(Summit News) 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 He concludes that: “There can be no question that the mRNA vaccines should be withdrawn with immediate effect.”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).
