[All references pilfered from Dr. Paul Alexander‘s “Substack Alexander COVID News evidence-based medicine:” HERE]
Here the madman fell silent and looked again at his listeners; and they, too, were silent and stared at him in astonishment. At last he threw his lantern on the ground, and it broke into pieces and went out. “I have come too early,” he said then; “my time is not yet. This tremendous event is still on its way, still wandering; it has not yet reached the ears of men. Lightning and thunder require time; the light of the stars requires time; deeds, though done, still require time to be seen and heard. This deed is still more distant from them than most distant stars — and yet they have done it themselves.
Friedrich Nietzsche, The Parable of the Madman (1882)
By Jessica Rose
Hat tip: Jeffrey A Tucker
Source: Brownstone Institute
A new scientific study entitled “Serious adverse events of special interest following mRNA vaccination in randomized trials” provides the best evidence yet concerning the safety of the mRNA Covid vaccines. For most vaccines in common use, benefits far outweigh risks, but that may not be the case for the mRNA covid vaccines, according to this study by Joseph Fraiman and his colleagues. It depends on your age and medical history.
The randomized controlled clinical trial is the gold standard of scientific evidence. When regulators approved the Pfizer and Moderna mRNA vaccines for emergency use in December 2020, two randomized trials showed that the vaccines reduced symptomatic covid infection by over 90% during the first few months after the second dose.
Pfizer and Moderna did not design the trials to evaluate long-term efficacy or the more important outcomes of preventing hospitalization, death, or transmission.
The randomized trials did collect adverse event data, including the presence of mild symptoms (such as fever) and more serious events requiring hospitalization or leading to death. Most vaccines generate some mild adverse reactions in some people, and there were considerably more adverse such reactions after the mRNA vaccines compared to the placebo.
[. . .]
Continue reading this interpretation of the Joseph Fraiman et al. study ===> Are the Covid mRNA Vaccines Safe? — Martin Kulldorff | Brownstone Institute
Source: Unacceptable Jessica
By Jessica Rose
Slide 2: This is Moderna’s ‘efficacy data’ that reveals safety issues. The chi-square test indicates a statistically-significant difference between Severe Adverse Events (SAEs) in placebo versus messenger RNA (mRNA)-1273 groups. And it’s messed up how 2.7 times higher rate for mRNA arm. Sounds like old Moderna needs to go back to the drawing board to me.
Slide 3: R = 1 means perfect correlation. Not by chance. Each dot is the number of doses/disability per state.
[ . . . ]
amyloid-disease, blood coagulation, fibrinolytic disturbances, neurologic and cardiac problems, the amyloidogenicity of the SARS-CoV-2 spike protein (S-protein), the SARS-CoV-2 spike protein (S-protein)
[Norm’s note: reading this, keep in mind that the mRNA vaccines code for the the SARS-CoV-2 spike protein (S-protein). Question: is the bioactivity of transfected spike the same as that which comes with the virus? I strongly suspect that it is.]
Read the PDF of the entire study: HERE
SARS-CoV-2 infection is associated with a surprising number of morbidities. Uncanny similarities with amyloid-disease associated blood coagulation and fibrinolytic disturbances together with neurologic and cardiac problems led us to investigate the amyloidogenicity of the SARS-CoV-2 spike protein (S-protein). Amyloid fibril assays of peptide library mixtures and theoretical predictions identified seven amyloidogenic sequences within the S-protein. All seven peptides in isolation formed aggregates during incubation at 37 °C. Three 20-amino acid long synthetic spike peptides (sequence 192–211, 601–620, 1166–1185) fulfilled three amyloid fibril criteria: nucleation dependent polymerization kinetics by ThT, Congo red positivity, and ultrastructural fibrillar morphology. Full-length folded S-protein did not form amyloid fibrils, but amyloid-like fibrils with evident branching were formed during 24 h of S-protein coincubation with the protease neutrophil elastase (NE) in vitro. NE efficiently cleaved S-protein, rendering exposure of amyloidogenic segments and accumulation of the amyloidogenic peptide 194–203, part of the most amyloidogenic synthetic spike peptide. NE is overexpressed at inflamed sites of viral infection. Our data propose a molecular mechanism for potential amyloidogenesis of SARS-CoV-2 S-protein in humans facilitated by endoproteolysis. The prospective of S-protein amyloidogenesis in COVID-19 disease associated pathogenesis can be important in understanding the disease and long COVID-19.
Read the PDF of the entire study: HERE
Apr 25, 2022 Vinay Prasad, MD MPH
Physician & Associate Professor Google Scholar: https://scholar.google.com/citations?…
Personal Website: http://www.vinayakkprasad.com
Laboratory Website: http://www.vkprasadlab.com
Podcast Website: http://www.plenarysessionpodcast.com
Academic Publications: http://www.vinayakkprasad.com/papers
1. Here’s our detailed response to the .@DrSusanOliver1 video (praised by many who should know better) which attempted to ridicule a preprint by BMJ Editor Peter Doshi et al on vaxx adverse reactions.
2. We welcome the responses of important influencers like .@ProfPHansen and .@d_spiegel who were so impressed with the video. The claims in it are highly misleading (and rather offensive); we show the evidence and a Bayes reanalysis supports Doshi et al
3. Also posted here:
From FDA to MHRA: are drug regulators for hire?
BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1538 (Published 29 June 2022)Cite this as: BMJ 2022;377:o1538
Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they are meant to regulate? Maryanne Demasi investigatesSource: The BMJ
Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials
22 Pages Posted: 23 Jun 2022
To read this preprint, follow this link to the PDF: Serious adverse events of special interest following mRNA vaccination in randomized trials
Louisiana State University – Lallie Kemp Regional Medical Center
Navarre Health Service
Bond University – Institute for Evidence-Based Healthcare
University of California, Los Angeles (UCLA) – Jonathan and Karin Fielding School of Public Health
University of California at Los Angeles
University of Maryland – School of Pharmacy
Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We leveraged the Brighton Collaboration list to evaluate serious adverse events of special interest observed in phase III randomized trials of mRNA COVID-19 vaccines.
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 (NCT04368728 and NCT04470427), focusing analysis on potential adverse events of special interest identified by the Brighton Collaboration.
Results: Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase 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 absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9). The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).
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 such as hospitalization or death.
Funding Information: This study had no funding support.
Hat tip: Sandeep Chakraborty
Source: MDPI Open Access Journals
Intramyocardial Inflammation after COVID-19 Vaccination: An Endomyocardial Biopsy-Proven Case Series
Christian Baumeier 1,*, Ganna Aleshcheva 1, Dominik Harms 1, Ulrich Gross 1, Christian Hamm 2,3, Birgit Assmus 3, Ralf Westenfeld 4, Malte Kelm 4, Spyros Rammos 5, Philip Wenzel 6, Thomas Münzel 6, Albrecht Elsässer 7, Mudather Gailani 8, Christian Perings 9, Alae Bourakkadi 10, Markus Flesch 11, Tibor Kempf 12, Johann Bauersachs 12, Felicitas Escher 1,13,14 and Heinz-Peter Schultheiss 1
1 Institute of Cardiac Diagnostics and Therapy, IKDT GmbH, 12203 Berlin, Germany
2 Kerckhoff Heart Center, Department of Cardiology, 61231 Bad Nauheim, Germany
3 Department of Cardiology and Angiology, Universitätsklinikum Gießen und Marburg, 35391 Gießen, Germany
4 Department of Cardiology, Pulmonology and Vascular Medicine, Heinrich Heine University Düsseldorf, 40225 Düsseldorf, Germany
5 Onassis Cardiac Surgery Center, 176 74 Athens, Greece
6 Department of Cardiology, University Medical Center Mainz, 55131 Mainz, Germany
7 Department of Cardiology, Klinikum Oldenburg, 26133 Oldenburg, Germany
8 Frankenwaldklinik, 96317 Kronach, Germany
9 Department of Cardiology, St. Marien-Hospital, 44534 Lünen, Germany
10 Department of Internal Medicine, Cardiology, Geriatrics and Palliative Medicine, Gemeinschaftsklinikum Mittelrhein gGmbH, 56727 Mayen, Germany
* Author to whom correspondence should be addressed.
Academic Editors: Loredana Frasca and Steven Fiering
Int. J. Mol. Sci. 2022, 23(13), 6940; https://doi.org/10.3390/ijms23136940
Received: 8 April 2022 / Revised: 20 May 2022 / Accepted: 21 June 2022 / Published: 22 June 2022
(This article belongs to the Special Issue T-regulatory Cells in Autoimmunity and Transplantation)
Myocarditis in response to COVID-19 vaccination has been reported since early 2021. In particular, young male individuals have been identified to exhibit an increased risk of myocardial inflammation following the administration of mRNA-based vaccines. Even though the first epidemiological analyses and numerous case reports investigated potential relationships, endomyocardial biopsy (EMB)-proven cases are limited. Here, we present a comprehensive histopathological analysis of EMBs from 15 patients with reduced ejection fraction (LVEF = 30 (14–39)%) and the clinical suspicion of myocarditis following vaccination with Comirnaty® (Pfizer-BioNTech) (n = 11), Vaxzevria® (AstraZenica) (n = 2) and Janssen® (Johnson & Johnson) (n = 2). Immunohistochemical EMB analyses reveal myocardial inflammation in 14 of 15 patients, with the histopathological diagnosis of active myocarditis according the Dallas criteria (n = 2), severe giant cell myocarditis (n = 2) and inflammatory cardiomyopathy (n = 10). Importantly, infectious causes have been excluded in all patients. The SARS-CoV-2 spike protein has been detected sparsely on cardiomyocytes of nine patients, and differential analysis of inflammatory markers such as CD4+ and CD8+ T cells suggests that the inflammatory response triggered by the vaccine may be of autoimmunological origin. Although a definitive causal relationship between COVID-19 vaccination and the occurrence of myocardial inflammation cannot be demonstrated in this study, data suggest a temporal connection. The expression of SARS-CoV-2 spike protein within the heart and the dominance of CD4+ lymphocytic infiltrates indicate an autoimmunological response to the vaccination.
Myocarditis and pericarditis have been reported as a potential complication of the COVID-19 mRNA (messenger RNA) vaccines. Since the first observations of myocarditis in response to the Pfizer-BioNTech vaccine in April 2021 , numerous case reports, indicating a relationship between COVID-19 vaccination and the occurrence of myocarditis/pericarditis, have been published [2,3,4,5,6,7,8].
Meanwhile, large epidemiological studies reveal that the majority of COVID-19-vaccine-related myocarditis occur in young male individuals (median age of 21 years) following the second dose of mRNA based vaccines . Most cases (76.8%) have been observed in response to the Pfizer-BioNTech vaccine (Comirnaty®), whereas one quarter (23.2%) received the Moderna vaccine (Spikevax®). Despite total case numbers, general incidence of myocarditis was shown to be higher in patients receiving Spikevax® (1.3 to 1.9 (Spikevax®), and 0.26 to 0.57 (Comirnaty®) extra cases of myocarditis per 10,000 subjects) . Consequently, numerous national authorities recommended the use of Comirnaty® instead of Spikevax® for people aged 30 years and younger.
Signs of myocarditis after COVID-19 vaccination usually develop within 2 weeks [11,12] and clinical symptoms generally ease quickly without impairment of cardiac function . Although COVID-19-vaccine-related myocarditis has an overall marginal incidence and affected patients show a fast recovery in absence of short-term complications, myocarditis is an alarming side effect, which needs to be monitored carefully.
While the majority of published cases are based on cardiac magnetic resonance imaging (cMRI) and laboratory evaluation [2,3,4,5,6,7], endomyocardial biopsy (EMB)-proven cases are limited [8,14,15]. Here, we present a comprehensive analysis of EMBs from 15 patients with the suspicion of myocarditis after vaccination against SARS-CoV-2 and reveal a temporal relation between the vaccination and the occurrence of myocardial inflammation, ranging from mild inflammatory cardiomyopathy to severe active myocarditis and giant cell myocarditis.
'transient' damage, 15.4% reduction in sperm concentration, “sperm concentration was significantly lower”, “[total motile count] percentage change reduction of 22.1%”, no study done beyond two doses, serial samples from sperm donors, single timepoint post-inoculation, Testing based on in vitro fertilization, Very small numbers of samples
The Pfizer-BioNTech COVID-19 Shots Harm Sperm
Source: COVID Chronicles
Isn’t it great that new harms keep popping up as research into the safety of the COVID-19 ‘vaccines’ uses data from the public rollout to compensate for what should have been assessed properly and thoroughly prior to or during clinical trials?
A peer-reviewed paper has just been accepted for publication in the journal Andrology. This journal has an impact factor of 3.842, which is quite good considering it has such a specialized focus. This falls into the category of what I like to call the ‘meat and potato’ journals; they publish good solid science. I like these kinds of journals because they tend to be influenced less by advertising dollars.
The paper that I am referring to can be found here.
I found this paper to be interesting. First, the authors are clearly ‘pro-narrative’; to a point where there is an awful lot of inappropriate rhetoric. Rhetoric has no place in an objective scientific article and this aspect of the paper should never have survived the review process. Regardless of the clear bias of the authors in favour of the COVID-19 inoculations, the results of their study are extremely concerning.
The authors rightfully criticized earlier studies that were being used to support the idea that COVID-19 inoculations have no negative impact on male fertility. All these previous studies had major flaws, including but not limited to:
- Testing only a single timepoint post-inoculation.
- Testing based on in vitro fertilization where there is a quality control step that eliminates low-quality sperm. One wouldn’t expect to find problems if only the best performing specimens are selected.
- Very small numbers of samples.
One of the things that I really liked about the current study is that it used serial samples from sperm donors. Specifically, samples were obtained prior to ‘vaccination’ and at multiple time points after the ‘vaccine’ regimen was completed. This means that each person served as their own internal control, which is ideal. The Pfizer-BioNTech product was used. The authors of the paper confirmed that none of the donors had been diagnosed with COVID-19. As such, any effects could be attributed to the vaccine, not the disease caused by SARS-CoV-2.
By approximately three months after becoming ‘fully vaccinated’ (i.e., defined as having received two doses), this is what the data demonstrated (confirmed to be significant by multiple different statistical tests):
- “sperm concentration was significantly lower”. Specifically, it was reduced by 15.4%. Put another way, the sperm concentration was reduced by 12 million/mL of ejaculate.
- Worse, there was a “[total motile count] percentage change reduction of 22.1%”. This translated into there being 31.2 million fewer motile spermatozoa per ejaculate.
Two rules of thumb when it comes to male fertility are:
- The more sperm, the greater the chance of one of them getting into the egg.
- Getting to and entering the egg requires the sperm to be mobile.
As such, the findings of this paper are quite concerning in the context of male fertility.
The data also demonstrated that these defects in semen appeared to be largely resolved by the mean long-term follow-up time of approximately six months. Interestingly, this led the authors to promote the shots because, although there is short-term damage to sperm, it looks like it resolves long-term, at which point a man would be ‘in the clear’.
Unfortunately, this study was performed when ‘fully vaxxed’ meant two shots. The authors assumed one would be finished getting jabbed at that point. Now, many countries have or soon will have re-defined fully ‘vaccinated’ to mean three shots. Further, four doses and beyond are being strongly encouraged.
So, how is a male going to recover from the so-called ‘transient’ damage to their sperm if they keep getting dosed before recovery can occur?
Worse, no studies have been done looking into the consequences on male fertility beyond two doses. What if it exacerbates the problem and/or extends the length of the problem?
Since sperm donors were used in this study, those from whom the semen was sourced would be considered particularly ‘robust studs’ among the male population. Their samples have to meet stringent quality control standards to become enrolled into a sperm donor program. This means there is the potential for greater harm to the semen of males among the general population whose fertility potential may not be as high.
Continue reading this breaking news ===> Breaking News: The Pfizer-BioNTech COVID-19 Shots Harm Sperm — Dr. Byram Bridle | COVID Chronicles
Hat tip and link:
This is an open access publication: Published:December 01, 2021 DOI:https://doi.org/10.1016/j.eclinm.2021.101212
Identifying and testing individuals likely to have SARS-CoV-2 is critical for infection control, including post-vaccination. Vaccination is a major public health strategy to reduce SARS-CoV-2 infection globally. Some individuals experience systemic symptoms post-vaccination, which overlap with COVID-19 symptoms. This study compared early post-vaccination symptoms in individuals who subsequently tested positive or negative for SARS-CoV-2, using data from the COVID Symptom Study (CSS) app.
We conducted a prospective observational study in 1,072,313 UK CSS participants who were asymptomatic when vaccinated with Pfizer-BioNTech mRNA vaccine (BNT162b2) or Oxford-AstraZeneca adenovirus-vectored vaccine (ChAdOx1 nCoV-19) between 8 December 2020 and 17 May 2021, who subsequently reported symptoms within seven days (N=362,770) (other than local symptoms at injection site) and were tested for SARS-CoV-2 (N=14,842), aiming to differentiate vaccination side-effects per se from superimposed SARS-CoV-2 infection. The post-vaccination symptoms and SARS-CoV-2 test results were contemporaneously logged by participants. Demographic and clinical information (including comorbidities) were recorded. Symptom profiles in individuals testing positive were compared with a 1:1 matched population testing negative, including using machine learning and multiple models considering UK testing criteria.
Differentiating post-vaccination side-effects alone from early COVID-19 was challenging, with a sensitivity in identification of individuals testing positive of 0.6 at best. Most of these individuals did not have fever, persistent cough, or anosmia/dysosmia, requisite symptoms for accessing UK testing; and many only had systemic symptoms commonly seen post-vaccination in individuals negative for SARS-CoV-2 (headache, myalgia, and fatigue).
Post-vaccination symptoms per se cannot be differentiated from COVID-19 with clinical robustness, either using symptom profiles or machine-derived models. Individuals presenting with systemic symptoms post-vaccination should be tested for SARS-CoV-2 or quarantining, to prevent community spread.
UK Government Department of Health and Social Care, Wellcome Trust, UK Engineering and Physical Sciences Research Council, UK National Institute for Health Research, UK Medical Research Council and British Heart Foundation, Chronic Disease Research Foundation, Zoe Limited.
Continue reading =====>Disentangling post-vaccination symptoms from early COVID-19<======
Worth your time, I think: but i am left wondering about these claims and fear they may provide an example …
Hat tip: Date: 17 June 2022 ResearchGate censors spring into action when reads spike after news of report is heard outside …
Source: Surgical Neurological International Russell L. Blaylock Retired Neurosurgeon, Theoretical Neuroscience Research, LLC, Ridgeland, Mississippi, United States. Correspondence Address:Russell L. …
Originally posted on Charlie walker:
Many thousands of Russians have protested against the war in Ukraine, and have been imprisoned for…