> 18 the risk/benefit analysis is very clearly in favour of vaccine.
Please show the data and do the calculations! And yes exclude all death age < 35 that were on chemo or had complicated preconditions what says: Take the healthy ones. IFR here is much below 0.0001% So why do you recommend this vaccine and not the flu vaccine for young or stop driving cars or smoking, drinking....
Ivermectin saves INDIA
The last two states (Kerala,Marahashtra) did take the edge and finally report an overall reduction in cases.
Delhi and Uttar Pradesh are now on a record low with far less than 50 cases for 205mio people (U.P.). What is 1000x better than Switzerland with about 50% vaccines....or 10000 x better than UK > 50% vaccines.
Ivermectin Banzai!!
academic researcher
Probably Trialsite is looking for someone like Norman Fenton
Flaws of using PCR testing for propaganda Pfizer..etc
TM 16.57 the Pfizer vaccine effectiveness came down from claimed 95% to 75% after the bias was factored in..
Today be crossed the absolute low baseline (14 cases) in ICU usage with a steep increase by 3x back to July 1st levels. Normally after weekends the increase is 20% because of technical reasons but even without this its > 2x.
This allows to make some first conclusion for Delta and severe cases. This values currently is nothing more than a guess as we need at least 7 days more data. But just doing a 1:1 match, with June data, says delta is 1.6..2x less severe. This can change if ICU will increase much more during next days. Cases went up 6x the last 20 days!
Flaws of using PCR testing for propaganda Pfizer..etc
PCR is also flawed vaccine group positives...this is why only symptoms and a blood test should count.
The FM/R/X/B mafia generates between 120..400$ for a PCR test, whereas the 3x more reliable blood test only generates 20$ plus money for the doctor that usually is not a mafia member like the test-lab owner...
Quote
Okey, 3-6 hours, fair you seam to have defined a group here, yes you need to divide the day rate by (3..6)/24 =1/8 .. 1/4.
I trust that you search VAERS to find this for a subgroup, and that it is much higher than backround for the group. Just to have a clean post about this please define.
1. Sub group criteria: my guess 30-40 years, no comorbidities, suspicious death condition e.g. blod cloth and not traffic accident.
2. Number of cases found
3. The natural number of death for the sub group.
4. onset 3-6 hours after jab
I would like to know if we could find a similar signal in our databases, things that can go wrong here is that the numbers expected from
your finding is too small due to Sweden being smaller and or that we have not got many jabs from the group.
Did Pfizer Fail to Perform industry Standard Animal Testing Prior to Initiation of mRNA Clinical Trials?
TrialSite has learned of material information regarding mRNA vaccine safety revealed by a freedom of information act (FOIA) request filed by a group of Canadian physicians. These doctors have become concerned about COVID-19 mRNA vaccine safety. This new safety information involves the Pfizer mRNA-based vaccine known as BNT162b2 or “Comirnaty.” The FOIA documents reveal animal study results demonstrating that the Pfizer mRNA-based vaccine does not remain at the injection site, but rather appears to spread widely after injection. According to the documents, pre-clinical studies show that the active part of the vaccine (mRNA-lipid nanoparticles), which produce the spike protein, spreads throughout the body and is then concentrated in various organs, including the ovaries and spleen. The FOIA-produced data sets are incomplete, so the full meaning of these data cannot be determined at this time. TrialSite has also learned via regulatory documents that apparently (at least in their European Medicines Agency submission), Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies during vaccines, as key studies did not meet good laboratory practice (GLP). The full panel of industry-standard reproductive toxicity and genotoxicity studies were apparently also not performed. But does this matter in light of the risk-benefit analysis associated with regulatory emergency use authorization (EUA)?
Recently, there has been speculation regarding potential safety signals associated with COVID-19 mRNA vaccines. Many different unusual, prolonged, or delayed reactions have been reported, and often these are more pronounced after the second shot. Women have reported changes in menstruation after taking mRNA vaccines. Problems with blood clotting (coagulation) – which are also common during COVID-19 disease – are also reported.
Among the most critical tests, which must be performed prior to testing any drug or vaccines in a human being, is whether it can cause mutations in the DNA (genotoxicity), or whether it could cause problems with cells or tissues of the reproductive tract – including ovaries (reproductive toxicity). In the case of the Pfizer COVID mRNA vaccine, these newly revealed documents raise additional questions about both the genotoxicity and reproductive toxicity risks of this product. Standard studies designed to assess these risks were not performed in compliance with accepted empirical research standards. Furthermore, in key studies designed to test whether the vaccine remains near the injection site or travels throughout the body, Pfizer did not even use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA producing the luciferase protein.
These new disclosures seem to indicate that the U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine. It is certainly understandable why the vaccine was rushed into use as an experimental product under emergency use authority, but these new findings suggest that routine quality testing issues were overlooked in the rush to authorize use. People are now receiving injections with an mRNA gene therapy-based vaccine, which produces the SARS-CoV-2 spike protein in their cells, and the vaccine may be also delivering the mRNA and producing spike protein in unintended organs and tissues (which may include ovaries). Unfortunately, there is no way to know if this is related to vaccine safety signals or reports of menstrual irregularities; the required studies were either not done or not done properly.
How mRNA Vaccines are Believed to Work
The current mRNA vaccines are theorized to act locally in draining lymphoid tissue. Formulated lipid nanoparticles that contain mRNA able to produce the spike protein are syringe injected into a muscle such as the deltoid (shoulder muscle). Once the injection occurs, the muscle cells near the injection site are impacted by the mRNA-based vaccine (e.g. the lipid nanoparticles), while much of the dose moves into the intracellular fluid surrounding the muscle cells and consequently drains to lymph nodes (see for example here).
According to this theory, a properly functioning mRNA-based vaccine is delivered into and drives production of the SARS-CoV-2 Spike protein in muscle and lymph node cells. The cells then produce the Spike protein, which is then moved to the surface of these cells where it becomes attached. The foreign virus Spike protein then triggers the immune system to recognize and attack any cell in the body that is either infected by SARS-CoV-2 or has Spike protein on its surface. The vaccine was designed so that the Spike protein is affixed via a transmembrane anchor region, so that it cannot circulate around the body via the bloodstream (see here). The same general scenario applies to all mRNA-based vaccines as well as recombinant adenoviral vectored vaccines (such as the J&J vaccine) designed to use gene-therapy technology to express Spike protein in cells and tissues. This general strategy is designed to reduce the risk that any residual vaccine dose that does somehow end up in the bloodstream (or organs and tissues) ends up not being a safety risk due to unintended biologic effects. Spike protein will remain affixed to cell surfaces, and therefore is not released into the blood where circulating Spike might cause problems by binding to its natural target, ACE-2 receptors. However, any cell that has Spike protein (or protein fragments) anchored on its membrane or displayed on MHC antigen-presenting molecules becomes a target for vaccine-activated immune cells and antibodies, which would then attack, damage or kill those cells in the same way that SARS-CoV-2 virus-infected cells would be attacked. In other words, if very active mRNA delivery particles or recombinant adenoviral-vectored vaccines spread throughout the body, the resulting production of the vaccine antigen (Spike, in this case) will both stimulate immunity and also cause those same cells to be attacked by the immune system. If this actually happens, the resulting “vaccine reactogenicity” could resemble clinical symptoms seen with autoimmune syndromes.
EMA Pfizer/BioNTech Vaccine Distribution Studies
As standard practice, the European Medicines Agency (EMA) discloses their assessment of investigational new drug (IND) submissions. In the case of the Pfizer-BioNTech “Comirnaty” vaccine, the EMA assessment can be found on the Web here. This document includes a summary of EMAs evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer-BioNTech. These studies were carried out using two methods: 1) use of mRNA producing the luciferase protein and 2) use of radioactive label to mark the mRNA (a more sensitive approach). These studies reveal that the majority of radioactivity initially remains near the injection site. However, within hours, a subset of the stabilized mRNA-containing particles become widely distributed throughout the bodies of test animals.
Upon inspection of the EMA summary document, TrialSite found evidence suggesting that the issue of biodistribution and pharmacokinetics of the “Comirnaty” BNT162b2 vaccine was not thoroughly examined in accordance with industry norms prior to the EMA review of the BNT162b2 IND/CTD. The reviewers share an explicit admission that “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” Rapporteur (Filip Josephson) and Co-Rapporteur (Jean-Michael Race) suggest, however, that Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and suggest that “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.” However, the studies that were performed and submitted were non-GLP. Additionally, the EMA document states “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350, indicate a broader biodistribution pattern.” This EMA observation corresponds with what appears to be a growing number of adverse events and aligns with data TrialSite observed via the FOIA showing concentrations of LNP-formulated RNAs in the spleen, for example.
To obtain independent reviews of these EMA regulatory documents, TrialSite contacted both Dr. Robert W. Malone, MD, MS, and another expert that wished to remain anonymous, and provided them copies of the EMA analysis and the FOIA documents. Dr. Malone was the original inventor of the mRNA vaccine technology back in the late 1980s. He currently advises several companies in regulatory affairs and clinical development. One of TrialSite’s other sources is a senior regulatory specialist who currently serves as the President of a prestigious European association. When asked to review and comment on the EMA assessment, Dr. Malone noted that normal pharmacokinetic and pharmaco-toxicology studies had not been performed before EUA authorization for the product. “I was particularly surprised that the dossier of regulatory documents indicates allowance for use in humans based on non-GLP PK and Tox studies relying on formulations which are significantly different from the final vaccine.“ After completing a review, TrialSite’s other source noted the following:
“A quick review the Toxicology Section (2.3.3) of The European Medicines Agency (EMA) Assessment Report on Comirnaty (COVID-19 mRNA vaccine) issued on 19 February 2021, raises concerns about data applicability of preclinical study findings to clinical use:
To determine the biodistribution of the LNP-formulated modified mRNA (modRNA), the applicant did study distribution of the modRNA in two different non-GLP studies, in mice and rats, and determined the biodistribution of a surrogate luciferase modRNA.
Thus, one might question the validity and applicability of non-GLP studies conducted using a variant of the subject mRNA vaccine.
In addition, no genotoxicity data were provided to EMA.”
Based on the FOIA documents, the biodistribution results (which are not disclosed in the public EMA summary document) suggest that the delivery technology results in mRNA delivery and significant concentration of the delivery lipids in ovaries, spleen, and other tissues and organs.
Urgent Emergency?
The discovery and review of the biodistribution and pharmacokinetics data obtained by the FOIA request underscores the reservations disclosed in the public EMA assessment. Although not performed to industry GLP standards, these results seem to indicate that lipid/mRNA nanoparticles, which code for the Spike protein, circulate throughout the body and then collect in a variety of organs and tissues, including the spleen and ovaries. This means that the vaccine is not remaining localized near the injection site and draining lymph nodes, but rather is also circulating in both blood and lymph and is subsequently concentrating in important organs. If this results in Spike protein being produced in unintended places including the brain, ovaries, and spleen, it may also be causing the immune system to attack these organs and tissues.
What’s the Risk?
According to official government accounts, minimal risk is associated with this vaccine when compared to the risks of COVID-19 infection. That’s why the U.S. FDA approved the Emergency Use Authorization (EUA) based on a risk-benefit analysis. TrialSite, a vaccine proponent, only raises the issue to ensure full disclosure of any material safety implications to our readership, including clinicians, clinical research safety committees, and public health professionals.
While, according to the CDC’s VAERS database, over 4,000 deaths have been entered in association with all the vaccines, the US government argues that none of these deaths are formally linked to the jabs. About 291 million people have been vaccinated to date, hence overall reported adverse event risk is low. While it is true that many people are completely unscathed, the discovery of these documents and associated information may alter the risk-benefit assessment underlying the EUA decision.
TrialSite is aware that one must be particularly cautious about publishing or communicating speculations that might raise skepticism about vaccine use. Should researchers handle findings differently when there is a chance they might frighten the public? Perhaps small, inconclusive, worrying studies should not be published because they could do more harm than good. Dr. Paul Offit, Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, states: “Knowing that you’re going to scare people, I think you have to have far more data.”
One could argue that even an inconclusive paper can be important, as it can spur the larger, more definitive studies that are needed. It should be “put out there for the scientific community, to look at it, see it, know about it, refine study design and go and look again,” says Gregory Poland, a renowned Mayo Clinic vaccinologist and the Editor-in-Chief of Vaccine. It is crucial, though, for researchers to carefully explain such results in their papers and regulatory filings to prevent misinterpretation or misunderstandings.
Other Relevant New Data
A recent study led by researchers at Brigham and Women’s Hospital and the Harvard Medical School measured longitudinal plasma samples collected from 13 recipients of the Moderna vaccine. The manuscript has been accepted for publication by “Clinical Infectious Diseases” and the pre-print is available here. Out of these individuals, 11 revealed detectable levels of SARS-CoV-2 protein as early as day one right after first vaccine injection. The authors considered that to be normal clearance.
Clearance of detectable SARS-CoV-2 protein correlated with production of IgG and IgA. Measured mean S1 peak levels were 68 pg/mL ±21 pg/mL, and mean spike peak level was 62 pg/mL ± 13 pg/mL. Assuming an average adult blood volume of approximately 5 liters, this corresponds to peak levels of approximately 0.3 micrograms of circulating free antigen for a vaccine designed to only express membrane-anchored antigen. For comparison purposes, most influenza vaccines administer a total of about 15 micrograms of HA antigen per influenza strain. Total levels of antigen expressed by the experimental SARS-CoV-2 mRNA vaccines currently administered to patients are not known.
Root Cause Analysis Suggested
A root cause assessment is suggested to better understand if any of this information adjusts or modifies the EUA risk-benefit analysis. TrialSite suggests that regulators and pharma manufacturers at least review and assess the risk that foreign mRNA-based spike protein delivery and expression in tissues and organs distal to the actual injection site may be contributing to the unusual reactogenicity and adverse event profile associated with these products. The uptake in vaccination rates has slowed in the United States in part due to vaccine hesitancy. However, such a phenomenon can be overcome with acknowledgment, transparency, and continuous commitment to risk mitigation.
Today be crossed the absolute low baseline (14 cases) in ICU usage with a steep increase by 3x back to July 1st levels. Normally after weekends the increase is 20% because of technical reasons but even without this its > 2x.
This allows to make some first conclusion for Delta and severe cases. This values currently is nothing more than a guess as we need at least 7 days more data. But just doing a 1:1 match, with June data, says delta is 1.6..2x less severe. This can change if ICU will increase much more during next days. Cases went up 6x the last 20 days!
PCR is also flawed vaccine group positives...this is why only symptoms and a blood test should count.
The FM/R/J/B mafia generates between 120..400$ for a PCR test, whereas the 3x more reliable blood test only generates 20$ plus money for the doctor that usually is not a mafia member like the test-lab owner...
In order to work out how protective is the vaccine - assuming you are just counting cases in ICU - you would need to know number of unvaccinated infections and work out cases in ICU / unvaccinated infections.
We know the vaccines:
If you are only counting the vaccinated population then ICU numbers increasing will be because infections are increasing - which we know is what delta does.
How can you can work out protection offered from this data alone?
On the 1pm news just now I heard some wonderful COVID WyttenFacts, with explanation of why they are not true:
In UK Life expectancy is around median age of people dying with COVID (true) => COVID does not knock anything off your life expectancy (WyttenFact - false)
In fact COVID knocks on average 10 years of life of those who die from it.
In UK, most people dying in hospital of COVID are vaccinated (false, but will be true soon) => vaccination does not offer large protection from COVID death (WyttenFact - false)
Analogy: in UK almost everyone who dies in an RTA was wearing a seatbelt. It does not mean seatbelts do not reduce death - just that almost everyone having an accident is wearing a seatbelt.
Re the rash of TSM+N anti-vax articles.
It must now be tough for anti-vaxxers, when vaccines are clearly saving lives, and the real-world data on safety and efficacy looks good. So they have scare stories about how the safety testing deviated from industry standard, and how mRNA can migrate to any organ in the body.
TSN does - quite often - post unadulterated, false, potentially deadly, anti-vaxx propaganda, as here.
TSN: May 2021 (Steve Kirsh)
FULL CLAIM: 'Biodistribution of lipid nanoparticles which carry the mRNA show that the ovaries get the highest concentration. This turns the ovaries into a very large manufacturing plant to turn out toxic spike protein"; the benefit of the vaccine is "minuscule", with "less than a .5% reduction in absolute risk"
So everyone here realises that this article is 100% false, with multiple false claims, and used to boost the "vaccines interfere with fertility" false scare stories? They must influence some people. They are certainly widely distributed and would worry me had I ovaries and if I got all my information from social media - as many do, and distrusted, or did not seek, medical advice - as also many do.
Because I am not certain of the above - though it should be true - here we go.
In the latest iteration of this claim, the TrialSite News article and others presented information from official documents submitted by Pfizer to Japan’s regulator Pharmaceuticals and Medical Devices Agency (PMDA) as evidence for its claim. The article also contains a list of other claims, including several that were debunked previously (see our earlier reviews related to Geert Vanden Bossche, the Vaccine Adverse Events Reporting System, the Cleveland Study by Shrestha et al., comparison to the flu vaccine, and miscarriages in pregnant women). This technique, in which a long list of inaccurate and/or misleading information is propagated repeatedly, is also known as firehosing.
This review primarily focuses on the claims about the Pfizer biodistribution study, spike protein toxicity, and the RNA vaccine efficacy. These come together in the article to ultimately paint a misleading picture of COVID-19 vaccine safety for readers.
This data was obtained by injecting rats with a mix of lipid nanoparticles, which are identical to the ones used in the COVID-19 RNA vaccines, that carry a radioactive “label” (deuterium). Researchers then then measured the level of radioactivity in tissues at different time points after injection. The level of radioactivity acts as a proxy measurement for how much lipid nanoparticle is present in a given tissue. Changes in the level over time provide scientists with an idea of how long it takes for the body to eliminate the particles.
The article’s interpretation of the biodistribution data is inaccurate. As Abraham Al-Ahmad, an associate professor in pharmacology at Texas Tech University, pointed out in a blog post, the data showed that the injection site had the greatest accumulation of lipid nanoparticles, followed by the liver. Specifically, the peak concentration at the injection site was 52.6% of the administered dose at one hour post-injection. That of the liver was 18.1% of the administered dose at eight hours post-injection (see Table 1). A microgram is one-millionth of a gram.
However, instances of this claim, as seen in the TrialSite News article, tend to omit the table containing the data for the liver and injection site, instead drawing attention only to the data for the ovaries: 0.1%.
[500 X error]
Apart from the inaccurate interpretation of data, another critical aspect of the biodistribution experiment that TrialSite News failed to consider is the amount of lipid nanoparticles administered in the rats and its relevance, or more precisely, its lack thereof to the amount present in RNA vaccines given to people.
The study administered 50 micrograms of lipid nanoparticles to each rat. As explained by David Gorski, a professor of surgery at Wayne State University and editor of Science Based Medicine, this would effectively translate to a much higher dose in rats than in humans. This is due to the large difference in body weight:
Quote“The human vaccine contains […] basically ~0.46 mg lipids or 460 μg. Let’s just round it up to 500 μg (0.5 mg). That’s approximately 10x the dose given to the rats. However, for the typical ‘70 kg’ male, 0.5 mg represents a per-weight dose of 0.0071 mg/kg, or 7.1 μg/kg. Let’s compare to the rats, which generally weigh around 200 g (0.2 kg), give or take, at 8 weeks, which is the usual age rodents are used for experiments. That would translate to a per-weight dose of ~250 μg/kg. Even if you used much older rats, who can weigh as much as twice as much, that would still translate to a dose of 125 μg/kg. So we’re looking at a lipid nanoparticle [dose] of ~18-35 times higher (as a rough estimate) than the typical adult human dose.”
In other words, the dose administered to rats was far higher than the dose used in people.
[20X error]
There isn’t evidence showing that COVID-19 RNA vaccines are causing fertility problems. Notably, some participants in the clinical trials for COVID-19 RNA vaccines became pregnant during the trial. The Vaccines and Related Biological Products Advisory Committee that reviews the safety, effectiveness, and appropriate use of vaccines published briefing documents that detailed the outcomes in pregnant trial participants.
For the Pfizer-BioNTech vaccine, the briefing document stated:
Quote“Twenty-three pregnancies were reported through the data cut-off date of November 14, 2020 (12 vaccine, 11 placebo). […] Unsolicited [adverse events] related to pregnancy include spontaneous abortion and retained products of conception, both in the placebo group.”
For the Moderna vaccine, the briefing document stated:
Quote“Thirteen pregnancies were reported through December 2, 2020 (6 vaccine, 7 placebo). […] Unsolicited [adverse events] related to pregnancy include a case of spontaneous abortion and a case of elective abortion, both in the placebo group.”
As the above shows, adverse events related to pregnancy for both trials occurred only in the group that didn’t receive the RNA vaccine. That being said, these numbers are too small to provide any meaningful information about the safety of the COVID-19 vaccines in pregnant women. For this reason, researchers are conducting clinical trials specifically to address the question of the vaccines’ safety and efficacy in pregnant women.
Since pregnant women are more likely to develop severe COVID-19 and complications and the existing data doesn’t indicate that safety concerns in pregnant women are likely, both the U.S. Centers for Disease Control and Prevention as well as the American College of Obstetricians and Gynecologists state that pregnant women should be given access to COVID-19 vaccines, if they wish to be vaccinated.
The amount of spike protein generated by vaccination is extremely small; scientific evidence shows it doesn’t cause harm
The article also cited Canadian immunologist Byram Bridle, whose claims about the purported dangers of spike proteins induced by RNA vaccines went viral in early June 2021. It is of note that Bridle’s academic profile on the University of Guelph website (archived here) showed that his laboratory is doing work on COVID-19 vaccine development, albeit based on a different technology from RNA. Health Feedback covered Bridle’s claims in an earlier review; scientists who examined the claim found it to be misleading.
Bridle misinterpreted findings from a study in hamsters[1] and a study in vaccinated people[2]. In the animal study, which was conducted at the Salk Institute, hamsters that were infected with pseudovirus carrying the SARS-CoV-2 spike protein showed signs of damage in the blood vessels. Researchers concluded from their findings that vaccination could protect against blood vessel damage—directly contradicting Bridle’s claim that the study supports his claim.
In the other study, Ogata et al. measured the amount of spike protein in the blood of 13 people who received the Moderna COVID-19 vaccine. Researchers detected peak levels of spike protein up to 6812 picograms per milliliter during the first week after the first dose. A picogram is one thousand billionth of a gram. And after the second vaccine dose, spike protein was no longer detectable in the blood of these people. The study didn’t report any detrimental effects.
On Twitter, Uri Manor, one of the senior authors of the Salk Institute study, highlighted that the levels detected by Ogata et al. was about 100,000 times less than the amount used in their study:
[100,000X error]
In summary, neither of the two studies Bridle cited support his claim, and the first directly contradicts it. Clinical trials and safety monitoring of ongoing vaccination campaigns show that the RNA vaccines are very safe and their benefits outweigh their risks.
The TrialSite News article claimed that the vaccine benefits were “minuscule”, citing “less than a .5% reduction in absolute risk”. Similar claims also appeared in social media posts claiming that the absolute risk reduction (ARR) shows the RNA vaccines are ineffective and that the figure of 95% reported by the media is deceptive (see example), citing a Lancet Microbe comment[3].
These claims are inaccurate and misleading. Piero Olliaro, one of the authors of the Lancet comment, told Lead Stories that their comment had been grossly misinterpreted:
Quote“It is extremely disappointing to see how information can be twisted and how divisive discussions have become especially on COVID-19 vaccines, as they obviously overlap with general vaccine hesitancy and antivax segments of the population.
Bottom line: these vaccines are good public health interventions. Importantly, the effects of vaccination should not be seen merely as reducing individual risk, but its effects on reducing the risk in the entire population, with all its ramifications – reducing stress to health systems, hospital bed occupancy, societal costs, effects on economy, etc… a long list.
We do not say vaccines do not work. We say vaccines do work, and add considerations about intrinsic vaccine efficacy and their effectiveness when used in different populations.”
Olliaro also clarified their message in the Lancet Microbe comment, which was intended to highlight the fact that comparing relative risk reduction (RRR) between different vaccines can be misleading due to differences between populations, that even vaccines with a relatively lower RRR can still be effective in the real world, and that both ARR and RRR should be reported together to provide readers with a more accurate and comprehensive idea of vaccine efficacy.
In Olliaro’s own words:
Quote“It is incorrect to compare [vaccines] based on clinical trials conducted in different conditions, using relative risk reduction (RRR calculated as explained in the paper), and assume vaccines with lower RRR do not work well enough. Studies should therefore report also absolute risk reduction (ARR, calculated as explained in the paper).
Why? The RRR is a measure of vaccine efficacy in preventing disease in those at risk of getting infected and becoming ill; the ARR is a measure of vaccine effectiveness in a population where a certain proportion of individuals will get diseased without vaccine. ARR is more difficult to understand, but can be conveniently translated in NNV (number need to vaccinate = how many people need to be vaccinated in a population with a given background risk of getting covid-19 without vaccine to prevent one more case of covid-19.)
The article explains these concepts with numerical examples from vaccine trials, and that even vaccines with relatively lower RRR are totally worthy.
These numbers are evidence of effectiveness, since even the least ‘effective’ vaccine (AstraZeneca and J&J with RRR of ~67%) you just need to vaccinate ~80 people to prevent one case in populations where just under 2% of people get covid-19 within a certain period of time. This also shows that 2 vaccines with very similar, high efficacy (RRR ~95%) can have different effectiveness depending again on the risk of covid-19: NNV for Moderna vaccine ~80, Pfizer ~120 (the latter was studied in the population with the lowest risk of all).”
Experts at the Meedan Health Desk also explained that the approach used in the clinical trials means that the ARR “will always appear low”:
Quote“Researchers looked at vaccine efficacy once a specific number of COVID-19 cases had been confirmed in vaccine trials. With this approach, the ARR will always appear low, because it is tied to the number of cases confirmed in the study. Let’s say a study enrolled 20,000 patients into the control group and 20,000 in the vaccine group. In that study, 200 people in the control group got sick and 0 people in the vaccine group got sick. Even though the vaccine efficacy would be a whopping 100%, the ARR would show that vaccines reduce absolute risk by just 1% (200/20,000 = 1%). For the ARR to increase to 20% in our example study with a vaccine with 100% efficacy, 4,000 of the 20,000 people in the control group would have to get sick (4,000/20,000 = 20%). From a public health perspective, we would not want to wait for more control group infections and a higher ARR before sharing the study findings
In summary, both the RRR and ARR provide useful information about the efficacy of a vaccine or any other medical intervention. But the article misrepresented the ARR as evidence that the vaccine doesn’t work, which isn’t true.
Evidence in the real world demonstrates that the COVID-19 vaccines are effective. A study in Israel on more than 590,000 healthcare workers showed that the Pfizer-BioNTech COVID-19 vaccine was more than 90% effective in preventing symptomatic COVID-19, hospitalization, and death[4], one week after the second dose.
In addition, both the U.S. and the U.K. observed that unvaccinated people are making up the majority of COVID-19 cases requiring hospitalization, suggesting that vaccinated people are less likely to develop serious illness requiring medical care as compared to unvaccinated people.
Overall, the TrialSite News article contains several inaccurate and misleading claims. It is false to claim that Pfizer’s biodistribution study showed lipid nanoparticles accumulating in the highest concentration in the ovaries. Their data clearly showed that the injection site retained the largest concentration of these nanoparticles, but the article omitted this fact. The evidence so far doesn’t show that COVID-19 vaccination affects ovaries, leads to a higher risk of adverse events during pregnancy, or affects fertility.
The claim by Byram Bridle that spike protein generated by vaccination is toxic is based on misinterpretations of two studies, neither of which actually reported detrimental effects from vaccination. One study examined spike protein’s effect during infection in animals, while the other reported transient, infinitesimal amounts of spike protein in the blood of vaccinated individuals, with no ill effects.
While ARR provides helpful information on vaccine efficacy, it also needs to be interpreted in the context of the study’s design. The relatively smaller ARR compared to the RRR isn’t proof that the vaccines are ineffective, but reflects the difference in the way it is calculated. It is also influenced by other factors such as the non-pharmaceutical measures used to mitigate the spread of COVID-19. Real-world evidence shows that the RNA vaccines are highly effective at preventing illness and death.
In UK Life expectancy is around median age of people dying with COVID (true) => COVID does not knock anything off your life expectancy (WyttenFact - false)
In fact COVID knocks on average 10 years of life of those who die from it.
Surely you understand that these two "facts" are not mutually exclusive. ANY manner of death knocks some number of years of life expectancy of those who die.
Display Morethe current protocol calls for 24 mg IVM daily for those over 40 kg...
there is no 0.2 mg/kg anymore..the target is now >=0.4
if your paste is 1.87% IVM
24 mg divided by 1.87% yields equivalent mass of paste...=`1.28 gm..
you cannot measure this accurately on a kitchen scale
there should be enough for 4.7 days at 24 mg/D dosing.
which is about 5 days..
Pragmatically I would use the Marked gradations to divide the total paste volume by 5..
As Shane says... ask a doctor at FLCCC.
Also do not rely on IVM alone... keep taking Vit D one 25mcg capsule per day... at least
Irish research ..
"It was also discovered that 47 per cent of people aged 18-39 are deficient in the vitamin. Thirty-five per cent of 50-59 year olds are also deficient.
"The report says that vitamin D supplementation of 20-25 micrograms per day should be recommended to the entire adult population, and higher doses should be recommended for vulnerable groups under medical supervision
https://www.irishtimes.com/new…port-recommends-1.4531214
Thank you for the confirmation Robert! I will certainly reach out to a doctor recommended by FLCCC as well. I have a bottle or Vit D3 on my desk, currently take 5K+ iu a day and am nearing my targeting blood levels of 80 ng/ml. I had Covid a year ago, decided against being vaccinated and have recently (5 days ago) been exposed to two vaccinated (Pfizer) individuals that tested positive for Covid yesterday. My wife and I are both feeling symptomatic, headache, low grade fever, body aches but are being tested later today for confirmation. Thanks again. Bryan 
What do you think? Overall, as you said it is interesting. There have been other studies indicating the vaccine triggers a more robust, protective response, and a few others that say the opposite
I have read that the vaccine response is less robust, creating a lower level of antibodies. BUT in some patients it is more effective in warding off the disease despite that, and it seems to ward off a wider range of variants, including the Delta variant. That may seem contradictory to the layman but virologists are not surprised. I think that was in a New York Times article by a virologist.
That seems to be the story of this pandemic: everything could be this or maybe it could be that, with studies backing each positiion; i.e. masks/no masks/only the right type of mask, lockdowns save lives/lockdowns kill more people, vaccine better/natural better, Ivermectin good/Iver bad, leaked from the lab/did not.
These other claims about masks and lockdowns are bullshit, without a shred of scientific or statistical evidence. On the contrary, data from different U.S. states and other countries show that all of these claims are nonsense. This is right-wing disinformation spread by the GOP, Fox New and the Kremlin (who are close allies these days) intended to disrupt the Biden administration, kill people, and make GOP voters angry.
No wonder this thing has become so political.
It is only political in the U.S., not in Japan, Europe or anywhere else. It is only political because the GOP and the Russians want to weaken the U.S. by killing people and destroying the economy for political advantage.
What to do???
Tribal warfare rages on....
Vaccine warriors.... anything that reduces vaccine importance by any amount must be censored as "against science" and "fake news". No questioning nor investigating possible negative issues of the vaccine is allowed. Certainly one must never give possible credence to a report that casts a dim light on vaccines, no matter the source or content.
Vaccine warriors.... anyone who supports vaccines are "an expert" and can be quoted and believed. Anyone who questions vaccine safety or efficacy, no matter what qualifications they have, is a quack and anti-vaxxer. They are to be censored and reviled.... preferably personally attacked. Papers that they may write should automatically be censored. No credence can be given to them in any way. Evidence.... ALL reports listed here that question vaccines or propose postive alternatives to vaccines have been attacked......regardless...
If a fish oil report should be questioned due to "who funded the study", vaccine trials done by the big pharma companies who have billions of dollars at stake and same reports provide the vast majority of positive evidence for vaccines, should be believed without any skeptisism.
hmmm.....interesing....
Anti-Vaxxers - indeed just as bad.. anything to do with vaccines is automatically bad....
HOWEVER...
I do not think there are any anti-vaxxers on this forum. Just people who have concerns with a novel type of vaccine, never before approved for human use (still not approved under normal standards) with a very concerning safety record for early testing (mRNA development) and no current long term safety testing. Remember, it took 5 years for thalomide to be banned. You can still purchase tobbacco even though the Surgeon General has stated it is extremely bad for several years.... after many years of not saying anything when tobacco industry "safety trials" said it was ok. Surely this would not happen today!?!?!? 
Education?.... hmmm.. everyone on this site has some education... several advanced. Wyttenbach and THH both have advanced math.... yet are polar opposites.
Rothwell and THH both are educated and are pretty much in agreement with vaccines.... yet are bitterly opposed concerning LENR testing and results. While Rothwell and Wyttenbach both agree that LENR is a demonstrable event. Wyttenbach and Rothwell are bitterly opposed concerning Covid vaccinations. (Wyttenback is NOT an anti-vaxxer by the way and has said so many times)
Alan, Dennis Letts and I all have degrees. Yet Dennis and I disagree significantly with Alan concerning something as smple as IH! Where Dennis has personal experience with them and should have much more "weight" to his opinion. However, I doubt Alan has changed his view in the least about IH.
So education, while very important, does not solve tribal thnking.
"Following the science" meme is "BS" as everyone above states they ARE following the science.
Science is simply an interpetation of data, formed hypothoses and often faith. (Yes indeed). Some areas more concrete than others. ..
So it boils down to tribal association, whether you are of a political party, social system, a religion or yes, even a sports team fan, people are tribal and thier views and thinking are far, far more shaped by this than they would like to admit..... including my own! 
So the tribal warfare goes on.....I am unsure of anyway to fix it. 
TSN: May 2021 (Steve Kirsh)
FULL CLAIM: 'Biodistribution of lipid nanoparticles which carry the mRNA show that the ovaries get the highest concentration. This turns the ovaries into a very large manufacturing plant to turn out toxic spike protein"; the benefit of the vaccine is "minuscule", with "less than a .5% reduction in absolute risk"
This is extreme nonsense for many reasons:
The spike proteins are not toxic. If they were, the common cold would kill patients.
The mRNA only reaches a small portion of the arm where it is injected, not the ovaries. The virus, on the other hand, reaches all organs.
Actual blood samples from patients show that virus produces about a million times more spike proteins than the vaccine.
The amount of spike proteins that the vaccine can produce is self-limiting, because the mRNA is not reproduced in the body, the way it is with a virus. A tiny amount of mRNA is injected. (About a million times less than the virus produces.) This infects a few cells for a while, producing spike proteins. Within a few days the RNA is dissolved by natural processes that dissolve all RNA from any source. No new RNA is introduced, so the process stops. The ovaries could only be a "factory" if the supply of RNA was renewed by cells reproducing the entire virus, which would in turn trigger new cells to make more RNA and proteins.
If Kirsh knows anything about biology he must know this is a lie. Either that or he is a blithering idiot repeating disinformation. As noted, this lie is intended to frighten women so they do not get the vaccination. As I said, the goal is to sicken and kill as many people as possible, to disrupt society, ruin the economy, and re-elect the GOP. In other words, this is treason.
Vaccine warriors.... anything that reduces vaccine importance by any amount must be censored as "against science" and "fake news". No questioning nor investigating possible negative issues of the vaccine is allowed.
More nonsense. Every reported side effect of the vaccine has been investigated in more detail, with better diagnostics and more data than any vaccine in history. In fact, with more data and in more detail than all previous vaccines combined, in all of medical history. There have never been such careful investigations of possible negative consequences. They would not have been possible in any earlier era because we did not have big data, AI, modern communications and the internet.
In UK, most people dying in hospital of COVID are vaccinated (false, but will be true soon) => vaccination does not offer large protection from COVID death (WyttenFact - false)
Can you please show the original post of
your Huxley crap?
I never said what you did crappinize.
I also never use unsafe methods you mention and your friends use. I use raw data with proper groups not like Pfizer that counts in all people with natural protection (75%!!) being a vaccine protection positive case.
But may be you simply must follow the FM playbook and try to gain information leadership again...But this only work within cricket brains...
I would like to know if we could find a similar signal in our databases
You need access to EU vigelence DB for this!
When asked to review and comment on the EMA assessment, Dr. Malone noted that normal pharmacokinetic and pharmaco-toxicology studies had not been performed before EUA authorization for the product. “I was particularly surprised that the dossier of regulatory documents indicates allowance for use in humans based on non-GLP PK and Tox studies relying on formulations which are significantly different from the final vaccine.“ After completing a review, TrialSite’s other source noted the following:
Biontec (PFfizer) had a lag of 2 year to market. Only by extensive cheating and buddies (FM/R/XXX/B) help the could make giga tons of money.. with Dr. Mengle medicine.
Latest sad UK facts. More vaccinated die than unvaccinated. But are they now doing an age statistics among death/vaccinated to get a better match? Most likely No. Free mason (NHS/NIS) want to have information leadership that never is based on facts or just on the facts that tell nothing. True data is damaging vaccine business.
Fact is:: All CoV-19 vaccine are experimental and guarantee nothing. You sign a paper that you are a willing test monkey and even if you die this was your private joy. The death risk from current vaccines is in the range of 20..40/mio may be Sweden with magic mushroom/Herrings is an exception! Norway also with Herrings has the usual rate...
Fact is:: Current vaccines give you no added protection if you are younger than 55. It's your choice rare chance to die from CoV-19 or from a vaccine.
You also do not help to end the pandemic as we now have prove that the vaccines do not protect mucosa cells.
You can only show that you, if younger than 55, already are willing to follow the FM/R/XXX/B fascist league. This will give you a good start in many companies not so in some others, that still are lead by clear thinking (not drinking) people...
Surely you understand that these two "facts" are not mutually exclusive. ANY manner of death knocks some number of years of life expectancy of those who die.
Yes of course. it is obvious. But the anti-vax (false) meme is that if (for example) median age at which people die from COVID is 80, and median age at which people die is 81 (normally) then COVID reduces life expectancy buy only 1 year. False.
More nonsense. Every reported side effect of the vaccine has been investigated in more detail, with better diagnostics and more data than any vaccine in history. In fact, with more data and in more detail than all previous vaccines combined, in all of medical history. There have never been such careful investigations of possible negative consequences. They would not have been possible in any earlier era because we did not have big data, AI, modern communications and the internet.
Prime example...
Vaccine warriors.... anything that reduces vaccine importance by any amount must be censored as "against science" and "fake news". No questioning nor investigating possible negative issues of the vaccine is allowed. Certainly one must never give possible credence to a report that casts a dim light on vaccines, no matter the source or content.
Bob - you will remember as a prolific "vaccine warrior" I have happily researched and posted statistics on vaccine deaths, and other side effects. I have also pointed out many times that the original vaccines are much less effective against delta (though so far that has no effect on the risk equation because 90% protection and 100% protection are pretty similar when comparing a risk).
You should think of the vaccine as being just like a good drug. It may not stop you from getting COVID, though it makes that less likely, but it reduces chances of something bad by a factor 10 or so. Unlike a drug, you take it just one - in advance - and it will last for a year or whatever. Like a drug, it has occasional side effects which you accept on balance of risk. Unlike most drugs it is given to a very large number of people, and side effects at excruciatingly low levels are documented and considered. Finally, unlike some diseases COVID has an exponential dependence of risk on age which means how you judge this balance personally depends on age. That keeps things interesting - there will probably be an age where the balance of risk is equal, though at the moment we are not quite sure what it is.
Those vaccine warriors talk all the time about not being sure how well vaccines will work against the next variant. Everyone is relieved (very relieved) that it still provides very good protection against delta. It is better than we expected a year ago.
The reports about negative issues - for example the very detailed FDA or EMA or MHRC reports on vaccine side effects and possible side effects still under investigation are absolutely fine. I'm happy for us to discuss them. No-one hides them.
The questioning from that Kirsch article, and many many similar things, is against science in the sense that it contains statements that are dramatically misleading about the dangers related to the vaccines. And unfair in that it has an unshakable background suspicion that the authorities cannot be trusted.
COVID has dangers, vaccines have dangers, both are (a bit) uncertain. People need the best advice about the relative dangers. They get this - by and large - from 99% of personal doctors and the official advice. They get false (and therefore positively dangerous) information from Kirsch and the like. That is flourishing in the US because very many people are suspicious of all experts (included their own doctors) and view scare stories and anecdotes circulated on social media as the best source of advice. You can always find a maverick doctor on Youtube willing to argue things that are not true, as though they are true. To take an extreme but influential example Andrew Wakeman argued that MMR vaccine was causing Autism on false evidence and unshakable personal conviction.
It is only in the US that vaccination has become a political matter with one of the two main political parties viewing it with suspicion. You find that in Brazil, with Bolsanaro, and a few other autocratic regimes, but no democratic countries (correct me if I'm wrong). It is obvious to me that for many people in the US feelings about vaccination are related to politics and personal identity. I deeply regret that. Right or left wing does not need (and normally does not) have any clear relationship to questions of health and science.
I know full well that you have views quite a long way to the right of me (and vice versa) on many topics. It does not change the way I respect you - we are all entitled to our views, and politics has many valid viewpoints. I can't see that in any way has to effect evaluation of relative risks of COVID or vaccine. That is not a left/right issue, although it is an extreme politics / less extreme politics issue. Both extremes tend towards anti-vax conspiracy theories.
TSN is much posted here and contains a whole load of links to interesting papers - together with a good dose of editorial and invited anti-vaccination disinformation. If you do not understand that Kirsh's article on TSN and the like are plain disinformation, not one side of a complex scientific argument, I am happy to address in more detail the specific mistakes (lies) in it which badly mislead readers and are scientifically wrong. You will not find any normal scientist or doctor who thinks otherwise. There are in the US a few people with MDs and very strange views about science. A very few of them have in this pandemic peddled this type of misinformation. Unfortunately online space is such that a few well funded bad apples can have an enormous online impact.
I am happy (in fact interested) to discuss what exactly are the blood clot risks from AstraZeneca (they are the largest risk of all the known COVID vaccine side effects), or any otehr COVID vaccine side effect. Interested to discuss breakthrough infections (only the US seems to have this idea that you get very few breakthrough infections if fully vaccinated). In the UK we know they exist, just many fewer than if you were not vaccinated. The vaccine reduces severity a lot. For example it can turn deaths into symptomatic infections, symptomatic into asymptomatic infections, and prevents many infections
My problem is that 95% of the material online about such things is written in such a way as to mislead, like for example Wyttenbach's statement here. if you believe him, taking an mRNA vaccine increases personal risks, and does not massively reduce them, for a 24 year old (like my daughter). That is strongly counterfactual. On the other hand if a woman were pregnant, or llkely to be pregnant, and young (say 25) the risks are different because we have muhc less data about how vaccination effects pregnancy. Even so i'd expect most young women in that situation to get vaccinated. Why? Because the risks getting COVID when pregnant are higher than normal, and the effect of COVID on a foetus is equally unknown. In the Uk or US, now, pretty well all 25 year-olds will either get vaccinated or COVID.
Do you find an equal attention given to the scary unknown risks of COVID, and the scary unknown risks of COVID vaccines?
If you do - then you have disinformation. The somatic effect of any vaccine is enormously smaller than the somatic effect of COVID. Both challenge the immune system but the virus challenge is typically much larger and longer, in addition the virus has many other disease effects which the vaccine avoids. Any normal person should be more worried about unknown effects from COVID than from the vaccine, even though both are possible. Yet that is not what we find online. The vaccines have now been in a large real-world trial with 100s of millions of people. Effects are now much more known, and obviously smaller than COVID down to at least age 18. The most obvious uncertainty is long COVID. You should find it scary. For yourself, your family, anyone you know who is pregnant. More scary than the vaccines.
If you read TSN and other anti-vax media however you get lots of articles about scary speculative risks of vaccines, and no articles about scary speculative risks of long COVID.
THH
I never said what you did crappinize.
I also never use unsafe methods you mention and your friends use. I use raw data with proper groups not like Pfizer that counts in all people with natural protection (75%!!) being a vaccine protection positive case.
I will happily revise my possibly flawed view of your methods if you make statements that are precise, coherent, with all assumptions stated with links, so I can check your assumptions step by step.
Otherwise, if I misunderstand you, you have only yourself to blame!
Your results, as I understand them, are often wrong by a very large factor - and I'd happily help you to discover why this is so.
THH
