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COVID-19 vaccination campaigns around the globe have failed to meet fundamental standards of safety and efficacy, leading to mounting evidence of significant harm. More than 81,000 physicians, scientists, researchers, and concerned citizens, 240 elected government officials, 17 professional public health and physician organizations, 2 State Republican Parties, 17 Republican Party County Committees, and 6 scientific studies from across the world have called for the market withdrawal of COVID-19 vaccines. As of September 6, 2024, the CDC has documented 19,028 deaths in the United States reported to the Vaccine Adverse Event Reporting System (VAERS) by healthcare professionals or pharmaceutical companies who believe the product is related to the death. The total number of COVID-19 vaccine deaths reported to VAERS (37,544 among all participating countries) have far exceeded the recall limits of past vaccine withdrawals by up to 375,340%. The criteria for an FDA Class I recall, which applies to products with a reasonable probability of causing serious adverse health consequences or death, have been far exceeded. Excess mortality, negative efficacy, widespread DNA contamination, and a lack of demonstrated reduction in transmission, hospitalization, or mortality have undermined the rationale for continued administration. These unified requests for regulatory action underscore substantial shortcomings in data safety monitoring and risk mitigation. Immediate removal of COVID-19 vaccines from the market is essential to prevent further loss of life and ensure next steps are taken for accountability of the harm incurred.
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COVID-19 Vaccine, DNA Contamination, Excess Mortality, Market Withdrawal, Negative Efficacy, Pharmaceutical Recalls
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The approval of COVID-19 vaccines was based on expedited Emergency Use Authorization (EUA) processes that prioritized addressing the urgent public health crisis posed by SARS-CoV-2. Early randomized controlled trials (RCTs) demonstrated a 95% relative risk reduction in symptomatic COVID-19, a metric that underpinned the decision for widespread rollout [1, 2]. However, these trials present serious methodological concerns [3]. The trials were prematurely terminated, and placebo groups were unblinded, effectively eliminating the ability to assess long-term safety and adverse events. Key subgroups, such as children, pregnant women, and immunocompromised individuals, were excluded, and trial endpoints focused on reducing mild symptoms rather than severe disease or mortality. This design bias limited the ability to evaluate the true risk-benefit profile of the vaccines [3]...
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Excess Mortality
Instead of saving lives, mass COVID-19 vaccination has likely led to increased mortality (Table 1) [9-20]. The largest autopsy study published to date indicates that 73.9% of deaths after vaccination are a direct cause or significantly contributed to by COVID-19 vaccination, demonstrating a high likelihood of a causal link between COVID-19 vaccines and death [9]. By September 2023, Rancourt et al. estimated 17 million COVID-19 vaccine-related deaths worldwide [10]. Mostert et al. reported 3.1 million excess deaths potentially attributed to COVID-19 vaccination and lockdowns across 47 Western countries from 2020 to 2022 [11]. The significant discrepancy in excess mortality figures between Rancourt and Mostert likely arises from the scope and timeframe of their estimates: Rancourt’s analysis accounts for 195 countries up to the end of 2023, while Mostert’s focuses on 47 Western countries up to 2022. In the United States, Skidmore estimated that 278,000 Americans may have died from COVID-19 vaccines by December 2021 [12], while Pantazatos and Seligmann projected between 146,000 to 187,000 vaccine-associated deaths by August 2021 [13]. Hulscher et al. estimated 49,240 excess cardiac arrest deaths in the U.S. between 2021 and 2023, potentially linked to COVID-19 vaccination [14]. Aarstad and Kvitastein found a significant association between higher vaccine uptake and increased all-cause mortality [15]. Alessandria et al. revealed that individuals vaccinated with one or two doses faced higher all-cause mortality risks compared to unvaccinated individuals, with those receiving two doses losing 37% of life expectancy during follow-up [16]. Lataster further demonstrated a consistent positive correlation between COVID-19 vaccination rates and excess mortality for every month analyzed [17]. Allen uncovered a significant correlation between Australian excess deaths and COVID-19 booster injections, whereas no significant correlation was observed with the unvaccinated population [18]. Kuhbandner and Reitzner observed a significant positive correlation between COVID-19 vaccination rates and the rise in excess mortality during the second and third pandemic years in Germany, with this correlation becoming particularly pronounced in the third year [19]. Rodrigues and Andrade found that COVID-19 vaccination nearly doubles the risk of death from all causes after one-year post-COVID infection [20].
While these studies highlight concerning correlations and potential causative links between COVID-19 vaccines and death, the calculations and findings reported are subject to several limitations. Variability in data quality across different studies, reliance on observational data, and potential confounding factors such as underlying health conditions, reporting biases, and incomplete vaccination records may influence the results. Additionally, causation cannot be definitively established from correlations alone, necessitating further investigation through well-controlled longitudinal studies. Nonetheless, these findings raise profound concerns about the safety and public health impacts of COVID-19 vaccination programs.
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FDA Class I Recall Indicated
The FDA’s threshold for a Class I recall—defined as a situation where the use or exposure to a violative product poses a reasonable probability of causing serious adverse health consequences or death [21]—has been greatly surpassed. This involves completely withdrawing a product from public markets. In most cases, product recalls are initiated by the company itself, either voluntarily or following the FDA’s recommendation, with the FDA overseeing the recall process. However, for vaccines, biologics, medical devices, and controlled substances, the FDA holds the authority to mandate a recall if necessary [22]. The FDA recalls thousands of products each year and the number of Class I recalls continues to trend upward [23]. According to Anne Reid, program director of the Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) at the FDA, “Medical devices lead the number of recalled products in fiscal years 2012 through 2024, with a total of 32,336 recalls occurring over that time period compared to product types such as food and cosmetics (26,184 recalls), drugs (16,137 recalls), and biologics (11,605 recalls)” [24].
As of April 26, 2024, according to VAERS, the total number of reported COVID-19 vaccine deaths (37,544 among all countries that use VAERS) have far exceeded the recall limits of past vaccine withdrawals by up to 375,340% (Figure 2) [25, 26]. In 1955, the Cutter polio vaccine was immediately recalled after 10 death reports [27]. The swine flu vaccine of 1976 was recalled after 53 reported fatalities [25]. In 1999, the Rotashield vaccine was suspended after 15 cases of intussusception [28]. The substantial contrast between COVID-19 vaccine death reports and historical vaccine recalls indicates significant shortcomings in data safety monitoring.
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Reported Deaths for Major Drug/Vaccine Recalls Versus Total COVID-19 Vaccine Deaths Reported to VAERS. *Figure reprinted from Rhodes and Parry [25], who obtained permission from VAERS Analysis to use their figure [26]. Permission to use this figure has been granted in accordance with the open access Creative Common CC BY-NC 4.0 license.
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...These findings indicate that DNA contamination, reported across multiple manufacturers, vaccine platforms, and geographic regions, far exceeds the thresholds recommended by regulatory agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), typically set at <10 ng per clinical dose [45]. Moreover, DNA contamination levels below regulatory thresholds may still pose significant health risks...
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Calls for Market Removal of COVID-19 Vaccines
More than 81,000 physicians, scientists, researchers, and concerned citizens, 240 elected government officials, 17 professional public health and physician organizations (Figure 3), 2 State Republican Parties, 17 Republican Party County Committees, and 6 scientific studies from across the world have called for the market withdrawal of COVID-19 vaccines (Table 3)...
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We expect that calls for an immediate moratorium on COVID-19 vaccines will continue to increase until a critical mass is reached, and the products are finally removed from the market. Excess mortality, negative efficacy, and widespread DNA contamination associated with COVID-19 vaccines have been sufficiently demonstrated. The FDA’s criteria for a Class I recall have been far exceeded. No large-scale, conclusive, randomized, double-blind, placebo-controlled trials have demonstrated reduction in infection transmission, hospitalization, or death as primary endpoints. Thus, the COVID-19 vaccines are not proven to be effective in reducing important clinical outcomes. A position supporting COVID-19 vaccination goes against good medical practice and violates the Hippocratic Oath to above all, do no harm. Immediate removal of COVID-19 vaccines from the market is essential to prevent further loss of life and ensure the next steps for accountability are taken.
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We want to thank Dr. Kenji Fujikawa, PhD, (Institute of Medical Statistics, Information, and Communications, Japan) for granting us permission to use the table he created, Verifications of mRNA Vaccine DNA Contamination in the World.
Funding: None
Conflicts of Interest: None
Institutional Review Board Statement: The paper did not require ethical approval.
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References
1
Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577. https://doi.org/10.1056/NEJMoa2034577
2
Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389. https://doi.org/10.1056/NEJMoa2035389
3
Mead, M. N., Seneff, S., Wolfinger, R., Rose, J., Denhaerynck, K., Kirsch, S., & McCullough, P. A. (2024). COVID-19 Modified mRNA “Vaccines” Part 1: Lessons Learned from Clinical Trials, Mass Vaccination, and the Bio-Pharmaceutical Complex. International Journal of Vaccine Theory, Practice, and Research, 3(2), 1112–1178. doi: 10.56098/fdrasy50. https://doi.org/10.56098/fdrasy50
4
Jones JM, Manrique IM, Stone MS, et al. Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections Among Blood Donors, by COVID-19 Vaccination Status – United States, April 2021-September 2022. MMWR Morb Mortal Wkly Rep. 2023;72(22):601-605. Published 2023 Jun 2. doi:10.15585/mmwr.mm7222a3. https://doi.org/10.15585/mmwr.mm7222a3
5
Centers for Disease Control and Prevention. COVID Data Tracker. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2024, December 01. https://covid.cdc.gov/covid-data-tracker...
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