January 28, 2023

Best Scientist on COVID Vaccines: “Withdraw Them Immediately”

Unequivocal safety signals meant for heart, blood and duplication found in yellow card vaccine data.

Dr . Richard Ennos, a retired Professor associated with Evolutionary Biology at Edinburgh University, has undertaken a thorough analysis of the U. Nited kingdom. ‘s COVID-19 ‘ Yellow-colored Card’ vaccine adverse event data and found what this means is “ unequivocal safety signals” for adverse reactions caused by the particular Pfizer and Moderna vaccines affecting the blood, the heart and female reproduction. He or she concludes that: “ There may be no question that the mRNA vaccines should be withdrawn along with immediate effect. ”

In the U. K., three COVID-19 vaccines – AstraZeneca (AZ), Pfizer (PF) and Moderna (MO) – have been utilized in a nationwide inoculation programme aimed at preventing harm from your SARS-CoV-2 virus. All three vaccines provide the genetic program code that enables vaccinees to produce within their bodies the spike proteins of the SARS-CoV-2 virus, the molecule associated with the pathology of COVID-19. In the AZ shot the genetic code for that spike protein takes the shape of DNA, and is released into recipient’s cells with a genetically modified chimpanzee virus (DNA, adenovirus vector). For the PF and MO vaccines, the introduced genetic program code takes the form of greatly modified RNA, and is carried to recipient’s cells inside lipid nanoparticles (mRNA, lipid nanoparticle). There is no control over possibly the tissues to which the particular vaccines are transported or maybe the length of time for which spike aminoacids are produced by those tissue.

All 3 vaccines rely on novel technologies that has never before been utilized in humans. At the time of their intro, they lacked any long lasting safety data, and therefore needed Conditional Marketing Authorisation from your Medicines and Healthcare products Regulatory Agency (MHRA). To monitor the safety of the 3 vaccines the MHRA established the COVID-19 vaccine Yellow-colored Card reporting scheme (C-19VYC).   This collates standardised reports of suspected side effects to the COVID-19 vaccines that can be analysed to detect basic safety signals and potentially bring about withdrawal of the vaccines. Right here we show that a comprehensive analysis of the C-19YC information indicates unequivocal safety signals for adverse reactions caused by the particular mRNA vaccines PF plus MO affecting the lymph system, the heart and women reproduction.

The effectiveness of the C-19VYC reporting system is that it is capable of generating an enormous amount of valuable information regarding adverse reactions to the experimental COVID-19 vaccines. Reports of suspected adverse reactions can be submitted not just by physicians but also by recipients of the vaccines by themselves, providing valuable feedback towards the MHRA based on first-hand experience. This inclusive aspect of the C-19VYC reporting scheme offers proved very successful, along with nearly half a million undesirable event reports submitted, roughly one for every hundred recipients of the COVID-19 vaccines in the U. K.

Despite this strength in terms of amount of data, the C-19VYC reporting scheme has a number of serious weaknesses related to the nature from the data collected. These weak points place limits on the scheme’s ability both to identify and to measure safety indicators. The first problem is that the system does not identify or incorporate a control group of individuals, who have not taken the vaccine, against which to compare individuals who have. Other major weaknesses are usually that reporting is unaggressive rather than planned and happens at a single point in time. Hence, reporting relies on the sufferer of the adverse reactions or their physician making the connection between the vaccine treatment and the adverse reaction. As a consequence, many undesirable events will go unrecorded, which becomes more likely the longer the delay between therapy and the associated adverse response. Reporting rates of side effects are also likely to represent only a fraction of actual instances because physicians or receivers may have too little time to fill in the onerous paperwork, might not have knowledge of the Yellow Cards scheme, or may be not willing to countenance the idea of causes harm to resulting from a medication by which they have placed trust.

As well as being low, reporting rates are expected to alter substantially between different areas of the population. Experience shows that females post roughly three times more adverse event reports than males, and the confirming rate for adverse reactions differs with age, dropping away in the elderly population exactly where adverse reactions may be obscured simply by multiple forms of pre-existing persistent illnesses. In addition , reporting prices are likely to vary with the severity of the adverse reaction. People are far more likely to have the inspiration and tenacity to file a report if their adverse reaction is certainly severe than if it is slight. On the other hand, if the adverse event results in death, grieving close friends or relatives may be as well preoccupied to file a C-19VYC report.

Recognising the limitations in the C-19VYC programme is a very necessary 1st step in exploiting the tremendous volumes of data that it has produced. In its  published summaries   the MHRA are at pains to emphasise that the Yellow Card data cannot be utilized to calculate true rates of adverse effects or to compare the particular safety of the different vaccines, both because of the nature of the data and the existence of many confounding factors. I see the MHRA’s statements as a problem. In the remainder of this article, I will endeavour to show that the MHRA’s view is overly depressed and that the enormous initiatives of those who have submitted Yellowish Card reports of COVID-19 vaccine adverse effects have not experienced vain.    

In order to independently analyze the C-19VYC reports, it is important to have access to the organic data. The first FOI request for access to the full anonymised C-19VYC data was made in June 2021. This, and subsequent FOI requests have been refused on the grounds that it would be too onerous to pass within the raw data, and that anyway the data would be published in a future date. However , it must be noted that the MHRA sends the C-19VYC data immediately to the companies that market the COVID-19 vaccines. A few 18 months after the first FOI request, the MHRA has at last released information gathered by the C-19YC scheme that is sufficiently detailed to allow 3rd party analysis and calculation of safety signals.

A cursory look at the C-19VYC data indicates that the price of reporting of severe and fatal adverse events is nearly three times higher for your adenovirus AZ vaccine (3. 912 serious or fatal reaction reports per one, 000 doses) than meant for either of the mRNA vaccines PF or MO (1. 341 and 1 . 344 serious or fatal response reports per 1, 000 doses respectively). Although there has been no formal withdrawal of the AZ vaccine by the MHRA, the use of the AZ vaccine has effectively been stopped, perhaps because of this worrying security signal. With the discontinuation from the AZ vaccine, the most important question becomes whether serious security signals can be detected for that remaining mRNA COVID-19 vaccines, PF and MO, which are still being employed.

As I have emphasised previously, the data available from the Yellowish Card scheme are the consequence of passive reporting. This means that any kind of detailed analyses based on total numbers of reports of adverse reactions are problematic. However , the well-established protocol, known as  proportional reporting rate analysis   (PRR) has been devised for finding safety signals using passive reporting data such as those collected by the C-19VYC scheme. The principles underlying the particular PRR protocol are explained below.

Suppose that we wish to see regardless of whether a novel vaccine substantially increases the frequency of a specific adverse reaction, say severe headache. If there is no link between administration of the shot and the frequency of serious headaches, then the proportion of most adverse reaction reports which are severe headache should be the same for the novel vaccine as for the established and thoroughly tested vaccines. However , if administration from the novel vaccine does trigger severe headaches, there will be a greater proportion of all adverse reaction reports that mention severe headaches for the novel shot than for the established vaccines. By dividing the percentage of adverse events which mention severe headache within the novel vaccine by this particular same proportion calculated for your established vaccines, we obtain a measure of the strength of the protection signal for severe head aches caused by the novel shot, the proportional reporting rate or PRR.

A safety signal can be formally detected if 3 conditions are met. 1st, there must be a substantial number of reviews of the chosen adverse response in the novel vaccine data source. Second, the proportion of all reports that mention the particular chosen adverse reaction should be statistically significantly greater for the book vaccine than for the established vaccines. This can be established utilizing a simple ‘ chi squared’ test. Thirdly, the proportion of adverse reactions calculated for the novel vaccine must be at least twice that calculated for the established vaccines (PRR> 2).

To apply this particular PRR methodology to detect safety signals for the story mRNA COVID-19 vaccines PF and MO, we make the very conservative assumption that the AZ vaccine does not boost the frequency of the particular side effects that we are investigating. The AZ vaccine thus takes on the role of the safe, established vaccine in the PRR analysis. Therefore , we use data from the AZ shot to calculate the percentage of the chosen adverse events that we would expect within an established, safe vaccine. All of us then calculate the dimensions of the chosen adverse occasion reports that occur in the PF and MO information, and compare these using the figure that we have calculated with regard to AZ to obtain the PRR. If there is a significantly higher percentage of the chosen adverse event reports in the mRNA vaccines than in the AZ vaccine, and the PRR for the mRNA vaccine is two or more, this particular constitutes a strong safety transmission requiring investigation and suitable action.

In December 2022, MHRA released two data files from the C-19VYC structure for each of the  three   COVID-19   vaccines . The first document contains an identifier for every Yellow Card report, the sex and age of the individual involved, and a classification of the severity of his or her adverse reaction – non-serious, serious or fatal. The second dataset includes the report identifier and various medical classifications of the adverse events experienced (there may be more than one adverse event per report). Probably the most accessible classification for that layman is based on the cells type affected by the adverse reaction e. g. muscle mass, nerve, blood. By marrying up the two datasets, it is possible to create a single file for each one of the COVID-19 vaccines that includes the particular report identifier, the sexual intercourse and age of the patient, the tissue type affected by the first adverse event listed in the report (to avoid pseudo-replication of the reports), and the intensity of the adverse reaction.

Data in the document described above are used in charge of PRR analysis to detect and measure the strength associated with safety signals associated with the negative effects of the mRNA vaccines PF and MO on  blood   (harm to the blood and lymph system), the  cardiac   system (harm to the heart), and  reproduction   within females (harm to the menstrual cycle). The analysis continues to be confined to severe side effects (serious plus fatal) to avoid the possible charge that the adverse reactions we are analysing are usually of little consequence to people they affect. To acknowledge the fact that reporting rates differ with both age and sexual intercourse, the reported PRR beliefs have been calculated in samples that are matched for each age and sex. This enables vulnerability to particular side effects to be compared between age ranges, and between females plus males. It should be noted that whenever the analysis is carried out in the manner described, it yields  minimum  estimates of the strength of the basic safety signals because it assumes the AZ vaccine does not raise the rate of the adverse response being studied. If this is not the case, the estimated strength of the safety signal linked to the mRNA vaccine concerned will be greater than we report.

Physique 1a
Figure 1b

Figure 1a and 1b show the results for females and males respectively of PRR analysis of adverse reactions associated with the PF vaccine that affects cells grouped under the MHRA classification  blood   (blood and lymph systems). For both sexes, plus across all except the oldest age class, there are very striking safety signals, with proportions of severe adverse event often greater than eight times higher right after PF vaccination than after AZ vaccination.

Figure 2a
Figure 2b

For the other mRNA vaccine MO, the proportional reporting rate will be again very significant plus well over the threshold degree for safety signals in most of the female age classes and in males aged in between 20 and 49. The vast majority of these severe adverse reactions impact the lymph system rather than the bloodstream, and the diagnosis given is certainly lymphadenopathy. It is very worrying that will in its “ Coronavirus vaccine – summary associated with Yellow Card reporting ” in January 2023 the MHRA fail to mention any possible adverse effects of the mRNA vaccines on the lymph system, despite such a solid safety signal being existing when the Yellow Card data are appropriately analysed.

Physique 3a
Figure 3b

Whenever PRR analysis is placed on investigate possible adverse effects of PF vaccination on the center ( cardiac , Figures 3a and 3b), there is a clear and significant safety signal for males between the ages of ten and 50. For females values of PRR very near to the threshold value of 2 can be found for ages 30 to eighty.

Figure 4a
Amount 4b

For vaccine MO (Figures 4a and 4b) exactly the same pattern of safety signals for severe cardiac disorders are found as for PF: higher and significant proportional reporting ratios in young males from 10 through 40 years of age, and reporting proportions close to or just exceeding 2 in females 50 to 80 years of age.

The MHRA has conceded in its Yellow Card overview that: “ There has been a consistent pattern of higher reporting of such suspected events (myocarditis and pericarditis) with both the monovalent COVID-19 Vaccine Pfizer/BioNTech plus COVID-19 Vaccine Moderna, along with these occurring more frequently within males. ” However , it has not apparently made any attempt to use the Yellow Cards data to demonstrate a formal safety signal in the manner explained above. It is also apparently unaware of the safety signal in females. Its response to benefit number of reports of myocarditis and pericarditis generated with the mRNA vaccines has not been in order to withdraw the offending items, but instead to alter the safety information associated with these products plus alert health professionals to look out for these very serious adverse events following the relevant vaccines have been administered: “[T]he item information for both monovalent COVID-19 Vaccine Moderna and COVID-19 Vaccine Pfizer/BioNTech was updated to inform healthcare experts and patients of these reports and provide advice to be aware of essential symptoms for myocarditis plus pericarditis. ”

Figure 5a
Figure 5b

The final bit of analysis reported here investigates whether the Yellow Card information yield a safety transmission associated with female  duplication   following inoculation with the mRNA COVID-19 vaccines. Figures 5a and 5b illustrate the results of PRR analysis for the PF plus MO vaccines respectively. For PF there are significant basic safety signals in age groups ten through to 40, while with regard to MO a formal safety signal is only found in the youngest (10 to twenty year) age groups. The vast majority of the adverse event reports with regard to female reproduction involve disruption to the menstrual cycle and excessive menstrual bleeding. Again, these types of have been recognised by the MHRA as side-effects of the mRNA vaccines but their severity continues to be downplayed, and no attempt has been made to formally identify protection signals despite the relevant data being available. As prior to, the MHRA has done absolutely nothing to protect the public from the severe adverse reactions to the mRNA vaccines that the Yellow Card data have revealed: “ Evidence from the most recent review suggested a possible association between the Pfizer and Moderna COVID-19 vaccines and heavy menstrual hemorrhaging. … The product information for your Pfizer and Moderna COVID-19 vaccines is therefore becoming updated to add heavy menstrual bleeding as a possible side effect. ”

A number of results can be drawn from the analyses reported above. The first is that will by applying PRR methodology it is possible to use the passively reported Yellowish Card data to detect and quantify safety indicators for novel vaccines, to get insights into particular intercourse and age classes that could be affected by particular adverse reactions, and to compare the safety user profile of different vaccines. The second bottom line is that the mRNA COVID-19 vaccines do not appear to be safe. Obvious safety signals are apparent indicating harm to the lymph system, the heart and to women reproduction. There can be no question that the mRNA vaccines must be withdrawn with immediate effect. The final conclusion is that the MHRA has provided no protection to the U. K. public from your adverse effects of the novel COVID-19 vaccines. Its regular publication “ Coronavirus vaccine — summary of Yellow Card reporting ” has been an exercise in protecting the COVID-19 vaccines from criticism rather than defending the particular U. K. public from your COVID-19 vaccines. Its reviews lack any scientific rigour, include not a single part of statistical analysis to support the conclusions drawn, and are a good affront to the huge number of people who have been injured or slain doing what they believed to be ‘ the right thing’.

Dr . Richard Ennos is a retired Professor associated with Evolutionary Biology at Edinburgh University. He writes: “ This article is dedicated to 2 groups within the U. Nited kingdom. First, the many who have been killed or injured by the rollout of the experimental and untested COVID-19 vaccines to an blameless and trusting U. Nited kingdom. public. Secondly to the dedicated physicians who have filed Yellow-colored Card reports cataloguing the COVID-19 vaccine injuries plus deaths. I would like you to realize that your suffering and work have not been in vain. ”

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