According to Dr. Richard Ennos, a retired Professor of Evolutionary Biology at Edinburgh University, his analysis of the U.K.'s COVID-19 ‘Yellow Card' vaccine data for Pfizer and Moderna vaccines suggests “unequivocal safety signals” for adverse reactions that impact blood, heart, and female reproduction. He believes that the mRNA vaccines should be withdrawn immediately based on his findings.
In the UK, there are three COVID-19 vaccines – AstraZeneca (AZ), Pfizer (PF), and Moderna (MO) – being used in a nationwide vaccination campaign to prevent harm from the SARS-CoV-2 virus. All three vaccines provide the genetic code for the spike protein of the virus, which is linked to the development of COVID-19, so that the vaccine recipient's body can produce it. The AZ vaccine uses DNA for the spike protein genetic code and introduces it into the recipient's cells through a modified chimpanzee adenovirus vector. The genetic code used in PF and MO vaccines is modified RNA carried by lipid nanoparticles. The vaccines cannot control which tissues they reach, and how long those tissues will produce spike proteins.
The three available vaccines use new technology that has not been tested in humans before. Although they lack long-term safety data, they received Conditional Marketing Authorisation from the MHRA. To ensure their safety, the MHRA created the COVID-19 vaccine Yellow Card reporting scheme (C-19VYC). C-19YC is a platform that gathers reports of potential negative side effects caused by COVID-19 vaccines. By analyzing this data, safety signals can be detected and the vaccines can be withdrawn if necessary. Recently, detailed analysis of C-19YC's data has found safety signals related to adverse reactions caused by the mRNA vaccines PF and MO. These adverse reactions may impact the lymph system, heart, and female reproductive system.
The C-19VYC reporting scheme is beneficial because it can produce a large quantity of important information concerning negative responses to the COVID-19 vaccines in testing. Individuals who receive the vaccines can submit reports of possible adverse reactions directly to the MHRA, as well as physicians. This information can provide valuable insights to the MHRA based on personal experience. The inclusive feature of the C-19VYC reporting system has been highly effective, resulting in almost 500,000 reports of adverse events. This is approximately one report for every hundred people who received the COVID-19 vaccine in the United Kingdom.
Although the C-19VYC reporting scheme collects a large amount of data, it has several critical shortcomings related to the type of information gathered. These limitations restrict the scheme's capacity for identifying and measuring safety signals. One significant issue is that the system fails to identify or incorporate a control group of non-vaccinated individuals for comparison with those who have been vaccinated.
One of the main weaknesses is that reporting for adverse reactions is not planned and is a passive process. This means that it only happens when the person who experienced the reaction or their doctor connects it to the vaccine treatment. Additionally, the reporting is only done at one point in time. If there is a delay between treatment and an adverse reaction, it becomes more likely that the adverse event will not be recorded. Additionally, the reporting rates of adverse reactions may only represent a fraction of actual cases. This is because physicians or recipients may not have enough time to fill out the paperwork, may not know about the Yellow Card scheme, or may not want to consider the possibility that a trusted medication could cause harm.
Different sectors of the population are expected to have varying reporting rates, even though overall rates are low. Based on previous experience, females tend to report adverse event reports around three times more frequently than males. Moreover, the reporting of adverse reactions varies with age and tends to decrease among elderly populations, where the multiple forms of pre-existing chronic illnesses can obscure adverse reactions. It is possible that reporting rates will differ based on the severity of the adverse reaction. People may be more inclined to submit a report if the reaction is severe rather than mild due to higher motivation and determination. However, if an adverse event leads to death, the grieving loved ones may not be able to file a C-19VYC report due to being preoccupied.
It is important to acknowledge the restrictions of the C-19VYC program in order to effectively utilize the substantial amount of data it has generated. The MHRA has indicated in its published summaries that the Yellow Card data cannot accurately determine the actual rates of unfavorable effects or make comparisons between the different vaccines' safety due to the limitations of the data and the presence of many variables. I see the MHRA's statements as a challenge. In the rest of this article, I will try to prove that the MHRA's viewpoint is too negative and that the significant efforts of individuals who have reported negative effects of COVID-19 vaccines through Yellow Cards have been worthwhile.
To conduct an independent analysis of the C-19VYC reports, it is crucial to have access to the raw data. An FOI request was submitted in June 2021 for the full anonymized C-19VYC data. Requests for raw data, including this one, have been declined because it is deemed too burdensome to provide and because the data is expected to be published in the future. The MHRA promptly shares C-19VYC information with COVID-19 vaccine manufacturers. It took 18 months for the MHRA to release detailed C-19YC scheme data that allows for independent analysis and calculation of safety signals.
Based on a quick analysis of the C-19VYC data, the adenovirus AZ vaccine has a much higher rate of reporting serious and fatal adverse events compared to the mRNA vaccines from PF and MO. Specifically, there are 3.912 serious or fatal reaction reports per 1,000 doses for the AZ vaccine, while the PF and MO vaccines have 1.341 and 1.344 serious or fatal reaction reports per 1,000 doses respectively. While the MHRA has not officially withdrawn the AZ vaccine, it is no longer being used due to safety concerns. The focus now shifts to identifying any potential safety issues with the remaining COVID-19 vaccines, which are the PF and MO mRNA vaccines still in use.
As I mentioned before, the data obtained from the Yellow Card scheme are based on passive reporting, which makes it difficult to perform detailed analyses using the absolute numbers of adverse reaction reports. However, there is a well-established method called proportional reporting rate analysis (PRR) that can be used to identify safety signals using passive reporting data collected by the C-19VYC scheme. The principles of the PRR protocol are explained below.
We want to determine if the new vaccine causes more cases of severe headaches than other vaccines. If there is no link between the new vaccine and severe headaches, then the percentage of severe headaches should be the same for both the new and established vaccines. If administering the new vaccine leads to severe headaches, the proportion of adverse reaction reports mentioning severe headaches will be higher for the new vaccine than for the existing vaccines. To measure the strength of the safety signal for severe headaches caused by the novel vaccine, we can divide the proportion of adverse events that mention severe headaches in the novel vaccine by the same proportion calculated for the established vaccines. This will give us the proportional reporting rate or PRR.
To formally detect a safety signal, three conditions must be met. Firstly, there should be a considerable number of reports related to the adverse reaction in the new vaccine database. Secondly, the percentage of all reports mentioning the adverse reaction should be significantly higher for the new vaccine compared to the established ones. To determine if the novel vaccine is effective, a ‘chi squared' test can be used. Additionally, the proportion of adverse reactions should be calculated and must be twice as high for the novel vaccine compared to the established vaccines (PRR>2).
In order to use the PRR methodology to identify safety signals for the PF and MO mRNA COVID-19 vaccines, we assume that the AZ vaccine does not make the specific adverse reactions we are investigating more common. This assumption is made with a great deal of caution. In the PRR analysis, the AZ vaccine is considered as the established, safe vaccine. This means that the proportion of the selected adverse events expected in a safe and established vaccine is calculated using data from the AZ vaccine.
Firstly, we determine the proportions of adverse event reports selected from both the Pfizer (PF) and Moderna (MO) data. Then, we compare these proportions to the proportion of adverse events calculated for AZ. This comparison allows us to calculate the PRR. If the mRNA vaccines have a considerably higher proportion of the chosen adverse event reports than the AZ vaccine and the PRR for the mRNA vaccine is two or greater, this indicates a strong safety signal. Appropriate action and investigation are then necessary.
In December 2022, the MHRA made public two data files for each of the three COVID-19 vaccines under the C-19VYC program. The initial file includes an identification number for every Yellow Card report, along with the gender and age of the person affected, and an indication of how severe their adverse reaction was, categorized as non-serious, serious, or fatal.
The second dataset contains the report identifier along with different medical classifications of the adverse events experienced. It's possible for one report to have multiple adverse events. The classification based on the type of tissue affected by the adverse reaction, such as muscle, nerve, or blood, may be the easiest for non-medical professionals to understand. One can merge the two datasets to make a single file for each COVID-19 vaccine which contains the report identifier, sex and age of the patient, type of tissue affected by the first adverse event mentioned in the report (to prevent repetitive reports), and the severity of the adverse reaction.
The file mentioned earlier is being utilized for PRR analysis, aimed at identifying and evaluating safety signals connected to the negative impacts of mRNA vaccines PF and MO on the blood (such as harm to the blood and lymph system), cardiac system (like harm to the heart), and reproduction among females (like harm to the menstrual cycle).
We focused only on severe adverse reactions (those that are serious or fatal), to ensure that the adverse reactions we are analyzing are not considered insignificant by those who experience them. The PRR values reported in our study have been calculated based on samples that are matched for age and sex. This was done because reporting rates can vary depending on these factors.
By doing so, we can compare the vulnerability to certain adverse reactions between different age groups and between males and females. This information is provided in the English language. Please be aware that the analysis method we used provides conservative estimates for the strength of safety signals since it assumes the AZ vaccine does not increase the rate of the adverse reaction being studied. If in reality the AZ vaccine does increase this rate, the safety signal strength associated with the mRNA vaccine concerned could be higher than what we have reported.
The PRR analysis results for adverse reactions associated with the PF vaccine that affect blood and lymph systems are presented in Figure 1a for females and Figure 1b for males. There are noteworthy safety signals observed for both sexes except the oldest age group, with severe adverse events often more than eight times higher after PF vaccine compared to AZ vaccine.
The safety signals for the other mRNA vaccine are above the threshold level in most female age groups and in males aged 20-49. This shows that there may be safety concerns related to the vaccine. Most of the severe adverse reactions caused by the COVID-19 mRNA vaccines affect the lymph system and are diagnosed as lymphadenopathy. It is concerning that the MHRA's “Coronavirus vaccine – summary of Yellow Card reporting” in January 2023 did not mention any possible adverse effects of the mRNA vaccines on the lymph system, despite the presence of a significant safety signal when analyzing Yellow Card data appropriately.
Applying PRR analysis to examine the potential harmful effects of PF vaccination on the heart (cardiac, Figures 3a and 3b) indicates a notable safety issue for males aged 10-50. For females, PRR values approaching the threshold level of 2 are observed for ages 30-80.
Figures 4a and 4b show that the pattern of safety signals for severe cardiac disorders in the vaccine MO is similar to that of PF. There are high and statistically significant proportional reporting ratios in young males aged 10 to 40 years old. In addition, females aged 50 to 80 years old show reporting ratios that are close to or slightly above 2.
According to the Yellow Card summary of MHRA, there is a higher reporting of myocarditis and pericarditis with both the COVID-19 Vaccine Pfizer/BioNTech and COVID-19 Vaccine Moderna. Additionally, these events appear to occur more frequently in males. However, it seems that no formal safety signal has been demonstrated using the Yellow Card data in the manner described above. The mRNA vaccines have been associated with an increased number of reports of myocarditis and pericarditis in females. However, instead of withdrawing the vaccines, the regulatory body has modified the safety information and instructed healthcare providers to monitor for these serious adverse events after administering the vaccines:
This analysis aims to determine if there is a safety concern for female reproductive health after receiving mRNA COVID-19 vaccines, by examining data from the Yellow Card reporting system. The PRR analysis results for the PF and MO vaccines are shown in Figures 5a and 5b. The results indicate that significant safety signals are observed for PF vaccine in age groups ranging from 10 to 40 years. However, for MO vaccine, a formal safety signal is only observed in the age groups of 10 to 20 years. Most of the adverse event reports related to female reproduction indicate problems with their menstrual cycles and excessive bleeding during periods.
The MHRA has acknowledged these as possible side effects of mRNA vaccines, but their seriousness has not been properly addressed. Although the relevant data is available, no formal safety signals have been identified yet. The Yellow Card data has revealed severe adverse reactions to the mRNA vaccines, and the MHRA has not taken action to protect the public. The latest review suggests a potential link between the Pfizer and Moderna COVID-19 vaccines and heavy menstrual bleeding. Therefore, the product information for these vaccines will be updated to include heavy menstrual bleeding as a possible side effect.
The analyses show that using the PRR methodology can help identify and measure safety signals for new vaccines based on passively reported Yellow Card data. It can also provide information on which age and sex groups may be more affected by specific adverse reactions. Additionally, it enables comparison of the safety profiles of different vaccines. The message suggests that the mRNA COVID-19 vaccines are not safe due to safety signals of harm to the lymph system, heart, and female reproduction. It recommends that the vaccines be withdrawn immediately. Based on the available information, it seems that the MHRA has not effectively protected the public in the UK from any negative effects caused by the COVID-19 vaccines. The publication “Coronavirus vaccine – summary of Yellow Card reporting” appears to be more focused on defending the vaccines instead of safeguarding the public. The reports do not have scientific evidence and do not use statistics to support the conclusions. They disrespect the individuals who were injured or died while trying to do the “right thing”.
Dr. Richard Ennos, who is a retired Professor of Evolutionary Biology at Edinburgh University, wrote: