Dr. Richard Ennos, a retired Professor of Evolutionary Biology at Edinburgh University, has undertaken a thorough analysis of the U.K.’s COVID-19 ‘Yellow Card’ vaccine adverse event data and found it indicates “unequivocal safety signals” for adverse reactions caused by the Pfizer and Moderna vaccines affecting the blood, the heart and female reproduction. He concludes that: “There can be no question that the mRNA vaccines should be withdrawn with immediate effect.”
In the U.K., three COVID-19 vaccines – AstraZeneca (AZ), Pfizer (PF) and Moderna (MO) – have been used in a nationwide inoculation programme aimed at preventing harm from the SARS-CoV-2 virus. All three vaccines provide the genetic code that enables vaccinees to produce within their bodies the spike protein of the SARS-CoV-2 virus, the molecule associated with the pathology of COVID-19. In the AZ vaccine the genetic code for the spike protein takes the form of DNA, and is introduced into recipient’s cells by a genetically modified chimpanzee virus (DNA, adenovirus vector). For the PF and MO vaccines, the introduced genetic code takes the form of heavily modified RNA, and is carried to recipient’s cells within lipid nanoparticles (mRNA, lipid nanoparticle). There is no control over either the tissues to which the vaccines are transported or the length of time for which spike proteins are produced by those tissues.
All three vaccines rely on novel technology that has never before been used in humans. At the time of their introduction, they lacked any long-term safety data, and therefore required Conditional Marketing Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). To monitor the safety of the three vaccines the MHRA established the COVID-19 vaccine Yellow Card reporting scheme (C-19VYC). This collates standardised reports of suspected adverse reactions to the COVID-19 vaccines that can be analysed to detect safety signals and potentially trigger withdrawal of the vaccines. Here we show that a thorough analysis of the C-19YC data indicates unequivocal safety signals for adverse reactions caused by the mRNA vaccines PF and MO affecting the lymph system, the heart and female reproduction.
The strength of the C-19VYC reporting scheme is that it is capable of generating an enormous amount of valuable information about adverse reactions to the experimental COVID-19 vaccines. Reports of suspected adverse reactions can be submitted not only by physicians but also by the recipients of the vaccines themselves, providing valuable feedback to the MHRA based on first-hand experience. This inclusive aspect of the C-19VYC reporting scheme has proved very successful, with nearly half a million adverse event reports submitted, roughly one for every hundred recipients of the COVID-19 vaccines in the U.K.
Despite this strength in terms of quantity of data, the C-19VYC reporting scheme has a number of serious weaknesses related to the nature of the data collected. These weaknesses place limits on the scheme’s ability both to detect and to measure safety signals. The first problem is that the scheme does not identify or include a control group of individuals, who have not taken the vaccine, against which to compare those who have. Other major weaknesses are that reporting is passive rather than planned and takes place at a single point in time. Thus, reporting relies on the sufferer of the adverse reactions or his or her physician making the connection between the vaccine treatment and the adverse reaction. As a consequence, many adverse events will go unrecorded, and this becomes more likely the longer the delay between treatment and the associated adverse reaction. Reporting rates of adverse reactions are also likely to represent only a fraction of actual cases because physicians or recipients may have too little time to fill out the onerous paperwork, may not have knowledge of the Yellow Card scheme, or may be unwilling to countenance the idea of harms resulting from a medication in which they have placed trust.
As well as being low, reporting rates are expected to vary substantially between different sectors of the population. Experience shows that females post roughly three times more adverse event reports than males, and the reporting rate for adverse reactions varies with age, dropping off in the elderly population where adverse reactions may be obscured by multiple forms of pre-existing chronic illnesses. In addition, reporting rates are likely to vary with the severity of the adverse reaction. Individuals are far more likely to have the motivation and tenacity to file a report if their adverse reaction is severe than if it is mild. On the other hand, if the adverse event results in death, grieving friends or relatives may be too preoccupied to file a C-19VYC report.
Recognising the limitations in the C-19VYC programme is a very necessary first step in exploiting the enormous volumes of data that it has produced. In its published summaries the MHRA is at pains to emphasise that the Yellow Card data cannot be used to calculate true rates of adverse effects or to compare the safety of the different vaccines, both because of the nature of the data and the existence of many confounding factors. I view the MHRA’s statements as a challenge. In the remainder of this article, I will endeavour to show that the MHRA’s view is overly pessimistic and that the enormous efforts of those who have submitted Yellow Card reports of COVID-19 vaccine adverse effects have not been in vain.
In order to independently analyse the C-19VYC reports, it is essential to have access to the raw 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 on the raw data, and that anyway the data would be published at a future date. However, it should be noted that the MHRA sends the C-19VYC data without delay to the companies that market the COVID-19 vaccines. Some 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 independent analysis and calculation of safety signals.
A cursory look at the C-19VYC data indicates that the rate of reporting of serious and fatal adverse events is nearly three times higher for the adenovirus AZ vaccine (3.912 serious or fatal reaction reports per 1,000 doses) than for either of the mRNA vaccines PF or MO (1.341 and 1.344 serious or fatal reaction 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 discontinued, perhaps because of this worrying safety signal. With the discontinuation of the AZ vaccine, the most important question becomes whether serious safety signals can be detected for the remaining mRNA COVID-19 vaccines, PF and MO, that are still being employed.
As I have emphasised earlier, the data available from the Yellow Card scheme are the result of passive reporting. This means that any detailed analyses based on absolute numbers of reports of adverse reactions are problematic. However, a well-established protocol, known as proportional reporting rate analysis (PRR) has been devised for detecting safety signals using passive reporting data such as those collected by the C-19VYC scheme. The principles underlying the PRR protocol are explained below.
Suppose that we wish to see whether a novel vaccine substantially increases the frequency of a particular adverse reaction, say severe headache. If there is no connection between administration of the vaccine and the frequency of severe headaches, then the proportion of all adverse reaction reports that are severe headache should be the same for the novel vaccine as for the established and thoroughly tested vaccines. However, if administration of the novel vaccine does cause severe headaches, there will be a higher proportion of all adverse reaction reports that mention severe headaches for the novel vaccine than for the established vaccines. By dividing the proportion of adverse events which mention severe headache in the novel vaccine by this same proportion calculated for the established vaccines, we obtain a measure of the strength of the safety signal for severe headaches caused by the novel vaccine, the proportional reporting rate or PRR.
A safety signal is formally detected if three conditions are met. First, there must be a substantial number of reports of the chosen adverse reaction in the novel vaccine database. Second, the proportion of all reports that mention the chosen adverse reaction must be statistically significantly greater for the novel vaccine than for the established vaccines. This can be established using 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 PRR methodology to detect safety signals for the novel mRNA COVID-19 vaccines PF and MO, we make the very conservative assumption that the AZ vaccine does not increase the frequency of the particular adverse reactions 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 vaccine to calculate the proportion of the chosen adverse events that we would expect in an established, safe vaccine. We then calculate the proportions of the chosen adverse event reports that occur in the PF and MO data, and compare these with the figure that we have calculated for AZ to obtain the PRR. If there is a significantly higher proportion 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 constitutes a strong safety signal requiring investigation and appropriate action.
In December 2022, MHRA released two data files from the C-19VYC scheme for each of the three COVID-19 vaccines. The first file contains an identifier for each 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 suffered (there may be more than one adverse event per report). Perhaps the most accessible classification for the layman is based on the tissue type affected by the adverse reaction e.g. muscle, nerve, blood. By marrying up the two datasets, it is possible to create a single file for each of the COVID-19 vaccines that includes the report identifier, the sex 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 severity of the adverse reaction.
Data in the file described above are used here for PRR analysis to detect and measure the strength of safety signals associated with the adverse 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 in females (harm to the menstrual cycle). The analysis has been confined to severe adverse reactions (serious plus fatal) to avoid the possible charge that the adverse reactions we are analysing are of little consequence to those they affect. To acknowledge the fact that reporting rates vary with both age and sex, the reported PRR values have been calculated in samples that are matched for both age and sex. This allows vulnerability to particular adverse reactions to be compared between age groups, and between females and males. It should be noted that when the analysis is conducted in the manner described, it yields minimum estimates of the strength of the safety signals because it assumes that the AZ vaccine does not increase the rate of the adverse reaction being studied. If this is not the case, the estimated strength of the safety signal associated with the mRNA vaccine concerned will be greater than we report.
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 tissues grouped under the MHRA classification blood (blood and lymph systems). For both sexes, and across all except the very oldest age class, there are very striking safety signals, with proportions of severe adverse event often more than eight times higher after PF vaccination than after AZ vaccination.
For the other mRNA vaccine MO, the proportional reporting rate is again very significant and well over the threshold level for safety signals in most of the female age classes and in males aged between 20 and 49. The vast majority of these severe adverse reactions affect the lymph system rather than the blood, and the diagnosis given is lymphadenopathy. It is very worrying that in its “Coronavirus vaccine – summary of 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 strong safety signal being present when the Yellow Card data are appropriately analysed.
When PRR analysis is applied to investigate possible adverse effects of PF vaccination on the heart (cardiac, Figures 3a and 3b), there is a clear and significant safety signal for males between the ages of 10 and 50. For females values of PRR very close to the threshold value of 2 are present for ages 30 to 80.
For vaccine MO (Figures 4a and 4b) the same pattern of safety signals for severe cardiac disorders are found as for PF: high and significant proportional reporting ratios in young males from 10 through 40 years of age, and reporting ratios close to or just exceeding 2 in females 50 to 80 years of age.
The MHRA has conceded in its Yellow Card summary that: “There has been a consistent pattern of higher reporting of these suspected events (myocarditis and pericarditis) with both the monovalent COVID-19 Vaccine Pfizer/BioNTech and COVID-19 Vaccine Moderna, and of these occurring more frequently in males.” However, it has not apparently made any attempt to use the Yellow Card data to demonstrate a formal safety signal in the manner described above. It is also apparently unaware of the safety signal in females. Its response to the high number of reports of myocarditis and pericarditis generated by the mRNA vaccines has not been to withdraw the offending products, but instead to alter the safety information associated with these products and alert health professionals to look out for these very serious adverse events after the relevant vaccines have been administered: “[T]he product information for both monovalent COVID-19 Vaccine Moderna and COVID-19 Vaccine Pfizer/BioNTech was updated to inform healthcare professionals and patients of these reports and provide advice to be aware of important symptoms for myocarditis and pericarditis.”
The final piece of analysis reported here investigates whether the Yellow Card data yield a safety signal associated with female reproduction following inoculation with the mRNA COVID-19 vaccines. Figures 5a and 5b illustrate the results of PRR analysis for the PF and MO vaccines respectively. For PF there are significant safety signals in age groups 10 through to 40, while for MO a formal safety signal is only found in the youngest (10 to 20 year) age groups. The vast majority of the adverse event reports for female reproduction involve disruption to the menstrual cycle and excessive menstrual bleeding. Again, these have been recognised by the MHRA as side-effects of the mRNA vaccines but their severity has been downplayed, and no attempt has been made to formally identify safety signals despite the relevant data being available. As before, the MHRA has done 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 bleeding. … The product information for the Pfizer and Moderna COVID-19 vaccines is therefore being updated to add heavy menstrual bleeding as a possible side effect.”
A number of conclusions can be drawn from the analyses reported above. The first is that by applying PRR methodology it is possible to use the passively reported Yellow Card data to detect and quantify safety signals for novel vaccines, to gain insights into particular sex and age classes that may be affected by particular adverse reactions, and to compare the safety profile of different vaccines. The second conclusion is that the mRNA COVID-19 vaccines do not appear to be safe. Glaring safety signals are apparent indicating harm to the lymph system, the heart and to female reproduction. There can be no question that the mRNA vaccines should be withdrawn with immediate effect. The final conclusion is that the MHRA has provided no protection to the U.K. public from the adverse effects of the novel COVID-19 vaccines. Its regular publication “Coronavirus vaccine — summary of Yellow Card reporting” has been an exercise in defending the COVID-19 vaccines from criticism rather than defending the U.K. public from the COVID-19 vaccines. Its reports lack any scientific rigour, include not a single piece of statistical analysis to support the conclusions drawn, and are an affront to the huge number of individuals who have been injured or killed doing what they believed to be ‘the right thing’.
Dr. Richard Ennos is a retired Professor of Evolutionary Biology at Edinburgh University. He writes: “This article is dedicated to two groups within the U.K. First, the many who have been killed or injured by the rollout of the experimental and untested COVID-19 vaccines to an innocent and trusting U.K. public. Secondly to the dedicated physicians who have filed Yellow Card reports cataloguing the COVID-19 vaccine injuries and deaths. I would like you to know that your suffering and endeavours have not been in vain.”
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We are governed by an aristocracy of socialist nitwits who worship at the altar of Paul McCartney and Climate Change. It’s not hard to work out why things have deteriorated as they have when the so called right has effectively caved to this aristocracy over everything from gay marriage, nut zero and lock downs. Look at the stupid women wearing her spider, does she thinks she’s clever or something?
I wonder who you thing is in this “so called right”. All those who have “caved” seem to me to be social democrats.
Good observation, this is why I used the term so called, all worship Thunberg and McCartney. The low culture has infantilised almost all. Sorry but pop music is childish rubbish that pollutes the mind and morally corrupts.
The leftists were so in thrall of that spider broach, they were selling copies on ebay.
Is having a ruling class consistent with democracy?
There is always a ruling class, the question is are they in it for themselves/indifferent about whether ppl improve their lot, or in it for themselves/desperate to worse everyone else’s lot. Things worked fine with the former since the former till about 1995, since then with environmentalism it’s very much the latter. Nut zero and mass migration are the hammar for them to wreck ppls living standards.
If you have a democracy you can’t have a “ruling” class. You can have representatives that act on behalf of the people. But they aren’t rulers.
I agree with you that we’ve always had a ruling class and so by extension, never had a democracy really. The only thing that has changed in my view is that our ruling class, which has always acted on behalf of powerful, special interests, has lost much of its sense of moderation and are now doing it shamelessly without any guise or pretence.
Part of what has unmasked them is the internet and that has accelerated with smartphones and social media as uncontrolled information flows more quickly than ever. That’s a genie they are trying to put back in bottle with their new draconian digital laws.
Btw, everyone is in for themselves. Everyone. To expect otherwise is futile and will only lead to disappointment. It’s better to accept it and manage it as best as possible by identifying interests and incentives and aligning them.
We do need to love ourselves, to look after ourselves: but part of that should include wanting our neighbours to be content. After all, it will make our lives easier, and more enjoyable.
Not long after the Berlin Wall came down then, maybe there is some connection there.
1995 is three years after the Maastricht Treaty, time, for those inclined, to develop a new social network, ready to spread their malevolence, disguised as European Democracy. Perhaps there’s no disguise.
What’s your idea of democracy?
A system of collective government in which laws and rules are made by the majority or are understood to have the approval of the majority.
That would be my definition.
Then, it’s obviously possible to have a ruling class in a democracy, provided the ruling class gets popular approval for its policy decision, say, by holding Hitler-style ex post factum referendums.
I wouldn’t call them a ruling class though because they don’t rule. They represent. The majority of the people rule, supposedly.
It could be just semantics except that words seem to matter and if you call someone your ruler, that’s what you tend to end up thinking.
We used to have an aristocratic class which held sway in the HoL. Generally it was efficient and responded to democratic or social and economic pressure.
What we now have is a political class, Matt Goodwin calls them an elite, and David Goodhart descibes them as coming from the Nowhere section of the community. We did not used to have that. People could and did get into the senior ranks of the civil service and into Parliament without joining a club or adopting group-think. We were better governed than but instead we have had rulers imposed upon us who are every bit as oppressive as the less good sovereigns use to be and against whom deadly riots and the threat of insurrection hung over the country.
I’m not sure we were better governed. I think that perhaps the scope of governance has expanded to the point where we now have rules and regulations for every little bit of our lives, directly or indirectly.
But we shouldn’t forget that the rulers of the past were able to get away with, for example, sending millions of people to be butchered in trench warfare, in defence of god knows what exactly.
It’s beginning to seem to me as if we may just have lived through some very unusual goldilocks period in the late 20th century and very early 21st of prosperity and relative freedom. And now were heading back to a more common form of society where a ruling class shits all over the masses.
I get that impression when I watch old British comedies from the 70s 80s & 90s. We seem to be in a decay now despite state of the art technology.
The Political Bubble and those involved creating the ‘state of the art technology’ are two very different ‘communities’, probably distinguished by the usefulness of the undergraduate degrees.
In fact 2.67 million British soldiers joined as volunteers and 2.77 million as conscripts during WW1.
We have lived through ‘The (European) Long Peace’, 1945-2014, as a consequence of conventional deterrence in Europe, Britain defence spending 5% of gdp in 1950, dropping to 4% in the 1990s, to 3% in 1997 and then to 2%.
Hmmm…….
Recall the pax Britannica too.
There was less government and less government is invariably better government.
I call it the Liberal Progressive Virus. Symptoms include Group Think, decision making based on ideology rather than common sense, indulging in a symbiotic relationship with the scientists that you fund in order to give an air of authority to decision making, a desire to put the interests and goals of global entities like the UN and WEF first and the people that vote for you last.
There is only one cure. A return to Equal Justice for all, and Social Justice thrown into the trash. A ditching of post normal science and the return of evidence and observation based science. Conservatives must re-adopt conservative values and stop with this morphing into Labour Lite because they think there are more votes in it. Clearly as the polls are showing, there are not.
I’d argue most Tories are hard left, they just don’t know it.
I think a large part of the love affair with the EU, the UN, WEF, WHO and others is that our MP’s dont have to make decisions, the ‘correct’ decision having been given to them on a platter to implement. Our Government is not sovereign, just a link in a chain. This is also why we as the citizenry have become disillusioned with them. Integrity, openness, accountability, have all fallen by the wayside. Tony Benn used to say that democracy was the ability to say to our leaders, ‘we’ve had enough of you, now go’. How does that work when there are supra-national bodies above them, and quango’s below.
The Conservatives are not doing what they are doing because they think there are votes there.
First of all, our political parties don’t represent ordinary people. They are there to control ordinary people. They represent powerful, special interests who pick the individuals to lead the parties based on (a) their ability to pursue the policies that those power special interests want and (b) their ability to sell those policies to the general public while keeping them pacified.
Truss for example failed on (a) so she got tossed out and replaced by Rishi Sunak who at least fulfilled good stick to the right policy. But he has clearly failed with (b). The Conservatives have no public support. Luckily they have Starmer in the Labour Party or Team B as I like to call it. He is good with (a) – the policy. And will just about get the job done with (b) – by winning an election and at least temporarily giving the impression that these monstrous policies have public support, because after all that’s what winning an election means, right?
Sunak is falling on his sword by sticking to grotesque unpopular policies because he’s really interviewing for some future establishment post in an NGO or an institution for when he gets dumped in the election.
And just for good measure, any attempt to create a new party that isn’t beholden to these powerful special interests and actually represents ordinary people is quickly crushed. The system is rigged against any new party anyway, but if by any chance it gets momentum they’ll do whatever it takes to crush it.
That’s the piece of shit of system we have. To think it’s anything other than that is an illusion.
Best to get out of one’s mind that any of these clowns represent any of us or care about anything but themselves. Certainly none of the ones who make it to senior positions.
So, Increase the perceived level of personal threat by hard-hitting emotional messaging
was an example of holders of public office acting honestly while Johnson’s I honestly don’t give a shit about this virus! wasn’t? Would it have been more honest for Johnson to maintain the facade of lies even in private, then?
How utterly bizarre.
We can expect more of the same downward spiral with assistance from graduates from Brasenose.
I do not agree that the habit of handing over regulatioin to unaccountable Quangos is only ten years old. The Financial Standards Authoruty had the power to make its own rules which had the authority of the law and to judge its own priorities for enforcement and penalties.
When it favoured big business and penalised the small it could not be challenged; when big business told it to get out of the way, it did so. Subsequently its trainees were given high paid jobs in the regulated businesses and with their successors at the FSA formed a nomenclatura who could not be gainsaid.
Ministers and MPs and journalists were not prepared to consider any complaints because they held the FSA as righteous and beyond challenge. That’s how Northern Rock went wrong but it could not be admitted nor dealt with other than with ever more regulations, higher cost and restrictions oin business innovation and competitiveness.
Huge amounts of business has left or stopped coming to London because of the FSA.
The administrative state has been growing out of control for several decades. The scope of the state is far too great. Reducing the state’s overall scope and decentralizing as far as practicable are imperative if democratic oversight of the state is to be restored.
“Holders of public office must avoid placing themselves under any obligation to people or organisations that might try inappropriately to influence them in their work. They should not act or take decisions to gain financial or other material benefits for themselves, their family, or their friends”
I think that ship has well passed, and back again!
“Holders of public office should act and take decisions in an open and transparent manner. Information should not be withheld from the public unless there are clear and lawful reasons for so doing”
Speaking of the epic fail LOL.
A somewhat over long review of a nonsensical power grab book. Ever since Blair and his Wicked Witch introduced the laughable Supreme Court the lawyers et al have sought to be “The Power” rather than simply implement the Law laid down by an elected Parliament.
One notes that at no point does the author of the book mention who polices the Courts. He wishes to introduce a list of things other people must adhere to. He and his brethren then hold them to account. Who holds him to account?
There is a very good reason in these disparate and divided nations why Parliament is Sovereign: fools like the author of the book would decide everything and who votes for a senior Judge? Judges.
“A somewhat over long review of a nonsensical power grab book”
I disagree. It is a worthwhile review which is highly critical and necessarily explains those criticisms.
Furthermore if the book is a blueprint for news laws by Starmer’s national socialist party then it is worth having the reviewer’s J Sorel’s views spelt out to counter those of the book’s author, John Bowers KC.
It is ironic that the book’s author is a KC when a large part of the decline of standards particularly in law and the legal system has been created by corrupt practices in the English Bar and by some of the judges who fill the benches of the courts who are drawn from the English Bar’s ranks.
The leftist establishment is a neo-aristocracy whose purpose is to rule not serve the public. They will use the courts and international treaties to negate the democratic will. Any future government serious about restoring freedom and prosperity will need first to restore democracy. The Conservative Party is incapable of such a radical, reforming mission and the destruction of this utterly corrupt party is a necessary condition for a free and prosperous future.