Friday, July 14, 2023
Thursday, July 13, 2023
University of Zurich COVID-19 Vax Adverse Effect Study
A team at the University of Zurich, Epidemiology, Biostatistics and Prevention Institute (EBPI) led a population-based cohort study involving 575 individuals who received a SARS-CoV-2 vaccine, and as part of the study, were monitored and followed up over 12 weeks, with participants sharing commonly reported adverse effects, mostly local pain, fatigue, headache and fever. Not surprisingly, a majority of adverse effects were mild to moderate and resolved within three days. The findings here are comparable to other reported prevalence and severity of adverse effects in randomized controlled trials. Hospitalizations out of the cohort totaled 0.7%.
Context
The results of this Swiss study concerning the prevalence and severity of adverse effects are overall similar to previously reported data from randomized controlled trials and other observational studies as cited by the Swiss-based study authors.
The team provides an overview of other important safety surveillance studies for some perspective. For example, in one online survey among persons who received either the Pfizer (BNT162b2), Moderna (mRNA-1273) or J&J (JNJ-78436735), study team of Beatty et al. reported that 80.3% of participants experienced adverse effects, with comparable estimates for each vaccine type.
The proportion of adverse effects that were self-reported as severe or required hospitalization in the current study (14.7%) was well below that of Swiss and European governmental surveillance systems (37.9% in Swiss ElViS). These are actually high rates.
Furthermore, safety surveillance systems in America reveal higher estimates of serious adverse events based on hospitalization rates, serious illness and deaths (9.2% vs. our 0.7%). The Swiss authors propose: “These higher estimates from governmental reporting systems are likely related to the underreporting of mild symptoms and underscore the importance of real-world data.”
Reports on prevalence of anaphylaxis and severe allergic reactions vary from 0.03% to 3% based on differing definitions. In the current University of Zurich study, two (0.4%) participants reported allergic reactions, without the need to consult a medical professional.
The study
Data is derived from participants at a University of Zurich vaccination center. Individuals receiving BNT162b2 or mRNA-1273 vaccines were recruited between March 10, 2021, and July 21, 2021, while participants receiving JNJ-78436735 were recruited between October 20, 2021, and January 27, 2022.
The findings
Out of the entire study population, 454 participants reported experiencing at least one adverse event up to three months post-vaccination equaling 79.0% of the total. The study showed a total of 2233 adverse events meaning on average there were 3.88 adverse events reported per study participant.
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Canadian Investigators Discovery Unique Blood Plasma Protein Patterns in Long COVID Patients
A Canadian research unit may come up with a way to treat at least some long COVID patients more effectively. The condition has emerged since the pandemic as a real problem. With anywhere from 10-20% of people that have been infected with SARS-CoV-2 susceptible to long COVID, some estimate north of 14 million people in America alone struggling with the condition, which can last for many months. Often impacting the quality of life, symptoms from brain fog and fatigue to breathing difficulties can be outright debilitating. Led by Dr. Douglas Faser, a professor in pediatrics at Schulich School of Medicine & Dentist, and physician at London Health Sciences Centre (LHSC) a team of Canadians designed a study using artificial intelligence (AI) as part of advanced research to discover unique patterns of blood plasma proteins in patients with suspected long COVID, with an aim on improving patient outcomes. Enter the “plasma proteome,” as the research centers on proteins identified in blood plasma, released by cells often playing a vital role in pathogen immune response.
With study results recently published in the Journal of Translational Medicine this study team sought out to better understand how these plasma cells impact patients with long COVID, and why some patients struggle more than others.
Corresponding authors Dr. Douglas Faser and Cristiana Losef, both with Children’s Health Research Institute, Victoria Research Laboratories, and colleagues investigated possible mechanisms, and to inform the prognosis and treatment of long COVID.
This technology allowed researchers to determine unique patterns in the blood proteins. The team discovered that people with suspected long COVID have prolonged inflammation associated with changes in their immune cells and blood vessels. These changes may lead to problems in specific organs, like the brain and the heart, as reported by Western University.
Called “the plasma proteome,” the proteins are found in blood plasma and are released by cells that often play an important role in the body’s immune response to viruses. The research team is studying how those proteins adapt and change in long COVID.
The study
With a green light from the local Ethics Committee (Western University), the study team enrolled patients from London Health Sciences Center in London, Ontario, Canada and St. Joseph's including patients diagnosed with long COVID as well as acutely ill COVID-19 patients.
Upon diagnosis of long COVID, study patients were referred to a specialist clinic based on prolonged, diffuse symptoms according to the author's account in the Journal of Translational Medicine.
Conducting a series of tests including venous blood work, the study team analyzed patient plasma. COVID-19 patients were approached when they were admitted to the hospital or medical ward or intensive care unit. Healthy subjects were included—persons without disease, acute illness or any prescription medicine, but previously banked by the Translational Research Center in London, Ontario.
All samples in the study were matched by age and gender (e.g., long COVID patients to acutely ill patients to healthy controls).
Results
Unlike acutely ill COVID-19 patients as well as healthy subjects---both matched by age and sex—the long COVID outpatients evidenced natural killer cell redistribution with a dominant resting phenotype, opposite to active and neutrophils formed in extracellular traps.
The study team reports a possible “resetting of cell phenotypes” likely resulting from “prospective vascular events mediated by both angiopoietin (ANGPT1) and vascular endothelial growth factor-A (VEGFA).
Validating several biomarkers (ANGPT1, VEGFA, CCR7, CD56, citrullinated histone 3, elastase) the authors report also that “Signaling of transforming growth factor-β1 with probable connections to elevated EP/p300” pointed to both vascular inflammation as well as tumor necrosis factor- α driven pathways. The authors suggested that the progression from acute COVID-19 to long COVID was “a vascular proliferative state associated with hypoxia-inducible factor 1 pathway.”
Fraser and Losef write that this “vascular-proliferative process predicted in Long-COVID might contribute to changes in the organ-specific proteome reflective of neurologic and cardiometabolic dysfunction.”
PI Point of View
Cristiana Losef, a research analyst at Children’s Health Research Institute (CHRI), a program of Lawson went on the record, “We used novel technologies for this study, allowing us to analyze more than 3,000 proteins in blood plasma at the same time with multiple patients.”
Losef continued:
“We used a novel bioinformatic pipeline, a form of artificial intelligence (AI), to analyze the proteins to determine the specific changes that occur in long COVID.”
Dr. Michael Nicholson, associate scientist at Lawson, and respirologist at St. Joseph’s Health Care London reports on the influence of this study, “Trying to understand this mechanism is quite important because it provides further insight into how patients are affected,” says Dr. Michael Nicholson. He continued, “This paper sheds further light on a possible mechanism that may provide insight into why some patients have certain symptoms.”
Michael Knauer, an associate scientist at Lawson shared for Western University, “The saved blood plasma samples we are using helped us determine the long-term responses to COVID-19; serial blood plasma samples from individuals that had a COVID-19 infection and now presumed long COVID will help us determine how proteins are changing over time.”
What’s the potential value from a therapeutic perspective?
Dr. Faser, a professor at Schulich Medicine, said the proteins discovered could act as a potential drug target. The team is now examining potential new drug therapies with the hopes of improving outcomes for these patients.
Fraser emphasized:
“When we identify these signaling patterns within the blood plasma, we can then take the information and screen drug databases to better understand which drugs would be best to target the changes we identified in long COVID patients.” Pointing to the potential of these findings, “With this understanding, the identified drugs may be used in future long COVID clinical trials.”
Key Point: This research, which used multiple state-of-the-art technologies, was enabled by existing expertise and infrastructure through Children’s Health Research Institute (CHRI). It reveals that the findings point to a “vascular-proliferative process in Long-COVID that is likely initiated either prior hypoxia (localized or systemic) and/or stimulatory factors (i.e., cytokines, chemokines, growth factors, angiotensin, etc.). Analyses of the plasma proteome, used as a surrogate for cellular signaling, unveiled potential organ-specific prognostic biomarkers and therapeutic targets.”
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, July 12, 2023
Text Messages of Top Scientists Shed Light on COVID Origin Response
A new report released by Republican members of the House Select Subcommittee on the Coronavirus Pandemic includes new evidence that a group of scientists who received funding from the National Institute of Allergy and Infectious Diseases (NIAID), conspired to dismiss the origin of the pandemic in order to protect China.
The text messages were exchanged between authors of the Proximal Origin paper, initiated by then-NIAID Director Anthony Fauci, which had the explicit purpose of dismissing the lab leak theory for the pandemic’s origin. The Proximal Origin paper, which declared that no “laboratory-based scenario is plausible,” became one of the most cited science papers of all time and was prominently used by Dr. Fauci as proof that the COVID-19 virus came from nature.
While Dr. Fauci’s role in directing the paper’s creation as well as the paper’s many scientific and logical flaws have been widely documented, the exact circumstances of the paper’s origin have remained unclear. Text messages released by the Subcommittee on the Coronavirus Pandemic now reveal that it was fear of upsetting international relations, and the Chinese regime in particular, that drove the inception of Proximal Origin.
According to emails obtained by the Subcommittee on the Coronavirus Pandemic, concerns regarding COVID-19’s engineered-looking features were first discussed by Proximal Origin author Eddie Holmes of the University of Sydney and British pharmaceutical trust director Jeremy Farrar on Jan. 8, 2020. Mr. Farrar is now the World Health Organization’s chief scientist. Dr. Francis Collins, then-director of the National Institutes of Health (NIH), as well as unnamed Chinese officials were also included in these early, behind-the-scenes discussions.
It remains unknown why Mr. Farrar—who later co-organized with Dr. Fauci a Feb. 1, 2020, teleconference that resulted in the drafting of Proximal Origin—was deeply entangled in the effort to suppress the lab leak theory and instead elevate the natural origin narrative. Notably, Mr. Farrar is a close personal friend of Gao Fu, who was at the time the head of the Chinese Center for Disease Control. Mr. Farrar later admitted in his book “Spike” that he was concerned at the time about Sino–U.S. relations.
While Mr. Holmes, Mr. Farrar, Dr. Collins, and the unnamed Chinese officials were discussing the virus’s unusual features, NIAID-funded scientist Kristian Andersen of the Scripps Institute contacted Mr. Holmes to share his own concerns about the new virus, in particular its unusual receptor binding domain and furin cleavage site. Mr. Andersen had also uncovered that the director of the Wuhan Institute of Virology (WIV), Shi Zhengli, had—together with Ralph Baric of the University of North Carolina, who is sometimes referred to as the godfather of gain-of-function experiments—inserted furin cleavage sites into SARS viruses. In other words, Mr. Andersen had detected a highly unusual furin cleavage site in COVID-19, a site that has to this day never been observed in naturally occurring viruses of this kind, and found direct evidence that the WIV had inserted such sites into coronaviruses. Mr. Holmes responded, “[expletive], this is bad” and “oh my god what worse words than that.”
On Jan. 31, 2020, Mr. Farrar talked to Dr. Fauci about the virus’s unusual features. At the same time, Mr. Andersen contacted Dr. Fauci by email, saying that the virus’s features looked potentially engineered and that its genetic makeup was “inconsistent with expectations from evolutionary theory.”
It was at this point that Dr. Fauci and Mr. Farrar organized the teleconference, which was held the next day, on Feb. 1, 2020. The ostensible purpose of the teleconference was to develop the Proximal Origin paper to counter the lab leak theory. Mr. Andersen became the paper’s lead author and was joined by fellow teleconference participants Mr. Holmes, Andrew Rambaut of the University of Edinburgh, and Robert Garry of Tulane University as co-authors.
A fifth co-author, Ian Lipkin of Columbia University, was brought on board later in February 2020. Mr. Lipkin did not participate in the teleconference and has since distanced himself from the natural origin narrative. Chairman of the Subcommittee on the Coronavirus Pandemic Rep. Brad Wenstrup (R-Ohio) has stated that Mr. Lipkin is cooperating with congressional investigators.
The new text messages released by Mr. Wenstrup’s Committee reveal for the first time that the four Proximal Origin authors who attended Dr. Fauci’s teleconference started a Slack group to discuss the paper. In a message sent in the morning of Feb. 2, 2020, the day after the teleconference, Mr. Rambaut told co-authors Mr. Andersen, Mr. Holmes, and Mr. Garry:
“Given the [expletive] show that would happen if anyone serious accused the Chinese of even accidental release, my feeling is we should say that given there is no evidence of a specifically engineered virus, we cannot possibly distinguish between natural evolution and escape so we are content with ascribing it to natural process.”
Within three minutes, Mr. Andersen replied:
“Yup, I totally agree that that’s a very reasonable conclusion. Although I hate when politics is injected into science – but it’s impossible not to, especially given the circumstances. We should be sensitive to that.”
These messages contradict the public claims by Mr. Andersen that he was not concerned with politics and that it was others who politicized the question of COVID-19’s origin.
The exchange between Mr. Rambaut and Mr. Andersen indicate that the efforts of Dr. Fauci’s group to elevate the natural origin theory had nothing to do with science and were driven from the start by a desire to protect China. Mr. Rambaut’s admission that it is not possible to distinguish between natural evolution and lab creation and that the Proximal Origin group should therefore simply blame natural processes is tantamount to a smoking gun. It suggests the authors never had the intention of writing a scientific paper—instead, they were focused on covering up the pandemic’s true origin.
Mr. Andersen went even further, telling his co-authors that given the political concerns, the preprint site bioRxiv should “start screening submissions – it’s a slippery slope, but it’s justified at this stage.” A preprint site is a site where scientists can upload their research prior to peer review. Mr. Andersen was essentially proposing to censor scientists who did not toe the political line on COVID-19’s origin.
The political motivations of the origins cover-up are further corroborated by a previously released message from Ron Fouchier, who also attended the teleconference. At the same time that the Proximal Origin authors were having their discussion on Slack on Feb. 2, Mr. Fouchier wrote an email to the teleconference group stating that “further debate about such accusations would unnecessarily distract top researchers from their active duties and do unnecessary harm to science in general and science in China in particular.”
Mr. Fouchier is a Dutch virologist whose controversial gain-of-function experiments, whereby he created airborne viruses, led the Obama administration to impose its 2014 moratorium on such experiments. The moratorium was later lifted by Dr. Fauci and Dr. Collins during the Trump administration.
In response, NIH head Dr. Collins chimed in, telling the group, “the voices of conspiracy will quickly dominate, doing great potential harm to science and international harmony.”
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Is CDC Manipulating ICD Codes Involving COVID-19 Vaccine Side Effects on Death Certificates?
A review of Minnesota death certificates from an embedded source in that state reveals that of all the death certificates in Minnesota between 2015-Q1 2023, ten CoDs clearly identify a vaccine as a Cause of Death (CoD), including nine identifying a covid vaccine.
Surprisingly, our group discovered that on seven of these nine death certificates, the CDC had failed to apply an appropriate ICD-10 diagnostic code for vaccine side effects (either T88.1 or Y59.0).
I authored an article delineating the details that was republished in Brownstone. As a result of that investigation, multiple reporters contacted the CDC requesting a response to our allegations that the CDC had inappropriately omitted these ICD codes. The CDC issued the following statement to a reporter from Just The News:
“Thanks for reaching out to CDC. The claim in this post is incorrect. The ICD-10 codes in question pertain to adverse effects of vaccines, not vaccination. Vaccination is not a disease or cause of death, so simple mention of the vaccine or vaccination without mention of adverse effects will not get coded. The examples in the article for which the adverse effects codes are included are those that mention adverse or side effects of the vaccine. The examples for which the codes are not included do not contain such language.
COVID-19 vaccines are undergoing the most intense safety monitoring in U.S. history. To date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed TTS deaths following the Janssen vaccine.
When an adverse event, including death, is reported to CDC’s Vaccine Adverse Event Reporting System, it is classified as serious or non-serious. The code of Federal Regulation defines “serious” as: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomalies or birth defects. For reports classified as serious, CDC requests and reviews the available medical records, examines death certificates and autopsy reports. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy.”
The CDC’s response induces considerable concern. Far from resolving this important public health-related issue, the agency’s statement, in fact, raises critical questions about the intentions and integrity of at least some aspects of the large, sprawling public health agency.
The CDC claims that they only apply ICD codes for vaccine side effects where the death certificate documents a vaccine as a CoD using language materially similar to “side effects of vaccination”--semantics that explicitly attributes the CoD to side effects from the vaccine as opposed to the act or fact of vaccination itself.
So, the CDC stipulates that a coroner who writes language such as “vaccinated 10 hours before death” as a Cause of Death means to convey that the decedent did NOT experience any adverse effects from the vaccine and that the vaccine did NOT contribute to the demise of the decedent.
But it seems implausible that a coroner or medical professional filling out a death certificate would choose to convey clinically irrelevant and misleading information about the decedent’s vaccination by writing it as a Cause of Death on the death certificate. This is all the more so regarding the Covid vaccines, where there was and still is intense professional, social, and political pressure to avoid doing or saying anything that can promote “vaccine hesitancy”.
Additionally, the standard articulated by the CDC presumes that medical professionals would be aware that in order to document a vaccine as a CoD, they must use language that explicitly describes “side effects of” a vaccine. Considering the extreme rarity of vaccines being documented on a death certificate – there was only ONE such instance in Minnesota from 2015-2019, out of >230,000 death certificates – it is highly unlikely that medical professionals would be aware of such a requirement.
The conceptual basis of the distinction drawn by the CDC’s standard likewise seems deficient. It is axiomatic that vaccine side effects must be caused by the vaccine. Thus, any medical sequelae precipitated or initiated by vaccine side effects by definition, are attributable to the vaccine itself. Furthermore, the CDC does not draw any such distinctions regarding any other medical product or substance when listed as a CoD, even though a similar argument can be made that “the ICD-10 codes in question pertain to adverse effects of [the medical product or substance]”, “not the [medical product or substance itself]” which “is not a disease or cause of death.”
It is critical to note that the CDC does not dispute our characterization of the CDC’s role of assigning and adjudicating ICD codes for death certificates and admits the decision to omit ICD codes for vaccine side effects on the death certificates we identified was a conscious and deliberate choice.
Another troubling assertion from the CDC’s statement is their claim that “to date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed TTS deaths following the Janssen vaccine.”
There are numerous case report studies documenting autopsies of deaths that occurred shortly after vaccination with one of the mRNA vaccines in the scientific literature, many of which have already passed peer review.
A recent meta-review of these studies found that “a total of 240 deaths (73.9%) were independently adjudicated as directly due to or significantly contributed to by COVID-19 vaccination.” The study concludes, “The consistency seen among cases in this review with known COVID-19 vaccine adverse events, their mechanisms, and related excess death, coupled with autopsy confirmation and physician-led death adjudication, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death in most cases. Further urgent investigation is required for the purpose of clarifying our findings.”
It is inconceivable that anyone could still claim that there have been ZERO deaths linked to the mRNA vaccines. TrialSite has chronicled deaths recognized by government health agencies around the world, such as Taiwan, Vietnam and the UK. The CDC’s insistence to contradict in defiance of numerous published studies is puzzling and possibly indicative that the CDC, or at least some factions within, lacks honesty in its appraisal of overall mRNA vaccine safety.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, July 11, 2023
Researcher’s Latest Stats Suggest Strong Influence of COVID Vax on Excess All-Cause Mortality
In a recent paper uploaded to ResearchGate, author Hervé Seligmann argues that data associated with 2021 excess all-cause mortality is most likely attributable to what he describes as the “secondary effects of COVID-19 injections.” While his paper is not peer-reviewed, and thus no claims should be made based on the findings, generally, governments are avoiding their responsibility to systematically look into the topic of excess death causation between 2020, and 2023. Consequently, civil society drives research and media investigations.
Seligmann’s CV shows he earned both his B.Sc. Biology and MSc in Plant Physiology from Hebrew University of Jerusalem; his Ph.D. earned in 1995 also from the same Israeli university focused on “lizard microevolution.” Seligmann doesn’t appear to be a frequent outspoken activist, which caught this media’s attention. We increasingly distrust academics and activists that exclusively make a living off of COVID-related crises, as the risk of interest-induced subjectivity and bias becomes an ever more uncomfortable dynamic.
Most of Seligmann’s publications uploaded to the open-source research repository involve mainly investigations into his core interest of cellular molecular machinery origins, with an emphasis on genetic code.
The author used data from the Centers for Disease Control and Prevention (CDC) National for Health Statistics as well as a 2019 National Vital Statistics Report to access and attempt to analyze deaths and death rates on a state-by-state basis across America. Claiming that when comparing the year 2021 to 2019 there was a total of 613,779 deaths, the academic points out 114,336 deaths comparing 2021 to 2020. See the mortality table from NIH for 2016-2020 and 2020.
The author presents a graph based on the data inputs that need to be peer-reviewed for validation, showing “excess 2021 state-wise all-cause mortality increases proportionally to state-wise VAERS death rates." This is based on the number of COVID-19 vaccination-associated VAERS reports per 100,000 individuals who received at least one dose in that specific state.
In 2021, Seligmann and Spiro Pantazatos uploaded a non-peer-reviewed paper titled “COVID Vaccination and age-stratified all-cause mortality risk” that used regional variation in vaccination rates as a basis to predict all-cause mortality and non-COVID deaths in ensuing periods based on two independent, publicly available datasets. In that paper, they said that “Vaccination correlated negatively with mortality 6-20 weeks post-injection, while vaccination predicted all-cause mortality 0-5 weeks post-injection in almost all age groups and with an age-related temporal pattern consistent with the US vaccine rollout.”
Seligman now has an update on that assessment based on the latest numbers. He posits now that based on a series of his calculations (which again need to be vetted by multiple independent reviewers) increase in all-cause death rates based on CDC VAERS data “shows that excess death rates increase 19 times faster than the VAERS death rate.” According to the author, this calculated rate “is very close to 21 times” the estimation done by himself and Pantazatos in 2021.
One challenge using the VAERS database is that the deaths cannot be automatically attributable to the vaccine, even though that’s why the system was established in the first place—safety signal detection/surveillance. But each case must be verified. Some research uses timing as an indicator of the likelihood of causation.
While no evidentiary claims can be made from this latest Seligmann paper as it is, this could change with multiple independent peer reviews by credible academic research sources. This media has tracked reports of excess mortality figures around the world. The most prominent explanation involves the pandemic, and the residual impacts of the crisis, in this case, a pandemic and its direct, secondary and tertiary effects. The COVID-19 pandemic has taken a horrific toll on the world.
Some media have shown an interest in probing this matter. For example, the Economist used machine learning algorithms to estimate that anywhere from 16.8 to 28.1 million excess deaths occurred due to all causes since the onset of the COVID-19 crisis. All sorts of problems can be derived from the pandemic including the ripple effects of myriad health concerns, put off by the pandemic, which have spiraled since then. Other factors include the widening wealth gap—the social determinants of health in many cases intensified due to pandemic conditions from 2020 to 2023.
But this media has found it quite fascinating how mainstream media and fact-checkers refuse to even consider the obvious possible impacts of the mass emergency countermeasure programs as a potential contributing force to excess deaths. The mainstream summarily dismisses any such questions as merely anti-vax hyperbole.
TrialSite is unapologetically pro-vax and is one of the few if perhaps, the only media that has consistently reported on study data evidencing both the positive and negative elements of the COVID-19 vaccines. This is just called journalism, with a biomedical research focus.
While the reality is that no pathbreaking studies have produced conclusive evidence as to what’s behind all-cause deaths since the pandemic this is in part, due to the fact that governments are generally avoiding any substantial investment to research the matter from the perspective of causation. Itself an interesting, and disturbing trend.
Hence, the importance of such research supported by civil society, that is, the community of citizens linked by common interests and shared activity for the betterment of humankind.
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Time to Regulate mRNA Vaccines as Gene Therapies: French Biomedical Scholar
Published in the International Journal of Molecular Sciences, independent French researcher Helene Banoun, Ph.D. asks the question: Why are the COVID-19 mRNA vaccines not regulated as gene therapies? TrialSite has reported that technically, at least according to the vaccine manufacturers’ investor disclosures, the products are in fact, a form of gene therapy.
But these investigational products—now licensed, were developed in an unprecedented manner under heretofore not considered regulatory, environmental and political conditions given the state and nature of the COVID-19 pandemic.
Banoun, a Ph.D. at the French Institute of Health and Medical Research/INSERM recently raised profound regulatory issues involving the COVID-19 mRNA vaccines in “mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues.” The French researcher frames the real challenge in the context that at the time of the release of these products “no specific regulations existed.” But now with the passing of the COVID-19 emergency, isn’t it time to reconsider not only the regulations of this class of product but also the true safety considerations?
According to various stances from apex research institutes, regulators and public health authorities, the mRNA vaccines are not gene therapies as biased fact checker after fact checker “busts the myth” that the mRNA products are gene therapies. The argument goes that with the mRNA vaccines, because the mRNA itself doesn’t enter the cell nucleus or for that matter, interact with the DNA whatsoever, these products fail to meet the gene therapy test.
However, as TrialSite has reported, in fact, the mRNA vaccines are very much considered gene therapies when reviewing Moderna’s own investor disclosures to the Securities and Exchange Commission, for example. See “Are mRNA COVID-19 Vaccines a Form of Gene Therapy? Yes, According to a Bayer Pharma Exec & Moderna.”
Dr. Banoun also concurs, declaring in her latest paper, “The mode of action of COVID-19 mRNA vaccines should classify them as gene therapy products (GTPs), but they have been excluded by regulatory agencies.”
But the French scholar’s concerns with the vaccines rise well above baseline concerns of definition, as she points to a regulatory track record of “non-compliant results in terms of purity, quality and batch homogeneity.”
It’s as if every validation talking point from the vaccine companies themselves, to regulators poses an ideal story of what the vaccines are supposed to be, yet the reality on the ground portends a troubling direction. Did the spike protein remain stable and localized like industry and authorities declared they would do? No, as persistent biodistribution of mRNAs and their protein products, like the spike protein, turn out to travel to every organ and cell in the body, often many months after the vaccination event.
Does this wandering spike protein threaten human health? While industry, regulators and public health agencies declare a resounding no. Unfortunately, that’s not the case. TrialSite has accumulated dozens of studies in peer-review journals evidencing a spike protein capable of inducing inflammation and more, and likely at least somehow a factor in post-COVID-19 vaccine adverse events. Of course, more research and data are necessary for conclusive understanding, but who and what will finance the research needed? What happens if the very entities that are supposed to police and regulate need policing and monitoring themselves?
Dr. Banoun’s concerns are not necessarily conclusively proven, but nonetheless valid. “Post-marketing studies have shown that mRNA passes into breast milk and could have adverse effects on breastfed babies. Long-term expression, integration into the genome, transmission to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be studied in light of the adverse events reported in pharmacovigilance databases.”
While a collection of anti-vaxxers, medical freedom fighters and libertarian types pounce on COVID-19 as a cause immediately promote the scary concept of vaccine shedding, and TrialSite has, on a handful of occasions, scanned the literature for any scientific validity, Banoun raises the specter that such a phenomenon must be evaluated. As well, she argues, “in-depth vaccinovigliance” all as part of a series of expectations civil society will demand of the industry, regulators and public health agencies for any future mRNA-based products.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Monday, July 10, 2023
The Media’s Hypocrisy on Vaccines
Since Robert F. Kennedy Jr. tossed his hat into the 2024 presidential ring, his detractors have repeatedly pointed to one issue as evidence that he’s unfit to be president: his skepticism of the COVID-19 vaccines. The reality, however, is that the same media institutions depicting Kennedy as a wingnut spreading fringe conspiracy theories played a key role in popularizing vaccine resistance.
The sheer volume of sudden reversals in public health policy makes it difficult to recall what anyone was claiming a few years ago, but there is a simple formula to understand why “the science” keeps changing: It’s often about who benefits politically. In the months before the 2020 election, the Trump administration seemed close to hitting its stated goal of delivering a COVID vaccine by the end of the year. That would have been a clear boost to the president’s electoral chances.
Evidently alarmed by this prospect, the mainstream media, led by The New York Times, hit on the novel tactic of claiming that Big Pharma had used its financial might to corrupt government oversight of their development. The storyline had the distinct benefit of being a direct offshoot of the media’s larger narrative about Trump’s thoroughgoing and relentless corruption.
One of the first, most detailed and fleshed-out versions of the Big Pharma-COVID vaccine theory can be found in the early days of The New York Times’ COVID-19 reporting. On May 20, 2020, the Times launched its first broadside in this effort. The headline of the article, “Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts,” painted a picture of lurking corruption, invoking a network of malfeasance reminiscent of Hillary Clinton’s “vast right-wing conspiracy.”
The first paragraph underscored this point, alleging that Trump’s new virus “czar,” Moncef Slaoui, former head of vaccines at GlaxoSmithKline, had “intricate ties to big pharmaceutical interests.” The Times went on to enumerate the $12.4 million worth of Slaoui’s shares in Moderna—even though Slaoui had sold those shares as he stepped into his government role. The Times also repeatedly implied that administration officials involved in the development of the vaccines possessed vast conflicts of interest, writing that Health Secretary Alex Azar “is a former Eli Lilly executive” and former FDA commissioner Scott Gottlieb “has moved in and out of government twice.”
The paper’s later stance on the integrity of the vaccine development process aside, this all would have been worthy reporting, important for the American public to know. But the Times went far beyond showing the ties of officials to the pharmaceutical industry and—months before a single vaccine had been produced—began insinuating that any vaccine produced could carry major risks. “[Moderna’s vaccine] technology, which uses genetic material from the virus called mRNA, is relatively new and unproven. And many vaccine candidates fail after showing preliminary promise, or cause serious side effects in later human trials,” the Times wrote in its May 2020 piece (emphasis added).
Just two weeks later the paper went much further, implying in a June 3, 2020 article that COVID vaccine corruption was systematic and political. “Operation Warp Speed amounts to a sprawling, on-the-fly experiment in industrial policy by a Republican administration that has been otherwise dedicated to giving private industry a free hand,” two Times reporters asserted.
There is a simple formula to understand why ‘the science’ keeps changing: It’s often about who benefits politically.
There were, to be sure, irregularities and conflicts of interest in the emergency authorization to produce the COVID vaccines (not surprising given that pharma is the largest and most powerful lobby in the United States). But the media coverage of the issue, which reached a fever pitch in the Trump years but fell mostly silent on the topic once Trump was out of power, ignored nuances to score political points. The unintended consequence was that, imbued with more than a grain of truth, the story about Big Pharma putting profit ahead of prudence took on a life of its own. Now that the political winds have shifted, the media is essentially fighting a narrative of its own creation.
By late summer 2020, this narrative was braided with another about vaccine malfeasance, simultaneously slamming Trump for rushing the vaccine development process and for allegedly lying about the rollout date. In May 2020, after Trump said he was “confident” vaccines would be available by the end of the year, it triggered a barrage of snark from supposedly neutral fact-checkers attempting to refute the president’s claim. NBC’s fact-check offers an example of the genre: “experts say [Trump] needs a ‘miracle’ to be right.” Trump was simultaneously painted as an unreliable fibber who would never be able to follow through on his promises while being accused of rushing to get the vaccines ready ahead of the November election.
But the gut punch came when the Times again questioned the safety of the vaccines being produced. “Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation,” the Times reported in an August 2020 piece.
By that month, the media’s effort began to pay dividends. A week after the Times claimed the Trump administration was “desperate for a silver bullet,” news broke that House Democrats had opened an investigation into Slaoui on the basis of the Times’ unfounded allegations. NBC News, citing the Times’ claims, reported that Democratic Rep. Jim Clyburn had called financial arrangements involving Operation Warp Speed “opaque.”
In September, the Times ran an op-ed by American historian Rick Perlstein that cast the government’s plan to use emergency authorization for the COVID vaccine as Trump’s “most reckless obsession yet.” This bid, the Times op-ed blared in alarm, could end with the vaccines being distributed “before some scientists believe it would be safe to do so” and in a way that could “further erode public confidence in vaccines—and possibly kill.”
Those tropes in fact were and are similar to those advanced by Robert F. Kennedy Jr.—tropes that, as if by magic, are now roundly condemned by the media that lent them credibility and seeded them into the public consciousness.
By the time of the 2020 election, the notion that Big Pharma had unduly influenced the COVID vaccines for profit was media gospel. The accepted narrative was that, with a nod from Trump, Big Pharma had rushed out potentially dangerous experimental vaccines with a bevy of unknown side effects. With so much momentum behind it, this idea continued to gather steam. And now it’s more like an out-of-control freight train than the power-corridor Acela it was supposed to be. The media is reaching for the brakes but the public, long since convinced, is racing full steam ahead.
https://www.tabletmag.com/sections/news/articles/media-hypocrisy-on-vaccines
*****************************************************Research Review at Univ. of Patras: COVID-19 Vax Can Induce Liver Injury
An internist and infection expert, and colleagues at University of Patras in Greece’s third largest city and regional capital of Western Greece, in the northern Peloponnese approximately 130 miles west of Athens, investigated whether the COVID-19 vaccines associated with the occurrence of autoimmune phenomena involving the liver.
Karolina Akinosoglou and colleagues find that while rare, several studies indicate an increase in the incidence of vaccine-induced live injury pointing to specific instances of hepatocellular injury that involve immune-mediated pathways. Professor Akinosoglou, and colleagues from University of Patras conduct a mini review, looking into the underlying pathophysiology involving immune-mediated liver injury post COVID-19 vaccination. The team located in Western Greece also investigated the most widely distributed vaccine formulations’ autoimmune and hepatotoxic potential.
Recent findings from a Patras led investigation were published in the World Journal of Virology.
Background: rare but real--liver injuries
A rare injury secondary to COVID-19 vaccine administration, the incidence of such injuries became a topic of research given the continuous pharmacovigilance post the mass immunization program across much of the world including Greece.
The Greek medical internists represented by the corresponding author Dr. Akinosoglou declare on absolute terms that the three most commonly used COVID-19 vaccines (other than in China and parts of Asia) including the two mRNA -based products (Pfizer-BioNTech—BNT162b2 and Modena—mRNA-1273) plus the AstraZeneca/Oxford jab (ChAdOx1-S) “can induce liver injury that may involve immune-mediated pathways and result in autoimmune hepatitis-like presentation that may require therapeutic intervention in the form of corticosteroid administration.”
But what is causing these rare, but real injuries?
Review of the research
Various investigations have sought to establish vaccine and liver injury causality involving attempts to highlight immune checkpoint inhibition. Moreover, when vaccine-induced liver injuries are established, researchers search for underlying vaccine mechanisms across the different platforms.
To date, the Greek team points to evidence that both mRNA-containing lipid nanoparticles and adenoviral vector platforms “contribute to the inflammatory background that leads to an exaggerated immune response, while patterns of molecular mimicry between the spike (S) protein and prominent liver antigens may account for the autoimmune presentation.”
What is proposed vaccine-induced immune mediators?
Akinosoglou and team point to unfolding research that suggests that the combination of ingredients in the COVID-19 vaccines, plus autoreactive antibodies, cytokines as well as cytotoxic T-cell populations are possible culprits behind hepatocellular damage via well-established pathways.
Concluding thoughts
Overall, COVID-19 vaccine injuries are rare, and liver injury as a result of some immune-mediated process remains an even rarer incidence. Thus, the authors declare “Immune-mediated liver injury remains an elusive, but rare entity following COVID-19 vaccination.” They encourage investigators and scientists around the world to keep an eye out for these and other injuries, no matter how rare. Yet the study authors remind all that at least according to their logic, the benefits of COVID-19 vaccination outweigh the higher risks associated with the disease itself.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Sunday, July 09, 2023
COVID-19 Vaccines Linked to Kidney Disease Safety Signal—Fujita Health University Investigation
Clinical investigators across disciplines affiliated with Fujita Health University in Toyoake, Japan, south and west of Tokyo, review the large national pharmacovigilance database capturing real-world spontaneous adverse event (AE) reports to identify any signals involving the most common form of glomerular injury post-COVID-19 vaccination known as IgA nephropathy (IgAN).
Represented by corresponding author Mizuno Tomohiro in the Department of Clinical Pharmacy at Fujita Health University, the team sought to investigate the frequency of IgAN post-COVID-19 vaccination based on a designed study of the Japanese Adverse Drug Event Report (JADER) database. Reviewing a total of 697,885 cases, Tomohiro and colleagues detected safety signals for IgAN (ROR: 6.49, 95% CI: 4.38–9.61; IC: 2.27, 95% CI: 1.70–2.83). Identifying a total of 30 COVID-19 vaccine-associated IgAN cases, 16 of these had information about the cases at the time of onset.
Of these, 11 of the cases occurred 2 days after vaccination, and two occurred >28 days after vaccination. Safety issues are raised by these findings as the Japanese clinical investigators write “These results suggest that compared with other drugs, COVID-19 vaccination is associated with a higher frequency of IgAN. Monitoring of gross hematuria following COVID-19 vaccination should be needed.”
The recent results of the study titled “COVID-19 mRNA Vaccination is associated with IgA nephropathy: an analysis of the Japanese adverse drug event report database” were published in the Journal of Pharmacy & Pharmaceutical Sciences.
Before delving into study findings, a brief overview of the condition—IgAN.
What is IgAN?
Also known as IgAN or Berger’s disease, IgA nephropathy is a chronic kidney disease characterized by the deposition of immunoglobulin A (IgA) antibodies in the glomeruli, which are the filtering units of the kidneys. It is the most common form of glomerulonephritis worldwide.
With this disease, there is an abnormal immune response where IgA antibodies, which are part of the immune system and normally help protect against infections, become deposited in the glomeruli instead of being cleared from the body. This deposition triggers an inflammatory response and can lead to kidney damage over time.
The study
This study team analyzed data on drug-associated AEs reported between April 2004, and May 2022, via the JADER database on the Pharmaceuticals and Medical Devices Agency website. The team calculated reporting odds ratios (RORs), information components (ICs), and their 95% confidence intervals (CIs) using two-by-two contingency tables in the study team’s quest to evaluate the safety signals for the targeted AEs.
Findings
The authors report, “A total of 697,885 cases were included in the analysis. Safety signals were detected for IgAN (ROR: 6.49, 95% CI: 4.38–9.61; IC: 2.27, 95% CI: 1.70–2.83). Of 30 cases of IgAN associated with COVID-19 mRNA vaccines, 16 had information available on time to onset. Of the 16 cases, 11 occurred ≤2 days after vaccination, and two occurred >28 days after vaccination.” Note, 11 cases never recovered, at least not to date.
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Canadian Investigators Discovery Unique Blood Plasma Protein Patterns in Long COVID Patients
A Canadian research unit may come up with a way to treat at least some long COVID patients more effectively. The condition has emerged since the pandemic as a real problem. With anywhere from 10-20% of people that have been infected with SARS-CoV-2 susceptible to long COVID, some estimate north of 14 million people in America alone struggling with the condition, which can last for many months. Often impacting the quality of life, symptoms from brain fog and fatigue to breathing difficulties can be outright debilitating.
Led by Dr. Douglas Faser, a professor in pediatrics at Schulich School of Medicine & Dentist, and physician at London Health Sciences Centre (LHSC) a team of Canadians designed a study using artificial intelligence (AI) as part of advanced research to discover unique patterns of blood plasma proteins in patients with suspected long COVID, with an aim on improving patient outcomes. Enter the “plasma proteome,” as the research centers on proteins identified in blood plasma, released by cells often playing a vital role in pathogen immune response.
With study results recently published in the Journal of Translational Medicine this study team sought out to better understand how these plasma cells impact patients with long COVID, and why some patients struggle more than others.
Corresponding authors Dr. Douglas Faser and Cristiana Losef, both with Children’s Health Research Institute, Victoria Research Laboratories, and colleagues investigated possible mechanisms, and to inform the prognosis and treatment of long COVID.
This technology allowed researchers to determine unique patterns in the blood proteins. The team discovered that people with suspected long COVID have prolonged inflammation associated with changes in their immune cells and blood vessels. These changes may lead to problems in specific organs, like the brain and the heart, as reported by Western University.
Called “the plasma proteome,” the proteins are found in blood plasma and are released by cells that often play an important role in the body’s immune response to viruses. The research team is studying how those proteins adapt and change in long COVID.
The study
With a green light from the local Ethics Committee (Western University), the study team enrolled patients from London Health Sciences Center in London, Ontario, Canada and St. Joseph's including patients diagnosed with long COVID as well as acutely ill COVID-19 patients.
Upon diagnosis of long COVID, study patients were referred to a specialist clinic based on prolonged, diffuse symptoms according to the author's account in the Journal of Translational Medicine.
Conducting a series of tests including venous blood work, the study team analyzed patient plasma. COVID-19 patients were approached when they were admitted to the hospital or medical ward or intensive care unit. Healthy subjects were included—persons without disease, acute illness or any prescription medicine, but previously banked by the Translational Research Center in London, Ontario.
All samples in the study were matched by age and gender (e.g., long COVID patients to acutely ill patients to healthy controls).
Results
Unlike acutely ill COVID-19 patients as well as healthy subjects---both matched by age and sex—the long COVID outpatients evidenced natural killer cell redistribution with a dominant resting phenotype, opposite to active and neutrophils formed in extracellular traps.
The study team reports a possible “resetting of cell phenotypes” likely resulting from “prospective vascular events mediated by both angiopoietin (ANGPT1) and vascular endothelial growth factor-A (VEGFA).
Validating several biomarkers (ANGPT1, VEGFA, CCR7, CD56, citrullinated histone 3, elastase) the authors report also that “Signaling of transforming growth factor-β1 with probable connections to elevated EP/p300” pointed to both vascular inflammation as well as tumor necrosis factor- α driven pathways. The authors suggested that the progression from acute COVID-19 to long COVID was “a vascular proliferative state associated with hypoxia-inducible factor 1 pathway.”
Fraser and Losef write that this “vascular-proliferative process predicted in Long-COVID might contribute to changes in the organ-specific proteome reflective of neurologic and cardiometabolic dysfunction.”
PI Point of View
Cristiana Losef, a research analyst at Children’s Health Research Institute (CHRI), a program of Lawson went on the record, “We used novel technologies for this study, allowing us to analyze more than 3,000 proteins in blood plasma at the same time with multiple patients.”
Losef continued:
“We used a novel bioinformatic pipeline, a form of artificial intelligence (AI), to analyze the proteins to determine the specific changes that occur in long COVID.”
Dr. Michael Nicholson, associate scientist at Lawson, and respirologist at St. Joseph’s Health Care London reports on the influence of this study, “Trying to understand this mechanism is quite important because it provides further insight into how patients are affected,” says Dr. Michael Nicholson. He continued, “This paper sheds further light on a possible mechanism that may provide insight into why some patients have certain symptoms.”
Michael Knauer, an associate scientist at Lawson shared for Western University, “The saved blood plasma samples we are using helped us determine the long-term responses to COVID-19; serial blood plasma samples from individuals that had a COVID-19 infection and now presumed long COVID will help us determine how proteins are changing over time.”
What’s the potential value from a therapeutic perspective?
Dr. Faser, a professor at Schulich Medicine, said the proteins discovered could act as a potential drug target. The team is now examining potential new drug therapies with the hopes of improving outcomes for these patients.
Fraser emphasized:
“When we identify these signaling patterns within the blood plasma, we can then take the information and screen drug databases to better understand which drugs would be best to target the changes we identified in long COVID patients.” Pointing to the potential of these findings, “With this understanding, the identified drugs may be used in future long COVID clinical trials.”
Key Point: This research, which used multiple state-of-the-art technologies, was enabled by existing expertise and infrastructure through Children’s Health Research Institute (CHRI). It reveals that the findings point to a “vascular-proliferative process in Long-COVID that is likely initiated either prior hypoxia (localized or systemic) and/or stimulatory factors (i.e., cytokines, chemokines, growth factors, angiotensin, etc.). Analyses of the plasma proteome, used as a surrogate for cellular signaling, unveiled potential organ-specific prognostic biomarkers and therapeutic targets.”
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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