaning tools offered by the body itself.”

    Arber noted that another breakthrough element of this treatment is its delivery.

    “We are employing exosomes, very small vesicles derived from the membrane of the cells which are responsible for the exchange of information between them,” he said.

    “By managing to deliver them exactly where they are needed, we avoid many side effects,” he added.

    The team is now ready to launch the last phase of the study.

    “As promising as the findings of the first phases of a treatment can be, no one can be sure of anything until results are compared to the ones of patients who receive a placebo,” he said.

    Some 155 coronavirus patients will take part in the study. Two-thirds of them will be administered the drug, and one-third a placebo.

    The study will be conducted in Israel and it might be also carried out in other places if the number of patients in the country will not suffice.

    “We hope to complete it by the end of the year,” Arber said.

    If the results are confirmed, he vowed that the treatment can be made available relatively quickly and at a low cost.

    “In addition, a success could pave the wave to treat many other diseases,” he concluded.

    Fully vaccinated people who get a Covid-19 breakthrough infection can transmit the virus, CDC chief says


    Fully vaccinated people who get a Covid-19 breakthrough infection can transmit the virus, CDC chief says
    Fully vaccinated people who get a Covid-19 breakthrough infection can transmit the virus, US Centers for Disease Control and Prevention Director Dr. Rochelle…
    amp.cnn.com


    (CNN)Fully vaccinated people who get a Covid-19 breakthrough infection can transmit the virus, US Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said Thursday.


    "Our vaccines are working exceptionally well," Walensky told CNN's Wolf Blitzer. "They continue to work well for Delta, with regard to severe illness and death -- they prevent it. But what they can't do anymore is prevent transmission."


    That's why the CDC changed its guidance last week and is now recommending even vaccinated people wear masks indoors again, Walensky said.

    Last week, the agency released a study that showed the Delta variant produced similar amounts of virus in vaccinated and unvaccinated people if they got infected -- data that suggests vaccinated people who get a breakthrough infection could have a similar tendency to spread the virus as the unvaccinated.


    "If you're going home to somebody who has not been vaccinated, to somebody who can't get vaccinated, somebody who might be immunosuppressed or a little bit frail, somebody who has comorbidities that put them at high risk, I would suggest you wear a mask in public indoor settings," Walensky said.


    The dangerous Delta variant has fueled the country's latest surge of Covid-19 cases and if more Americans don't get vaccinated and mask up, the country could soon be seeing "several hundred thousand cases a day," similar to the winter surge, Walensky said.


    And while states across the South -- including Florida and Louisiana -- have seen exponential rises in cases, Walensky said, they have not reached their peak just yet.


    'Next variant is just around the corner'

    Getting more people vaccinated won't just help crush this surge, experts say. It will help prevent other -- potentially even more aggressive -- variants from arising in the future.


    "The next variant is just around the corner, if we do not all get vaccinated," Adm. Brett Giroir, the former coronavirus testing czar under President Donald Trump, told CNN's Chris Cuomo.

    I just beg the American people to understand that to defeat this virus, we have to get everybody's level of immunity up, and that's just the way it is," he added.


    Roughly 58.2% of the US population has received at least one Covid-19 vaccine dose, CDC data shows, and about 49.9% is fully vaccinated.


    There was some encouraging news Thursday, as White House data director Dr. Cyrus Shahpar tweeted there was the most number of doses reported administered in a single day in more than a month. He said that more than 864,000 doses had been reported administered over the previous day's total, including about 585,000 people who got their first shot.


    In the coming weeks, surges will likely reach all across the US, not just areas with low vaccination rates, former CDC Director Dr. Tom Frieden said Wednesday. The outbreaks, however, will not be as explosive in areas with higher vaccination coverage, Frieden added.


    As cases increase, hospitalizations and deaths will likely rise as well, according to ensemble forecasts published Wednesday by the CDC. The forecast predicts a total of 624,000 to 642,000 deaths will be reported by August 28. As of Wednesday, there have been 614,342 Covid-19 deaths in the US, according to data compiled by Johns Hopkins University.

    If you're not protected against Covid-19, the virus will likely infect you, Michael Osterholm, director for the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN's Pamela Brown on Wednesday.

    This virus is highly infectious. If you decide to try to run the game clock out, don't try to do it. This virus will find you, it will infect you eventually," Osterholm, said


    Fortunately, the available vaccines appear to offer a strong defense against the Delta variant, especially when it comes to severe illness and deaths, Frieden said.


    "We are at war with this virus that has already killed more than 610,000 Americans. We now have the tools with vaccines and masks to stop further death and suffering and destruction," CNN medical analyst Leana Wen said Wednesday.


    FDA could lay out vaccine booster strategy next month

    Meanwhile, as more questions arise over whether fully vaccinated Americans will need booster shots, a Biden administration official told CNN that internal discussions at the US Food and Drug Administration have centered around an early September timeline for laying out a strategy.

    That strategy would apply for all vaccinated people. A decision for those who are immunocompromised and face greater risk from Covid-19 is expected sooner, the official said.


    Earlier this week, Dr. Anthony Fauci said that people with compromised immune systems may need additional protection after receiving a Covid-19 vaccine -- and there is an effort to make vaccine booster shots available to those people "very soon."


    "There are those individuals who are immune compromised -- transplant patients, patients on cancer chemotherapy, patients on immunosuppressive regimen, for example, for autoimmune diseases," Fauci said during a virtual event hosted by Virginia Gov. Ralph Northam on Tuesday. "Those individuals we know almost invariably do not have an adequate response, so the need to give them an additional boost is much more emergent than the general population."

    Vaccine advisers to the CDC have met to discuss whether immunocompromised people may need additional protection from a vaccine booster but have not presented a recommendation or voted on guidance.


    On Wednesday, US Surgeon General Vivek Murthy said a recommendation from the federal government on vaccine boosters will come "if and when" there is evidence that rising infections are due to decreasing vaccine immunity.


    "I recognize that individual doctors and their patients may make a decision ... around ... getting an extra dose and that may be as it is but formally, we cannot make that recommendation yet until we feel that the data is clear and indicates boosters are required," Murthy said.


    'We've let our children down,' FDA vaccine adviser says

    Low Covid-19 vaccination rates in the US place children -- many of whom cannot get vaccinated -- at risk, Dr. Paul Offit, a vaccine adviser to the US Food and Drug Administration, said Wednesday.


    "I think we've let our children down," Offit told CNN's Wolf Blitzer.


    There is not currently a vaccine authorized for children under the age of 12 in the US, so young children rely on the vaccination of those around them to protect them, Offit explained. And many children who are 12 and older have not yet gotten the vaccine, he added.

    "We need to get vaccination rates up, so that these children can be protected," Offit said.


    Highlighting that point, the president of Our Lady of the Lake Children's Hospital in Baton Rouge, Louisiana, told CNN his staff is seeing babies in the neonatal intensive care unit sick with Covid-19.


    Dr. Trey Dunbar told CNN children are being victimized by a pandemic that has a simple solution: adult vaccination.


    "Covid is a preventable disease," he said. "It's hard for us as pediatricians to see kids affected by a preventable disease. Children aren't like adults. They don't have the choice to get vaccinated.


    "So, yes, it makes a big difference when adults make decisions for kids and adults make decisions that could maybe prevent diseases that we see in children," Dunbar said.


    Concerns over America's youngest come as schools across the country gear up for reopening -- and as district leaders try to navigate the safest way to return to class. Having children wear masks remains a point of contention in communities throughout the US -- with some states requiring masks in schools while others have prohibited mask mandates.


    On Thursday, Metro Nashville Public Schools sent a letter to families saying students, staff and visitors will be required to wear masks in school buildings when the school year kicks off next week. Masks will also be required on school buses, but not outdoors, the district said, adding the rule will stay in place "until further notice."


    Only six ICU beds available in one state

    Even after the development and release of Covid-19 vaccines that so many health care professionals had hoped for, rising cases have led to overwhelmed hospitals.


    Arkansas health officials reported a "record low number of available ICU beds," Wednesday. According to Arkansas Department of Health public information officer Danyelle McNeill, the state had just 25 ICU beds available.

    According to Arkansas' Covid-19 dashboard, there was a total of 1,232 Covid-19 positive admissions. The total number of Covid-19 positive admissions in the ICU is 466, and the total Covid-19 positive admissions on ventilators is 260.


    As of Wednesday morning, Mississippi had only six open ICU beds available in the entire state, Dr. Jonathan Wilson, chief administrative officer and Covid-19 incident manager, said during a Covid-19 briefing with University of Mississippi Medical Center leaders.


    "A very simple number, six. That's how many open ICU beds we had in the state of Mississippi, this morning. Six. So, the situation is getting dire, not just here at the Medical Center, here in Metro Jackson, but the entire state. Our neighboring states are having similar situations," Wilson said.


    "We're doing the best we can, from a state standpoint, to try to distribute patients to ensure healthcare as we know it is delivered. But we aren't on the cusp of this, we know that we aren't at the crest of this wave and it's bad, but it's probably going to get a little worse," Wilson added.


    Clarification: This story has been updated to specify that Dr. Walensky was referencing fully vaccinated people who get a breakthrough infection when saying that vaccines no longer prevent transmission of Covid-19.


    CNN's Lauren Mascarenhas, Elizabeth Stuart, Kaitlan Collins, Naomi Thomas, Deidre McPhillips, Jeff Simon, Nadia Romero and Raja Razek contributed to this report.

    Fauci Out Selling Early Oral Treatments Now—Seeking to Monetize the Majority of COVID-19 Cases


    Fauci Out Selling Early Oral Treatments Now—Seeking to Monetize the Majority of COVID-19 Cases
    Dr. Anthony Fauci is back in sales mode, now representing his pharmaceutical patrons. After spending many billions already on what in many cases have
    trialsitenews.com


    Dr. Anthony Fauci is back in sales mode, now representing his pharmaceutical patrons. After spending many billions already on what in many cases have become throw-away monoclonal antibodies and several questionable therapies in the pipeline, the head of the National Institute of Allergy and Infectious Diseases (NIAID) and chief medical advisor to POTUS spent lots of time minimizing the mounting evidence associated with many generic early COVID-19 treatment options, from fluvoxamine and ivermectin to even hydroxychloroquine used in select scenarios. Now Fauci will deliver to the market the perfect pill and help the industry monetize the massive market for early-onset COVID-19 mild-to-moderate cases—the 90%+ of total cases that fit in that category.


    Reuters recently showcased some of Fauci’s latest pitches, including the ability to care for individuals early, stopping the virus from progressing to an upper airway infection, thus turning the virus into what is more like a common cold.


    Fauci suggests his perfect pill—one that blocks a specific viral function, is taken once a day and is low in toxicity with minimal drug-drug interactions. It is orally administered and given for seven to ten days. Do you think he would be open to generic options such as ivermectin? With the Fauci pivot, he begins now moving away from vaccines and early treatments, something that’s about 1.5 years late.

    Another side effect linked to Pfizer!

    Pfizer COVID-19 vaccine linked to rare cases of eye inflammation - study


    Pfizer COVID-19 vaccine linked to rare cases of eye inflammation - study
    Twenty-one people developed anterior uveitis and two developed Multiple Evanescent White Dot Syndrome (MEWDS).
    m.jpost.com


    Twenty-one people developed anterior uveitis and two developed Multiple Evanescent White Dot Syndrome (MEWDS)

    The Pfizer coronavirus vaccine may be linked to a form of eye inflammation called uveitis, according to a multicenter Israeli study led by Prof. Zohar Habot-Wilner from Tel Aviv’s Sourasky Medical Center.

    The research was conducted at Rambam Health Care Campus, Galilee Medical Center, Shaare Zedek Medical Center, Sheba Medical Center in Tel Hashomer, Kaplan Medical Center and Sourasky. It was accepted for publication by the peer-reviewed ophthalmology journal Retina.

    Habot-Wilner, head of the Uveitis Service at the hospital, found that 21 people (23 eyes) who had received two shots of the Pfizer vaccine developed uveitis within one to 14 days after receiving their first shot or within one day to one month after the second.

    Twenty-one people developed anterior uveitis, and two developed Multiple Evanescent White Dot Syndrome (MEWDS).


    “All the patients in the study met the World Health Organization and Naranjo criteria linking the onset of uveitis to the vaccination,” Habot-Wilner said. “This time frame is consistent with other reports of uveitis following various vaccines.”

    She said that any patients that had other systemic diseases that could have been related to uveitis were under control before vaccination. In addition, none of the patients had any changes in their systemic treatments for at least six months before getting the shots.

    Eight of the patients had a prior history of uveitis, but no less than one to 15 years prior.

    Specifically, most cases were mild – only three were severe – and all anterior uveitis cases were able to be treated by topical corticosteroids and eye drops for pupil dilation. MEWDS cases, as accepted, were not addressed.

    “Only one case worsened after receiving the second dose,” according to Habot-Wilner, but she said that with appropriate treatment the disease also resolved for that individual.

    “An examination at the end of the follow-up period found that in all eyes visual acuity improved and disease was completely resolved,” she said.

    “The conclusion is that I do recommend getting vaccinated for people with or without a history of uveitis,” Habot-Wilner stressed. But she said that if people do experience a uveitis attack after taking the vaccine, they should get a good ocular examination and be treated appropriately. And, if the uveitis occurs after the first dose, they should still get the second one.

    Habot-Wilner stressed that developing uveitis from vaccination in general is “quite rare,” but that the eye inflammation has been associated with other vaccines.

    “It is very uncommon, but if you do feel something is wrong with your eyes, if you have pain, redness or vision deterioration,” she said, “please go and visit your eye doctor.”

    University of Manitoba Participates in Two Studies Indicating Full Dose Blood Thinners Benefit Moderately Ill COVID-19 Patients


    University of Manitoba Participates in Two Studies Indicating Full Dose Blood Thinners Benefit Moderately Ill COVID-19 Patients
    The use of heparin (a blood thinner) in hospitalized patients with COVID-19 improves survival and reduces the need for vital organ support such as
    trialsitenews.com


    The use of heparin (a blood thinner) in hospitalized patients with COVID-19 improves survival and reduces the need for vital organ support such as mechanical ventilation in moderately ill patients but doesn’t yield the same positive outcomes among critically ill patients already requiring life support. This conclusion is based on two Canadian-led clinical trials published on August 4th in the New England Journal of Medicine.


    These collaborative international clinical trials tested full-dose anticoagulation, titled Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19 and Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. Dr. Ryan Zarychanski, associate professor of internal medicine, University of Manitoba, and hematologist, critical care physician and senior scientist at CancerCare Manitoba, Canada, shared in the University of Manitoba news, “We had an unprecedented opportunity to work with colleagues across Canada, the United States and around the world to test the benefit of full-dose blood thinners on hospitalized COVID-19 patients. Therapeutic heparin improved survival and decreased progression to severe disease, thus reducing the pressure on intensive care units globally.”


    The Background

    Early in the pandemic, physicians around the world observed increased rates of blood clots and inflammation among COVID-19 patients, which affected multiple organs and led to complications such as lung failure, heart attack, and stroke. Whether providing increased doses of blood thinners routinely administered to hospitalized patients would be safe and effective was unknown at that time.


    Participating Trial Platforms

    The participating trial platforms that contributed to the global trial were Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); Randomized, Embedded, Multi-factorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP); and Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) platforms.


    The Study

    The worldwide, multi-platform trial spanned five continents in over 300 hospitals to test blood thinners on both sets of patients.


    “The goal [of our trials] was to improve survival and prevent patients from requiring ICU-level care or developing multi-organ failure,” said Dr. Patrick Lawler, cardiologist at the University of Toronto and Peter Munk Cardiac Centre at University Health Network. He was co-principal investigator of ATTACC, a member of the international trial steering committee for REMAP-CAP, and on the ACTIV-4a protocol development committee.


    In December 2020, results indicated that full-dose anticoagulation with heparin was not beneficial and appeared to be harmful among critically ill patients – but the findings were completely different in non-critically ill patients. In January 2021, results of the treatment among moderately ill COVID patients showed full doses of heparin reduced the need for life support with improved survival.


    Moderately ill patients are defined as hospitalized COVID-19 patients who were not in ICU and not receiving organ support such as mechanical ventilation at trial enrollment.


    The trial involved 1,074 critically ill and 2,219 moderately ill patients. Physician investigators gauged how long participants were free of organ support up to 21 days after enrolling in the clinical trial. The investigators discovered that in moderately ill patients, full-dose heparin reduced the need for organ support compared to those who received lower-dose heparin. By contrast, full-dose heparin was associated with a high probability of a worse outcome for critically ill patients.


    New ‘Standard of Care’

    “Our conclusions have set a new standard of care for moderately ill hospitalized COVID-19 patients around the world using an affordable, accessible, and familiar drug. As such, the results of the trial can be immediately applied,” said Dr. Ewan Goligher, critical care physician and scientist at Toronto General Hospital, co-chair of the therapeutic anticoagulation domain in REMAP-CAP and co-principal investigator of the ATTACC platform.


    “While the trial results will immediately impact care around the world, it is the methods of collaboration created that will be an enduring contribution of this first of a kind clinical trial that paves the way for future multiplatform clinical trial collaborations on a global scale,” said Zarychanski, senior author, chair of the ATTACC trial and the REMAP-CAP anticoagulation domain and member of the ACTIV-4a protocol development committee.


    “We were excited to provide leadership on these innovative, large scale clinical trials – especially at a critical time during the COVID-19 pandemic – and our findings demonstrate the value of international multiplatform collaboration and the future possibilities for continuing to study ways to improve health outcomes in COVID-19 and possibly other diseases,” said Lawler.


    “It is a testament to the dedication of researchers around the world who worked closely and collaboratively during a very difficult time that we were able to discover a treatment that can prevent patients from becoming severely ill and improve their recovery and outcomes, but our work is not over yet,” added Goligher.


    “The Manitoba government is proud to have been an early supporter of this ground-breaking, life-saving research led out of our province,” Manitoba Premier Brian Pallister said. “The $5 million COVID-19 research fund announced last spring through Research Manitoba allowed local clinician-scientists to embed clinical trials into clinical care and collaborate in new ways so that their research findings can have global impact by advancing COVID-19 treatments.”


    Funding Support

    In Canada, the trials were supported by multiple international funding organizations, including the Canadian Institutes of Health Research (CAN), LifeArc, the Provinces of Ontario and Manitoba, the Peter Munk Cardiac Centre, the Thistledown Foundation, CancerCare Manitoba Foundation, and the Victoria General Hospital Foundation. Trial management and data coordination were provided by Ozmosis Research and Socar Research. Internationally, the trials were supported by the NIH National Heart, Lung & Blood Institute, Translational Breast Cancer Research Consortium and the UPMC Learning While Doing Program (US), National Institute for Health Research (UK), National Health and Medical Research Council (AUS), Health Research Council of New Zealand, and the PREPARE and RECOVER consortia (EU).

    86% of Youth Getting First Pfizer COVID-19 Shot Experienced Adverse Reactions According to FDA Data


    86% of Youth Getting First Pfizer COVID-19 Shot Experienced Adverse Reactions According to FDA Data
    According to The Daily Expose, a “Shocking 86% of Children suffered an Adverse Reaction to the Pfizer Covid Vaccine in Clinical Trial.” Some consider this
    trialsitenews.com


    According to The Daily Expose, a “Shocking 86% of Children suffered an Adverse Reaction to the Pfizer Covid Vaccine in Clinical Trial.” Some consider this particular outlet to be fringe, so we can compare their version of the facts with the June FDA EUA Fact Sheet’s description of the data which the article relied on. On May 10, the FDA granted a EUA for Pfizer’s mRNA COVID-19 vaccine for folks aged 12 and up. Pfizer’s clinical trials on 12-15 years old showed that 86% of subjects had an adverse response from mild to serious. This data can be found in the FDA Fact Sheet on page 25, Table 5 onwards. These tables show that 1,127 kids got the first shot and 1,097 got the second dose. The Daily Expose implies that the missing 30 kids had adverse effects, but this claim is not sourced. 86% of those getting the first shot had an adverse reaction. 78.9% of those getting the second shot responded similarly.


    According to Table 6 in the Fact Sheet, 20.3% of kids who got the first shot got a fever, while 39.3% of those getting the second shot got the same side effect. 60.1% of kids had fatigue from the first shot; the figure is 66% for the second dose. 55.3% had a headache after the first shot, and 64.5% did so after the second shot. Other problems were chills, 27.6% for the first dose and 41.5% for the second; vomiting, 2.8% for the first dose and 2.6% for the second; and diarrhea, 8.0% for the first shot and 5.9% for the second shot. Per FDA, 0.04% of kids had an “extremely serious adverse reaction” of an unspecified nature. If all four million 12–15 year-olds in the UK were given this shot, we could “expect to see 1,600 suffer an extremely serious adverse reaction which could include death.” The Daily Expose points out that we need to compare these risks to the actual risk to kids from COVID-19. Given that youth don’t tend to get very sick from this pandemic, we should ask why we need to vaccinate them if real risks are involved?

    Structural basis for enhanced infectivity and immune evasion of SARS-CoV-2 variants


    Structural basis for enhanced infectivity and immune evasion of SARS-CoV-2 variants
    As battles to contain the COVID-19 pandemic continue, attention is focused on emerging variants of the severe acute respiratory syndrome coronavirus 2…
    science.sciencemag.org


    SARS-CoV-2 from alpha to epsilon

    As battles to contain the COVID-19 pandemic continue, attention is focused on emerging variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that have been deemed variants of concern because they are resistant to antibodies elicited by infection or vaccination or they increase transmissibility or disease severity. Three papers used functional and structural studies to explore how mutations in the viral spike protein affect its ability to infect host cells and to evade host immunity. Gobeil et al. looked at a variant spike protein involved in transmission between minks and humans, as well as the B1.1.7 (alpha), B.1.351 (beta), and P1 (gamma) spike variants; Cai et al. focused on the alpha and beta variants; and McCallum et al. discuss the properties of the spike protein from the B1.1.427/B.1.429 (epsilon) variant. Together, these papers show a balance among mutations that enhance stability, those that increase binding to the human receptor ACE2, and those that confer resistance to neutralizing antibodies


    Abstract

    Several fast-spreading variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have become the dominant circulating strains in the COVID-19 pandemic. We report here cryo–electron microscopy structures of the full-length spike (S) trimers of the B.1.1.7 and B.1.351 variants, as well as their biochemical and antigenic properties. Amino acid substitutions in the B.1.1.7 protein increase both the accessibility of its receptor binding domain and the binding affinity for receptor angiotensin-converting enzyme 2 (ACE2). The enhanced receptor engagement may account for the increased transmissibility. The B.1.351 variant has evolved to reshape antigenic surfaces of the major neutralizing sites on the S protein, making it resistant to some potent neutralizing antibodies. These findings provide structural details on how SARS-CoV-2 has evolved to enhance viral fitness and immune evasion.


    Discussion

    Transmissibility and immune evasion are independent selective forces driving emergence of viral genetic diversity. The changes of most concern in the SARS-CoV-2 S protein would be those that simultaneously enhance transmission, augment disease severity, and evade immune recognition in previously exposed hosts. Our data suggest that the most problematic combination of such mutations is not yet present in the existing variants examined here.


    In the B.1.1.7 virus, mutations A570D and S982A lead to an outward shift of the CTD1, thereby relaxing the FPPR and 630 loop, which help retain the RBD in its “down” position in the parental strain. The mutations increase the frequency with which the S trimer samples the RBD-up conformation, allowing B.1.1.7 to better present the receptor binding motif (RBM) to ACE2 on the host cells. Once one RBD flips up, the fully or partially ordered 630 loops of the neighboring protomers stabilize the CTD2, which folds together with the N-terminal segment of S2, and thus prevent the premature S1 dissociation. N501Y in the ACE2 binding site of the RBD also increases the affinity of that domain for the receptor, probably because of the hydrophobic interaction of Tyr501 with Tyr41 of ACE2 (36) and a possible cation-π interaction with ACE2 Lys353 (fig. S16). The combination of enhanced RBM presentation and additional local interactions might allow the B.1.1.7 virus to infect cell types with lower ACE2 levels than those of the nasal and bronchial epithelial cells that the virus typically infects; an expanded cell tropism could account for the increased risk of mortality in patients infected with this variant (9, 10). The mutations in B.1.1.7 caused no major structural rearrangements in the RBD and NTD, consistent with minimal changes in the sensitivity of the B.1.1.7 variant to the potently neutralizing antibodies [tables S1 and S2; (33)].


    In the B.1.351 virus, the S protein largely retains the structure of the G614 trimer with almost identical biochemical stability. N501Y, K417N, and E484K in the RBD have not caused major structural changes, but the loss of salt bridges between Lys417 and ACE2 Asp30 and Glu484 and ACE2 Lys31 mitigates the increased receptor affinity imparted by N501Y (fig. S16). K417N and E484K probably lead to loss of binding and neutralization by antibodies that target the RBD-2 epitopes (fig. S4A). The accompanying mutations in the NTD remodel the antigenic surface and greatly reduce the potency of neutralizing antibodies against NTD-1 epitopes. The B.1.351 variant was probably selected under a certain level of immune pressure, because it altered two major neutralizing sites on the S trimer simultaneously with only a slight compromise in its ability to engage a host cell.


    The global range of SARS-CoV-2 and the daily vast number of replication events make emergence of new variants inevitable and substantially increases the viral genetic diversity. In many cases, antibody resistance may compromise viral fitness, as in the B.1.351 variant, which resists neutralization by RBD-directed antibodies but also loses the enhanced affinity and transmissibility imparted by N501Y, as a consequence of the immune-escape mutations. It is also possible to combine immune evasion and virulence through continuous viral evolution, such as a B.1.1.7 variant that contains the E484K mutation (B.1.1.7+E484K) (41). Such a combination will bring greater challenges for vaccine development compared with the beginning of the pandemic. If SARS-CoV-2 becomes seasonal, innovative strategies already developed against other human pathogens—such HIV-1, hepatitis C virus, and influenza virus—may be applicable to on-going control of the COVID-19 pandemic. The B.1.351 S trimer, which has superior biochemical stability and new epitopes, should be an excellent starting point for developing next-generation vaccines designed to elicit broadly neutralizing antibody responses

    FLCCC weekly update


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    The timing of natural killer cell response in coronavirus infection: a concise model perspective


    The timing of natural killer cell response in coronavirus infection: a concise model perspective
    Coronaviruses, including SARS-CoV, MERS-CoV, and SARS-CoV-2 cause respiratory diseases with remarkably heterogeneous progression. This in part reflects the…
    www.biorxiv.org


    Abstract

    Coronaviruses, including SARS-CoV, MERS-CoV, and SARS-CoV-2 cause respiratory diseases with remarkably heterogeneous progression. This in part reflects the viral ability to influence the cytokine secretion and thereby the innate immune system. Especially the viral interference of IFN-I signaling and the subsequent deficiency of innate immune response in the early phase have been associated with rapid virus replication and later excessive immune responses. We propose a mathematical framework to analyze IFN-I signaling and its impact on the interaction motif between virus, NK cells and macrophages. The model recapture divergent dynamics of coronavirus infections including the possibility for elevated secretion of IL-6 and IFN-γ as a consequence of exacerbated macrophage activation. Dysfunction of NK cells recruitment increase disease severity by leading to a higher viral load peak, the possibility for excessive macrophage activation, and an elevated risk of the cytokine storm. Thus the model predicts that delayed IFN-I signaling could lead to pathogenicity in the latter stage of an infection. Reversely, in case of strong NK recruitment from infected cells we predict a possible chronic disease state with moderate and potentially oscillating virus/cytokine levels.

    Delta variant will lead to increase in breakthrough Covid infections among vaccinated, Moderna says


    Delta variant will lead to increase in breakthrough Covid infections among vaccinated, Moderna says
    Modern said it believes a booster will likely be necessary before winter.
    www.cnbc.com


    KEY POINTS

    The highly contagious delta variant will lead to an increase in breakthrough infections among the fully vaccinated as people begin moving indoors, Moderna said.

    While Moderna's two-dose vaccine remains "durable" six months after the second shot, immunity against the virus will continue to wane and eventually impact vaccine efficacy, it said.

    "Given this intersection, we believe dose 3 booster will likely be necessary prior to the winter season," Moderna wrote.

    Despite Near-Total Vaccination, Iceland Experiences Its Worse Delta-driven Pandemic Surge


    Despite Near-Total Vaccination, Iceland Experiences Its Worse Delta-driven Pandemic Surge
    What’s becoming clear is that the most heavily vaccinated nations are in some ways an indicator for what can or will happen with COVID-19 in the future.
    trialsitenews.com


    What’s becoming clear is that the most heavily vaccinated nations are in some ways an indicator for what can or will happen with COVID-19 in the future. For example, in Iceland, one of the most vaccinated populations on the planet at 75.8% with at least one jab and about 71.3% fully vaccinated, the number of cases due to Delta are on the rise as the vaccines are not leading to herd immunity as predicted by many. In fact, Iceland is experiencing its worst outbreak of the pandemic, despite the heavily vaccinated population. With an accelerating Delta variant, it becomes clear that those vaccinated get infected with ease, and the vaccinated are becoming spreaders of Delta, much like TrialSite has found in other heavily vaccinated nations. There is a positive in that the rate of serious illness has declined due to the vaccinations, reports Iceland’s Chief Epidemiologist, Þórólfur Guðnason, but many assumptions will have to be reset moving forward.


    The country has current social controls in place until August 13. Yet, health authorities have drafted a formal referendum, articulating concern about the most recent strains on the Icelandic healthcare system based on the present infection rate.


    TrialSite summarizes findings from an Iceland Review live-tweeting of the recent COVID-19 situation. Included in the recent panel is Víðir Reynisson, Director of Civil Protection and the Chief Epidemiologist. The nation currently has 1,304 active cases, with 16 people in the hospital.


    The Chief Epidemiologist (Þórólfur) reminded everyone that infection rates were very low by June, and the majority in the country were vaccinated. The only group with low vaccination rates is the age 12-16 group.


    The Surge

    The Delta variant has become the dominant variant in all of Iceland. Health authorities have found that vaccinated individuals can contract the Delta variant with ease, thus becoming vectors themselves. Much of the new infections, based on sequencing, have been determined to come from group events such as clubbing in downtown Reykjavík or group trips abroad.


    Vaccination Prevents Serious Illness

    Icelandic authorities report that only about 1% of the current cases end up in hospitalization compared to 4-5% for previous waves during the pandemic. 2.4% of unvaccinated people in Iceland that contract the Delta variant end up hospitalized.


    Vaccines

    Those in Iceland that received the Johnson and Johnson vaccine will be offered a Pfizer booster shot. Moreover, the authorities here will offer the Pfizer-BioNTech mRNA vaccine to 12 to 15 year-olds in the future. There are also concerns about the remaining unvaccinated elderly who face particular risks, and who could put a strain on the relatively limited healthcare resources on this small island nation.


    Iceland’s Chief Epidemiologist reminded all that the COVID-19 pandemic is not nearly over and won’t be over until it’s over everywhere.

    I have no idea what you mean by gravy train rolling and can I suggest that it is not a helpful way to be thinking about this stuff.

    yes you do and not helpful to who? Are you suggesting that greed has not played a part in Covid?

    Will the Delta Variant Peak and Then Burn Out?


    Will the Delta Variant Peak and Then Burn Out?
    Some experts are heartened by the recent decrease in COVID-19 cases in the U.K. and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked…
    www.webmd.com


    Aug. 4, 2021 -- When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.


    Within months, the Delta variant had spread to more than 98 countries, including Scotland, the U.K., Israel, and now, of course, the U.S. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.


    Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.


    Some experts are heartened by the recent decrease in COVID-19 cases in the U.K. and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

    t 30,500 daily.


    Are You Protected Against the Delta Variant?

    WebMD's Chief Medical Officer, John Whyte, MD, speaks with Eric Topol, MD, Executive VP, Scripps Research & Editor-in-Chief, Medscape, about the COVID-19 Delta variant.


    ABOUT

    Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that if the Delta variant acted the same in the U.K. as in India, it would have a quick rise and a quick drop.


    The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared to more than 46,800 July 19.


    So the question of the summer has become: "When will Delta burn out here?"


    Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:


    Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks -- so by August 11.

    Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, says that, "Right now for the U.S. as a country, cases will peak mid-August" and then decline. He is citing projections by the university's Institute for Health Metrics and Evaluation. In its "most likely" scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)

    September: "I am hoping we get over this Delta hump [by then]," says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, CA, and editor-in-chief of Medscape. "But sometimes, I am too much of an optimist."

    Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, say the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.

    Unclear: Because cases are underestimated, "I think it is unclear when we will see a peak of Delta," says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security. He predicts a decline in cases as "more people get infected and develop natural immunity."

    The predictions are based on different scenarios, such as most likely or worst-case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.


    What a Difference Vaccination May Make

    An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC says. (And 80.1% of those 65 and over were.)


    But that's a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.


    Mokdad of the University of Washington estimates that by Nov. 1, based on the current rate of infections, 64% of people in the U.S. will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.


    Justin Lessler, PhD, a University of North Carolina epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.


    "I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.


    It's a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?


    That's hard to predict, Topol says. Some unvaccinated people may feel like soldiers in a foxhole, he says, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the "breakthrough" cases in the vaccinated, may dig in their heels and ask, "Why bother?" as they mistakenly conclude that the vaccine has not done its job.


    Roles of Public Policy, Individual Behavior

    Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts say.


    "Don't 'stress test' your vaccine, " Topol says.


    The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

    The best advice now, Topol says, is: "Don't be inside without a mask."


    Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.


    Mokdad finds that "when cases go up, people put on their best behavior," such as going back to masks and social distancing.


    "Unfortunately, we have two countries," he says, referring to the way public health measures and mandates vary from state to state.


    Once the Delta Variant Subsides, What's Next?

    It's not a matter of if there is another variant on the heels of Delta, but when, Topol and other experts say. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country's infections.


    There's also Delta-plus, just found in two people in South Korea.


    Future variants could be even more transmissible than Delta, "which would be a horror show," Topol says. "This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us."


    On the Horizon: Variant-Proof Vaccines

    What's needed to tackle the next variant is another approach to vaccine development, according to Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.


    Writing a commentary in Nature published this year, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely due to the vaccine's ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body's cells.

    The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Topol and Burton write. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

    To be fair, delta is only a doomsday variant in places like parts of the US where too many people refuse vaccination. Elsewhere it is worse than alpha by some way, but manageable.


    And newer worse variants are always possible, no-one is saying when they will appear or how much worse they will be. Because we do not know.

    Go to google news it's the main headline all over the world. Fauci warns of more deadly mutations. Keep the gravy train rolling!!!!

    A Doomsday COVID Variant Worse Than Delta and Lambda May Be Coming, Scientists Say


    A doomsday COVID variant worse than Delta and Lambda may be coming, scientists say
    Delta has shown how destructive new strains of COVID can get. Scientists fear future mutations of the virus could be even worse: "Delta on steroids."
    www.newsweek.com


    U.S. DELTA VARIANT CDC

    Scientists keep underestimating the coronavirus. In the beginning of the pandemic, they said mutated versions of the virus wouldn't be much of a problem—until the more-infectious Alpha caused a spike in cases last fall. Then Beta made young people sicker and Gamma reinfected those who'd already recovered from COVID-19. Still, by March, as the winter surge in the U.S. receded, some epidemiologists were cautiously optimistic that the rapid vaccine rollout would soon tame the variants and cause the pandemic to wind down

    Delta has now shattered that optimism. This variant, first identified in India in December, spreads faster than any previous strain of SARS-CoV-2, as the COVID-19 virus is officially named. It is driving up infection rates in every state of the U.S., prompting the Centers for Disease Control and Prevention (CDC) to once again recommend universal mask-wearing.


    The Delta outbreak is going to get much worse, warns Michael Osterholm, an epidemiologist who leads the Center for Infectious Disease Research and Policy at the University of Minnesota. "The number of intensive-care beds needed could be higher than any time we've seen," he says. He adds that his team's analysis shows that almost every single one of the 100 million unvaccinated Americans who hasn't had COVID-19 yet will likely get it in the coming months, short of taking the sort of strong isolation and masking precautions that seem unlikely in the vaccine-hesitant population.

    The variant is so contagious that it's set to smash through every previous prediction of how soon the U.S. might reach herd immunity. "We've failed to shut this down as we have other pandemics," says Jonathan Eisen, a biologist at the University of California, Davis, who studies how pathogens evolve. "It may be around forevermore, leaving us continually trying to figure out what to do next."

    I'm happy for anyone to make predictions. Clear ones if possible.


    I'd just point out that in the UK, because we have no 5-15 year old vaccination, schools being on holiday will make a big difference. So starting from September onwards we will get an up-tick in infections due to spread in schools. there is also an effect from colder weather from october. those two things together make October/November look worse.


    But we really cannot tell yet how much high vaccination rate (it is still happening) will improve things.

    So you admit that Covid is seanonal