COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign
Careful, objective evaluation of COVID-19 mRNA product safety is crucial for upholding ethical standards and evidence-informed decision-making. Our narrative review concerning the registrational trials and the EUA’s aftermath offers evidence-informed insights into how these genetic vaccines were able to enter the market. In the context of the two pivotal trials, safety was never assessed in a manner commensurate with previously established scientific standards either for vaccines or for GTPs, the more accurate classification of these products. Many key trial findings were either misreported or omitted entirely from published reports. The usual safety testing protocols and toxicology requirements were bypassed by the FDA and vaccine manufacturers, and the premature termination of both trials obviated any unbiased assessment of potential SAEs due to an insufficient timeframe for proper trial evaluation. It was only after the EUA that the serious biological consequences of rushing the trials became evident, with numerous cardiovascular, neurological, reproductive, hematological, malignant, and autoimmune SAEs identified and published in the peer-reviewed medical literature. Moreover, the COVID-19 mRNA vaccines produced via Process 1 and evaluated in the trials were not the same products eventually distributed worldwide; all of the COVID-19 mRNA products released to the public were produced via Process 2 and have been shown to have varying degrees of DNA contamination. The failure of regulatory authorities to heretofore disclose process-related impurities (e.g., SV40) has further increased concerns regarding safety and quality control oversight of mRNA vaccine manufacturing processes.
Since early 2021, excess deaths, cardiac events, strokes, and other SAEs have often been wrongly ascribed to COVID-19 rather than to the COVID-19 mRNA vaccinations. Misattribution of SAEs to COVID-19 often may be due to the amplification of adverse effects when mRNA injections are followed by SARS-CoV-2 subvariant infection. Injuries from the mRNA products overlap with both PACS and severe acute COVID-19 illness, often obscuring the vaccines’ etiologic contributions. Multiple booster injections appear to cause immune dysfunction, thereby paradoxically contributing to heightened susceptibility to COVID-19 infections with successive doses. For the vast majority of adults under the age of 50, the perceived benefits of the mRNA boosters are profoundly outweighed by their potential disabling and life-threatening harms. Potential harms to older adults appear to be excessive as well. Given the well-documented SAEs and unacceptable harm-to-reward ratio, we urge governments to endorse and enforce a global moratorium on these modified mRNA products until all relevant questions pertaining to causality, residual DNA, and aberrant protein production are answered.
