The Totally Civil Covid Thread.

  • The US state fascists in FDA/CDC just handwaved new boosters to boost the share value of Pfizer/Moderna


    FDA authorizes new COVID shot boosters without proper testing
    WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) has authorized new boosters August 31 for the Moderna and Pfizer-BioNTech COVID-19 shots, even…
    www.thedesertreview.com


    In Canada, the provincial government of Manitoba reported in July 2022 that the booster shot administration rate in the province was 43.8 percent in May 2022. However, people who had received booster injections accounted for more than 70 percent of COVID-related deaths, per the release.


    No human tests made. No consulting among a doctors panel held.


    Just allowing injections with new dirt from Pfizer....

  • Neuropathic symptoms with SARS-CoV-2 vaccination


    Neuropathic symptoms with SARS-CoV-2 vaccination
    Background and Objectives Various peripheral neuropathies, particularly those with sensory and autonomic dysfunction may occur during or shortly after acute…
    www.medrxiv.org


    Abstract

    Background and Objectives Various peripheral neuropathies, particularly those with sensory and autonomic dysfunction may occur during or shortly after acute COVID-19 illnesses. These appear most likely to reflect immune dysregulation. If similar manifestations can occur with the vaccination remains unknown.


    Results In an observational study, we studied 23 patients (92% female; median age 40years) reporting new neuropathic symptoms beginning within 1 month after SARS-CoV-2 vaccination. 100% reported sensory symptoms comprising severe face and/or limb paresthesias, and 61% had orthostasis, heat intolerance and palpitations. Autonomic testing in 12 identified seven with reduced distal sweat production and six with positional orthostatic tachycardia syndrome. Among 16 with lower-leg skin biopsies, 31% had diagnostic/subthreshold epidermal neurite densities (≤5%), 13% were borderline (5.01-10%) and 19% showed abnormal axonal swelling. Biopsies from randomly selected five patients that were evaluated for immune complexes showed deposition of complement C4d in endothelial cells. Electrodiagnostic test results were normal in 94% (16/17). Together, 52% (12/23) of patients had objective evidence of small-fiber peripheral neuropathy. 58% patients (7/12) treated with oral corticosteroids had complete or near-complete improvement after two weeks as compared to 9% (1/11) of patients who did not receive immunotherapy having full recovery at 12 weeks. At 5-9 months post-symptom onset, 3 non-recovering patients received intravenous immunoglobulin with symptom resolution within two weeks.


    Conclusions This observational study suggests that a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.

  • An autopsy case of fulminant myocarditis after severe acute respiratory syndrome coronavirus 2 vaccine inoculation


    https://onlinelibrary.wiley.com/doi/10.1111/pin.13267


    Abstract

    A 61-year-old woman without significant medical history developed fever 3 days after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and went into shock the next day. She was negative for SARS-CoV-2 mRNA in real-time polymerase chain reaction (PCR). Finally, she died 10 days after vaccination. At autopsy, the heart showed moderate dilatation of both ventricles, and the myocardium showed an uneven color change and decreased elasticity. Histologically, severe myocarditis with extensive myocytolysis was observed. The myocarditis showed severe inflammatory cell infiltration with T-lymphocyte and macrophage predominance, and in addition to the inflammatory cells described above, vast nuclear dust accompanying neutrophilic infiltration was observed. In the bone marrow and lymph nodes, hemophagocytosis was observed. In postmortem examination, nucleic acids of any cardiotropic viruses including SARS-CoV-2 were not detected using multivirus real-time PCR system. We discussed the relationship between the possible immune reaction after vaccination and the myocarditis observed in this case from immunopathological viewpoints. This mRNA vaccine is the first applied nucleic acid vaccine for humans, and its mechanism of efficacy and immune acquisition remain unclear. We hope the accumulation of more detailed analyses of the similar cases to reveal the mechanism of this kind of adverse reaction.

  • Retrospective Study: 1st Ivermectin Dose Associates with Increase in SpO2 Levels in COVID-19 Patients


    Retrospective Study: 1st Ivermectin Dose Associates with Increase in SpO2 Levels in COVID-19 Patients
    During the pandemic TrialSite chronicled the study and use of repurposed drugs such as ivermectin as a possible therapy for COVID-19,  This media followed…
    www.trialsitenews.com


    During the pandemic TrialSite chronicled the study and use of repurposed drugs such as ivermectin as a possible therapy for COVID-19, This media followed Zimbabwe with particular interest where surges in SARS-CoV-2 were met with heavy societal use of ivermectin in combination with doxycycline. A dynamic Harare-based physician, Dr. Jaqueline (Jackie) Stone saved many lives during SARS-CoV-2 surges in 2021 as TrialSite learned in multiple interviews and investigations. Stone and others successfully cared for thousands of people from the local proletariat and economically challenged rural populations to high elites in government and military, the latter of which led to the temporary acceptance of the drug by the Medicines Control Authority of Zimbabwe (MCAZ). By February 2021 TrialSite reported in “Zimbabwe Officials Green light Massive Importation of Ivermectin to Treat COVID-19” officials form the Health and Child Care function sent a letter to MCAZ instructing them to allow for the importation of the drug for human use under the guiding principle that ill patients should not be denied effective treatment regimens. Essentially introducing an emergency use authorization, TrialSite observed a striking seeming association: the ivermectin wave in Zimbabwe appeared to link with the marked reductions in COVID-19 cases. By April 2021 this media reported in “Physician Reports Ivermectin Correlated with Dramatic Decrease in [COVID] Cases & Deaths” significant reductions in COVID-19 cases since the MCAZ acceptance of the drug. Dr. Stone and colleagues, including U.S.-based corresponding author David Scheim and Colleen Aldous, clinical and professional practice University of Kwazulu-Natal now offer results of a small, but nonetheless, important real-world retrospective study revealing the seeming association of a first dose of an ivermectin-based regimen and marked increases in COVID-19 patient oxygen levels, an important diagnostic indicator.


    A deadly pandemic outbreak makes it very difficult to methodically and systematically conduct research while patients suffer and die, particularly in low-and middle-income countries LMICs) such as Zimbabwe. A nation with limited medical infrastructure and medicinal supplies to counter COVID-19, physicians there embraced ivermectin-based combination treatment options based on emerging data points from in vitro studies to what were already a couple dozen completed clinical trials testing the common therapy targeting parasite-born conditions such as River Blindness in the tropics.


    In Zimbabwe Dr. Stone and others embraced a combination regimen involving ivermectin and doxycycline and/or doxycycline and zinc as was the case in Bangladesh where this regimen was referred to as “the people’s medicine” parts of India such as Uttar Pradesh and even in the West in nations such as Australia where proponents such as Dr. Thomas Borody embraced and advocated for study on the regimen.


    The Study

    In this retrospective study the authors analyzed oxygen saturation (SpO2) data for 34 severe, hypoxic COVID-19 patients all on room air (without supplemental oxygen). With an average age of 56.5, the patients were treated either at Harare-based clinics or in the home between August 2020 to May 2021.


    Importantly the researchers found measured markedly greater SpO2 values within 24 hours after the first dose of ivermectin administered in 31 of the 34 patents (91.1%). What follows are some central observations for the retrospective review:


    Timing/post first IVM dose


    Mean increase in SpO2 as % of normalized SpO2=97


    12 hour


    55.1%


    24 hour


    62.3%


    * paired t-test, p < 0.0000001


    This real-world observational study also included a small cohort in the United States treated with ivermectin. In that instance 24 mostly severe COVID-19 patients, all on room air, were administered the ivermectin-based combination regimen which led to comparable, rapid surges in SpO2. In this latter California-based cohort all patients recovered.


    Investigator’s Observation

    The use of ivermectin combination regimen associates in two small retrospective analyses with a rapid rise in SpO2 values which contrasts with declines in SpO2 and associated pulmonary function through the second week post the onset of moderate or severe COVID-19 symptoms under standard of care.


    Corresponding author David E. Scheim told TrialSite “Ivermectin led to a sharp increase in oxygen saturation within hours after administration.”


    Dr. Stone shared with TrialSite that the use of the generic drug-based combination has “resulted in Zimbabwe having some of the best comparable COVID-19 statistics.” The dynamic doctor told TrialSite “Africa has limited resources, so we needed to manage patients early in their homes and were able to capture and document at least components pointing to the efficacy of ivermectin based combination therapy.”


    Comments & Limitations

    A small retrospective (observational) study, this type of real-world analysis is important as they represent a cost effective means of executing clinical research as compared to randomized control trials for example.


    As with all studies tracked by TrialSite limitations are possible from the fact that SARS-CoV-2 has mutated since the time of the Zimbabwe-based care under investigation here to the potential for bias, confounding are often elements that could be present.


    Lead Research/Investigator

    Jaqueline C. Stone, MD College of Primary Care Physicians of Zimbabwe, Harare, Zimbabwe



    Pisirai Ndarukwa, Department of Health Sciences, Bindura University of Science Education, Bindura, Zimbabwe; School of Nursing and Public Health, University of KwaZulu Natal, Durban 4041, South Africa

    David E. Scheim, US Public Health Service, Commissioned Corps, Inactive Reserve, Corresponding Author

    Barry M. Dancis, Independent Researcher

    Jerome Dancis, Department of Mathematics, University of Maryland, College Park, MD

    Martin G. Gill, ENT Surgeon, Private Practice, Fourways Life Hospital, Gauteng 2191, South Africa

    Colleen Aldous, College of Health Sciences, University of KwaZulu-Natal, Durban 4041, South Africa



    Vitamin D deficiency contributes directly to the acute respiratory distress syndrome (ARDS)

    Vitamin D deficiency contributes directly to the acute respiratory distress syndrome (ARDS)
    Rationale Vitamin D deficiency has been implicated as a pathogenic factor in sepsis and intensive therapy unit mortality but has not been assessed as a risk…
    thorax.bmj.com

  • Potential of black seeds (Nigella Sativa) in the management of COVID-19 among children


    Potential of black seeds (Nigella Sativa) in the management of COVID-19 among children - IJMDAT


    Abstract

    Objective: The impact of Coronavirus disease (COVID-19) among children, appears to be milder with a significantly lower mortality rate and 1-5% of global pediatric population was identified with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. This review article focuses on the potential health benefits of black seeds (Nigella Sativa) in the management of children with COVID-19.


    Materials and Methods: The literature was looked in databases such as Medline/PubMed Central/PubMed, Google Scholar, bioRxiv, medRxiv, Science Direct, EBSCO, Scopus, Web of Science, EMBASE, Directory of Open Access Journals (DOAJ), and reference lists to identify published manuscripts relevant to the use of black seeds (N. sativa) to treat COVID-19 in children.


    Results: Numerous clinical studies and in-silico molecular docking studies were performed to determine the potential beneficial effects of N. sativa in COVID-19 management. In addition, various clinical studies demonstrated the antiviral, antioxidant, anti-inflammatory and other pharmacological effects of N. sativa. Moreover, various clinical studies proved the safety of Black seeds (N. sativa) in pediatric population.


    Conclusions: Children with COVID-19 may use N. sativa seeds or oil as an adjunctive therapy along with standard care, to prevent MIS-C like consequences, and hospitalizations. Randomized controlled clinical trials specifically in COVID-19 children would further establish the safety and efficacy of N. sativa.

  • How the ACTIV-6 ivermectin investigators got away with fraud


    How the ACTIV-6 ivermectin investigators got away with fraud
    ACTIV-6 is a closely watched trial of ivermectin and other repurposed drugs in COVID-19. The trial principal investigators are Susanna Naggie and Adrian…
    www.trialsitenews.com


    ACTIV-6 is a closely watched trial of ivermectin and other repurposed drugs in COVID-19. The trial principal investigators are Susanna Naggie and Adrian Hernandez. The results for ivermectin were reported on medRxiv on June 12, 2022. The publication concluded: “Ivermectin at 400 µg/kg was safe and without serious adverse events as compared with placebo (ivermectin [n=10]; placebo [n=9]).”


    However:


    “The lack of treatment effect was consistent for the primary outcome of time to symptom resolution and the secondary clinical outcomes including hospitalization, death, or acute care visits.”


    As reported earlier, none of the actual results for the primary outcomes of the study were reported. Instead, the reported results were for a new primary endpoint that the investigator disclosed only with the medRxiv publication. Specifically, there is no outcome registered in ClinicalTrials.gov for “time to symptom resolution” for this trial. One registered endpoint is: “Number of symptoms as measured by patient reports,” which is similar to a reported result for “time to symptom resolution”. However, the registered endpoint was for a 14 day time frame, whereas the published result was based on a 28 day time frame.


    The trial drew national attention and coverage. The question is: how is it possible that there was little public concern for this fraud? The reasons are twofold:


    One reason is that larger media platforms such as New York Times did not report on the fraud. It is possible that the fraud went unnoticed, but the reasons for the lack of coverage at such media platforms is unclear. Generally, such platforms have supported minimal investigative journalism, especially on topics related to COVID-19 that is contradictory to federal government policy. Federal health agencies are strongly opposed to the use of ivermectin.


    Insight into the trial may have been obscured by the trial investigators who dispensed with oversight. In particular, the trial never conducted an interim analysis that involves the assessment of the progress of the trial with respect to the primary trial endpoints. Such analysis can lead to early termination of the trial for reasons of futility or of overwhelming evidence of benefit.


    In this trial, the schedule for “interim analysis” by the Independent Data Monitoring Committee according to the trial protocol was as follows:


    “…. will be performed per study drug appendix, after approximately every 200 participants (100 in study drug arm and 100 in placebo arm) have completed the Day 14 Visit.”


    However, although the study ultimately enrolled 817 participants in the intervention arm and 774 in the placebo arm, no interim analyses were performed. The following justification for the failure to perform an interim analysis was given:


    “Due to extremely rapid enrollment related to the Omicron variant surge, 2000 participants were enrolled in the platform trial from December 15, 2021, to February 1, 2022. This resulted in the full accrual of the ivermectin arm before the first planned interim analysis by the independent data monitoring committee review.”


    First of all, that statement does not explain why an interim analysis could not be held during that period of high enrollment. Secondly, that statement is false. The trial began enrolling subjects on June 23, 2021, and there was certainly adequate time for an interim analysis based on the trial enrollment update on October 20, 2021.




    A more limited schedule for the interim analysis cited in the medRxiv publication was as follows:


    “Interim analyses are planned at intervals of approximately 300 participants contributing to a study drug arm.”


    However, that dramatic change in the interim analysis schedule was never reflected in the published trial protocol.


    The fraud of ACTIV-6 in the false reporting of the primary outcomes is thus potentially tied to the fraud of the trial investigators in the evasion of trial oversight. The interim analysis was bypassed with a deceitful justification

  • One reason is that larger media platforms such as New York Times did not report on the fraud. It is possible that the fraud went unnoticed,

    NyTimes is an FM/F mafia journal and as Pfizer is ruled by the same folks it is obvious they never will damage their buddies...


    Pfizer is allowed - by said mafia that also rules FDA - to inject you 30% crap RNA!

  • NextBigFuture "Unknown cause of 1 million excess deaths per year".


    "Many countries saw 18% excess deaths during the two years of the pandemic. There should have been a drop in excess deaths as we got COVID under control. More people who would have died this year from old age and natural causes died in the past 2 years from covid. Therefore, this year’s excess deaths should be below average. Excess deaths are at the 10-20% level in many countries even as COVID deaths droped and gone from pandemic to epidemic.

    In England and Wales, for 14 of the past 15 weeks, around 1,000 extra deaths each week, (none of which are due to covid. IF the current trajectory continues, then non-Covid excess deaths will be more than COVID deaths this year. This was reported by Prof Carl Heneghan, director of the Centre for Evidence Based Medicine, Oxford University.

    The excess deaths seem to be primarily circulatory, diabetes and cancer. But the reason for those extra deaths is unknown. IF this remains unsolved and is not fixed or does not stop on its own then this would be an extra 1 million deaths per year. [2 billion people with an extra 20% deaths.] If it also was impacting China, India, other Asian and African countries at the same level then this would be an extra 3 million deaths per year.

    The US excess deaths is currently at about 8%, but the US has a population is over five times the level of the UK. This is about 2000-4000 extra deaths per week in the US."


    So, I have to say that this would be potentially supportive of Wyttenbach's views about vaccine mortality.

    However things may not be that simple the article goes on to say;

    "Possible mix of causes related to increased systemic increases in stress, systemic decline in lifestyle and diet or some hidden and subtle long post-COVID related issues."

    So currently hand-waving and guess a cause.


    Certainly an interesting and unexpected effect (unexpected to the authorities, not unexpected to Wyttenbach and some others on here of course).


    I do know that in the UK the health service has been on its knees since COVID hit, and was not in great shape before. There are long queues of patients, suffering from cancer and other serious conditions where treatment has been seriously delayed. Hard to see a GP or get a hospital appointment.

    However that would not explain excess deaths in other countries.

    Basically the stats are the facts but the cause of the stats has not been clarified at this point.

    I think it might be difficult to attribute excess deaths from circulatory causes to vaccines vs some kind of long Covid effect, or even lack of exercise and poor diet during lock-downs.

  • "Possible mix of causes related to increased systemic increases in stress, systemic decline in lifestyle and diet or some hidden and subtle long post-COVID related issues."

    The lockdown did fatten many people. I did add about 4-5kg too...Cancer test/treatment did halt for many - not always negative for survival time...

    But what doctors now see are excess deaths with heart damage and turbo cancers and simply fade away's, that are untreatable. Every booster will increase the damage done by the extremely toxic spike protein. Almost all excess deaths are at age > 75. This only tells that the wave among the younger will take a bit longer to evolve.

    15% excess deaths means that the total human population will be reduces by at least 15% at the end. But in parallel the fertility has gone down by about 10-15% during the last vaccine year...Most western countries report a strong reduction in births. Certainly also a social issue and now with the free mason JF mafia organized fake war in Ukraine some countries will collapse anyway.

    All this is good news for the planet and Africa/India that did use Ivermectin that works for 100% as a prevention according latest study among 120'000 people in Brazil.

  • Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

    Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
    In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potentia…
    www.sciencedirect.com


    Abstract

    Introduction

    In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.


    Methods

    Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.


    Results

    Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).


    Discussion

    The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets

  • My dear old uncle (in law) died yesterday in hospital. He had only just turned 90. This was the guy I had mentioned who had developed shingles, pulmonary oedema and gout soon after his 3 injections. He was over all that and had moved into a wonderful retirement home just a month ago. He loved eating (yet he was slim), and the food at the retirement home was very high level. I ate with him there about 6 weeks ago before he moved in and it felt like a 4 star restaurant.

    He seemed very excited. We joked that it was great that the women in the home far outnumbered the men. He got around fine with a cane.


    After he moved in, his one remaining child came up from the States to take charge of getting his old home sold and deal with his estate, and I frankly was pushed out of the picture. No more notifications for me from his doctor's office or the home.


    A week ago I got a call from a pastor that he was in hospital with congestive heart failure. My wife and I saw him shortly thereafter in the hospital and though he was weak and bedridden he was still feisty and his voice strong at times. But when I saw him on Thursday night he could barely open his eyes and couldn't speak. He had a loose fitting oxygen mask on that often fell off. He seemed thirsty, and when I asked the nurse if there was water for him to drink she said he can't have water because he would aspirate it. I then enquired about an IV for providing fluids and nutrients. She looked at me and silently shook her head, 'no'. So, they were basically hastening his demise. Is that standard practice these days? I don't know. I was taken aback, but knew I could ultimately do little about it because I didn't have power of attorney.


    Anyway, I am going to try to find out if he had recently received his fourth dose. His decline was so rapid and unexpected that I feel that some event precipitated it. We'll see, I hope.


    I called his 95 year old sister in London, Ontario to tell her the news. We chatted, and I asked her about how she did after her vaccines. She's had four doses and told me she didn't have any side effects at all, not even a sore arm. In the last month however she has been using a nasal cannula with oxygen, and the doctor just told her she has fibrosis of the lung from unknown cause. Such a life on such a planet.

  • Covid-19 Injections in Pregnant Women Lead to 8X Increase in Spontaneous Abortions and 3X Increase in Stillbirths.


    Covid-19 Injections in Pregnant Women Lead to 8X Increase in Spontaneous Abortions and 3X Increase in Stillbirths.
    Medical establishment and government lied to pregnant women. The New England Journal of Medicine lied too, but professionally, with statistics. "But the plans…
    www.trialsitenews.com


    Medical establishment and government lied to pregnant women. The New England Journal of Medicine lied too, but professionally, with statistics.

    "But the plans were on display . . ."

    "On display? I eventually had to go down to the cellar to find them."

    "That's the display department."

    "With a torch."

    "Ah, well the lights had probably gone."

    "So had the stairs."

    "But look, you found the notice, didn't you?"

    "Yes," said Arthur, "yes I did. It was on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying Beware of the Leopard."


    Douglas Adams, “The Hitchhiker’s Guide to the Galaxy”.


    Campaign to Vaccinate Pregnant Women

    Under the initial declaration of health emergnecy in early 2020—and recently updated by the Biden Administraiton following the guidance of the World Health Organization’s International Health Regulations. -- countermeasures were rapidly developed that are not subject to the same laws governing medicines and vaccines. Associated wiht this effort under the pretext of public health has been a massive, relentless campaign to get the needle into every arm over the past 2 years, but the group hunted with conspicuous vigilance by the government-pharma cartel from the start were pregnant women, followed by children and babies. An avalanche of what this author deems unlawful direct to consumer ads screaming about tremendously “safe in pregnancy” Covid-19 shots started appearing on social media and other major platforms before these shots were even authorized for emergency use (December 2020). EUA does not permit advertising any drug as safe and effective. But the government is exempt from following laws, remember?


    A side note for every over-zealous vaccinator out there: you were “following orders” from the HHS and coercing every pregnant woman in your care by lying about safety and efficacy of these injections. You were paid for lying to your patients, and you may have been promised a liability cover. You may still be held liable under state laws for not providing informed consent. Talk to your attorney.


    Given the avalanche of “tremendously safe in pregnancy” messages out there, including from the top FDA and CDC officials, one may be surprised that as of today, these shots are officially not recommended in pregnancy according to the product labels, that state there is no data to make these recommendations.


    For example the Pfizer label declares “ailable data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” But apparently the urgencies of the pandemic, and subsequent need for these countermeasures was so great that some small lab experiments invovling female rats sufficied for the safety checklist. But this is a vast deviation from good clinical practices. See 8.1.


    Furthermore, maternal toxicity, skeletal abnormalities, and accumulation of the potentially toxic injection substances in the ovaries have been documented by non-clinical studies for these products. Of course, to find this information, you need to descent into a dark cellar and find a locked file cabinet – i.e. know how to find the drug labels in the bowels of the FDA website, read sections buried deep in those labels, and in addition, sue the HHS for freedom of information, and wait months for the lawsuit to hopefully turn out in your favor. See, this is easy, you just have to follow the proper procedure!


    Pfizer and Moderna’s Nonclinical Studies

    I have written extensively about Pfizer’s and Moderna’s nonclinical studies that revealed in my professinoal opinion what is clear harm for pregnancy and neonatal development. The studies were in FDA’s possession at the time the shots were authorized, yet the FDA chose to ignore the safety signals, and in case of Moderna’s product, they went even further and wrote an outright lie in the product’s summary document, stating that there was no vaccine related skeletal malformations in baby rats, while Moderna’s own documents admit that these were observed at a statistically significantly increased rate in vaccinated rats’ offspring.


    Additionally, Pfizer’s own published study in reproductive toxicology showed nearly 300% increase in skeletal malformations in babies and doubling of the pre-implantation embryo loss in injected female rats. You will not find this information in the cheery title of the paper nor it's abstract. You will have to "get deep into the cellar" to find the numbers in the tables of the results section.


    In standard, lawful, ethical and regulations compliant pharmaceutical development process, novel medicines are never given to pregnant women or to women of childbearing potential until the risks to reproductive system and pregnancy can be excluded with confidence through both animal toxicology studies and clinical trials that exclude women who are pregnant or can become pregnant. For very novel technologies, the general rule was that the products would be tested first on healthy male volunteers, and if women need to be enrolled in early phase clinical studies, then the women are not of childbearing potential, e.g., surgically sterilized or post-menopausal.


    These long-established safety and ethics practices were disregarded in the development of Covid-19 injections, classified as counter. The animal studies were not done prior to the initiation of the large-scale clinical trials, they were compiled much later and were both deficient and outright fraudulent in many aspects as discussed in my articles linked above.


    Exclusion criteria for pregnancy were written into the human clinical trial protocols, however, as is well known in clinical trial practice, pregnancy listed as exclusion is insufficient for prevention of enrolling subjects that subsequently become pregnant into the trial, especially with large populations such as 40,000+ subjects for each of these trials. Given that everyone involved in this activity is experienced in clinical trials, this author strongly suspects Pfizer, Moderna, and FDA were well aware that this would happen and likely counted on getting pregnant women into experiments in this manner.


    The outcomes of those experiments are not yet clear, as the data from Pfizer’s clinical trials is still being delivered through FOIA, and has not been made available in Moderna’s case at all. At any rate, that experimental activity lasted only about 4 months, after which time the manufacturers unilaterally decided that their products are simply too safe and effective to withhold from the placebo subjects and destroyed the experimental design that was supposed to deliver long term safety data by unblinding and injecting the placebo cohort. The FDA never found a single breaking of the regulation by Pfizer and Moderna that it did not wholeheartedly embrace, and they didn’t find this one objectionable either.


    The injections were swiftly pushed through EUA in December 2020, and the actual study of the safety in pregnancy was included as a “postmarketing commitment”, i.e. manufacturers’ promise to complete certain research by certain dates after a drug goes on the market. That postmarketing study was initiated in February 2021, but eventually it was simply abandoned. “The study enrollment was stopped with incomplete numbers because recruitment was slow and it became unreasonable/inappropriate to randomize pregnant women to placebo given the amount of observational evidence that the vaccine is safe and effective, coupled with increasing number of technical committees supporting immunization of pregnant women,” according to the email from Jelena Vojicic, Pfizer vaccines medical lead in Canada from April 4, 2022, as reported by The Epoch Times (see ref at the end). Let me translate from pharmaspeak: “slow enrollment” means women are becoming increasingly aware of the danger to them and their babies posed by these not sufficiently tested products and are not lining up to be injected while pregnant anymore; “unreasonable to randomize to placebo” = we desperately wish to not have a control group; “observational evidence that the vaccine is safe and effective” = we assert that these injections are safe, because we assert so.


    Data Review

    This brings me to the part about lying professionally, with statistics. A retrospective analysis of a vaccine registry dataset was published by New England Journal of Medicine in June 2021. The study by Shimabukuro et al was called “preliminary” and characteristically called pregnant women “persons” in obedience to the woke jargon of their controllers in academia as well as the NEJM. This group reviewed data collected over about 10-week period, from December 14, 2020, to end of February 2021 by vSafe database, or mobile application which was distributed to the newly injected at the beginning of the rollout. The dataset that was reviewed in the study contained enrollment and outcomes data for 827 pregnancies, although it referred to a total of approximately 3500 pregnant women who got the app (but either did not enroll in the registry or did not supply the outcomes data). The number by itself shocked this author. There was no data available for the injections’ safety in pregnancy at the time. The product was and still is entirely experimental. Pregnant women were excluded from clinical trials (sort of), and bad results in animal studies were known to the FDA but hidden from public. By February 2021, 3500+ women already fell for propaganda and fear mongering by CDC or were forced by unlawful (at least some of the mandates were ruled by the Supreme Court as overreach) and highly immoral mandates and offered themselves for a very unethical experiment.


    Of the 827 studied pregnancies, 700 received injections (and enrolled in the vSafe registry in the 3rd trimester of pregnancy.) 127 women enrolled in the 1-2 trimester. The study concluded that there were no obvious safety signals for pregnancy. To find out the truth however, one would need to skip past the abstract, conclusions and all text of the paper and go to Table 4 and its footnotes (highlights are mine):




    It is not difficult to decipher the lie. The numbers are all there but presented in a manner designed to obfuscate. First notable omission is regarding the statistics for spontaneous abortions (defined as pregnancy loss <20 weeks of gestation). The total in the examined vSafe set was 104. While the “normal” incidence numbers (i.e. normal background rate of the event based on long-term statistical reference) are included for all other research parameters, for this parameter the authors did not include the normal incidence rate and instead declared it “not applicable”. The excuse given in the footnotes is amateurish – they state it is because “only” 92.3% of these miscarriages occurred in women injected in the 1st trimester, and that they need to wait for data from further 1224 participants. This makes no sense. Incidence is a background historical estimate, not derived from the current study dataset. In addition, the authors provide reference 15, a paper that states that the incidence rate for spontaneous abortions is 10% for clinically recognized pregnancies, and up to 25% for very early pregnancies that are not yet recognized. Why did they include the reference, but pretended it was not applicable to include in the table?


    I calculated the true approximate rates of the spontaneous abortions, and stillbirths (loss of pregnancy/baby after 20 weeks of gestation):




    Since it is impossible to have a spontaneous abortion attributed to the 700 women injected and enrolled in the registry in the 3rd trimester, the 104 miscarriages can be all attributed to the 127 women from 1-2 trimester. There could be 31 women (127-96), who were injected in the 2nd trimester who ended up with a stillbirth in the 3rd, but none the other way around. That adjustment would not affect the results very much, and if anything, would reduce the denominator for spontaneous abortions, making the rate even worse. When calculated correctly, removing 700 subjects that were not relevant for the spontaneous abortion denominator (but were included by the NEJM study authors to hide the horrendous result), the rate is a staggering 82%. Comparing to the 10% “normal” rate, this is an 8x increase! Furthermore, in the 700 group of 3rd trimester pregnancies, the rate of stillbirth is ~1.5%, while a quick search of CDC data shows that the historical norm is around only 0.6%. The injected women experienced about 3x increased rate.


    Pregnancy Loss

    Alarming numbers for lost pregnancies are coming from a variety of sources now, from doctors and from safety surveillance databases. As of February 2022, the VAERS database contained over 2000 reports of loss of pregnancy before 20 weeks in injected women. For reference, the entire VAERS database, since its inception and for all products other than covid-19 injections (approximately 98 other vaccines) contained ~700 such reports. Below is the VAERS data compiled by Jessica Rose, PhD.




    Notable, that over a year has passed since the NEJM study was published as "preliminary", but as of yet, no updated data with more subjects analyzed have been made available. Did the authors lose interest in the topic and abandoned it just like Pfizer abandoned its post marketing commitment for study of the vaccine safety in pregnancy? We shall have to wait.


    In the meantime, this author believes these investigational products are associated with more risk than disclosed , and they are particularly harmful to the otherwise healthy population – pregnant women, children, babies. Government lies, coercion, gaslighting, and other malignant policies must stop.

  • I called his 95 year old sister in London, Ontario to tell her the news. We chatted, and I asked her about how she did after her vaccines. She's had four doses and told me she didn't have any side effects at all, not even a sore arm. In the last month however she has been using a nasal cannula with oxygen, and the doctor just told her she has fibrosis of the lung from unknown cause. Such a life on such a planet.

    Far to many people I know lost their oldest relatives due to vaccination. Not a single CoV-19 death...


    As I say since 1.5 years. To speed up a heritage booster your ancestors...

  • He seemed thirsty, and when I asked the nurse if there was water for him to drink she said he can't have water because he would aspirate it. I then enquired about an IV for providing fluids and nutrients. She looked at me and silently shook her head, 'no'. So, they were basically hastening his demise. Is that standard practice these days? I don't know. I was taken aback, but knew I could ultimately do little about it because I didn't have power of attorney

    Deliberate Death by dehydration has been common in UK NHS since 1980s


    Occasionaaly there's an investigation, lessons will be learned... However it contnues unabated

  • Transverse myelitis following SARS-CoV-2 vaccination: a pharmacoepidemiological study in the World Health Organization's database


    https://onlinelibrary.wiley.com/doi/10.1002/ana.26494


    Abstract

    Background

    Transverse Myelitis (TM) has recently been associated by health authorities with Ad26.COV2.S (Janssen/Johnson & Johnson), one of the five U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) labelled SARS-CoV-2 vaccines. It is unknown whether a similar association exists for the other FDA or EMA labelled SARS-CoV-2 vaccines (BNT162b2 [Pfizer/BioNTech], mRNA-1273 [Moderna], ChAdOx1nCov-19 [Oxford–AstraZeneca], and NVX-CoV2373 [Novavax]). This study aimed to evaluate the association between SARS-CoV-2 vaccine class and TM.


    Methods

    This observational, cross-sectional, pharmacovigilance cohort study examined individual case safety reports from VigiBase®, the World Health Organization’s pharmacovigilance database. We first conducted a disproportionality analysis with the Information Component (IC) using the reports of TM that occurred within 28 days following exposure to FDA or EMA labelled SARS-CoV-2 vaccines, from December 1, 2020 (first adverse event related to a SARS-CoV-2 vaccine) to March 27, 2022. Secondly, we analyzed the clinical features of SARS-CoV-2 vaccine-associated TM cases reported in VigiBase®.


    Results

    TM was significantly associated both with the messenger ribonucleic acid (mRNA)-based (n=364; IC025=0.62) and vector-based (n=136; IC025=0.52) SARS-CoV-2 vaccines that are authorized by the FDA or the EMA.


    Conclusions

    Findings from this observational, cross-sectional pharmacovigilance study showed that mRNA-based and vector-based FDA/EMA labelled SARS-CoV-2 vaccines may be associated with TM. However, because TM remains a rare event, with a previously reported rate of 0.28 cases per one million vaccine doses, the risk-benefit ratio in favor of vaccination against SARS-CoV-2 virus remains unchallenged. Rather, this study suggests that clinicians should consider the diagnosis of TM in patients presenting with early signs of spinal cord dysfunction after SARS-CoV-2 vaccination.


    Vitamin D and Transverse Myelitis

    Vitamin D and Transverse Myelitis | Johns Hopkins Transverse Myelitis Center
    JHTMC is investigating the role of vitamin D in the pathogenesis of spinal cord inflammatory diseases.
    www.hopkinsmedicine.org


    Evaluation of correlation between vitamin D with vitamin B12 and folate in children

    Evaluation of correlation between vitamin D with vitamin B12 and folate in children
    The aim of this study was to assess the association of vitamin D levels with vitamin B12 and folate levels in children.A cross-sectional retrospective…
    www.sciencedirect.com