Monday, December 18, 2023
Chinese Scientists Make Inhalable Dry Powder COVID-19 Vaccine
Scientists from China have made an aerosol-based inhalable vaccine against COVID-19, which they claim provides “effective protection” against infection based on animal trials.
The study, published in the Nature journal on Dec. 13, involved researchers testing “an inhalable, single-dose, dry powder aerosol SARS-CoV-2 vaccine” that they developed. The vaccine uses nanoparticles and contains SARS-CoV-2 antigens, or substances that trigger the immune system to generate antibodies against it. Researchers designed the vaccine to target multiple COVID-19 lineages. The particles were one to four micrometers in size, optimized to be deposited in the deep lung region.
The vaccine was found to induce “strong production of IgG and IgA,” two types of antibodies. It also triggered a response from local T cells, a type of white blood cell that helps fight germs. Collectively, this conferred “effective protection” against COVID-19 among mice, hamsters, and nonhuman primates.
The study noted that while several intranasal immunization products are developing, many are largely limited to the nasal passage. In contrast, aerosol-inhaled vaccines, like the one developed by the researchers, “can penetrate deeper and wider (to major and small airways).” This can confer the vaccine's benefits even to the lower respiratory tract.
The vaccine also showed promise for “readily responding” to future co-circulation of multiple COVID-19 strains and preventing the transmission of the Omicron variant, the dominant variant under circulation in the United States.
The study noted that the current crop of COVID-19 vaccines was delivered via intramuscular injections to alleviate the infection. However, “vaccines delivered intramuscularly do not provide a first line of protection at the respiratory tract owing to deficiencies of secretory IgA and IgG.”
Several intranasal vaccines are being developed or approved to overcome this. But such vaccines “are in liquid form, necessitating cold chain transportation and storage, and generally require two or three inhaled immunizations or the use of a heterologous booster vaccination.”
These limitations “motivated” the researchers to develop “a dry powder vaccine suitable for single-dose inhalation.”
“The inhalable vaccination addresses a known public health issue, in that there is more enthusiasm for this type of administration than for traditional injection, and a single-dose regimen is favorable for substantially increasing the proportion of total completed vaccination recipients,” the study said.
“Furthermore, the dry powder form of the vaccine can provide savings in storage and transportation costs, potentially supporting increased immunization coverage to remote areas,” it stated.
Moreover, the dry powder vaccine uses a microcapsule that is based on a material already approved by the U.S. Food and Drug Administration (FDA), thus boosting the prospects of the vaccine’s “clinical translation.”
“We envision that our inhaled vaccine could serve as a promising multivalent platform for fighting COVID-19 and other respiratory infectious diseases.”
The study received funding from the National Natural Science Foundation of China, Beijing Natural Science Foundation, the CAS Project for Young Scientists in Basic Research, the National Key Research and Development Program of China, the Strategic Priority Research Program of the Chinese Academy of Sciences, CAMS Innovation Fund for Medical Science, and the Major Science and Technology Special Projects of Yunnan Province.
Some “competing interests” were reported. Authors Hengliang Wang and Li Zhu have patent applications related to cholera toxin B subunit (CTB) nanoparticles submitted by the Beijing Institute of Biotechnology. The dry powder vaccine uses CTB with SARS-CoV-2 antigens.
Author Guanghui Ma is an inventor in a patent application related to porous microcapsules submitted by the Institute of Processing and Engineering.
‘Scandal of Epic Proportions’
A Dec. 13 article in Nature, which commented on the study, calls the dry powder vaccine a “unique approach” to dealing with COVID-19. However, it notes that the vaccine’s “safety and immune potency remain to be tested by clinical trials in humans.”
The researchers “have shown that the dry-powder shot remains stable at room temperature for at least one month, but it will be essential to determine how long this stability lasts at room temperature and above, and how degradation of the vaccine affects immune potency.”
“The question remains whether this 1−4-µm (micrometer) dry powder vaccine will be safe and drive an immune response when inhaled by people,” it said while raising concerns about potential “undesired inflammation.”
Regarding the dry powder vaccine’s effectiveness against emerging COVID-19 variants, the article noted that the study demonstrated the feasibility of including the spike antigens of multiple COVID-19 variant viruses into the vaccine. However, the vaccine’s protective efficacy “was not assessed,” it stated.
In addition, “frequently updating the spike antigen in vaccines might not be a viable solution to the emergence of new strains because SARS-CoV-2 evolves rapidly and thereby evades targeting by antibodies.”
The article has stoked controversy due to a statement that “intramuscularly injected vaccines cannot induce immunity in the mucosal tissues of the airways, which is the site of SARS-CoV-2 entry.”
“There's a scandal of epic proportions brewing here. A new study in Nature now asserts that mRNA ‘vaccines’ were, by their very nature, never able to stop the spread. Impossible in theory and practice. Yet that was the excuse used to force everyone to get injected with this stuff,” legal author Hans Mahncke said in a Dec. 14 X post.
“I reported this years ago. The mechanism by which the spike proteins work does not innoculate the epithelial lining from infection. Thus, it can still be spread by sneezing and coughing. Nature is a little late to the party,” podcast host Kyle Becker said in a Dec. 15 post on X.
“Intramuscular vaccines cannot induce mucosal immunity in airways (the site of SARS2 entry). This is why they did not stop the spread of Covid. Nor do much to prevent Longcovid. So let’s put that fable to rest & focus on blocking infection already,” author Dana Parish said in an X post.
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Australian Scholar Picks Apart Study Justifying Risk-Benefit of mRNA COVID Vax--Points to Mistakes & Errors
Recently, a University of Sydney professor issued a refutation to an American Journal of Epidemiology (AJE) article declaring the COVID-19 vaccines being worth the risk in the omicron era. Why is this topic relevant? Because as the science unfolds it becomes clearer that the risks associated with the Omicron version of SARS-CoV-2 become less severe (although still quite transmissible) while more safety information becomes available about the COVID-19 vaccines. Not to mention the significant benefits of preexisting and hybrid immunity against Omicron. Will someone lose their job over this one as the author Down Under implies?
Recently Raphael Lataster, Ph.D. wrote “Revisiting a Risk Benefit Analysis of mRNA COVID-19 Vaccines during the Omicron Era” declaring in his blog as well that “Someone may well lose their job over this one.”
The Challenged Piece
Published by Oxford University Press, the AJE is one of the top epidemiology-focused journals. A Johns Hopkins study (Kitano et al.) pointed out that COVID-19 vaccines are still worth the risk in the Omicron era, across all groups. Source.
Ironically, or perhaps not so, Professor Lataster reports that much of the study’s funding came from industry—grants from Merck and Johnson & Johnson. Of course, this doesn’t mean bias on its face but it most certainly should be noted.
Professor Lataster, a supporter of TrialSite, pointed to our attention that the AJE published a follow-up article by Lataster, who informs the world he has zero funding industry. In his rebuttal the Australian academic points to numerous issues and errors with the study.
What’s wrong with Kitano et al.?
As Lataster delineates in this study and corresponding blog:
The study employs peculiar timeframes, such as “Less than 5 months (days 14–149) after the primary 2 doses versus no doses.” No explanation is given. Recall a recent series of journal articles on counting window issues, likely leading to exaggerated efficacy and safety estimates in clinical trials and observational studies, that I was involved with.
"I note that there can be no valid reason why adverse effects caused by the vaccine, in the several months between the 1st injection and 14 days after the 2nd injection, should be ignored”, pointing to an anaphylaxis death occurring very soon after vaccination.
“The authors themselves made reference in their article to a Japanese study, Suzuki et al., which concerns deaths “within seven days after COVID-19 vaccination”, including myocarditis deaths, and found that several of these deaths did “show a causal relationship to vaccination”. Not only are the authors inexplicably omitting relevant data from their analysis, but they knowingly do also so.”
It’s not just when the counting windows begin that is the problem, but their length as well. “The authors only consider vaccine effectiveness and safety up to around 5 months after the last injection. This is problematic with regards to effectiveness as the vaccine is known to rapidly decline in effectiveness around that time and can even become negatively effective. This is also problematic with regards to safety as the vaccine’s long-term safety profile is still, by definition, unknown. We do know that the vaccines can cause myocarditis, however, a potentially long-term and deadly issue. While the authors effectively assume no myocarditis deaths due to a lack of data, there are recent studies that do provide some data on myocarditis deaths caused by the mRNA vaccines, meriting a reanalysis.”
Even with the data as limited and selected as it is, “the stated net benefits of the vaccines are minute”, as “the smallest gain was found to be 18.7 QALY “per 100,000 vaccinees in the 4–5 months after vaccination” (5–11-year-old males with no comorbidities, third dose vs. no third dose, Pfizer vaccine), or less than 2 hours per person”. “And even these are subject to the uncertainties and estimations admitted to by Kitano et al, to say nothing of the aforementioned criticisms, all of which may well reduce these QALY gains to effectively zero, or even negative figures.” Read that again. By having very limited data, and by being very selective with that data (just ignoring highly relevant data, because why not…), their stated net benefits are almost nothing. The actual net benefit could be zero, or even less than zero. Worth potentially risking your life for?
Lataster comments, “While attempting to argue that COVID-19 vaccination is still worthwhile, the authors inadvertently demonstrate that in the omicron era, COVID-19 is now extremely benign and that the potential benefits to the vaccines are minimal at best, at least in the young and healthy.”
TrialSite emphasizes the importance of critical review of journal material during the COVID-19 period, and frankly all the time. Industry bias, ever so subtle, is real and must be identified, called out, and countered.
While it's up to the reader to determine the merits of (Kitano et al.) and the Lataster refutation, it’s unfortunate that more media channels don’t encourage this kind of unbiased, objective presentation for critical review.
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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, December 17, 2023
FDA Fails to Address DNA Adulteration Concerns
The failure of government regulatory authorities to identify and disclose DNA fragment contamination of the Moderna and Pfizer/BioNTech COVID vaccine products prior to independent laboratories disclosing their contamination study findings has raised serious questions about quality control oversight of the manufacturing processes used to produce these products, as well as their overall safety. Rather than rigorously addressing specific safety questions concerning the previously undisclosed contamination or adulteration of both modified-mRNA vaccines, in a written Dec. 14 reply to a prior Dec. 6 inquiry, Dr. Peter Marks of the FDA Center for Biologics Evaluation and Research has resorted to redirecting, gaslighting, and stonewalling the Surgeon General of the State of Florida.
Experts from around the world have raised concerns about the safety implications of DNA fragment contamination in COVID gene therapy-based “vaccine” products. Leading regulatory authorities have conceded that these rushed novel and complex biological products are contaminated, and deliver both synthetic modified messenger ribonucleic acid (mod-mRNA) and a wide variety of uncharacterized shorter DNA fragments into the cells and tissues of those who have accepted these product. The Biden administration has previously mandated and currently markets these products in the United States for Americans of all ages including during pregnancy, fraudulently claiming that they prevent SARS-CoV-2 infection and spread as well as COVID-19 disease and death.
These DNA fragments are left over contaminants from manufacturing the mod-mRNA “payload.” The contamination was first detected and reported by experienced U.S. and Canadian genomic researchers, and their findings have been replicated by many other laboratories.
To manufacture the COVID shots, both the DNA contaminants and the mod-mRNA are assembled into the most highly active lipid nanoparticle genetic delivery system ever developed, and this final drug product has been injected into over a billion human arms. After injection, the material distributes throughout the body and delivers both DNA and mod-mRNA to a wide variety of cells and tissues including ovaries.
Both mRNA and DNA can control a wide variety of cell functions. The mod-mRNA directs cells and tissues of the recipient to produce genetically engineered SARS-CoV-2 spike protein (as well as other uncharacterized “frameshifted” proteins and peptides). The DNA fragments come from the circular bacterial DNA (“plasmids”) used to manufacture the mod-mRNA. These plasmids include DNA sequences which can produce a variety of functions inside both bacterial and human cells; proteins which confer antibiotic resistance, sequences which guide DNA into the nucleus of cells, and highly active genetic switches for turning on adjacent genes in either bacterial or animal cells.
In a Dec. 6 letter from Dr. Joe Ladapo M.D., Ph.D. sent to FDA director Robert Califf, the following questions concerning DNA contamination of these mod-mRNA products were posed:
“1. Have drug manufacturers evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer? Has FDA inquired any information from the drug manufacturers to investigate such risk?
“2. Do current FDA standards for acceptable and safe quantity of residual DNA (present as known contaminants in biological therapies) consider the lipid nanoparticle delivery system for the mRNA COVID-19 vaccines?
“3. Considering the potentially wide biodistribution of mRNA COVID-19 vaccines and DNA contaminants beyond the local injection site, have you evaluated the risk of DNA integration in reproductive cells with respect to the lipid nanoparticle delivery system?”
Earlier today, Dec. 15, the Florida Department of Health publicly posted the FDA response authored by CBER director Dr. Peter Marks to Surgeon General Dr. Ladapo dated Dec. 14, 2023. The response failed to address the questions posed by the Surgeon General, instead offering unsubstantiated platitudes such as “safe and effective” combined with redirection to irrelevant and poorly documented information.
Dr. Peter Marks (a hematologist and oncologist), together with the U.S. Government biowarfare specialist Dr. Robert Kadlec, was responsible for initial creation and regulatory management oversight of Operation Warp Speed, is very invested in the success of this program and has proposed that it be expanded to include cancer treatments. Operation Warp Speed exploited the special U.S. Emergency Use Authorization regulatory pathway to bypass many of the regulatory steps and procedures normally required to insure the safety and effectiveness of vaccine products, which typically require up to a decade of development before widespread deployment.
Worldwide administration of the resulting injectable products has been associated with over seventeen million excess deaths (globally), as well as large numbers of cases of heart damage (myocarditis) with a perverse predilection for young people, contradicting the repeated propaganda statement that these products are safe. U.S. Government officials have colluded in a widespread campaign to cover up data concerning myocarditis side effects. There are over 700 peer reviewed academic publications documenting these and many other types of damages and illnesses caused by these products.
In one of the most intensive global propaganda and marketing campaigns ever deployed, it has been widely asserted that these products will enable herd immunity, will prevent infection, replication, and spread of SARS-CoV-2, and will also prevent COVID-19 disease and death. However, it is now widely recognized that these mod-mRNA provide none of these benefits and are therefore not effective. The messaging used in this propaganda campaign has been supported by over 1,200 peer reviewed academic publications providing propagandists and marketing specialists advice how to overcome “vaccine hesitancy.”
Despite the proven and documented lack of safety and effectiveness, overlapping layers of legal protection (indemnification) prevent both deceived public and damaged individuals from obtaining compensation for this fraud.
In his response to the Surgeon General’s questions, Dr. Marks has provided a series of unsupported or misleading statements, combined with circuitous and not scientifically rigorous responses to the specific questions posed. These responses appear to suggest that the FDA has failed to require DNA integration studies to determine the dose limiting toxicity of bacterial plasmid DNA fragments when delivered into animal models using the specific formulations now injected into over a billion human beings. Dr. Marks failed to cite any studies which specifically address DNA fragment integration risks to those receiving these products, instead referring only to studies which can only detect other types of genotoxicity. DNA fragment integration is one of multiple types of genetic damage which such lipid nanoparticle formulations may cause.
In his response to Dr. Ladapo’s inquiry, Dr. Marks cites an FDA guidance document which addresses general requirements for assessing DNA contamination of vaccines (such as influenza) which are manufactured using cultured cell lines. This type of manufacturing process often yields vaccine material which is contaminated with large fragments of chromosomal DNA from the animal cells used to grow the vaccine. This contamination is substantially different from that involving the mod-mRNA products, in that we now know that those products are contaminated with small DNA fragments which are more likely to cross into the region of cells which contain the genome, and in contrast to traditional vaccines these mod-mRNA products and their DNA contaminants are assembled into highly active lipid nanoparticle delivery formulations, greatly increasing the risk that such DNA will enter both the cells and the part of the cells which house the genome (the nucleus).
Despite the fact that the risks of DNA contamination with traditional cell-based vaccines are much lower than for the novel mod-mRNA lipid nanoparticle-based products, the cited FDA guidance documents include the following specific warnings concerning DNA contamination:
“Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”
In his response to the Surgeon General, Dr. Marks refers to a specific clause in this guidance to support safety of the levels of DNA fragment contamination, which in turn refers back to a WHO document. What he fails to acknowledge is that this guidance refers to DNA contamination in a directly injected (parenteral) vaccine, not one employing the most highly active DNA and RNA lipid nanoparticle delivery system ever devised by man. This oversight either reveals Dr. Marks’ profound ignorance of this significant difference (despite the Surgeon General having pointed this out in his initial letter), or a fraudulent attempt to gaslight and obfuscate the truth of the matter. Either ignorance or intentional cover up, hard to differentiate. Here is the cited clause:
“You should limit residual DNA for continuous non-tumorigenic cells, such as low-passage Vero cells, to less than 10 ng/dose for parenteral inoculation as recommended by WHO (Ref. 31) ...”
Reference 31 refers to a WHO document developed and published in 1998, less than a decade after my initial discoveries relating to large scale mRNA manufacture and delivery and about the same time as Kariko and Weissman’s first report of their work with pseudouridine. This outdated WHO statement predates the development of the current generation of mod-mRNA delivery technology by approximately 20 years, and is completely irrelevant.
In additional efforts to cover up the apparent failure of the FDA to require the specific DNA integration toxicology studies both logically needed to rigorously assess patient risk and required for all previous DNA vaccine products prior to human experimental use, Dr. Marks cites the Summary approval document for the Pfizer/BioNTech mod-mRNA product “COMIRNATY” as well as the Summary approval document for the Moderna “SPIKEVAX” product. Specifically, Dr. Marks makes the following assertion:
“[S]tudies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine ...”
The very limited studies performed are incapable of detecting DNA fragment integration. Once again, this statement reflects either intentional gaslighting or incompetence. The COMIRNATY document provides no specific references to genotoxicity or integration studies having been performed prior to human authorization. In contrast, the SPIKEVAX document (SPIKEVAX is not the same product as COMIRNATY) lists the following assays performed:
“Other Supportive Toxicology Studies
“The safety of SPIKEVAX is further supported by the aggregate rat repeat-dose toxicity profiles observed in six GLP toxicity studies of five vaccines formulated in SM-102 lipid particles containing mRNAs encoding various viral glycoprotein antigens, demonstrating tolerance of repeat doses of these vaccines without any detrimental effects. Three other toxicology studies were also reviewed in support of safety of SPIKEVAX. A study report from an in vitro rat micronucleus assay evaluating the genotoxic potential of (b) (4) mRNA in SM-102 LNP revealed no genotoxic effects of SM-102 LNP. In addition, study reports from a bacterial reverse mutation test and an in vitro mammalian cell micronucleus test of PEG2000-DMG were also reviewed. No genotoxic effects of PEG2000-DMG were observed in these studies.”
Under the heading “Other Supportive Toxicology Studies,” this regulatory submission demonstrates the gross inadequacy of the testing performed for SPIKEVAX, which despite this inadequacy apparently still exceeds the testing performed for COMIRNATY. The SPIKEVAX documentation refers to an in vitro (ergo in a test tube) rat micronucleus assay of the formulated mRNA. No mention is made of any level of DNA fragment contamination in the tested preparation. The in vitro rat micronucleus assay is a method for rapidly testing the activity of a pharmaceutical or radiologic treatment in grossly disrupting chromosomes. It is completely inappropriate and incapable of detecting insertional mutagenesis. PEG2000-DMG is one of many components of the lipid nanoparticle, and these test results are irrelevant to the questions raised by the Surgeon General, as neither mod-mRNA nor DNA fragments were tested, and once again the tests performed would fail to detect any integration events.
The appropriate testing for DNA fragment integration is covered in the FDA guidance document “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications,” which Dr. Marks has failed to cite in his response. Dr. Marks’ makes the following assertion in his response to the Surgeon General:
“On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA.”
This statement is directly contradicted by the guidance cited above, which states the following:
“Theoretical concerns regarding DNA integration include the risk of tumorigenisis if insertion reduces the activity of a tumor suppressor or increases the activity of an oncogene. In addition, DNA integration may result in chromosomal instability through the induction of chromosomal breaks or rearrangements.”
In direct contradiction to the poorly cited assertion made by Dr. Marks, Moderna acknowledges these risks in its own patent filings. In the issued U.S. Patent #US2019/0240317 A1 (see image above) titled “HPIV3 Vaccines,” Moderna provides the following text:
“[0012] Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and/or RSV antigens. The direct injection of genetically engineered DNA (e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.”
The FDA’s own “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications” provides clear guidance concerning how the risks of DNA integration risk should be addressed:
“A typical integration study will assess all tissue(s) containing persisting DNA plasmid. We recommend that at least four independent DNA samples be analyzed. Each sample may include DNA pooled from several different donors. Q-PCR is generally used to detect and quantify the amount of plasmid DNA present in each genomic DNA preparation. Unintegrated plasmid DNA may be separated from high molecular weight genomic DNA by gel purification. Concatamer may be eliminated by restriction endonuclease digestion targeting a rare motif present in the DNA plasmid. Specifically designed PCR primers may be used to confirm integration and identify genomic integration sites.”
Based on these and many other examples of existing FDA guidance and prior regulatory submissions, there are both well-developed protocols and well-established precedent for performing DNA fragment integration studies. The failure of Dr. Marks to correctly cite FDA guidance, past precedent, or reference any relevant studies performed to assess these risks in the context of either the COMIRNATY or SPIKEVAX regulatory dossiers clearly demonstrates a tragic failure of proper regulatory oversight and diligence.
Conclusion
In its response to an appropriate and well-documented inquiry from the Florida Surgeon General, the U.S. FDA has clearly failed to establish that it was aware of the contamination or adulteration of COMIRNATY or SPIKEVAX final drug products with plasmid DNA fragments, and has completely failed to insist on the testing necessary to both establish dose limiting toxicity of DNA fragments when delivered to animals or humans using these highly active lipid nanoparticle formulations. Furthermore, in the written FDA response to the Dec. 6, 2023 inquiry from Dr. Ladapo concerning the risks of this contamination, the FDA has demonstrated a lack of rigor in addressing the questions posed which is combined with a series of statements which can only be interpreted as either ignorant, incompetent, or intentionally misleading.
The Surgeon General and citizens of the State of Florida, the U.S. public, and the citizens of the world deserve better than to be mislead and gaslight about the risks of the widely acknowledged DNA fragment contamination present in virtually all batches and lots of COMIRNATY and SPIKEVAX. Based on FDA’s the abject failure to address these risks in a serious manner, and its willingness to substitute platitudes, half truths, and outright falsehoods for actual data, the FDA, CBER, and Dr. Marks have once again damaged the credibility of the U.S. HHS in the eyes of both the U.S. public and the world. We all deserve better, but in the interim it must be concluded that the risks associated with DNA plasmid fragment adulteration when delivered with the highly active lipid nanoparticle formulations of COMIRNATY and SPIKEVAX are both real and uncharacterized, and consistent with U.S. Federal statute CFR Title 21, CHAPTER 9, SUBCHAPTER V § 351, the products must be withdrawn from the market until the necessary tests have been performed and safety demonstrated.
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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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Friday, December 15, 2023
Thursday, December 14, 2023
Long COVID & Chronic Conditions Impacting Workplace --Study
Recently, Integrated Benefits Institute (IBI), a health and productivity research non-profit, analyzed the impact of long-term COVID and certain chronic conditions on productivity, disability, and disability claims, finding that US employees with long-term COVID, along with certain comorbid conditions, have a two-fold increase in missed workdays. The chronic conditions highlighted in the analysis include cancer, cardiovascular disease, diabetes, obesity, musculoskeletal, respiratory, and mental health conditions.
A Real Problem Impacting the Workplace
The prevalence of long COVID has had a profound impact on disability claims, work absences, and healthcare expenses. According to a recent analysis of workforce absences in the Journal of Public Economics, around 500,000 individuals in the US were removed from the workforce due to COVID-related illnesses between March 2020 and June 2022. The study did not delve into the problem of long Vax, or COVID-19 vaccine-related injury.
Nearly one in five US adults who have had COVID-19 are still experiencing persistent symptoms three or more months after their initial COVID-19 diagnosis. The likelihood of developing long COVID was found to be more than five -times higher in those with severe COVID-19 symptoms, compared to those with mild or no symptoms. Those with moderate symptoms are more than two times more likely.
This recently published study used data from the National Health Interview Survey (NHIS) and the IBI Benchmarking Portal, the largest collection of claims for employer-sponsored short-term disability (STD), long-term disability (LTD), family and medical leave (FML), and workers' compensation (WC) in the US. The study's findings shed light on the complex relationship that exists between long COVID, chronic conditions, and work-related outcomes.
Chronic Conditions & Impact
Almost half (47%) of individuals with long COVID report obesity as a comorbid condition. More than one third (38.5%) of individuals with long COVID also report having a mental health condition – specifically, anxiety or depression, followed by musculoskeletal conditions (22.7%). Approximately 5.9% of long COVID cases are also affected by heart disease or stroke, 6.1% with cancer, and 9.1% with diabetes.
Certain chronic conditions are more strongly associated with developing long COVID. Those with asthma or chronic obstructive pulmonary disease (COPD) have 94% increased odds of developing long COVID. Those with musculoskeletal disorders have a 49% increase, obesity a 52% increase, and those with anxiety and depression have 38% increased odds of experiencing long COVID.
Long COVID in individuals without any chronic conditions results in an average of 10.2 missed workdays. Combining chronic illnesses with long COVID leads to a two-fold increase (102%) in missed workdays, from 8.9 to 17.9 missed days. For example, those with cardiovascular disease and long COVID results in an average of 26.2 workdays missed, a stunning 122.1% increase above 11.8 workdays missed for cardiovascular disease alone.
52.5% of NHIS working-age respondents with obesity and comorbid long COVID have a work disability, underscoring the significant obstacles they must overcome. The comorbid long COVID and mental health disorders group has an even higher work disability rate (61.1%). And 37.1% of people with MSK conditions and comorbid long COVID report a work disability.
Disability claims
Long COVID has had a significant impact on disability claims, duration, and costs.
The study data derived from IBI's Benchmarking Portal data reveals long COVID had 4,442 STD claims in 2021. The industries that report the highest STD claims are manufacturing (13,671 claims) and services (11,860 claims), followed by the finance, insurance, & real estate sector with 5,534 claims.
For COVID-19, the average payment per closed STD claim stands at $2,739. Long COVID, however, has a notably higher average STD payment of $5,417, reflecting the more substantial financial burden associated with managing long COVID-related STD claims. The construction sector has the highest average payment for long COVID-related STD claims, at $11,744, followed by the services sector with a significantly higher than average payment of $8,779 per closed long COVID claim.
Long COVID has a much higher number of calendar days lost per STD claim at 90 days, compared with COVID-19 claims (22 days). Notably, 16% of these STD claims transitioned into LTD claims, resulting in 5,427 cases of long COVID LTD claims. These LTD claims had significantly higher payments, averaging $9,307 per closed claim. Importantly, 35% of individuals with LTD claims successfully returned to work within two years.
What does this mean for employers?
Employers face the challenge of navigating reduced productivity, disability claim costs, and the prolonged symptoms experienced by individuals with long COVID.
IBI spoke with HR and benefits managers on how they are approaching the challenges this diagnosis presents.
Recognize long COVID's varied and extended symptoms, encompassing physical, cognitive, and emotional issues.
Promote a gradual transition back to work and consider the challenges employees face.
Be proactive in establishing policies to accommodate employees with long COVID.
Consider implementing a trial period and reevaluation process for accommodation requests.
Be prepared for the possibility of relapse after an employee returns to work.
Acknowledge long COVID's potential classification as a disability under the ADA.
Collaborate with affected employees to determine effective accommodation solutions.
Maintain open lines of communication to tailor accommodations based on specific symptoms and limitations.
Provide flexible scheduling to accommodate variations in energy levels and symptom severity.
Prioritize employees' mental well-being by encouraging behavioral therapy or counseling.
https://www.trialsitenews.com/a/long-covid-chronic-conditions-impacting-workplace-study-0be8a9b6
**********************************************Recent Vaccine Injury Settlement the Exception More than the Rule
The family of an 8-year-old paraplegic girl who was afflicted with transverse myelitis after receiving childhood vaccines as an infant has settled a personal injury claim with the federal government for $4 million, according to reports in the Missouri Lawyers Media. Such settlements are quite rare given the large number of vaccines administered, according to data from the U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA). But also making compensation is an onerous legal process involving complex science and several other factors.
In the most recent HRSA report citing CDC data, from 2006 to 2022, over 5 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 11,358 petitions were adjudicated by the Court, and of those, 8,131 were compensated via the Vaccine Injury Compensation Program (VICP).
The report cites that for every 1 million doses of vaccine that were distributed, about 1 individual ends up compensated.
Further, the report states that since 1988, over 26,862 petitions have been filed with the VICP. During this three-decade-plus period, 22,983 petitions were adjudicated, with 10,371 of those determined to be compensable, while 12,612 were dismissed. Total compensation paid over the life of the program is approximately $5 billion.
Of course, what the government doesn’t share is that it’s quite difficult to secure compensation from VICP. An onerous process with lots of disqualifying twists and turns
Determining whether a particular health condition is a result of a vaccine can be complex. Some injuries may have multiple potential causes and proving a direct link to a vaccine can be challenging.
Scientific Uncertainty
The science of vaccine-related injuries is not always clear-cut. Medical and scientific evidence may not definitively establish a causal relationship between a vaccine and a specific injury, leading to uncertainty in some cases.
Legal Complexity
The VICP operates within a legal framework with specific rules and procedures. Navigating this legal process can be challenging for claimants who may not be familiar with legal proceedings.
Statute of Limitations
There are strict deadlines for filing claims with the VICP. Some claimants may miss the filing window due to lack of awareness, delayed diagnosis, or other reasons.
Causation Burden
Claimants must demonstrate a plausible connection between the vaccine and the alleged injury. This burden of proof can be difficult to meet, particularly when dealing with rare or poorly understood medical conditions.
Limited Compensation
The compensation awarded by the VICP may not fully cover all the costs associated with a vaccine injury. Claimants may still face financial challenges despite receiving compensation.
Adverse Public Perception
Some individuals may view the VICP as a barrier to pursuing justice through the traditional legal system. There can be a perception that the program protects vaccine manufacturers more than it supports injured individuals.
Lengthy Process
The VICP process can be time-consuming. It may take months or even years for a case to be resolved, which can be stressful for individuals dealing with the aftermath of a vaccine injury.
As hard as it may be to secure compensation with VICP, the situation remains far worse for individuals injured by COVID-19 vaccines who are subject to the Countermeasures Injury Compensation Program (CICP). This is the program in the United States that provides compensation to individuals who suffer serious injuries or death as a result of certain medical countermeasures. These countermeasures are often used in response to public health emergencies, such as pandemics or bioterrorism events (e.g., COVID-19). The CICP is a part of the Public Readiness and Emergency Preparedness (PREP) Act.
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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, December 13, 2023
New Zealand Government Data Suggests Alarming Pfizer Death Rate
A statistician has come forward with disturbing information that, if correct, will promote doubt on the safety of mRNA vaccination for decades into the future. The whistleblower was involved with building and implementing the New Zealand government database vaccine payment system, a “pay per dose system” that would remit payments to vaccination providers.
In an interview with New Zealand journalist and lawyer Liz Gunn, and using a false name of Winston Smith, the statistician states that “science is all about being sceptical and curious at the same time. We shouldn’t be criticised for being sceptical, we shouldn’t be vilified for having a different opinion. We should be allowed to have that.”
Smith explained by way of introduction “I’m not anti-vax. I helped build the vaccination system. But I am pro-choice and I do believe in [the] fundamental freedoms of humans, and that we should not have a procedure forced onto us because of a mandate just to keep our jobs. That is against everything I stand for. It is a huge overreach by the government.”
Smith’s work also involved data analysis. Smith had noticed discrepancies almost immediately the system went live with people dying within a week of being injected.
Looking at the government data, he ran a query to identify days when more than one hundred and twenty people died in New Zealand. Historic peaks above this level, as Smith demonstrates, are rare. This normal distribution of deaths at this level is only rarely exceeded on the occasional day, or for disaster events, such as the 2011 Christchurch earthquake, mosque shooting in 2019, or an unusually bad influenza season.
In the small country of New Zealand, daily mortality levels that exceed one hundred and twenty could plausibly be considered to be a signal of a disaster event that should trigger public discussion and controversy.
New Zealand had a highly unusual winter flu season in June-July 2019, and no days exceeded the harm-signal level in 2020.
However, in June and July 2021 Smith observed 10 days where mortality exceeded the signal-level. This could be attributed to either COVID-19 or to the injections. Yet not more than a few deaths due to COVID-19 were registered in this time period.
This uptick in deaths coincided with expansion of the vaccine rollout. The mRNA gene therapy was offered to the general public, two million people from July 2021 onwards.
However, by April 2022, as Smith states “now the vaccine rollout comes into full effect.” Booster-injections had peaked in the first quarter of 2022, in the New Zealand summer.
In June 2022, 50 percent of all days exceeded the signal-level with excessive mortality rates rolling into 2023.
Smith bases his claim that the 2022 data is not muddied by COVID-19 deaths, as SARS-CoV-2 deaths were relatively stable in 2022, rarely exceeding 30 deaths per day and only once exceeding 50 deaths per day, and COVID-19 related deaths dropping steeply off after this date.
Smith claims that there are spikes in unexpected mortality rates in less populated regions outside the capital cities, far in excess of normal background rates.
Of the twenty worst sites, seven of them appear in Christchurch city, a university town with a population of 380,000.
Smith drew attention to one site in Invercargill, a city of 50,000 that he alleges had a vaccine-related death count of 253, following a total vaccine rate on that site, a medical centre, of 837. He claims that “one in three people who were vaccinated at this site are now dead.”
I note that in April 2022 media were reporting a spike in COVID-19 infections in Invercargill, but no corresponding death rate. People may have been compelled to get vaccinated in this period knowing the virus was circulating; however, it is plausible that they may have also been exposed to a “triple whammy” of the heart-damaging and inflammatory spike protein following injections, then boosters, and the circulating virus.
Smith’s data suggests that some vaccination sites, including medical centres, pharmacies, and rest homes for the elderly, had extremely high death counts above 20 percent and at times more than 30 percent for as many as 800 or 900 vaccinations onsite.
Smith is unclear about the time between injection and death, surmising that it could be up to two months, but adamant that even in the rest homes, the death rate exceeded the normal distribution for the very elderly.
Smith suspects that there could be an issue with batch numbers and irregularities in the vaccine. As a biologic drug, the mRNA gene therapy was always vulnerable to irregularities and contamination.
Smith toggled batch ID numbers with the associated death rate to arrive at a death count and a ratio of deaths by batch. The top ten batches were all Pfizer. (Note: global batch IDs can be sourced from “Find My Batch.”)
Registered deaths by vaccinator also suggests that vaccinators (or the batch numbers used by the vaccinators) increased risk, with death by vaccinator up to 25 percent of people vaccinated.
Deaths would also cluster on particular days, for example in Invercargill, discussed above there were ten clusters of 3–10 deaths per day, and four clusters of 21–30 deaths per day.
Smith maintains “this is not natural, this is man-made.” His IT system has 2.2 million New Zealanders registered, and the natural background mortality rate is 0.75, and all ages are registered. Smith insists that his data suggests not chance, or bad luck, but causality.
“There’s so much pain and tears.”
Smith had not come forward earlier, because as a scientist, he was aware he required a strong consistent signal in order for his findings to be accepted.
Interviewer Gunn stated, “I’d like to remind people. We were sold the jab to protect the old people.”
Smith approached former mainstream journalist and lawyer Liz Gunn to help disclose this information, and the two have worked with a global group of academics and experts to ensure the release of this information was suitably handled.
Smith was in an unusual position as the database administrator for the payment system. “Because New Zealand is a small country, you can get away with one database administrator. I am in a unique position, and because New Zealand is a Tier 1 country with really good IT, I was able to manage and build this system.”
“Death is the ultimate adverse event ... statistically it’s very difficult to disprove this.”
If it was settled science we’d be living on a flat earth and we’d be the centre of the universe.
Smith and Gunn are encouraging experts in data analysis to come forward and look at his data.
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United Kingdom Excess Deaths Surge 100% Between 2019 & 2023
The UK government reports on the latest excess death data, evidencing an ongoing disturbing increase in mortality. With a focus on England and Wales, provisional counts of the number of deaths registered by age, sex, and region in the latest weeks for which data are available. This data set includes the most up-to-date figures available for deaths involving coronavirus (COVID-19).
The latest data compares 2019, the year before the COVID-19 pandemic, and 2023, a year that represented the transition out of the global public health emergency.
What are excess deaths?
Referring to the number of deaths observed in a specific time period that exceeds the expected number of deaths based on historical data, excess deaths represent a metric often used to better understand the impact of events such as pandemics, natural disasters or other crises impacting mortality rates.
How are excess deaths calculated?
Excess deaths are calculated by comparing the actual number of deaths during a particular period to the expected number of deaths based on previous trends. The expected number of deaths is usually determined by looking at data from previous years, considering factors like population growth and age distribution.
Helps with broader understanding of scale of impact
During an event such as COVID-19, excess deaths can be a more comprehensive measure of the overall impact than just looking at the reported deaths directly tied to the specific cause (e.g., COVID-19 deaths). This is because some deaths related to the event may not be directly attributed to the cause, and other indirect effects, such as disruptions to healthcare systems, economic downturns, or stress-related health issues, can contribute to increased mortality.
What’s the true impact of a crisis on mortality? Calculating and analyzing excess deaths helps offer a more comprehensive picture of true impacts from events such as the COVID-19 pandemic, and associated tends, from disrupted health access to possibly, although it’s not dared mentioned in most mainstream media, impacts of pharmaceutical interventions (e.g., vaccines) to other intertwined factors and forces. We cannot be certain in the UK unless the government allocates the funding for academic medical centers to study the matter in detail.
https://www.trialsitenews.com/a/united-kingdom-excess-deaths-surge-100-between-2019-2023-74807ace
********************************************************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, December 12, 2023
Supreme Court endorses end of Federal COVID-19 Vaccine Mandates
In unsigned rulings, the justices said that rulings against mandates imposed by President Biden and the U.S. military have been vacated.
They also remanded the cases back to lower courts with instructions for the courts to vacate preliminary injunctions that had been in place against the administration as moot.
The decisions mean that the rulings won't act as precedent in future vaccine mandate cases.
“We believe the United States Constitution clearly does not permit the federal government to force federal workers—or any law abiding citizen—to inject their bodies with something against their will. In fact, the freedom to control your own body and your own medical information is so basic that, without those liberties, it is impossible to truly be ‘free’ at all," Marcus Thornton, president of Feds for Freedom, said in a statement. "We are disappointed that the Supreme Court dodged these important Constitutional arguments and instead chose to vacate our case on technicalities."
One case was brought by Feds for Freedom and involved President Biden's mandate for federal employees. The mandate was imposed in 2021, with the president claiming that vaccination was the "best way to slow the spread of COVID-19" and that requiring vaccination would "promote the health and safety of the federal workforce and the efficiency of the civil service.”
U.S. District Judge Jeffrey Brown had ruled previously that the president lacked the authority to impose the vaccine mandate.
Another case was brought by a federal worker who recovered from COVID-19 and thus enjoyed some protection against the illness but was still being forced to receive a vaccination under President Biden's mandate because the government refused to formally recognize the post-infection protection. Jason Payne, the worker, said the mandate exceeded President Biden's authority.
In the third case, federal judges ruled that the U.S. Air Force's handling of its mandate was illegal, and prevented the branch from taking disciplinary action against members who had requested religious exemptions.
Government lawyers urged the Supreme Court to rule the decisions in these cases as moot, given that the vaccine mandates were ended.
"Consistent with this court’s ordinary practice under such circumstances, the court should grant the petition for a writ of certiorari, vacate the judgment below, and remand with instructions to direct the district court to dismiss its order granting a preliminary injunction as moot," the lawyers wrote in one petition to the court.
Mr. Payne's lawyers also asked for the decisions to be ruled as moot, after two courts ruled against him and following the rescinding of the mandate that affected him.
Lawyers for the other federal workers and for the military members opposed the request.
The government was asking the Supreme Court to endorse a "heads we win, tails you get vacated" version of a previous court decision, United States v. Munsingwear, lawyers for the federal workers wrote in one brief. If granted, the government would be able to "litigate to the hilt in both district and circuit court and—only if they lose—then decline to seek substantive review from this court and instead moot the case and ask this court to erase the circuit court loss from the books," according to the brief.
Lawyers for the military members noted that Congress forced the military to rescind its mandate, but that the legislation didn't prevent the Department of Defense from issuing another mandate.
Government lawyers said the mandates were rescinded because the pandemic situation had changed, not because they were challenged. They also argued that the mandates "cannot be reasonably expected to recur."
Lawyers for the military members said that the claim was "in serious tension" with the demand to vacate the rulings under the Munsingwear precedent, given that the purpose of such a move "is to clear the path for future re-litigation without res judicata concerns."
None of the Supreme Court justices except for Justice Ketanji Brown Jackson, who was appointed by President Biden, explained their decisions on the cases.
"Although I would require that the party seeking vacatur establish equitable entitlement to that remedy, I accede to vacatur here based on the court’s established practice when the mootness occurs through the unilateral action of the party that prevailed in the lower court," she said in regard to Mr. Payne's case.
In the two other cases, Justice Jackson said that the government hadn't "established equitable entitlement" to vacatur, but that she concurred with the overall judgment from her colleagues.
She cited a Dec. 5 decision in which the court ruled against a civil rights activist who sought a ruling that would force hotels to make information for disabled people publicly available.
Justice Jackson sided with the majority in that ruling but contested the majority's decision to vacate a lower court ruling, arguing that vacatur—or the setting aside of the judgment—shouldn't be granted automatically.
"Automatic vacatur plainly flouts the requirement of an individualized, circumstance-driven fairness evaluation, which, as I have explained, is the hallmark of an equitable remedy," she wrote.
It's also "flatly inconsistent with our common-law tradition of case-by-case adjudication, which 'assumes that judicial decisions are valuable and should not be cast aside lightly,'" Justice Jackson said, quoting from yet another ruling.
"As a general matter, I believe that a party who claims equitable entitlement to vacatur must explain what harm—other than having to accept the law as the lower court stated it—flows from the inability to appeal the lower court decision."
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Covid has much more severe post vaccination symptoms than influenza
Many of my Op-eds have examined symptoms/diseases in VAERS (Vaccine Adverse Events Reporting System) following COVID-19 vaccinations. Each Op-ed has focused on a different organ (e.g., renal, skin) or system (e.g., cardiovascular, neurological, musculoskeletal). These Op-eds have also included a section comparing frequency of symptoms that occurred following COVID-19 vaccinations and Influenza vaccinations. For some symptoms, the difference between COVID-19 symptom frequencies and Influenza symptom frequencies was quite large, COVID-19 always being larger. For other symptoms, COVID-19 relative frequency was noticeable, but not nearly as large.
Are there any patterns to those symptoms showing either 1) massive differences in their frequencies following these vaccinations or 2) modest differences following these vaccinations? To answer this question, it was decided to examine ALL the symptoms listed in VAERS following COVID-19 vaccinations and following Influenza vaccinations. The focus would be on the two extremes: massive differences between the symptom frequencies of each vaccine, and extremely small differences, including the ~1/3% of cases where Influenza post-vaccination symptom frequencies were larger than those of COVID-19.
METHODOLOGY
In late November 2023, the VAERS database was accessed, and all the symptoms following COVID-19 vaccinations and following Influenza vaccinations were downloaded, including those symptoms with zero entries. For each case, a total of 17716 symptoms was downloaded. The two sets of symptoms were combined, and the ratios of 1) symptom frequencies following COVID-19 vaccinations to 2) symptom frequencies following Influenza vaccinations were computed.
RESULTS AND DISCUSSION
The ratios were divided into five groups, and the extreme ratios from each group are shown in Appendices 1-5. The five groups are: 1) Symptom frequency post-Influenza vaccination zero (total of 12771 symptoms - see Appendix 1); 2), Symptom frequency post-Influenza vaccination one (total of 1809 symptoms - see Appendix 2); 3) Symptom frequency post-Influenza vaccination two (total of 720 symptoms - see Appendix 3); 4) Symptom frequency post-Influenza vaccination greater than two, and the COVID-19/Influenza symptom frequency ratio is one or greater (total of 2346 symptoms - see Appendix 4); 5) Symptom frequency post-Influenza vaccination greater than two, and the COVID-19/Influenza symptom frequency ratio is less than one (total of 66 symptoms - see Appendix 5). The symptom frequencies for all symptoms following COVID-19 vaccinations total 4,186,684 events, and symptom frequencies for all symptoms following Influenza vaccinations total 178,284 events. This yields an overall aggregate COVID-19/Influenza post-vaccination symptom ratio of 23.48........
Overall, the number of symptoms post-COVID-19 vaccinations that have massively higher frequencies than their influenza vaccination counterparts are over a thousand even when limited to the very high threshold ratios of thirty or more that were used as cutoff. It is difficult to see how any credible scientist or regulator can consider differences on the order of those shown in this study as anything other than signals of an extremely unsafe substance.
SUMMARY AND CONCLUSIONS
All the symptoms listed in VAERS following COVID-19 vaccinations and following Influenza vaccinations were compared for numbers of events associated with each symptom. The analysis focused on the two extremes: massive differences between the two vaccines, and extremely small differences, including cases where Influenza post-vaccination symptom frequencies were larger than those of COVID-19.
The symptom frequencies for all symptoms following COVID-19 vaccinations totaled 4,186,684 events, and symptom frequencies for all symptoms following Influenza vaccinations totaled 178,284 events. Since the VAERS numbers strongly under-represent the real-world numbers, they need to be multiplied by an under-reporting factor (URF) to translate into numbers of real-world symptoms. Using my most recent URF value of 66, the real-world symptom frequencies for all symptoms following COVID-19 vaccinations totaled 276,321,144 events, and real-world symptom frequencies for all symptoms following Influenza vaccinations totaled 11,766,744 events. The ratio of these two event totals yields an overall aggregate COVID-19/Influenza post-vaccination ratio of 23.48.
Cardiovascular issues, blood issues, and cancer issues were some of the more noticeable sub-themes that displayed extreme differences between 1) post-COVID-19 vaccination symptoms and 2) post-influenza vaccination symptoms. However, neurological, immune/autoimmune, respiratory, renal, gastrointestinal, infection, endocrine, auditory, vision, skin, musculoskeletal, and myriad other disorders had significant representation at the extremes as well. One disturbing feature of the results is the large number of “breakthrough COVID-19” cases that occurred post-COVID-19 vaccinations. What kind of vaccine increases vulnerability to the infection that the vaccine is supposed to prevent?
While all these disorders are concerning, perhaps the disorders of highest concern are the Cancer issues. Cancers are appearing within (sometimes well within) the three years since COVID-19 vaccinations started, far sooner than would be expected from their typical latency periods. This does not bode well for the future. Given the destructive nature of the mRNA platform on the surveillance and attack/destroy functions of the immune system, all the vaccines projected to operate on this platform for the future (e.g., RSV (respiratory syncytial virus), HIV, Zika, Epstein-Barr virus, tuberculosis, malaria, shingles, and flu) will only increase the likelihood of Cancers cumulatively with each injection.
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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, December 11, 2023
CDC Reveals New 'Fastest-Growing' COVID-19 Variant in US
The U.S. Centers for Disease Control and Prevention (CDC) indicated that the JN.1 COVID-19 subvariant is increasingly across the United States, comprising potentially a third of all cases.
The variant comprised about 0.1 percent of all COVID-19 cases in the United States as of late October, according to the federal health agency in a Dec. 8 update. But as of Dec. 8, it now makes up about 15 to 29 percent of cases, it said.
"CDC projects that JN.1 will continue to increase as a proportion of SARS-CoV-2 genomic sequences," the CDC said. "It is currently the fastest-growing variant in the United States."
The CDC said in another update that the JN.1 level jumped from 8.1 percent to 21.4 percent in the past two weeks. JN.1 is now the second-most common variant in the U.S., behind only the HV.1 variant, according to the CDC.
Despite the fast growth of JN.1, there is "no evidence" at this time that it "presents an increased risk to public health relative to other currently circulating variants," said the CDC. There is also no signs of "increased severity" from the variant, the agency added.
Current COVID-19 treatments and tests are believed to be effective against JN.1, it said, adding that "the continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems."
The CDC also said it's unclear to what extent JN.1 is contributing to hospitalizations in the U.S. but said that COVID-19 activity is likely going to increase during the winter months.
Researchers and the CDC say that JN.1 is a COVID-19 variant that descended from the BA.2.86 lineage, which is another Omicron sub-variant.
“BA.2.86 has more than 20 mutations on the spike protein and there was a concern when it was first detected a while back that, wow, this might be a real problem,” Thomas Russo, professor and chief of infectious diseases at the University at Buffalo in New York, told Prevention.
Symptoms
There is no data to indicate if JN.1 causes any new symptoms, said William Schaffner, a professor at the Vanderbilt University School of Medicine.
“It’s an Omicron variant and looks to be similar,” he told the outlet.
The CDC says that symptoms include cough, shortness of breath, fever or chills, fatigue, muscle aches, loss of taste or smell, sore throat, runny nose, headache, vomiting, diarrhea, or nausea.
"It is not currently known whether JN.1 infection produces different symptoms from other variants," said the CDC update. "In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity and overall health rather than which variant causes the infection."
Other Respiratory Illnesses
Separate data provided by the CDC show that while COVID-19 hospitalizations have been on the rise in recent weeks, weekly COVID-19 hospitalizations have not reached the same levels as previous "surges" earlier on in the pandemic. As of the week ending Dec. 2, there were 22,513 recorded hospitalizations, which is significantly lower than the same weekly period in December 2022.
Flu hospitalizations are on the rise although the number of new admissions appears to be low with 5,753 admitted to the week ending on Dec. 2, which is an increase from 4,268 during the prior week, according to the most recent CDC data. The also data suggests that there have been 2.6 million influenza cases, 26,000 hospital cases, and 1,600 deaths during the flu season so far.
Earlier this month, the CDC said that despite reported spikes of pneumonia cases among children in several states, the CDC's director, Mandy Cohen, said earlier this month that transmission rates are considered "typical."
"As of today, we are not seeing anything that is atypical in terms of pneumonia-related emergency department visits," she told reporters.
It came amid concerns that a spate of pediatric pneumonia cases in mainland China could spread to the U.S., which drew an alert from the ProMed global surveillance system in late November.
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UK: Airforce intelligence officers joined Whitehall and Army in 'spying' on Covid lockdown critics - including David Davis and Peter Hitchens
RAF intelligence officers joined a shadowy Whitehall operation accused of spying on members of the public who criticised Covid lockdown policies, The Mail on Sunday can reveal.
Official military documents obtained by this newspaper show that analysts from RAF Wyton in Cambridgeshire helped to scour social media posts by the public.
The MoS revealed in January how the Army's secretive 'information warfare brigade' was tasked with scrutinising online posts – an activity the Ministry of Defence, in public, repeatedly denied doing.
Now this newspaper can show that the military's assistance to Government cells, such as the Counter Disinformation Unit, based in the Department for Digital, Culture, Media and Sport, and Rapid Response Unit in the Cabinet Office was far more extensive than previously thought.
These Whitehall outfits were tasked with tackling 'disinformation' and 'harmful narratives' during the pandemic. Their activities have faced fierce criticism after it emerged they also collected legitimate social media posts questioning Government lockdown policies.
Dossiers were compiled on public figures including Tory ex-Minister David Davis, who questioned the modelling behind alarming Covid death toll predictions, and The MoS's Peter Hitchens.
The documents reveal defence chiefs privately conceded the military's work for the Government could pose a 'potential presentational risk of Defence 'spying' or conducting 'Psyops' on the UK'. But the MoD feared that if the Armed Forces did not help the Government's online monitoring, then 'harmful misinformation and disinformation' could spread.
Jake Hurfurt, of the campaign group Big Brother Watch, last night branded Whitehall's use of military personnel as 'an attack on freedom of speech' and 'behaviour befitting an authoritarian state'. He added: 'The revelations that the RAF as well as the Army spied on the British people during the pandemic is yet more evidence that the MoD misled the public about the role of its psyops troops in 2020.'
'These documents prove that Whitehall officials knew deploying the military to monitor social media posts from politicians, journalists and the press would look like spying – but they carried on anyway.'
The RAF and Army's assistance to Whitehall is detailed in documents outlining official requests known as 'Military Aid to the Civil Authorities' (MACA). These are normally used by the Government when military help is needed to respond to natural disasters.
The papers also show how in 2020 the Government was considering a dramatic expansion of the Counter Disinformation Unit by ordering monitoring of online chatter about Brexit and the NHS.
Mr Hurfurt last night demanded that the Covid Inquiry also investigate how the Government 'monitored the British people'.
Peter Hitchens was monitored after sharing an article, based on leaked NHS papers, which claimed data used to publicly justify the lockdown was incomplete.
An internal Rapid Response Unit email said Mr Hitchens wanted to 'further [an] anti-lockdown agenda and influence the Commons vote'.
The Government said: 'Online disinformation is a serious threat, which is why in the pandemic we brought together expertise from across government to monitor disinformation about Covid.
'The units used publicly available data, including material on social media. They did not target individuals or take action that could impact the ability to discuss issues freely.'
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Descriptive Analysis of Japanese Deaths Associated with Pfizer-BioNTech mRNA COVID-19 Vax: Troubling Data
A physician-researcher based at YASP Medical Information Laboratory for Dermatology in Aichi, Japan, 188 miles south of Tokyo, recently published in peer-reviewed Cureus the study “An analysis of the Association Between BNT162b2 mRNA COVID-19 Vaccination and Deaths within 10 Days After Vaccination Using the Sex Ratio in Japan.” The study finding “indicates that the vaccination may influence the occurrence of death during the risk period and might be associated with death.”
An important study as mass vaccination necessitates a higher level of safety than pharmaceuticals used for treatment, and consequently, should have an exceptionally low vaccination mortality rate. It’s important to analyze vaccine safety using statistical methods able to detect significant differences even when the vaccination mortality rate is exceptionally low.
Background
The author reports that “the association between coronavirus disease 2019 (COVID-19) vaccinations and deaths after vaccination has been investigated primarily through cohort and self-controlled case series studies. In the present study, the sex ratios of reported deaths were compared by period.”
The Study
In this descriptive analysis-based study, Dr. Yasusi Suzumura tapped into and extracted data on deaths reported after vaccination with the Pfizer-BioNTech COVID-19 mRNA vaccine called BNT162b2. The data used were published by the Ministry of Health, Labour and Welfare in Japan.
For the study’s risk period, Dr. Suzumura’s study defined this parameter as within 10 days of vaccination, with the control period defined as 11 to 180 days post-administration of the COVID-19 jab.
Using sex ratios to calculate all-cause deaths, for each outcome the researcher divided the number of males by females all by 100. Then, the study author performed Fisher’s exact test (categorical data that results from classifying objects in two different ways; it is used to examine the significance of the association) for outcomes analysis. Thereafter, the author used graphs to present the data, including the number of days from vaccination to death, plus the reported death outcomes.
Study Findings
During the risk period (0-10 days) all-cause deaths among elderly persons (aged ≥65 years), Dr. Yasusi Suzumura reports a sex ratio of 92, which turns out to be “significantly lower than that during the control period (130) (p=0.0050).”
When analyzing the data for all-cause deaths of persons aged ≤64 years, the authors report the sex ratio during the risk period was 204, significantly higher than that during the control period (111) (p=0.044).
“Reported deaths were concentrated during the risk period in both groups. Sex ratios by period for each outcome were also examined. However, the differences were not significant across any of the outcomes.”
Takeaway
According to the Japanese study author the Pfizer-BioNTech mRNA vaccination for all-cause deaths among those aged ≤64 years, “vaccination may influence the occurrence of death during the risk period.”
The study finding here “indicates that the vaccination may influence the occurrence of death during the risk period and might be associated with death.”
TrialSite Breakdown
While a Japanese cohort study previously conducted led to no significant increase in all-cause mortality involving COVID-19 vaccination, the author points out, “This does not contradict the results of the present study.” While the previous cohort study points to support for COVID-19 vaccine safety, Dr. Suzumura points out that “This does not indicate that vaccine-related deaths are nonexistent; it only indicates that their number is not large enough to make a significant difference.”
On this occasion, it is difficult to determine whether a post-vaccination death is incidental or vaccine-related. A self-controlled risk interval design and a comparison of sex ratios by period may be useful in examining the association between vaccination and deaths after vaccination when a cohort study does not detect a significant difference due to a low mortality rate. The latter approach may be particularly useful for analyzing data with reporting bias. The author believes that this approach may not provide conclusive evidence, but it can offer valuable insights into assessing 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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The U.S. Centers for Disease Control and Prevention (CDC) indicated that the JN.1 COVID-19 subvariant is increasingly across the United States, comprising potentially a third of all cases.
The variant comprised about 0.1 percent of all COVID-19 cases in the United States as of late October, according to the federal health agency in a Dec. 8 update. But as of Dec. 8, it now makes up about 15 to 29 percent of cases, it said.
"CDC projects that JN.1 will continue to increase as a proportion of SARS-CoV-2 genomic sequences," the CDC said. "It is currently the fastest-growing variant in the United States."
The CDC said in another update that the JN.1 level jumped from 8.1 percent to 21.4 percent in the past two weeks. JN.1 is now the second-most common variant in the U.S., behind only the HV.1 variant, according to the CDC.
Despite the fast growth of JN.1, there is "no evidence" at this time that it "presents an increased risk to public health relative to other currently circulating variants," said the CDC. There is also no signs of "increased severity" from the variant, the agency added.
Current COVID-19 treatments and tests are believed to be effective against JN.1, it said, adding that "the continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems."
The CDC also said it's unclear to what extent JN.1 is contributing to hospitalizations in the U.S. but said that COVID-19 activity is likely going to increase during the winter months.
Researchers and the CDC say that JN.1 is a COVID-19 variant that descended from the BA.2.86 lineage, which is another Omicron sub-variant.
“BA.2.86 has more than 20 mutations on the spike protein and there was a concern when it was first detected a while back that, wow, this might be a real problem,” Thomas Russo, professor and chief of infectious diseases at the University at Buffalo in New York, told Prevention.
Symptoms
There is no data to indicate if JN.1 causes any new symptoms, said William Schaffner, a professor at the Vanderbilt University School of Medicine.
“It’s an Omicron variant and looks to be similar,” he told the outlet.
The CDC says that symptoms include cough, shortness of breath, fever or chills, fatigue, muscle aches, loss of taste or smell, sore throat, runny nose, headache, vomiting, diarrhea, or nausea.
"It is not currently known whether JN.1 infection produces different symptoms from other variants," said the CDC update. "In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity and overall health rather than which variant causes the infection."
Other Respiratory Illnesses
Separate data provided by the CDC show that while COVID-19 hospitalizations have been on the rise in recent weeks, weekly COVID-19 hospitalizations have not reached the same levels as previous "surges" earlier on in the pandemic. As of the week ending Dec. 2, there were 22,513 recorded hospitalizations, which is significantly lower than the same weekly period in December 2022.
Flu hospitalizations are on the rise although the number of new admissions appears to be low with 5,753 admitted to the week ending on Dec. 2, which is an increase from 4,268 during the prior week, according to the most recent CDC data. The also data suggests that there have been 2.6 million influenza cases, 26,000 hospital cases, and 1,600 deaths during the flu season so far.
Earlier this month, the CDC said that despite reported spikes of pneumonia cases among children in several states, the CDC's director, Mandy Cohen, said earlier this month that transmission rates are considered "typical."
"As of today, we are not seeing anything that is atypical in terms of pneumonia-related emergency department visits," she told reporters.
It came amid concerns that a spate of pediatric pneumonia cases in mainland China could spread to the U.S., which drew an alert from the ProMed global surveillance system in late November.
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UK: Airforce intelligence officers joined Whitehall and Army in 'spying' on Covid lockdown critics - including David Davis and Peter Hitchens
RAF intelligence officers joined a shadowy Whitehall operation accused of spying on members of the public who criticised Covid lockdown policies, The Mail on Sunday can reveal.
Official military documents obtained by this newspaper show that analysts from RAF Wyton in Cambridgeshire helped to scour social media posts by the public.
The MoS revealed in January how the Army's secretive 'information warfare brigade' was tasked with scrutinising online posts – an activity the Ministry of Defence, in public, repeatedly denied doing.
Now this newspaper can show that the military's assistance to Government cells, such as the Counter Disinformation Unit, based in the Department for Digital, Culture, Media and Sport, and Rapid Response Unit in the Cabinet Office was far more extensive than previously thought.
These Whitehall outfits were tasked with tackling 'disinformation' and 'harmful narratives' during the pandemic. Their activities have faced fierce criticism after it emerged they also collected legitimate social media posts questioning Government lockdown policies.
Dossiers were compiled on public figures including Tory ex-Minister David Davis, who questioned the modelling behind alarming Covid death toll predictions, and The MoS's Peter Hitchens.
The documents reveal defence chiefs privately conceded the military's work for the Government could pose a 'potential presentational risk of Defence 'spying' or conducting 'Psyops' on the UK'. But the MoD feared that if the Armed Forces did not help the Government's online monitoring, then 'harmful misinformation and disinformation' could spread.
Jake Hurfurt, of the campaign group Big Brother Watch, last night branded Whitehall's use of military personnel as 'an attack on freedom of speech' and 'behaviour befitting an authoritarian state'. He added: 'The revelations that the RAF as well as the Army spied on the British people during the pandemic is yet more evidence that the MoD misled the public about the role of its psyops troops in 2020.'
'These documents prove that Whitehall officials knew deploying the military to monitor social media posts from politicians, journalists and the press would look like spying – but they carried on anyway.'
The RAF and Army's assistance to Whitehall is detailed in documents outlining official requests known as 'Military Aid to the Civil Authorities' (MACA). These are normally used by the Government when military help is needed to respond to natural disasters.
The papers also show how in 2020 the Government was considering a dramatic expansion of the Counter Disinformation Unit by ordering monitoring of online chatter about Brexit and the NHS.
Mr Hurfurt last night demanded that the Covid Inquiry also investigate how the Government 'monitored the British people'.
Peter Hitchens was monitored after sharing an article, based on leaked NHS papers, which claimed data used to publicly justify the lockdown was incomplete.
An internal Rapid Response Unit email said Mr Hitchens wanted to 'further [an] anti-lockdown agenda and influence the Commons vote'.
The Government said: 'Online disinformation is a serious threat, which is why in the pandemic we brought together expertise from across government to monitor disinformation about Covid.
'The units used publicly available data, including material on social media. They did not target individuals or take action that could impact the ability to discuss issues freely.'
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Descriptive Analysis of Japanese Deaths Associated with Pfizer-BioNTech mRNA COVID-19 Vax: Troubling Data
A physician-researcher based at YASP Medical Information Laboratory for Dermatology in Aichi, Japan, 188 miles south of Tokyo, recently published in peer-reviewed Cureus the study “An analysis of the Association Between BNT162b2 mRNA COVID-19 Vaccination and Deaths within 10 Days After Vaccination Using the Sex Ratio in Japan.” The study finding “indicates that the vaccination may influence the occurrence of death during the risk period and might be associated with death.”
An important study as mass vaccination necessitates a higher level of safety than pharmaceuticals used for treatment, and consequently, should have an exceptionally low vaccination mortality rate. It’s important to analyze vaccine safety using statistical methods able to detect significant differences even when the vaccination mortality rate is exceptionally low.
Background
The author reports that “the association between coronavirus disease 2019 (COVID-19) vaccinations and deaths after vaccination has been investigated primarily through cohort and self-controlled case series studies. In the present study, the sex ratios of reported deaths were compared by period.”
The Study
In this descriptive analysis-based study, Dr. Yasusi Suzumura tapped into and extracted data on deaths reported after vaccination with the Pfizer-BioNTech COVID-19 mRNA vaccine called BNT162b2. The data used were published by the Ministry of Health, Labour and Welfare in Japan.
For the study’s risk period, Dr. Suzumura’s study defined this parameter as within 10 days of vaccination, with the control period defined as 11 to 180 days post-administration of the COVID-19 jab.
Using sex ratios to calculate all-cause deaths, for each outcome the researcher divided the number of males by females all by 100. Then, the study author performed Fisher’s exact test (categorical data that results from classifying objects in two different ways; it is used to examine the significance of the association) for outcomes analysis. Thereafter, the author used graphs to present the data, including the number of days from vaccination to death, plus the reported death outcomes.
Study Findings
During the risk period (0-10 days) all-cause deaths among elderly persons (aged ≥65 years), Dr. Yasusi Suzumura reports a sex ratio of 92, which turns out to be “significantly lower than that during the control period (130) (p=0.0050).”
When analyzing the data for all-cause deaths of persons aged ≤64 years, the authors report the sex ratio during the risk period was 204, significantly higher than that during the control period (111) (p=0.044).
“Reported deaths were concentrated during the risk period in both groups. Sex ratios by period for each outcome were also examined. However, the differences were not significant across any of the outcomes.”
Takeaway
According to the Japanese study author the Pfizer-BioNTech mRNA vaccination for all-cause deaths among those aged ≤64 years, “vaccination may influence the occurrence of death during the risk period.”
The study finding here “indicates that the vaccination may influence the occurrence of death during the risk period and might be associated with death.”
TrialSite Breakdown
While a Japanese cohort study previously conducted led to no significant increase in all-cause mortality involving COVID-19 vaccination, the author points out, “This does not contradict the results of the present study.” While the previous cohort study points to support for COVID-19 vaccine safety, Dr. Suzumura points out that “This does not indicate that vaccine-related deaths are nonexistent; it only indicates that their number is not large enough to make a significant difference.”
On this occasion, it is difficult to determine whether a post-vaccination death is incidental or vaccine-related. A self-controlled risk interval design and a comparison of sex ratios by period may be useful in examining the association between vaccination and deaths after vaccination when a cohort study does not detect a significant difference due to a low mortality rate. The latter approach may be particularly useful for analyzing data with reporting bias. The author believes that this approach may not provide conclusive evidence, but it can offer valuable insights into assessing 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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Sunday, December 10, 2023
Now BIDEN'S ex-Covid advisor admits pandemic may have been caused by a Wuhan lab leak - and warns there's a 50% chance of another pandemic by 2050
President Joe Biden's former Covid advisor has admitted the pandemic may have been borne out of a laboratory leak in Wuhan.
Speaking at a New York City health conference this week, Dr Raj Panjabi, former Special Assistant to the President, described the lab leak theory as 'plausible' and called on Governments around the world to 'do more to keep labs safe.’
Biden called former President Donald Trump 'nakedly xenophobic’ in May 2020, for suggesting Covid was the result of Chinese experiments gone wrong.
But now the FBI, Department of Energy and many scientists and US government officials believe it is the most likely origin of the pandemic.
However, the official line from Biden's White House is that the origin of Covid remains uncertain — a view echoed by National Security Advisor Jake Sullivan, who said there is 'no definitive answer' to the question.
But ex-Covid adviser Dr Panjabi appeared to veer away from the party line this week saying: ‘It is plausible that Covid originated in a lab accident in Wuhan...we have got to do more to keep labs safe.’
He also issued a chilling prediction: There's a 50/50 chance of another pandemic happening by 2050.
'The risk of a pandemic is only growing in the modern world,' Dr Punjabi said in a speech at the Forbes Healthcare Summit 2023 earlier this week.
'There is a 50 percent risk one will happen in the next 25 years. This is because of globalization, or what I call the three Ps.
‘These are: Pathogen spillover [when diseases jump from animals to humans]... planes [global travel], and poor public health systems that are shattered and lack investment.’
Dr Panjabi is a physician specializing in infectious disease and epidemiology. He has also been named as one of the 100 most influential people in the world by TIME magazine.
Panjabi worked for the Biden administration from 2021 to late 2023, playing a key role in two public health crises: the Covid-19 pandemic and the monkeypox outbreak that began in the Spring of 2022.
He also led the White House strategy for boosting Covid vaccine uptake in the US and abroad — a program that saw 1.1billion shots distributed to third-world countries.
Safety practices in US scientific laboratories are gaining increasing attention from Government officials, in a bid to prevent future pandemics.
Congress is currently considering tighter regulation of labs, with the House Energy and Commerce Committee currently holding hearings on the subject.
In September, Republicans escalated their Covid origins investigation, demanding the Biden administration and other politicians comply with their requests — or face being subpoenaed.
In a letter sent to HHS Sec. Xavier Becerra first obtained by DailyMail.com, the Republicans wrote they 'expect full and timely compliance' with their requests, which have gone unanswered since they launched the probe in February.
And Dr Anthony Fauci has finally agreed to testify to Congress on his involvement in the public cover up of Covid's origins.
The onetime White House doctor will be grilled on his former department's funding of dangerous experiments in Wuhan, as well as the stark difference between his public and private comments about the lab leak theory.
He is due to speak in front of the House in January, which will be the first time he has testified under oath since his infamous showdown in front of the Senate in July 2021.
The lab leak theory of Covid was dismissed as a conspiracy in the early days of the pandemic by leading figures including Dr Fauci.
Dr Panjabi is just the latest high ranking official to give credence to the lab leak theory, after Secretary of State Mike Pompeo, former top health official Dr Robert Kadlec and former national security director John Ratcliffe all came out in support of it.
Speaking to Sky News last month, Dr Ratcliffe said: ‘It’s more than just a possibility, it’s certainly a probability and it’s probably a certainty.’
Dr Rober Kadlec, who initially worked with Dr Fauci to hush the lab leak theory, has suggested in a report that Covid likely escaped during the work of scientist Dr Zhou Yusen at the Wuhan Institute of Virology (WIV).
He filed a patent for a Covid vaccine in February 2020, which suggested he had been working on it for months.
Countless reports have revealed lax practices at US labs - including a military research facility Fort Detrik, in Maryland.
The lab is accused of leaking Ebola and Anthrax into local water supplies in May 2018 after a tank holding wastewater from labs became over-pressurized and sprayed infectious waste for three hours.
There are also suggestions that pandemics have been caused by lab leaks before, including the 2004 and 2005 influenza outbreak.
Researchers said the strain that caused it bore a remarkable resemblance to one that had been spreading decades earlier.
https://www.dailymail.co.uk/health/article-12828911/biden-covid-advisor-lab-leak-Dr-panjabi.html
*******************************************Children With Respiratory Illnesses at Pediatric Centers More Likely to Be Hospitalized if Vaccinated: CDC Study
Children who reported to pediatric center emergency departments with respiratory illness and were hospitalized were more likely to have taken COVID-19 vaccines, according to a new study from the U.S. Centers for Disease Control and Prevention (CDC).
More than half of vaccinated children included in the study were admitted to hospitals as inpatients, compared to less than half of unvaccinated children.
The study examined children aged 6 months to 4 years who went to emergency departments at one of seven pediatric medical centers, including Children's Hospital of Pittsburgh and Seattle Children's Hospital. Some of the children were admitted to hospitals. The encounters happened as early as July 1, 2022, and as late as Sept. 30, 2023.
The children needed to have one or more symptoms indicating acute respiratory illness, such as fever, cough, or shortness of breath.
The overwhelming majority of the young children in the study never received a dose of a vaccine. That group of 6,377 far outnumbered the 281 children who received one dose and the 776 children who received at least two doses. Across the United States, most young children are unvaccinated.
Of the unvaccinated children in the study, 44 percent were hospitalized. Of the vaccinated, 55 percent were hospitalized.
"This means that upon visiting hospital emergency departments, compared to unvaccinated children, vaccinated children had *increased* risks of inpatient hospitalization, very statistically significantly so," Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, who was not involved with the study, told The Epoch Times in an email.
Vaccinated children were also more likely to receive intensive care, need supplemental oxygen, and die, according to the paper, though just three deaths were recorded among the study population and some of the differences were not statistically significant.
The CDC's media office, which promoted the study, told The Epoch Times in an email: "Although proportionally more hospitalized children had received a COVID-19 vaccine than children enrolled in the emergency department (ED), this does not mean that vaccinated children were more likely to be hospitalized."
The CDC also said the paper showed that vaccination was "effective at reducing emergency department visits and hospitalizations in children."
Dr. Eyal Shahar, an epidemiologist at the University of Arizona who reviewed the study, noted that the vaccinated children had worse underlying health. "That largely explains worse outcomes," Dr. Shahar told The Epoch Times via email. "We cannot attribute the outcomes to vaccination."
The CDC published the paper in its quasi-journal. Papers published by the journal are typically not peer-reviewed but are shaped to align with CDC policy. The CDC currently recommends COVID-19 vaccination for nearly all Americans, regardless of prior infection or underlying health.
The study's authors, some of whom work for the CDC, said the study showed that "receipt of ≥2 COVID-19 mRNA vaccine doses was 40% effective ... in preventing emergency department visits and hospitalization," referring to the Pfizer and Moderna modified messenger RNA (mRNA) vaccines.
The authors reached that conclusion after separating out patients who tested positive for COVID-19. There were 387, with 94 percent unvaccinated. The unvaccinated were only 85 percent of the study population, indicating they were at higher risk of visiting an emergency department with respiratory illness and then testing positive for COVID-19.
"No one cares whether the vaccines reduce COVID-associated hospitalization if at the same time they increase non-COVID-associated hospitalization," Dr. Risch said.
The researchers estimated that the effectiveness of one vaccine dose against emergency department presentation or hospitalization was 31 percent, increasing to 40 percent for at least two doses.
Dr. Tracy Beth Hoeg, an epidemiologist in California who reviewed the paper, said that the authors inappropriately inferred causality despite the study being observational.
"They should have said 'was associated with lower rate of...' rather than 'was effective in preventing,'" Dr. Hoeg told The Epoch Times via email.
The researchers did not present separate estimates for protection against hospitalization and emergency department visits, nor did they track how the effectiveness estimates changed over time. Vaccine effectiveness has been shown to drop over time in other studies.
Regarding effectiveness, the authors referred to an earlier CDC-published study that estimated vaccination provided from 7 percent to 80 percent protection against COVID-19-associated urgent care counters and emergency department visits. A third CDC-published study estimated protection against symptomatic COVID-19 infection among young children was typically under 50 percent.
Vaccines are supposed to provide at least 50 percent protection, according to U.S. Food and Drug Administration (FDA) and World Health Organization guidance.
Dr. Heidi Klein, who works for the CDC, and Dr. Eileen Klein, an emergency medicine doctor at Seattle Children's Hospital, did not respond to requests for comment. They were listed as the new study's senior authors.
The conflicts of interest described were lengthy, with three authors reporting funding from Pfizer.
Limitations of the paper, the authors said, included the low number of vaccinated children.
"This appears to be another substandard observational study of vaccine efficacy in children published without peer review by the CDC. The list of limitations is a mile long and understates the study's methodological limitations," Dr. Jay Bhattacharya, a professor of health policy at Stanford University who reviewed the study, told The Epoch Times via email. "If the CDC wants to answer the question of COVID vaccine benefits and harms to children, it should commission a large, rigorous, randomized trial with meaningful clinical endpoints like prevention of hospitalization and death."
More on Methods
Researchers collected data for the study through interviews with parents, chart reviews, and immunization records.
All children included had signs of acute respiratory illness.
Children who tested positive for COVID-19 were considered case patients while controls were children who tested negative for COVID-19.
Exclusions included children whose illness lasted more than 10 days, children without verified vaccination status, and children with inconclusive COVID-19 test results.
Ninety-five percent of the children tested negative for COVID-19. Many tested positive for other viruses, such as rhinovirus. Out of 7,434 children, just 387 tested positive for COVID-19.
Those children fared worse by many measures than those who did not, including having a higher probability of needing supplemental oxygen.
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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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Saturday, December 09, 2023
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