Published on Aug. 31 after being peer-reviewed in the journal Vaccine—known for publishing the highest quality vaccinology research—contains inconvenient findings about the safety of mRNA vaccines.
The researchers conducted a secondary analysis of randomized, controlled data from Pfizer and Moderna’s phase III clinical trials, focusing on “adverse events of special interest (AESIs)” as listed by the Brighton Collaboration—a “global authority” on vaccine safety. As the authors write, this World Health Organization-approved priority list of adverse vaccine events has not been used to examine side effects in COVID-19 vaccine trial data.
The stunning finding was as follows: The risk of serious adverse events from the Moderna and Pfizer vaccine exceeds the benefit of reduction of COVID-19 hospitalization. In the analysis, Moderna caused higher adverse events than Pfizer, but both were elevated compared to the placebo arm.
“[H]igher risk of serious AESI was observed in the mRNA COVID-19 vaccine group relative to placebo in both the Pfizer and Moderna adult phase III trials, with 10.1 (Pfizer) and 15.1 (Moderna) additional events for every 10,000 individuals vaccinated.”
The average risk difference across both vaccines was 12.5 serious AESIs per 10,000 individuals vaccinated. As the authors write, these results “raise concerns that mRNA vaccines are associated with more harm than initially estimated at the time of emergency authorization.”
One of the key differences between the authors’ analysis of the Pfizer trial and the FDA’s is the FDA calculated the number of participants with serious adverse events (SAEs) whereas the authors calculated the total number of SAEs (many vaccinated participants experienced multiple SAEs). Another difference between the two is the criteria for including participants. The FDA’s analysis (126 SAEs per 21,621 vaccinated participants) strangely included those with only one dose across a wide range of post-injection follow-up times. The researchers’ review used a “study population with median follow-up ≥ 2 months after dose 2 (minus 120 HIV-positive participants), of which 98.1 % had received both doses.” They comparatively found 127 SAEs per 18,801 vaccine recipients.
“The FDA’s analysis of SAEs thus included thousands of additional participants with very little follow-up, of which the large majority had only received 1 dose,” the authors wrote.
The authors also highlight the differential risk-reward propositions based on a variety of factors, including age, sex, and comorbidities. The calculus for younger, healthier, and previously infected individuals would “shift towards harm,” while older, more overweight, and vitamin-D-deficient individuals would have more to gain from vaccination. The most common adverse events in the Moderna and Pfizer trials were “coagulation disorders” (“disruptions in the body’s ability to control blood clotting”).
The authors are also honest about the limitations of their study:
“First, Pfizer’s trial did not report SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AESIs in the Pfizer trial. Second, for both studies, the limited follow up time prevented an analysis of harm-benefit over a longer period.”
All these limitations stem from the public unavailability of raw data from the vaccine trials, the authors add.
The most conservative, minimalist conclusion one can draw from this study is that vaccines may not confer net benefit to everyone, therefore universal mandates were dangerous, unscientific, and unethical. They led to marginalization and systemic discrimination of the unvaccinated and untold preventable vaccine injuries among healthy people in particular. Not to mention all the economic, cultural, and political divisions that were exacerbated.
Prior to this study, numerous real-world case studies and informal analyses by observers indicated vaccine risks exceeded benefits. Other data—advertised by governments and media organizations—pointed in the opposite direction.
However, this robust study—even if limited and flawed—has cast doubt on the indisputable religious truth that getting vaccinated is in everyone’s best interest. Unlike other analyses where critics come after “fringe” and “conspiratorial” scientists, this study was led by epidemiologists working at prestigious institutions such as UCLA and Stanford. Notably, Dr. Sander Greenland, one of the leading epidemiologists and biostaticians in the United States, co-authored the study.
When citing sources for one’s rational vaccine hesitancy (assuming a relatively young age and negligible risk factors), one need not reference blog posts or highly confounded real-world data. Greenland and colleagues have set a precedent for honest vaccine research, and a much more rigorous study needs to be conducted before making further extrapolations.