As a university academic, and former pharmacist, whose speciality is misinformation, disinformation and fake news, I have been very active of late in collecting (and writing) papers appearing in medical journals that provide evidence and arguments against the COVID-19 vaccines. Below is a summary of some of the recent papers I find to be most concerning.
Vaccine effectiveness and safety exaggerated
An article appearing in the Journal of Evaluation in Clinical Practice, including BMJ Editor Peter Doshi amongst its authors, discusses several biases that, if not accounted for, indicate that the effectiveness of the mRNA COVID-19 vaccines in observational studies is being heavily exaggerated. The most important appears to be one many of us have worried about from the beginning, the dubious ‘case-counting window bias’, which concerns the seven days, 14 days or even 21 days after the jab where we are meant to overlook jab-related issues, particularly poor effectiveness, as “the vaccine has not had sufficient time to stimulate the immune system”. In an example using some data from Pfizer’s clinical trial, the authors show that thanks to this bias, a vaccine with effectiveness of 0%, which is confirmed in the hypothetical clinical trial, could be seen in observational studies as having effectiveness of 48%.
In a follow-up article in the same journal I revealed ways in which the situation may even be worse. The aforementioned ‘case-counting window bias’ is often accompanied by a ‘definitional bias’, whereby the Covid cases in the vaccinated are not just ignored, but shifted over to the unvaccinated. So building on the above example, a vaccine with 0% effectiveness can actually be perceived as having 65% effectiveness. My article also shows, touching on the intriguing (horrifying?) issue of negative effectiveness, “a vaccine with minus-100% effectiveness, meaning that it makes symptomatic COVID-19 infection twice as likely, can be perceived as being 47% effective”. Furthermore, “Repeated calculations will show that moderate vaccine effectiveness is still perceived even with actual vaccine effectiveness figures of minus-1,000% and lower”. I also explained that this exaggeration could equally apply to studies on vaccine safety, which would be important when comparing the overall health of the vaccinated and unvaccinated, as may be appropriate when looking into the mysterious rise in non-Covid excess deaths post-pandemic.
Doshi, joined by one of his earlier co-authors, decided to produce another article in the same journal, a follow-up to my follow-up, shifting the focus from observational studies to the clinical trials. They found that case counting “only began once participants were seven days (Pfizer) or 14 days (Moderna) post Dose 2, or approximately four to six weeks after Dose 1”. The obvious implication:
Decisions on when to initiate the case counting window affected calculations of vaccine efficacy. Because cases occurring in the four to six weeks between Dose 1 and the case counting window were excluded, reported vaccine efficacy against COVID-19 (the primary endpoint) at the time of Emergency Use Authorisation was higher than what would have been calculated had all COVID-19 cases after Dose 1 been included, as in a conventional Intent-to-Treat analysis.
They also found that “different case counting windows” were used at different times, ‘coincidentally’ yielding better results.
Not yet published, though under peer review, is my intended fourth and final article in this unofficial ‘series’. Firstly, I justify my earlier concern of exaggerated safety in observational studies, or studies built on observational data and models rather than data from controlled trials, by discussing a recently published paper in another journal, noting how the authors only count vaccine adverse effects from 14 days after the second dose (or seven days after the latest booster shot), and stopping the count at around four to five months. As if to highlight the potential magnitude of safety exaggeration with so many adverse effects being overlooked, the study, flawed as it is, showed only a very slight net benefit to vaccination. A more complete view of adverse effects (as well as cases in the ‘partially vaccinated’) could easily lead to the conclusion that the risks of COVID-19 vaccination outweigh the benefits. I also explain that there are issues with the adverse effect counting windows in the clinical trials in relation to their short length. The safety monitoring ends mere months after vaccination, though adverse effects can manifest clinically years later.
Vaccine-induced myocarditis and young males
In the latter article, and in a rapid response published by BMJ Open, I also discuss recent evidence and journal articles on myocarditis, with one finding a “Covid vaccine-induced myocarditis incidence rate of around one in 100,000, and around one in 19,000 for males between the ages of 12 and 17 years”. These authors also found that a significant number of people with Covid vaccine-induced myocarditis end up dead soon afterwards. Go ahead and contrast this with the U.K. Government’s determination of numbers needed to vaccinate to prevent a severe Covid hospitalisation being in the hundreds of thousands for young ‘no risk’ groups.
In research I hope to be published soon, I show how Pfizer estimates an even greater incidence of myocarditis in young males, and it also estimates that one million vaccinated will result in zero to one saved lives. Yes, zero is included as a real possibility. By Pfizer. It would appear that, at least for certain groups, this one adverse effect alone undoes the claim that the ‘risks outweigh the benefits’. The risk of vaccine-induced myocarditis may indeed be very small, but the risk of serious Covid in the young and healthy is smaller still. If you’re a young male and if you’ve received one of these novel COVID-19 vaccines, it may be worthwhile testing for preclinical myocarditis.
I couldn’t leave you hanging after dangling this juicy but horrifying morsel in front of you earlier. I managed to get another rapid response published, in the BMJ proper this time, on the topic of negative effectiveness. While rapid waning of effectiveness and exaggeration of effectiveness is concerning enough, particularly as we learn more about the adverse effects, the phenomenon of COVID-19 vaccine negative effectiveness could completely end the discussion as to whether the COVID-19 vaccines are net useful or not. There is increasing evidence for this phenomenon (in relation to infections, hospitalisations and deaths), with one study revealing a dose-dependent relationship. The more COVID-19 jabs, the more the risk of COVID-19. If that sounds concerning to you, well, quite. My rapid response effectively refuted an article in the BMJ trying – and failing horribly – to explain this phenomenon away. If negative effectiveness is occurring, there is no such thing as ‘risks vs benefits’. There is only ‘risks plus risks’. We need explanations from the manufacturers and regulators, as a matter of urgency.
Dr. Raphael Lataster is an Associate Lecturer at the University of Sydney, specialised in misinformation, and a former pharmacist. This summary is adapted from several entries originally appearing in Lataster’s Substack newsletter, Okay Then News. Read more on his research and legal actions, including his recent win against the healthcare vaccine mandate in New South Wales.