Our understanding of COVID-19 vaccinations and their impact on health and mortality has evolved substantially since the first vaccine rollouts. Published reports from the original randomized phase 3 trials concluded that the COVID-19 mRNA vaccines could greatly reduce COVID-19 symptoms. In the interim, problems with the methods, execution, and reporting of these pivotal trials have emerged. Re-analysis of the Pfizer trial data identified statistically significant increases in serious adverse events (SAEs) in the vaccine group. Numerous SAEs were identified following the Emergency Use Authorization (EUA), including death, cancer, cardiac events, and various autoimmune, hematological, reproductive, and neurological disorders. Furthermore, these products never underwent adequate safety and toxicological testing in accordance with previously established scientific standards. Among the other major topics addressed in this narrative review are the published analyses of serious harms to humans, quality control issues and process-related impurities, mechanisms underlying adverse events (AEs), the immunologic basis for vaccine inefficacy, and concerning mortality trends based on the registrational trial data. The risk-benefit imbalance substantiated by the evidence to date contraindicates further booster injections and suggests that, at a minimum, the mRNA injections should be removed from the childhood immunization program until proper safety and toxicological studies are conducted. Federal agency approval of the COVID-19 mRNA vaccines on a blanket-coverage population-wide basis had no support from an honest assessment of all relevant registrational data and commensurate consideration of risks versus benefits. Given the extensive, well-documented SAEs and unacceptably high harm-to-reward ratio, we urge governments to endorse a global moratorium on the modified mRNA products until all relevant questions pertaining to causality, residual DNA, and aberrant protein production are answered.
COVID-19 can have short- and long-term health consequences, including various cardiovascular, respiratory, hematologic, autoimmune, and neurological conditions. Although it is often claimed that COVID-19 mRNA vaccinations reduce COVID-19 severity and post-acute sequelae, these assertions are refuted by evidence of extensive mRNA immunization-related harms that appear to be amplified by SARS-CoV-2 infection, resulting in considerable overlap in reported adverse outcomes. Spike proteins from both sources persist in the human body over the long-term, leading to immune dysfunction, inflammation, autoimmunity, organ dysfunction, and overlapping toxicities. We hypothesize that the mRNA vaccinations create a persistent toxic milieu of spike protein, inflammatory lipid nanoparticles, and DNA impurities, amplifying morbidity and mortality risks commonly ascribed to SARS-CoV-2 infection. Many 2021-2024 morbidity/mortality events in highly vaccinated populations, though often attributed solely to COVID-19 illness (due to close temporal associations with laboratory-confirmed infection), were more likely to result from these interactions or “hybrid harms”. Evidence supporting our hypothesis includes studies of negative efficacy, overlapping pathologies (e.g., myocarditis and thrombosis), redundant mechanisms, and epidemiological surges in excess mortality during the Omicron era (since December 2021) in extensively vaccinated countries. Case report data indicate that spike protein production along with associated “spikeopathies” may persist for at least three years, during which a coronavirus infection could trigger a new disease syndrome that would logically be attributed to the infection based on the timing. In contrast there is a relatively mild course for Omicron infections in the unvaccinated. Ongoing spike production from prior mRNA vaccinations is likely to predispose Omicron-infected individuals to cumulative adverse effects over time. The amplified toxicities and immunopathologic effects may help account for near-synchronous waves of COVID-19 and all-cause mortality in the Omicron era. This novel framework calls for re-examining the unique immunopathological consequences of SARS-CoV-2 breakthrough infection in COVID-19 mRNA-vaccinated individuals and consideration of the implications for future public health strategies.
The currently approved COVID-19 mRNA boosters carry a warning for acute, clinically apparent, vaccine-induced myocarditis. This serious condition has resulted in hospitalization and, in well-documented cases, fatalities. However, there is growing concern that long-lasting synthetic mRNA and persistent production of SARS-CoV-2 Spike protein may accumulate in the heart and cause cardiotoxicity over time. Additionally, subtler cardiovascular symptoms, which may not require immediate hospitalization, can also develop. Such symptoms include atypical or pleuritic chest pain, palpitations, intermittent arrhythmias, labile blood pressure with hyper- and hypotension and effort intolerance. Areas of inflammation found at autopsy too small to be detectable by cardiac magnetic resonance imaging have been associated with sudden death. Alarmingly, the initial presentation can include cardiac arrest with no premonitory symptoms. A thorough evaluation, including history of SARS-CoV-2 infections, the number and type of mRNA COVID-19 vaccines received, quantitative Spike protein antibody levels, ECG, imaging, and laboratory tests, form the cornerstone of initial assessment. Clinical and preclinical observations suggest combined oral administration of nattokinase, bromelain, and curcumin may support detoxification of the heart and cardiovascular system from Spike protein. The addition of colchicine and other targeted therapies may be essential in reducing myocardial and systemic vascular inflammation. These approaches hold promise to risk mitigation of sudden cardiac death in immunized individuals affected by subclinical COVID-19 vaccine induced myopericarditis.
The coronavirus disease of 2019 (COVID-19) has the potential to cause or promote a number of health problems in both the short and long terms. It is often claimed that the COVID-19 messenger RNA (mRNA) vaccinations can reduce the severity of COVID-19 and its sequelae. We counter this claim with evidence and moreover hypothesize that the mRNA vaccinations are triggering mechanisms that result in an amplification of COVID-19 morbidity along with the “post-acute sequelae of COVID-19” or PASC. Since 2021, the coronavirus infections were often superimposed on a preexisting mRNA vaccine-induced milieu of toxic spike protein, inflammatory lipid nanoparticles, and residual process-related DNA impurities. Spike proteins resulting from both the mRNA vaccination and the natural SARS-CoV-2 infection have been shown to persist for extended periods, raising parallel concerns regarding potential implications for long-term safety with this vaccination. Many, if not most, of the morbidity and mortality events attributed to COVID-19 in extensively-vaccinated populations in 2022-2023 were due to the long-term background persistence of spike protein and other vaccine-associated components resulting from previous COVID-19 mRNA vaccinations. Although close temporal associations with laboratory-confirmed SARS-CoV-2 often engendered the assumption of viral causation, the morbidity and mortality events are plausibly attributed to a combination of mass vaccination and coronavirus infections. The overlapping spike-related toxicities and immunological effects of mRNA vaccinations and coronavirus infections have resulted in pronounced immune dysregulation and inflammatory cascades that likely account for near-synchronous waves of COVID-19 and all-cause mortality. We present research suggesting a potential for coronavirus infection-induced amplification of adverse events (AEs) associated with the COVID-19 mRNA vaccinations, including a diverse range of cardiovascular, hematological, autoimmune, and neurological conditions that frequently overlap with PASC. In this paper, we coin the phrase “Hybrid Harms Hypothesis”, which calls for re-examining the unique immunopathological dynamics of coronavirus infection in COVID-19 mRNA-vaccinated individuals and their implications for public health strategies.
We revisit a 2023 JAMA-published analysis of data from patients admitted for either COVID-19 or influenza to U.S. Veterans Administration (VA) hospitals in the fall/winter of 2022-2023. We note that baseline characteristics between the cohorts were similar, and the difference in vaccination rates was minimal, even after propensity score weighting. Had the vaccines been even minimally effective, significant differences in vaccination percentages would be expected. These findings call into question any efficacy claims associated with either the COVID-19 or influenza vaccines. Furthermore, the lack of efficacy of the influenza vaccines in reducing hospitalization is consistent with an earlier detailed study that found the same lack of efficacy, further validating the current result. This suggests that comparing vaccination rates between those hospitalized for different vaccine-preventable diseases can serve as a practical method for validating the vaccine efficacy claims of different vaccines.