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    Prominent Research Scientists Suggest Plausibility of Lab-Created SARS-CoV-2


    Prominent Research Scientists Suggest Plausibility of Lab-Created SARS-CoV-2
    A well-known group of research scientists from France, Austria, and Australia strongly suggest the time is now to launch an objective, unbiased and
    trialsitenews.com


    A well-known group of research scientists from France, Austria, and Australia strongly suggest the time is now to launch an objective, unbiased and apolitical probe into the origins of SARS-CoV-2. While other scientists send research letters to prominent medical journals strongly arguing for a natural origin, the strongest evidence now suggests no clear argument for a nature-based origin while a research-based human-engineered hypothesis becomes ever more plausible. The importance of getting to the truth cannot be underestimated. Given the magnitude, scope, and severity of COVID-19, the scientific and research community have a moral, ethical, and professional responsibility to investigate SARS-CoV-2 origins, unencumbered by political meddling. Too much is at stake, at least for those of us fortunate enough to live in democratic market-based societies.


    While much of the scientific world conveniently agreed with a push early on, supported by Dr. Anthony Fauci and certain colleagues at the National Institutes of Health (NIH) and academia—that the pathogen originated directly from a bat while making its’ way to humans via some other animal at the Wuhan wet market, the authors herein ask frankly, where is the evidence?


    With the case for a human-engineered version recently published in prestigious The Lancet, corresponding author Jacques van Helden and team are no lightweights nor loony conspiracy theorists. van Helden, a Professor of bioinformatics at Aix-Marseille Université (AMU) in Marseille, and team possess the credentials for immediate attention. They put forth the argument that “so far no scientifically validated evidence that directly supports a natural origin” and that of all the references by proponents of the natural origin hypothesis, “all but one simply show that SARS-CoV-2 is phylogenetically related to other beta coronaviruses.”


    The authors point out that while previous coronavirus outbreaks were associated with evidence for natural origin, that simply isn’t the case with SARS-CoV-2. For example, “Neither the host pathway from bats to humans nor the geographical route from Yunnan (where the viruses most closely related to SRS-CoV-2 have been sampled) to Wuhan (where the pandemic emerged) has been identified.” They emphasize that even after the review of 80,000 samples collected in China, no evidence exists for a natural cause.


    A Plausible Explanation: Research Origin

    The authors first suggest that two questions become relevant in association with the research origin argument—which they declare is “plausible” or likely. They note that 1) “several peer-reviewed scientific papers have discussed the likelihood of research-related origin…” while the authors get closer to the heart of the matter, pointing out that “Some unusual features of the SARS-CoV-2 genome sequence suggest that they may have resulted from genetic engineering” an approach “widely used in some virology labs.”


    Or conversely, the authors posit 2) the origin of SARS-CoV-2 may have resulted from “undirected laboratory selection during serial passage in cell cultures or laboratory animals including humanized mice.” For this latter scenario, ample examples exist as researchers such as those at University of North Carolina were involved with the modification of mice to “display the human receptor for entry of SARS-CoV-2 (ACE2)…to test the infectivity of different virus strains.”


    But a research-based origin points to other possible scenarios such as gain-of-function experiments testing the possibility of chimeric viruses’ crossing species barriers.


    Arguments for the Lab

    In Segreto et al. titled “The genetic structure of SARS-CoV-2 does not rule out a laboratory origin, “ An Austrian and a Canadian argues that the “furin cleavage site in the spike protein of SARS-CoV-2 confers to the virus the ability to cross species and tissue barriers, but was previously unseen in other SARS-CoV-2 like COVs.” Segreto et al. ask the uncomfortable question if “genetic manipulations” were performed as part of an effort to determine if specific animals, such as pangolins, could serve as potential “intermediate hosts for bat derived CoVs that were originally unable to bind to human receptors.”


    The authors educate the reader that laboratory personnel may have employed site-directed mutagenesis leading to both cleavage site and specific RBD in a way that doesn’t leave any trace.


    Enough of the Bias

    While for many months anyone that wrote about a research-based hypothesis was automatically categorized as a conspiracy theorist, often censored along the way, many research scientists suggest that such purges, for example, were more political than scientific-based. During the COVID-19 pandemic, often those in power censoring the “misinformation” were actually guilty of perpetuating misinformation themselves. That is, whoever has the money, power and influence gets to write the history.


    A Pathway Forward

    There just isn’t enough compelling evidence pointing one way or the other—that is a natural or research-based origin.


    So you want to get to the truth? The authors suggest “An evidence-based, independent, and prejudice-free evaluation”…necessitating “an international consultation of high-level experts with no conflicts of interest.” Multi-disciplined and multi-national, the team would establish the various rational scenarios and associated hypotheses, followed by protocols and methods to ultimately capture the true origin. Not undertaking this important research opens us all up another dangerous worldwide crisis.


    DEFINE_ME

    New Movement by Physicians to Fight Medical Tyranny


    New Movement by Physicians to Fight Medical Tyranny
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.Very, very few physicians are
    trialsitenews.com


    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.


    Very, very few physicians are courageous enough to stand up against the vaccine-but-not-early treatment with generics tyranny pushing mass COVID vaccination. Few will prescribe ivermectin. Few acknowledge the many vaccine risks that, for most people, outweigh the benefits. Few accept the science that natural immunity is better than vaccine immunity, and people with it should not get the jab.


    When do Americans see the data on COVID deaths of over 600,000 who or what should they blame? The truth is this: Better than blaming the virus, they should blame hospitals and the vast majority of physicians. Why? Because the medical establishment has never had the courage to stand up to the medical tyranny engineered by Fauci and implemented by the CDC and FDA. People still are dying from COVID because their physicians refuse to genuinely follow the science and prescribe cheap, safe, and proven generics like ivermectin.


    Of course, there have always been a minority of doctors who have since March 2020 been curing their patients of COVID by using a variety of protocols that US hospitals and their doctors refuse to use.


    Why are so many nurses and physicians refusing to be vaccinated? Because they have seen on a daily basis large numbers of patients suffering and dying not from the virus but from the COVID vaccines.


    Now one of the most respected physicians and medical researchers, Dr. Robert Malone, has spearheaded a movement to combat medical tyranny by organizing physicians from all over the world and creating just days ago a Physicians Declaration. Here are some key highlights from this historic action.


    — There is an unprecedented assault on our ability to care for our patients.


    — Public policy [think Fauci] has chosen to ignore fundamental concepts of science, health, and wellness, instead of embracing a “one size fits all” treatment strategy [think COVID vaccines] that results in too much illness and death when the individualized, personalized approach to health care is safe and equally or more effective.


    –Thousands of physicians are being denied the right to provide treatment to their patients [think ivermectin] as a result of barriers put up by pharmacies, hospitals, and public health agencies, rendering the vast majority of healthcare providers helpless to protect their patients in the face of disease. Physicians are now advising their patients to simply go home (allowing the virus to incubate) and return when their disease worsens, resulting in hundreds of thousands of unnecessary patient deaths due to failure-to-treat [other than using vaccines].


    — Physicians must defend their right to prescribe treatment, observing the tenet FIRST, DO NO HARM. Physicians shall not be restricted from prescribing safe and effective treatments [other than vaccines]. These restrictions continue to cause unnecessary sickness and death. The rights of patients, after being fully informed about the risks and benefits of each option [especially vaccines], must be restored to receive those treatments [such as ivermectin].


    — We invite patients who believe in the importance of the physician-patient relationship and the ability to be active participants in their care to demand access to science-based medical care.


    That last point is where you, the reader, must join this revolt and demand from your physicians and hospitals your right to get access to generic medicines like ivermectin. Print the Declaration and give it to your doctor. If this Declaration simply remains words but not profound changes in the practice of medicine in this pandemic, then all hope for saving lives will be lost.


    We are rapidly approaching the point where more people will die from COVID vaccines than the virus. Fauci and his allies will not easily admit their many evil wrong actions. If you want to examine extensive medical science details on the emerging Vaccine Dystopia, then read this truth-telling article.


    COVID Vaccine Dystopia: A Manifesto by Dr. Joel S. Hirschhorn | Principia Scientific Intl.
    The views of many distinguished medical experts paint a bleak view of COVID vaccines.
    principia-scientific.com


    JoelSHirschhorn

    The past administration was accused of not following the science and recommendations of the CDC, FDA, republicans in general don't follow science or recommendations, it's all over the news! Democrats follow the science or recommendations? Confusion rules!!!



    CDC director recommends COVID-19 booster for younger at-risk workers, defying advisory panel

    The CDC panel voted 9-6 against the recommendation


    CDC director recommends COVID-19 booster for younger at-risk workers, defying advisory panel | Fox News

    OkFauci Defends NIH Funding Wuhan Lab: 'Only Regret' Is That It's Caused 'Such a Degree of Distraction'


    Fauci Defends NIH Funding Wuhan Lab: 'Only Regret' Is That It's Caused 'Such a Degree of Distraction'
    During an interview with CBS' "The Takeout" podcast recorded on Wednesday and released on Thursday, White House Chief Medical Adviser Dr. Anthony Fauci…
    www.breitbart.com


    During an interview with CBS’ “The Takeout” podcast recorded on Wednesday and released on Thursday, White House Chief Medical Adviser Dr. Anthony Fauci defended the NIH funding research at the Wuhan Institute Virology and said that “the only regret is that what it has caused right now is such a degree of distraction” from combating the pandemic.

    Host Major Garrett asked, [relevant exchange begins around 7:35] “There were two grants from the National Institutes of Health into investigatory work in the field in the Wuhan Institute of Virology and another institution there. Have you run to ground what those did or didn’t do in terms of creating any atmosphere in which a leak could have occurred or might have occurred?”


    Fauci responded, “Well, the grants that [were] funded were to do surveillance in the environment to ask and answer questions that I just mentioned, when you go out, do you see any viruses out there that could potentially evolve to infect humans and do you do surveillance among people in those areas in China to see if there’s any inkling that, under the radar screen, such viruses may have been circulating. In fact, one of the papers that came out from studies from that grant was extremely important in putting a definitive stamp of understanding of how the original SARS-CoV-1 was able to evolve. So, those were questions that got a high priority in peer review to do the research to try and understand that.”


    Garrett then asked, “And to those who think there might be some type of scandal or something incorrect or ill-advised about those grants, what would you say, Dr. Fauci?”

    Fauci answered, “Well, what you do, Major, is you take a look at the viruses that [were] worked on under the auspices of that grant and what the grant was directed for. And you look at the publications that came from the research associated with that grant. The viruses that were worked with in that environment, in that particular context of that grant could not possibly molecularly evolved into what we know now as SARS-CoV-2. Because when you look at how you can go from one virus and do something with it to get to be another, the viruses that the grant allowed the investigators, competent investigators to work with, molecularly, were so different than what ultimately came out to be SARS-CoV-2 that anyone that looks at those two viruses who knows anything about evolutionary virology will tell you that they’re so far apart that you couldn’t possibly have had it emerge into that particular virus.”


    Garrett then asked, “Real quickly, no regrets about those grants?”


    Fauci responded, “Well, the only regret is that what it has caused right now is such a degree of distraction [from] trying to do what we really should be doing, is addressing the outbreak, and what we did, and did quite successfully, was to develop vaccines that have now been life-saving. That’s what the job of myself and my team and my institute is, and, thankfully, we did that very successfully.”

    High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape


    High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape - Nature


    Abstract

    The number and variability of the neutralizing epitopes targeted by polyclonal antibodies in SARS-CoV-2 convalescent and vaccinated individuals are key determinants of neutralization breadth and the genetic barrier to viral escape1–4. Using HIV-1 pseudotypes and plasma-selection experiments with vesicular stomatitis virus/SARS-CoV-2 chimeras5, we show that multiple neutralizing epitopes, within and outside the receptor binding domain (RBD), are variably targeted by human polyclonal antibodies. Antibody targets coincide with spike sequences that are enriched for diversity in natural SARS-CoV-2 populations. By combining plasma-selected spike substitutions, we generated synthetic ‘polymutant’ spike protein pseudotypes that resisted polyclonal antibody neutralization to a similar degree as circulating variants of concern (VOC). By aggregating VOC-associated and antibody-selected spike substitutions into a single polymutant spike protein, we show that 20 naturally occurring mutations in SARS-CoV-2 spike are sufficient to generate pseudotypes with near-complete resistance to the polyclonal neutralizing antibodies generated by convalescents or mRNA vaccine recipients. Strikingly, however, plasma from individuals who had been infected and subsequently received mRNA vaccination, neutralized pseudotypes bearing this highly resistant SARS-CoV-2 polymutant spike, or diverse sarbecovirus spike proteins. Thus, optimally elicited human polyclonal antibodies against SARS-CoV-2 should be resilient to substantial future SARS-CoV-2 variation and may confer protection against potential future sarbecovirus pandemics.

    The Origins of SARS-CoV-2 Are Elusive—Could it Be Because Too Many


    The Origins of SARS-CoV-2 Are Elusive—Could it Be Because Too Many
    In what sounds like something out of a B science fiction/horror movie, recently leaked documents associated with a group of researchers investigating the
    trialsitenews.com


    In what sounds like something out of a B science fiction/horror movie, recently leaked documents associated with a group of researchers investigating the origins of COVID-19 indicate that in 2018 controversial director of EcoHealth Alliance, Peter Daszak proposed a collaboration with Wuhan Institute of Virology involving the manipulation of bat coronaviruses in the lab and then even more controversially, the releasing of the bats back into the wild to study what would happen in a sort of contemplated real-world study.


    While his intentions were probably good, seeking to stop zoonotic transfer from bat to human, anyone with common sense could think of some adverse outcomes with such a scheme. After all, Daszak wanted to not only release a pathogen with ‘novel chimeric spike proteins’ into bat colonies in Yunnan over 1,200 miles southwest of Wuhan but also perform what appears to be gain-of-function research, genetically enhancing a coronavirus pathogen to make it more transmissible to humans. As part of what is known as the DEFUSE proposals, the research group sought $14.2 million from the taxpayer via the U.S. Defense Advanced Research Projects Agency (DARPA). Thankfully wiser minds in the Department of Defense prevailed, rejecting what in reality would be a grossly reckless scheme. The DoD asked, for example, the question: what about the local villagers in the human community?


    The DEFUSE project was leaked by a group known as Drastic and TrialSite shares some of the documents here. The documents were apparently leaked by a whistleblower—a former member of the Trump administration, according to British press. An executive overview of the scheme can be viewed here.


    TrialSite reported on leaked documents to The Intercept that possibly implicate Dr. Anthony Fauci’s association with gain-of-function research programs. These projects, it is claimed, were funded by the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Fauci heads up NIAID.


    GOP House Members Target Fauci for Answers

    In a hearing on Capitol Hill, Dr. Fauci has declared with full knowledge that it’s a crime to lie to Congress that he nor NIAID/NIH were involved with funding gain-of-function research. As TrialSite reported the recently leaked documents to The Intercept, however, implicate Fauci’s involvement in at least greenlighting payment


    GOP lawmakers led by Rep. Chip Roy of Texas have sought more information from NIAID to no avail. Nearly two weeks ago, on Sept 14, this group of Republicans sent a letter to House Speaker Nancy Pelosi in a bid to subpoena Fauci on the actual origins of SARS-CoV-2.


    Conflict of Interest

    At the start of the year, the World Health Organization (WHO) sent a team over to Wuhan as part of an ongoing effort to investigate the origins of SARS-CoV-2. Strangely only one person from America was invited to join the group—Peter Daszak, the President of the EcoHealth Alliance. It was Daszak that was adamantly opposed to any so-called lab-leak theory even though no proof existed at the time that there was another source of origin.


    That group published results of their probe in the spring (March), reporting that the findings were inconclusive. They were highly dismissive of the lab leak theory. At the time, even writing about the topic got one censored on Facebook. Months later, it became politically acceptable to discuss showcasing how political interests trump science in the age of COVID-19. The origins of SARS-CoV-2 to date are not known—at least by the public.


    TrialSite Chronology

    In TrialSite’s “Origin of the Pandemic are Elusive & Timeline Reveals Glimpse into Path to Better Tomorrow,” the case is made that the U.S. government’s push for a “global biosafety system” gained momentum some years ago. The Wuhan Virology institute merely served as a regional node.


    Much of the research centering on coronaviruses in China could well have good intentions, but with intensifying gain-of-function research, the prospects of an accident were real. That drove a prominent group of scientists, the Cambridge Working Group, to sign a consensus statement advising governments to stop gain-of-function testing. Citing the dangers of developing a highly pathogenic virus, the group sought that the ends (saving the world from future pandemics) didn’t justify the means, that is, tinkering with specific coronavirus pathogens in dangerous ways.


    Consequently, in 2014 under the Obama administration put a halt to this dangerous research in the United States. The White House Office of Science and Technology Policy (OSTP) announced a mandatory moratorium on research aimed at making the coronavirus pathogens more deadly.


    Of course, the paper trail indicates that the EcoHealth Alliance thereafter served as an intermediary to get around this moratorium. Grants from NIAID—approved by Fauci—went to Daszak’s organization, and they distributed those funds in some cases to the Wuhan Virology Institute.


    Right before the pandemic, Daszak was in an interview bragging about their research and the fact that there were hundreds of coronaviruses.


    Of course, by 2015, a controversial study was published out of University of North Carolina. Led by a brilliant Ralph Baric and team—including Zhengli-Li Shi or the “Bat Lady” from the Wuhan Institute of Virology—the team showcased their tinkering with mother nature, generating a chimeric virus expressing the spike of a bat coronavirus in a mouse-adapted SARS-CoV-backbone.


    Essentially a Frankenstein-like virus, the chimeric viruses are genetically engineered pathogens, consisting of combined components from multiple distinct viruses. The authors almost boasted of the pathogen’s highly infectious nature via transfer from human cells via the ACE2 receptor in the human epithelial airway. The authors sounded the alarm for more funding for vaccines due to the risks associated with their project. At this point, the reader should be exceedingly concerned.


    The authors published in Nature to get the word out—funding was needed for more research.


    TrialSite reviewed some of the names of the human-made pathogens, which were interesting, to say the least. Names such as WIV1-MA15 and WIV-CoV indicated “Wuhan Institute of Virology. Again the authors, including Baric, centered their attention on securing more money in a bid to protect the world from the type of pathogens that their experiments were actually creating.


    Engineered bat virus stirs debate over risky research  - Nature
    Lab-made coronavirus related to SARS can infect human cells.
    www.nature.com

    Serious Group of Scientists Declare COVID-19 Vaccine Risks Too High to Ignore


    Serious Group of Scientists Declare COVID-19 Vaccine Risks Too High to Ignore
    In what will most likely be ignored by the mainstream is a potential bombshell of a peer-reviewed, published paper warning the world to slow down on the
    trialsitenews.com


    In what will most likely be ignored by the mainstream is a potential bombshell of a peer-reviewed, published paper warning the world to slow down on the mass COVID-19 vaccinations. A diverse, multi-disciplined group from both Europe and the U.S. recently raised questions about COVID-19 vaccination in children. About 42.5 million recorded COVID-19 cases in America have led to the highest number of deaths worldwide: approximately 681,222 deaths, according to Johns Hopkins University. With their findings published in the journal Toxicology Reports, the researchers first clarify that the bulk of the official COVID-19-attributed deaths per capita occur in the elderly with high comorbidities, while the COVID-19 attributed deaths per capita in children are negligible. The paper’s authors write that the great majority of “normalized post-inoculation” deaths occur in the elderly with high comorbidities, while “normalized post-inoculation” deaths in kids are small but not negligible. A provocative piece given the dominant societal narrative at this point in time, the authors’ data crunching leads to what undoubtedly is a claim rejected by much of the academic medical establishment, which is that COVID-19 vaccination leads to a five-fold increase in deaths in the most vulnerable age (65 and above) demographic. Therefore, the risk-benefit ratio of the mass vaccination program for children must be thoroughly vetted. While most may disagree with these research findings, what if they are correct…, or even just partly correct?


    A Serious Group

    TrialSite emphasizes that the group of authors behind this controversial piece appear to pack a serious punch. Hailing from America, Russia, Greece, and Romania, the group appears to bring highly compatible skills and expertise to the investigational pursuit.


    Corresponding author Ronald N. Kostoff, a Ph.D. in Aerospace and Mechanical Sciences from Princeton University, has collaborated with many biomedically-trained scientists to produce dozens of medical-related research papers. The Ph.D. led the writing of the paper.


    Kostoff is joined by a highly credible group of authors that includes Daniela Calina, MD, Ph.D., PharmD, a professor at University of Medicine and Pharmacy at Craiova, Romania, who helped perform data analysis and manuscript authoring. A Professor of Medicine and Medical Sciences at University of Bari, Darja Kanduc, also helped crunch numbers while writing pieces of the manuscript.


    Another author, Michael B. Briggs, earned a BS and MS in Nuclear Engineering and a ME in Radiological Health Engineering from the University of Michigan. Briggs, a Lieutenant Colonel in the United States Marine Corps Reserve, has previously published with Kostoff and contributed data analysis, results validation, and graphics.


    A Greek Professor of Medicine and Immunology at the prestigious National and Kapodistrian University of Athens Medical School, Panayiotis Vlachoyiannopoulos, helped write the manuscript, while Andrey A. Svistunov, a pharmacologist affiliated with I.M Sechenov First Moscow State Medical University (Sechenov University), contributed an editorial review. Finally, Aristidis Tsatsakis, an expert in forensic sciences and toxicology with the University of Crete, Greece, also provided an editorial review.


    Key Assumptions

    Before delving into the authors’ controversial conclusions, a brief review of key assumptions is important. The data backing this study covers the span of the pandemic until May 2021. At that point, the authors shared that a total of 4,863 reports of death were entered into the Center for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS). Noting the passively managed nature of VAERS, the authors claim that “[H]istorically, VAERS has been shown to report about 1% of actual vaccine/inoculation adverse events” based on conclusions from a previous study that corresponding author Kostoff helped produce.


    The authors’ key assumptions for expected deaths associated with the mass COVID-19 vaccination program exist In Appendix A titled “Expected Deaths in 65+ Demographic vs. COVID-19 Inoculation Deaths.” The authors estimate the actual number of deaths associated with the vaccine based on the amount of deaths reported in VAERS.


    They cite numerous issues with VAERS, including “gross underreporting of adverse events,” which they suggest associates with “a major conflict of interest for the CDC.” They argue this because the CDC funds mass inoculations by providing billions of dollars to various vaccination programs.


    Fundamental to the Kostoff et al. argument for CDC conflict of interest centers on the Coronavirus Response and Relief Supplemental Appropriations Act, 2021 (P.L. 116-260), where the agency received $8.75 billion “to plan, prepare for, promote, distribute, administer, monitor, and track coronavirus vaccines to ensure broad-based distribution, access and vaccine coverage.” That the CDC gets enormous sums of money to keep vaccination programs going could slant their focus to widespread vaccine distribution and maintaining good rapport with the funding elements within the U.S. government and vaccine manufacturers.


    However, the CDC is also responsible for monitoring the safety of the COVID-19 vaccines. But are they doing this thoroughly, systematically, and objectively? The authors declare they are not and state that with a waiver of liability, along with material interests in promoting vaccination, the CDC is not a trustworthy agency.


    Central Position

    The architects of mass vaccination programs should employ risk-benefit analyses, particularly in the case of vulnerable cohorts, like children, and when new vaccine technology is being used. The probability of severe COVID-19 and death must be thoroughly vetted, understood, and weighed against the risks vs. benefits of taking the vaccine. Parents deserve to have honest, reliable, nonpromotional information to make these choices for their children.


    Data shows that the probability of severe disease or death is low among children infected with COVID, meaning that the bar for administering a new vaccine in this population must be high. Because the vaccines are given to healthy kids, the safety profile and vaccine efficacy need to be significantly high when compared to the very low probability of serious illness and death from the virus.


    This study team highlighted issues that raise the risk premium associated with COVID-19 vaccination. They include:

    Very short-term clinical trials of COVID-19 vaccines

    Limited sampling of children, not representative of full population

    Small size of study population for adolescent/children equals poor predictive power

    Lack of focus on biomarkers that could be early warning indicators of risk of serious diseases

    No focus on long-term effects whatsoever (children are monitored for a year, but studies are only months old; serious long-term effects would be a high price to pay for short-term gains)

    Risks Associated with COVID-19 Vaccines

    The authors present risks associated with COVID-19 vaccines that industry and government may reject. While the paper was peer-reviewed, TrialSite hopes a constructive dialogue ensues, one that ensures multiple points of view are included. The authors identify the following risk factors:


    mRNA vaccines instruct the body to produce spike proteins, which according to some unfolding studies, may lead to vascular and “other forms of damage.”

    Spike protein “bypasses front-line defenses of the innate immune system” and can enter the bloodstream. The authors assume the injection “ensures” the spike protein and the surrounding LNP are toxins that persist and can cause damage (Industry and the NIH both refute this claim)

    While biodistribution ultimately determines where and when the aforementioned injected material ends up in the body, the authors cite the Pfizer biodistribution documentation from the Japanese submission. That document revealed that injected mRNA material could end up in “myriad critical organs throughout the body.” Pfizer has countered those biodistribution reports by stating that they were associated with far higher doses in rodents, not humans, and are not relevant for making conclusions about humans

    Study focused on one injection, but two injections plus boosters could have “cumulative effects”

    Findings

    Using the expected death rate simulation, the authors report a novel “best-case scenario” where the “cost-benefit analysis” on a very conservative basis reveals that there are five-fold the number of deaths associated with COVID-19 vaccination versus deaths that are attributable to COVID-19 in the most at-risk cohort, age 65+. The authors argue that given “the risk of death from COVID-19 decreases drastically as age decreases,” the unknown, long-term effects associated with the COVID-19 vaccines in the young-age cohort only serve to boost the risk-benefit ratio.


    94% of deaths associated with COVID-19 are not due strictly to the coronavirus but include a combination of underlying factors, such as age, obesity, and other comorbidities, etc. The authors suggest the actual number of deaths attributed solely to COVID-19 amounts to 35,000 across all age groups. The study team argues that this number could be inflated due to A) high number of false-positive PCR tests and B) inclination of healthcare professionals to attribute more deaths to COVID-19 than may actually be the case.


    The authors concur with two independent studies authored by Virginia Stoner and Jessica Rose that deaths recorded in VAERS are in fact “strongly related to inoculation” and not “coincidental” as government spokespersons, media favorites, and many in academia claim. But who is right?


    Assuming the authors’ underlying premise is correct, that VAERS historically underreports adverse events by “two orders of magnitude,” the authors suggest that “COVID-19 inoculation deaths in the short-term could be in the hundreds of thousands for the USA.”


    Given a mass vaccination strategy to eradicate COVID-19, intensified by the POTUS vaccine mandates and the government using OSHA to force nearly 100 million people to get vaccinated or risk losing their jobs, the authors warn that lag times related to adverse events ensure that many people could be at grave risk.


    Going back to the children…, regardless of whether the authors’ assumptions are correct or not, a rational and rigorous review of risks versus benefits must be accomplished in a very public way. This means full transparency from both industry and regulators and allowing for dissenting views to be heard, not buried. The people deserve this.


    Why are we vaccinating children against COVID-19?
    This article examines issues related to COVID-19 inoculations for children. The bulk of the official COVID-19-attributed deaths per capita occur in th…
    www.sciencedirect.com

    Ho Chi Minh City Dept. of Health Rolls out Investigational Molnupiravir: But Not in a Clinical Trial


    Ho Chi Minh City Dept. of Health Rolls out Investigational Molnupiravir: But Not in a Clinical Trial
    At the pandemic’s onset, Vietnam’s fast and effective response efforts drew high praise, and rates of infection and deaths were low. Efforts
    trialsitenews.com


    At the pandemic’s onset, Vietnam’s fast and effective response efforts drew high praise, and rates of infection and deaths were low. Efforts included immediately closing the borders when the virus began circulating in China. However, early successes may have contributed to a very different situation in 2021. The government did not prioritize vaccinations and most Vietnamese to this day go unvaccinated. When the Delta variant crossed Vietnam’s borders in April 2021, the number of cases soared. Ho Chi Minh City, Vietnam’s biggest city, has become the epicenter of the virus. Some 80% of fatalities and half of infections originate in the city, and from August 23, Ho Chi Minh went into a government-imposed lockdown. The city’s Department of Health launched what could be considered a controversial COVID-19 home-based ambulatory care program. The program centers on the use of a medicine kit with Merck’s experimental Molnupiravir. Not part of a controlled clinical trial the use of the investigational product raises ethical questions although apparently the COVID-19 home medication program results will be evaluated by experts under a research protocol that has been approved by the nation’s National Ethics Committee in Biomedical Research under the Vietnamese health ministry.


    Response to the Latest Wave

    As of September 16, 2021, the country reports 216,153 active cases and 16,425 COVID-19 deaths. Hospitals are full, and although Vietnam is due to receive vaccine supplies, they won’t accept them until the end of 2021. The government has been forced to look for other means to combat the pandemic and reduce the risk of patients requiring hospitalization. In particular, they are opting for early-onset antiviral treatments.


    With a surge of new cases and deaths, low vaccine supplies, and the majority of the country in lockdown, Pham Minh Chinh, the newly elected prime minister, found himself under severe pressure. He has prioritized mass testing, and deployed soldiers to enforce lockdowns as well as distribute food and other necessities.


    Exploration into Antivirals

    While some Southeastern nations have embraced ivermectin at least informally that doesn’t seem to be the case here. By July Vietnam hadn’t embraced any antiviral drugs targeting COVID-19. As reported in Vietnamese news the Vice President of Vietnam Association of Infectious Diseases, Nguyen Hong Ha shared that the Southeast Asian nation had not embraced infectious diseases such as Favipiravir and Remdesivir in its treatment regimen for the novel coronavirus.


    While remdesivir was approved in the U.S. the World Health Organization (WHO) Solidarity study indicated the drug wasn’t effective and nonetheless for Vietnam the price tag was also too high.


    But Vietnam was studying Favipiravir, the antiviral drug used to treat influenza in Japan and now used in dozens of nations targeting COVID-19, for domestic production. By early July scientists at the Institute of Chemistry under the Vietnam Academy of Science and Technology announced they successfully synthesized Favipiravir in labs there. Called Avigan and produced by FUJIFILM Chemical Toyama (FUJIFILM) the drug was now off-patent.


    But time was of the essence. By August 19 Vietnam’s Ministry of Health during a meeting with FUJIFILM announced their decision to acquire 1 million tablets Avigan from Japan’s FUJIFILM with an imminent expected arrival date reported Anh Kiet writing for the Hanoi Times. The FUJIFILM and Vietnam deal would be brokered by the Vietnamese conglomerate AIC Group.


    The AIC Group would buy all the available Avigan tablets in FUJIFILM stock, turn around and distribute the drugs at no charge to fight the pandemic.


    Home Program—App & Medicine Kits

    However with an unfolding crisis particularly in Ho Chi Minh City more was needed. Undoubtedly the Vietnamese government observed the dramatic turnaround made by India’s largest state, Uttar Pradesh. Public health agencies in this Indian state-led a dramatic turnaround for the better. By employing health outreach teams across tens of thousands of villages and districts the state government conducted frequent testing while distributing home medicine kits for those infected or even exposed to the pathogen. These kits included ivermectin and contributed to the complete turnaround in the pandemic. https://trialsitenews.com/msn-…based-home-medicine-kits/


    The Ho Chi Minh City Department of Health developed a mobile application named HCM City Health that is downloadable via App Store and Google Play. The main purpose of the application is to make health consultations and declaration of health accessible to the patients. It also makes the contacting of health authorities easier, especially for patients who are receiving a home health medicine pack.


    The city government needs to provide 11,000 tons of goods, including medicine packs, to residents each day. Of interest, a Vietnamese home program included at least three different for different situations. TrialSite reported a controversial part of one pilot involving Ho Chi Minh City Department of Health includes the experimental drug Molnupiravir. Still, in clinical trials, the investigational product hasn’t been approved or provisionally authorized for emergency anywhere.


    A TrialSite investigation into the Vietnamese situation found that there are three types of medicine packs presently provided including the following:


    Pack A: Paracetamol and vitamins to boost immunity. These are distributed to patients with mild symptoms.

    Pack B: Either prednisolone, dexamethasone, or methylprednisolone. There are also anti-coagulants like rivaroxaban, apixaban, or dabigatran. These are distributed to patients who have more severe symptoms and may be waiting to be transferred to the hospital.

    Pack C: Molnupiravir, an experimental antiviral drug produced by Merck and Ridgeback Biotechnology. These are also distributed to patients with mild symptoms. A total of 300,000 doses arrived on August 31, and another 1.7 million tablets arrived the following month. There’s still another batch expected to arrive. The Ho Chi Minh City Department of Health also uses the HCM City Health app in conjunction with the Molnupiravir home medicine kit.

    Move to Molnupiravir

    Molnupiravir, originally developed by Emory University, was licensed in March 2020 at the pandemic’s onset to Ridgeback Biotherapeutics via Emory’s Drug Innovation Ventures at Emory (DRIVE) LLC. Known as EIDD-2801, TrialSite notes that the majority of discovery and early development was funded by the American government via the National Institute of Allergy and Infectious Diseases (NIAID) as well as the Defense Threat Reduction Agency (DTRA) targeting a number of viruses.


    Research or Care?

    TrialSite shared that this Ho Chi Minh City initiative led by the Department of Health involved a home-based, self-care, ongoing monitoring (including app) including physicians monitors. Additionally, Department of Health teams monitor the patients to determine the rate of negative SARS-CoV-2 as well as the rate of any disease progression to a more severe level after five days.


    Moreover, the care protocol calls for ongoing monitoring over a 14-day period for any side effects or adverse events. While this Ho Chi Minh City program isn’t a clinical trial Vietnam News reported that “The program results will be assessed by health experts under a scientific research protocol approved by the National Ethics Committee in Biomedical Research and the health ministry.”


    The ethics of the Ho Chi Minh City are questionable. The investigational product has been licensed by producers in India and not by Merck directly. Merck acknowledged that they have licensed the investigational product to multiple Indian generic pharmaceutical producers and in fact disclosed in July that one of them, Hetero Labs Limited (Hetero) reported positive clinical trial data. The producers in India include Cipla Limited, Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Sun Pharmaceutical Industries and the aforementioned Hetero.


    Regardless this program appears to expose residents in Ho Chi Minh City to what is still an experimental drug not in a controlled clinical trial. This effort has not been covered by any trade press or media in the West other than TrialSite.


    What is molnupiravir and how does it work?

    Molnupiravir was originally developed to treat influenza at Emory University. The antiviral drug is also effective against COVID-19, reducing viral replication and pathogenesis in patients included in the clinical trial.


    In February, Ridgeback Biotherapeutics initiated a US-based multicenter clinical study, where 204 outpatients with mild symptoms were randomly picked and divided into 4 groups that received 200 mg, 400 mg, or 800 mg of Molnupiravir, or a placebo, twice a day for 5 days.


    Only 7 patients experienced adverse effects of the drug, preventing further participation in the trial, but the remainder showed promising results. The tolerability and safety of the drug showed minimal side effects for most participants and those who had the 800mg dose had the lowest rate of adverse symptoms. The adverse symptoms reported were headache, insomnia, and increased alanine aminotransferase levels.


    Results showed the drug was well tolerated and showed potent antiviral efficacy. When they swabbed the participants, they isolated infectious viruses from 43.5%. On the third day of taking the drug, the group who took an 800mg dose had an infection rate of 1.9% compared to 16.7% of patients who took a placebo. Participants in the 400mg group also showed a decrease of infection by the fifth day. All participants who took the drug had a reduced contagious level compared to the control group by the end of the study.


    Currently, molnupiravir is undergoing the final phase of clinical trials for outpatients, the results of which will determine its status as an FDA authorized drug. Clinical trials for hospitalized patients were discontinued since they didn’t demonstrate a benefit in hospitalized patients.


    The clinical trials are promising; however, there is no data on any long-term side effects after its use as a flu or COVID-19 antiviral. After the trial’s preliminary results, the US government established a $1.2 billion agreement with Merck to supply molnupiravir once the FDA approves or authorizes it on an emergency basis. TrialSite recently covered a move of Merck’s ‘Household Contacts’ molnupiravir study to a lead investigator in Arizona.


    Final Thoughts on Molnupiravir Safety for HCM Residents

    As mentioned above, the Vietnamese regulatory authority, nor any other regulatory agency have approved molnupiravir for use yet, but the Department of Health in Ho Chi Minh has given the green light for its distribution among patients isolating at home, raising critical questions about the government’s policies in distributing an unapproved drug for public use.


    Within this framework, medical staff are taking steps to acquire informed consent about the use of molnupiravir. Patients are briefed on the program and must give their consent to receive the medications. They also receive written information sheets regarding the medication, monitoring, and who to contact if their symptoms worsen. Nevertheless, the point of informed consent could be considered moot when the only other option for these self-isolating Vietnamese patients is to refuse treatment. Under lockdown, they are unable to procure alternative medicines from a doctor or pharmacist.


    The Department of Health states that patients will be monitored regularly throughout via the aforementioned 14-day treatment period, and that they will evaluate COVID antigen rates on day 2 of treatment and progression of disease on day 5. However, this monitoring is virtual; there appears to be no physician monitoring of the dosage, nor actual blood tests and physical check-ups to see how their body is reacting to the drug.


    TrialSite News will continue to monitor the situation in Ho Chi Minh City and any data released by the Vietnam Department of Health.

    Infectious SARS-CoV-2 in Exhaled Aerosols and Efficacy of Masks During Early Mild Infection


    Infectious SARS-CoV-2 in Exhaled Aerosols and Efficacy of Masks During Early Mild Infection
    AbstractBackground. SARS-CoV-2 epidemiology implicates airborne transmission; aerosol infectiousness and impacts of masks and variants on aerosol shedding are n
    academic.oup.com


    Abstract

    Background

    SARS-CoV-2 epidemiology implicates airborne transmission; aerosol infectiousness and impacts of masks and variants on aerosol shedding are not well understood.


    Methods

    We recruited COVID-19 cases to give blood, saliva, mid-turbinate and fomite (phone) swabs, and 30-minute breath samples while vocalizing into a Gesundheit-II, with and without masks at up to two visits two days apart. We quantified and sequenced viral RNA, cultured virus, and assayed sera for anti-spike and anti-receptor binding domain antibodies.


    Results

    We enrolled 49 seronegative cases (mean days post onset 3.8 ±2.1), May 2020 through April 2021. We detected SARS-CoV-2 RNA in 45% of fine (≤5 µm), 31% of coarse (>5 µm) aerosols, and 65% of fomite samples overall and in all samples from four alpha-variant cases. Masks reduced viral RNA by 48% (95% confidence interval [CI], 3 to 72%) in fine and by 77% (95% CI, 51 to 89%) in coarse aerosols; cloth and surgical masks were not significantly different. The alpha variant was associated with a 43-fold (95% CI, 6.6 to 280-fold) increase in fine aerosol viral RNA, compared with earlier viruses, that remained a significant 18-fold (95% CI, 3.4 to 92-fold) increase adjusting for viral RNA in saliva, swabs, and other potential confounders. Two fine aerosol samples, collected while participants wore masks, were culture-positive.


    Conclusion

    SARS-CoV-2 is evolving toward more efficient aerosol generation and loose-fitting masks provide significant but only modest source control. Therefore, until vaccination rates are very high, continued layered controls and tight-fitting masks and respirators will be necessary.

    70% of fully vaccinated prisoners caught COVID-19 in a Texas Delta outbreak, the CDC says — but vaccines protected against severe disease


    70% vaccinated prisoners got COVID, 93% of unvaccinated: Texas study
    Of 129 fully vaccinated prisoners who caught COVID-19, only one was hospitalized. Unvaccinated people at the prison caught COVID-19 at a higher rate.
    www.businessinsider.com

    About 70% of fully vaccinated people in a Texas prison caught COVID-19 in an outbreak, the CDC said.

    The data suggests that while Delta can spread among vaccinated people, vaccines protect against severe COVID-19.

    Of the unvaccinated prisoners, 93% caught COVID-19, and one died, the CDC said.

    More than two-thirds of fully vaccinated people in a Texas prison caught COVID-19 during an outbreak of the Delta variant in July, but vaccines protected against severe illness, a study from the Centers for Disease Control and Prevention found.


    Of 185 fully vaccinated prisoners at the unnamed prison, 129, or about 70%, caught the virus, data compiled by the CDC and the Federal Bureau of Prisons showed. This was a much lower rate than the unvaccinated prisoners, 39 of 42 of whom – or about 93% — caught COVID-19 during the outbreak, said the study, published Tuesday in the CDC's Morbidity and Mortality Weekly Report.


    Four people, three of whom were unvaccinated, needed treatment in a hospital, the study said. One unvaccinated person died, it said.


    Most of the prisoners were white men, and many had received Pfizer's vaccine at least four months before the outbreak, the data showed.

    The study adds to growing evidence that COVID-19 vaccines cut the risk of severe disease and hospitalization. Prisons tend to have higher rates of COVID-19 and deaths because of cramped living conditions and underlying health conditions, the CDC said.


    Another CDC study from this month found that unvaccinated Americans were 11 times as likely to die of COVID-19 as vaccinated people. About 45% of people in the US are unvaccinated, according to the CDC.


    The latest CDC study showed that the Delta variant can spread among both vaccinated and unvaccinated people. "Infectious virus was cultured from vaccinated and unvaccinated infected persons," the study said.


    Measures like masks and regular testing are "critical" where physical distancing is "challenging," even if vaccination rates are high, the CDC said.

    Wuhan Lab Wanted to Genetically Enhance Bat Viruses to Study Human Risks, Documents Show


    Wuhan lab wanted to genetically enhance bat viruses to study human risks, documents show
    The documents promise to fuel the controversy around the Wuhan lab's role in the pandemic.
    www.newsweek.com


    Less than two years before the COVID-19 pandemic began, scientists at the Wuhan Institute of Virology planned to genetically alter viruses to make them more infectious for humans and release them into bat caves

    The research proposal was part of a trove of documents released this week by a group of scientists and activists who are trying to determine the origins of the pandemic, which has killed 4.7 million people around the world, according to Johns Hopkins University.


    The Wuhan scientists were listed as partners on a funding proposal the environmental health nonprofit EcoHealth Alliance made to the U.S. government's Defense Advanced Research Projects Agency (DARPA)

    DARPA rejected the proposal and it is not clear what happened to the research project, which the documents described as having "a good running start"

    The proposal promises to fuel the controversy around the Wuhan lab's role in the pandemic. The Chinese government maintains that the outbreak began at a wet market and bristles at suggestions that experiments conducted at the Wuhan Institute of Virology led to a leak of dangerous pathogens.


    A growing number of scientists and governments around the world including the Biden administration, have refused to rule out the lab leak theory and demanded that China cooperate fully in a global scientific investigation.

    fully in a global scientific investigation.



    The growing suspicion of China's official version has been driven in large measure by the Decentralized Radical Autonomous Search Team Investigating COVID-19 or DRASTIC, which released the documents this week. The documents could not be verified by Newsweek.


    Throughout the pandemic, about two dozen DRASTIC researchers and correspondents, many anonymous, working independently from many different countries, have uncovered obscure documents, pieced together the information, and explained it all in long threads on Twitter. Gradually, the quality of their research has gained the acclaim of professional scientists and journalists.

    Richard Ebright, board of governors professor of chemistry and chemical biology at Rutgers University and laboratory and director at the Waksman Institute of Microbiology, tweeted out the findings of the latest DRASTIC document dump and said the world should be furious at the news.

    The documents showed researchers aspired to genetically alter coronaviruses and monitor their release and transmission in bat caves to determine the risks those viruses posed to humans.


    In a Monday post on DRASTIC Research's website, the group said documents shared by an unnamed whistleblower showed the EcoHealth Alliance "collaborated" with the Wuhan Institute of Virology to "carry out advanced and dangerous human pathogenicity Bat Coronavirus research" through a grant proposal EcoHealth Alliance filed with DARPA.


    DARPA is a research agency within the U.S. Department of Defense which aims to "preserve military readiness by protecting against the infectious disease threat" through its PREEMPT program.

    In its funding request, EcoHealth Alliance "proposed injecting deadly chimeric bat coronaviruses collected by the Wuhan Institute of Virology into humanised and 'batified' mice," DRASTIC Research said.

    A copy of EcoHealth Alliance's proposal shared by DRASTIC Research said the proposed project aimed to "defuse the potential for spillover of novel bat-origin high-zoonotic risk SARS-related coronaviruses in Asia." The proposal's executive summary said researchers would "intensively sample bats" in field locations where scientists "identified high spillover risk" for coronaviruses.

    EcoHealth Alliance wrote in the document shared by DRASTIC Research that it planned to work with researchers at the Duke-NUS Medical School in Singapore, the University of North Carolina, the Palo Alto Research Center in California, U.S. Geological Survey's National Wildlife Health Center and the Wuhan Institute of Virology in Wuhan, China. It requested $14 million from DARPA to conduct its research, which was estimated to take three and a half years.


    The proposal was dated March 2018, less than two years before SARS-CoV-2, the coronavirus that causes COVID-19, began spreading around the world. The virus is believed to have begun spreading among humans in Wuhan, where the first wave of infections was reported.


    Thanks to DRASTIC, the world now knows that the Wuhan Institute of Virology had an extensive collection of coronaviruses gathered over many years of foraging in the bat caves, and that many of them—including the closest known relative to the pandemic virus, SARS-CoV-2—came from a mineshaft where three men died from a suspected SARS-like disease in 2012. It knows that the Institute was actively working with these viruses, using inadequate safety protocols, in ways that could have triggered the pandemic, and that the lab and Chinese authorities have gone to great lengths to conceal these activities. It is also clear the first cases appeared weeks before the outbreak at the Huanan wet market that was once thought to be ground zero. None of that is conclusive proof that a lab leak caused the virus.

    As the DRASTIC revelations swayed a once skeptical Western media and scientific community, President Joe Biden ordered a U.S. intelligence investigation to determine the origins of the pandemic. The intelligence agencies issued an inconclusive report last month.


    In one document shared by DRASTIC Research, a DARPA official wrote he was not recommending funding for the project. DARPA's assessment of the project said it "aims to identify and model spillover risk of novel, pandemic-potential SARS-related coronaviruses (SARSr-CoVs) in Asia, focusing specifically on known hotspot bat caves in China."

    El Salvador, Guatemala, and Bolivia Offer Medicine Kits for COVID-19 Without Anticipating Adverse Reactions


    El Salvador, Guatemala, and Bolivia Offer Medicine Kits for COVID-19 Without Anticipating Adverse Reactions
    TrialSite recently reported that in the Central American nation of El Salvador, the nation’s Ministry of Public Health (Ministerio de Salud
    trialsitenews.com


    TrialSite recently reported that in the Central American nation of El Salvador, the nation’s Ministry of Public Health (Ministerio de Salud Publica—MINSAL) had embraced the anti-parasitic drug ivermectin as part of a combination of recommendations for early-onset treatment of COVID-19 via an ambulatory home patient kit.


    As shared by Salud Conlupa, every citizen in El Salvador (Central America) is provided with an “anti-COVID-19 kit” containing the following products free of charge by the government if needed.


    The kit contains:


    Paracetamol and aspirin (anti-inflammatory)

    Loratadine (antihistamine)

    Ivermectin (against parasite infestation)

    Azithromycin (antibiotic)

    Vitamin C (500mg)

    Vitamin D (2000 IU)

    Zinc (50mg)

    Electrolytes (minerals)

    Guatemala and Bolivia are now also implementing this program.


    The world is a big place and depending on what nation different approaches are contemplated to help treat the coronavirus. While the mainstream media in the United States will only publish misinformation at best, and outright lies in more egregious cases, health consumers should understand what’s unfolding around the world. It’s important to note however that in places like America and Australia the health authorities are on the information warpath, ensuring that when the pharmaceutical companies testing antiviral drugs for COVID-19 are done, the market will be wide open for monetization.


    Call to Action: Learn more about the details of this program here.


    El Salvador, Guatemala y Bolivia ofrecen kits de medicinas para COVID-19 sin prever reacciones adversas
    La entrega indiscriminada de una caja de medicamentos a los pacientes con sospechas de COVID-19 puede perjudicar su salud al no tomar en cuenta sus historias…
    saludconlupa.com

    Large Retrospective Study Tracks Use of HCQ, Remdesivir & Dexamethasone in Real-World Settings


    Large Retrospective Study Tracks Use of HCQ, Remdesivir & Dexamethasone in Real-World Settings
    While research has uncovered ever more information about the safety and efficacy of various therapies targeting SARS-CoV-2, the virus behind COVID-19,
    trialsitenews.com


    While research has uncovered ever more information about the safety and efficacy of various therapies targeting SARS-CoV-2, the virus behind COVID-19, little is known about how treatments perform in real-world settings. Consequently, a group of researchers known as the National COVID Cohort Collaborative (N3C) sought to study use patterns of potential pharmacologic treatments of COVID-19 in the United States. The team designed a retrospective cohort study of three (3) COVID-19 therapies to better understand the real-world evidence for hydroxychloroquine, remdesivir, and dexamethasone. The results were published recently in the Annals of Internal Medicine.


    The National COVID Cohort Collaborative (N3C)

    The study team leveraged data from the National COVID Cohort Collaborative (N3C), a large multicenter longitudinal study sponsored by a partnership involving the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), and National Center for Data to Health (CD2H), and NIGMS supported by the Institutional Development Award Networks for Clinical and Translational Research (IDeA-CTR). NCATS provided overall stewardship.


    This particular sub-study within the broader N3C involved a subset of study data accessible via electronic medical records. With 137,870 hospitalized adults primarily in major academic medical centers, the study ran for a year, from February 1, 2020, and February 28, 2021.


    Findings

    Out of the entire patient base of 137.870, a total of 8754 (6.3%) patients received hydroxychloroquine, 29,272 (21.2% were administered remdesivir, and 53,909 received the corticosteroid dexamethasone. Hydroxychloroquine use in the study increased early in the pandemic but then declined due to the U.S. Food and Drug Administration (FDA) withdrawal of the emergency use authorization in 2020. While the use of remdesivir did rise, the use of dexamethasone was most prominent due to the findings of the University of Oxford RECOVERY (Randomized Evaluation of COVID-19 Therapy) study.


    The study authors reported that the use of remdesivir and dexamethasone varies measurably across participating health centers—reporting an intraclass correlation coefficient of 14.2% for dexamethasone and 84.6% for remdesivir. The authors reported that variation was greater for remdesivir, which the authors declare reduced the length of hospital stay (based on NIH study) but not mortality.


    The authors suggest that dexamethasone was underused by persons who are mechanically ventilated. Additionally, a number of influences impact the variation in remdesivir and dexamethasone, including patient case mix, drug access, protocols, and quality of care involved at the particular site.


    Academic medical centers were the most prominent contributor of N3C data, hence don’t reflect community hospital setting experience.


    Lead Research/Investigator

    Caleb G. Alexander, MD, Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine


    ACP Journals

    Biodiversity intervention enhances immune regulation and health-associated commensal microbiota among daycare children


    AAAS


    Abstract

    As the incidence of immune-mediated diseases has increased rapidly in developed societies, there is an unmet need for novel prophylactic practices to fight against these maladies. This study is the first human intervention trial in which urban environmental biodiversity was manipulated to examine its effects on the commensal microbiome and immunoregulation in children. We analyzed changes in the skin and gut microbiota and blood immune markers of children during a 28-day biodiversity intervention. Children in standard urban and nature-oriented daycare centers were analyzed for comparison. The intervention diversified both the environmental and skin Gammaproteobacterial communities, which, in turn, were associated with increases in plasma TGF-β1 levels and the proportion of regulatory T cells. The plasma IL-10:IL-17A ratio increased among intervention children during the trial. Our findings suggest that biodiversity intervention enhances immunoregulatory pathways and provide an incentive for future prophylactic approaches to reduce the risk of immune-mediated diseases in urban societies.

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    Covid-19: How is vaccination affecting hospital admissions and deaths?


    Covid-19: How is vaccination affecting hospital admissions and deaths?
    An analysis of UK data from the National Immunisation Management Service (NIMS) and the Coronavirus Clinical Information Network (CO-CIN),1 endorsed by the UK…
    www.bmj.com


    What do the data on hospital admissions show?

    An analysis of UK data from the National Immunisation Management Service (NIMS) and the Coronavirus Clinical Information Network (CO-CIN),1 endorsed by the UK Scientific and Advisory Group for Emergencies (SAGE),2 shows that of 40 000 patients with covid-19 who were admitted to hospital between December 2020 and July 2021 a total of 33 496 (84%) had not been vaccinated. It found that 5198 (13%) of these patients had received their first vaccine and 1274 (3%) their second. A total of 611 patients with previous covid-19 (reinfection) were not included in the analysis.


    Is the picture similar for deaths?

    The important figure here is the number of “breakthrough” deaths, those involving covid-19 that occurred in someone who had received both vaccine doses and had a first positive PCR test result at least 14 days after the second vaccination dose. Data from the Office of National Statistics show that 256 (0.5%) of the 51 281 covid related deaths that occurred in England between 2 January and 2 July 2021 were breakthrough deaths.3 Nearly two thirds (61.1%) of the breakthrough deaths were in men, whereas 52.2% of other covid-19 deaths were in men. And 13.1% of breakthrough deaths were people who were identified from hospital episode data or causes of death as likely to have been immunocompromised, compared with 5.4% for other covid-19 deaths. SAGE noted this trend in its latest minutes, stating, “Vaccination generally reduced the odds of in-hospital mortality, although immunocompromised patients in the study had persistently high risk of mortality after both first and second dose vaccines.”4


    What effect have higher vaccination rates had on these trends?

    SAGE noted that most patients admitted to hospital with covid after 16 June 2021 were fully vaccinated.5 Public Health England said that even with a “highly effective vaccine” this was expected, given the high rate of vaccine uptake and a policy of vaccinating higher risk people first. In its latest surveillance report Public Health England emphasised that the rate of hospital admissions and death from covid remained “substantially greater” in unvaccinated than in vaccinated people.6 For example, between the week beginning Monday 16 August 2021 and the week ending Sunday 12 September, the rate of hospital admissions of over 80s was 50.5 per 100 000 in the fully vaccinated and 143.9 per 100 000 in the unvaccinated, while deaths were 45.5 and 145.4 per 100 000, respectively. These trends were seen across the board. For example, for 60-69 year olds the hospital admission rates were 13.5 per 100 000 in the fully vaccinated and 74.3 per 100 000 in the unvaccinated, while deaths were 4.1 and 24.3 per 100 000, respectively.


    Which patient groups are most at risk after vaccination?

    In a paper published by The BMJ,7 researchers from the University of Oxford reported on their updated QCovid tool, which identifies vaccinated people who are at greatest risk of severe covid-19 leading to hospital admission or death from 14 days after their second dose. It highlighted an elevated risk among people who are immunosuppressed as a result of chemotherapy, a recent bone marrow or solid organ transplantation, or HIV and AIDS; people with neurological disorders, including dementia and Parkinson’s; care home residents; and people with chronic disorders, including Down’s syndrome. Julia Hippisley-Cox, professor of clinical epidemiology and general practice at Oxford and coauthor of the paper, said that the tool could be used to help identify patients at highest risk of serious outcomes despite vaccination for targeted intervention, and to “inform discussions between doctors and patients about the level of risk to aid shared decision making.”

    Imperial College of London Researcher Suggests Investigation into COVID-19 Vaccine Impact on Menstrual Cycle


    Imperial College of London Researcher Suggests Investigation into COVID-19 Vaccine Impact on Menstrual Cycle
    Recently The BMJ published an opinion piece from Dr. Victoria Male,  an esteemed faculty member from the Imperial College of London specializing in
    trialsitenews.com




    Recently The BMJ published an opinion piece from Dr. Victoria Male, an esteemed faculty member from the Imperial College of London specializing in medicine with an emphasis on metabolism, digestion, and reproduction. Dr. Male communicates to that journal’s influential readers that recently while the UK’’s drug regulator—the Medicines and Healthcare Products Regulatory Agency (MHRA)—listed side effects associated with the COVID-19 vaccines such as “sore arm, fever, fatigue, and myalgia” they presently exclude growing reports of “changes to periods and unexpected vaginal bleeding.” Importantly Dr. Male introduces that general practitioners increasingly hear about complaints from post-jab patients about these menstrual-related side effects; the regulators in the UK are not yet responding. They should—given that over 30,000 of these incidents have been reported in the UK alone. Occurring directly after vaccination, Male did some digging into the UK’s “yellow card surveillance scheme for adverse drug reaction” as of September 2, 2021. While she emphasizes that these incidents are still rare (considering how many vaccines have been administered), she nonetheless believes it’s important to address this topic via more research to help overcome vaccine hesitancy among young women.


    While this news undoubtedly raises an alarm, thankfully, Male reports that the menstrual instability “…returns to normal the following cycle.” Moreover, the Imperial College of London lecturer emphasized, “…there is no evidence that COVID-19 vaccination adversely affects fertility.” She reminds all that no apparent impact on fertility was observed during Phase 3 clinical trials investigating the COVID-19 vaccines.


    Probably an Immune Response

    The Imperial College of London author emphasizes that these menstrual cycle impact findings occur despite vaccine product—whether it’s mRNA-based or adenovirus vectored vaccines. This indicates not a specific vaccine product but rather “…likely…a result of the immune response to vaccination rather than a specific vaccine component.”


    For example, Dr. Make informs the reader that the human papillomavirus (HPV) vaccine also has triggered similar reports of side effects. She emphasizes that “…immunological influences on the hormones driving the menstrual cycle” or, for that matter, “effects mediated by immune cells in the lining of the uterus” represents a “biologically plausible mechanism.”


    Further Study Needed

    Dr. Male reminds all readers of The BMJ that the yellow card scheme in the UK cannot be used to determine causal relationship—such as “a link between changes to menstrual periods and COVID-19 vaccine” because already the number is low and the commonplace natural of menstrual disorders. She does emphasize the need for investigation into the topic, however declaring that the National Institutes of Health recently allocated $1.67 million to encourage such research. Thus Dr. Male suggests that clinical research be employed to investigate any links between the coronavirus and changes to menstrual cycles. She concludes, “Robust research into these possible adverse reactions remains critical to the overall success of the vaccination program” given young women’s persistent vaccine hesitancy, largely caused by “false claims that COVID-19 vaccines could harm their chances of pregnancy.”


    Lead Research/Investigator

    Dr. Victoria Male, Faculty of Medicine, Department of Metabolism, Digestion, and Reproduction


    Home - Dr Victoria Male


    Menstrual changes after covid-19 vaccination
    A link is plausible and should be investigated Common side effects of covid-19 vaccination listed by the UK’s Medicines and Healthcare Products Regulatory…
    www.bmj.com

    WHO reiterates warning against Covid boosters for healthy people as U.S. weighs wide distribution of third shots


    WHO reiterates warning against Covid boosters for healthy people as U.S. weighs wide distribution of third shots
    The U.S. has already administered over 2 million Covid booster shots nationwide, according to the CDC.
    www.cnbc.com


    KEY POINTS

    The WHO strongly opposes the widespread rollout of booster shots, asking that wealthier nations instead give extra doses to countries with minimal vaccination rates.

    The U.S. has already administered over 2 million boosters nationwide, according to the CDC.

    An advisory panel to the FDA unanimously recommended boosters on Friday for anyone 65 and older.


    World Health Organization officials repeated their protests Tuesday against Covid-19 booster shots for the general public, even as the U.S. readies this week to authorize their distribution across a wide swath of America.


    The WHO strongly opposes the widespread rollout of booster shots, asking that wealthier nations instead give extra doses to countries with minimal vaccination rates. The U.S. has already administered over 2 million third doses nationwide, according to the Centers for Disease Control and Prevention, and an advisory panel to the Food and Drug Administration unanimously recommended boosters on Friday for anyone 65 and older.

    What WHO is arguing is that booster doses in the general population, who had wide access to vaccines, who have already been vaccinated, is not the best bet right now," Dr. Mike Ryan, director of the WHO's health emergencies program, said during a live Q&A aired Tuesday on the organization's social media channels.


    Ryan reiterated the WHO's support for third doses administered to the elderly, medically vulnerable people and anyone needing an immune system boost after a full Covid vaccine regimen. He reiterated the organization's calls for a moratorium on booster shots through the end of the year to give nations enough time to immunize at least 40% of their populations against Covid.

    WHO Director-General Tedros Adhanom Ghebreyesus said on Sept. 14 that most countries with under 2% vaccination coverage are in Africa, where less than 3.5% of the continent's eligible population is fully inoculated against Covid. Africa will likely miss the WHO's target of a 10% vaccination rate by the end of the year, Tedros added.


    But in the U.S., where almost 55% of the population is fully vaccinated, according to the CDC, the FDA is expected to issue formal guidance on Pfizer's boosters before the CDC holds its two-day meeting on the shots on Wednesday and Thursday.


    An FDA advisory committee rejected a proposal Friday to recommend boosters for all Americans over 16, citing concerns about insufficient data and the potential for myocarditis. The group, instead, narrowed that plan, endorsing third doses for people 65 and over and other medically vulnerable people.

    World leaders further discussed the global vaccination effort at a meeting Tuesday of the United Nations General Assembly. President Joe Biden will hold a Covid summit Wednesday to encourage international dignitaries to help improve global vaccine distribution, noting in a speech to the General Assembly that the U.S. had donated more than 160 million Covid vaccine doses to the cause.


    "It's a real moment of truth," Ryan said. "We, as a world, are getting another chance, chances we haven't taken before, to focus on vaccine equity."

    Is The Worst Over? Modelers Predict A Steady Decline In COVID Cases Through March


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    Americans may be able to breathe a tentative sigh of relief soon, according to researchers studying the trajectory of the pandemic.


    The delta surge appears to be peaking nationally, and cases and deaths will likely decline steadily now through the spring without a significant winter surge, according to a new analysis shared with NPR by a consortium of researchers advising the Centers for Disease Control and Prevention.




    For its latest update, which it will release Wednesday, the COVID-19 Scenario Modeling Hub combined nine different mathematical models from different research groups to get an outlook for the pandemic for the next six months.


    "Any of us who have been following this closely, given what happened with delta, are going to be really cautious about too much optimism," says Justin Lessler at the University of North Carolina, who helps run the hub. "But I do think that the trajectory is towards improvement for most of the country," he says.


    The modelers developed four potential scenarios, taking into account whether or not childhood vaccinations take off and whether a more infectious new variant should emerge.


    The most likely scenario, says Lessler, is that children do get vaccinated and no super-spreading variant emerges. In that case, the combo model forecasts that new infections would slowly, but fairly continuously, drop from about 140,000 today now, to about 9,000 a day by March.


    Deaths from COVID-19 would fall from about 1,500 a day now to fewer than 100 a day by March 2022.

    That's around the level U.S. cases and deaths were in late March 2020 when the pandemic just started to flare up in the U.S. and better than things looked early this summer when many thought the pandemic was waning.




    And this scenario projects that there will be no winter surge, though Lessler cautions that there is uncertainty in the models, and a "moderate" surge is still theoretically possible.


    There's wide range of uncertainty in the models, he notes, and it's plausible, though very unlikely, that cases could continue to rise to as many as 232,000 per day before starting to decline.


    "We have to be cautious because the virus has shown us time and time again that new variants or people loosening up on how careful they're being can lead things to come roaring back," Lessler warns.


    William Hanage, an epidemiologist at Harvard's T.H. Chan School of Public Health, notes there is a fair amount of uncertainty in the models. "I would be concerned about interpreting these in an overly optimistic fashion for the country as a whole," he says.


    He agrees that overall the pandemic will be "comparatively under control by March," but says, "there could be a number of bumps in the road."


    Last winter, the worst surge of the pandemic in the U.S. hit midwinter when weather was cold and more people spent time indoors. "If you look at the seasonal dynamics of coronaviruses, they usually peak in early January. And in fact, last year we saw a peak like that with SARS-CoV-2," he says.


    Both Hanage and Lessler note that there will be regional variation, with some states continuing to surge for possibly a few weeks. Essentially, things could still get worse in some places before the get better.


    Lessler says he is especially worried about Pennsylvania, for example, and he notes that in some Western states like Idaho and Utah, there's a risk of resurgence. Hanage notes that places with cold winter weather may be susceptible to some increase in cases later in the year.


    And hospitals are going to continue to get flooded with patients for a while before infections taper off, and many are already being pushed past the breaking point.

    Another caveat: This scenario assumes that the U.S. doesn't get hit with a new variant that's even more contagious than delta. If it does, a bleaker scenario from the Modeling Hub projects far worse numbers: just below 50,000 cases a day by next March. But Lessler emphasizes this is very hypothetical.


    He's hopeful that the most optimistic scenario is the most likely.


    "I think a lot of people have been tending to think that with this surge, it just is never going to get better. And so maybe I just need to stop worrying about it and take risks. But I think these projections show us there is a light at the end of the tunnel," he says.


    Lessler thinks that at this point there's enough immunity in this country from a combination of enough people getting vaccinated and enough people having been exposed to the virus.


    "The biggest driver is immunity," he explains. "We've seen really big delta waves. The virus has eaten up the susceptible people. So there are less people out there to infect." The virus is still fighting to back, he says, but "immunity always wins out eventually."


    But transmission is still very high and will remain so for a while, so precautions are still called for until new infections come down to moderate levels.


    Natalie Dean, an assistant professor of biostatistics at Emory University, notes that even though we may see a decline this fall, we will still see "a lot of cases and deaths."


    Getting everyone eligible vaccinated is still key to preventing further deaths. Even in this optimistic scenario, the U.S. is projected to reach a cumulative total of over 780,000 deaths by March.


    Modeling is an imprecise science but the Modeling Hub brings together many of the the top disease modelers around the country, doing their best to look far down the road and make sense of a very unpredictable, complicated pandemic that's thrown one curve ball after another.


    "I hope it's true, obviously, but I can't shake a little unease I have about about what could be coming," says Dean.


    So like many Americans, Dean is keeping her fingers crossed.

    CDC study says COVID-19 can spread in vaccinated


    CDC study says COVID-19 can spread in vaccinated
    Severe illness was more common among the unvaccinated. The hospitalization rate was almost 10 times higher for them compared with those who got the shots.
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    NEW YORK — A new study of Texas prison inmates provides more evidence that coronavirus can spread even in groups where most people are vaccinated.


    A COVID-19 outbreak at a federal prison in July and August infected 172 male inmates in two prison housing units, according to a Centers for Disease Control and Prevention report released Tuesday.


    About 80% of the inmates in the units had been vaccinated. More than 90% of the unvaccinated inmates wound up being infected, as did 70% of the fully vaccinated prisoners.


    Severe illness, however, was more common among the unvaccinated. The hospitalization rate was almost 10 times higher for them compared with those who got the shots.

    It echoes research into a July outbreak in Provincetown, Massachusetts, where several hundred people were infected -- about three-quarters of whom were fully vaccinated.


    Such reports have prompted a renewed push by health officials for even vaccinated people to wear masks and take other precautions. They believe the delta variant, a version of coronavirus that spreads more easily, and possibly waning immunity may be playing a role.


    The authors did not identify the prison, but media reports in July detailed a similar-sized outbreak at the federal prison in Texarkana.