Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits

Abstract

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.

Introduction

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].

The CDC estimated that 70.3% of Americans aged ≥16 years had contracted COVID-19 by September 2022, using SARS-CoV-2 antibodies as measurement [4]. As of December 1st, 2024, we estimate that at least 90% of the entire U.S. population has contracted COVID-19 illness and has natural immunity to SARS-CoV-2. The CDC reported 1,212,008 fatalities occurring between January 1, 2020 and November 23, 2024, with a positive test for COVID-19 at some point before death [5]. Among those, 94% were above age 50 years. If adjudication was performed by expert clinicians, we estimate that approximately 10% of the total casualty count or 121,200 deaths may have COVID-19 pneumonia as the primary cause of death. Procter et al. have published that 85% of these deaths may have been avoidable with early multidrug protocols started on day 1 at home [6]. Figure 1 shows that, by September 6, 2024, the CDC has recorded 19,028 American COVID-19 vaccine deaths reported to them in the Vaccine Adverse Event Reporting System (VAERS) by healthcare professionals or pharmaceutical companies who believe the product is related to the death [7]. Approximately 1175 deaths have occurred on the same day of vaccination, and 1250 deaths on the day following vaccination. The deaths reported in VAERS are estimated to be underreported by a conservative multiplier of 31, based on a comparison between expected serious adverse event (SAE) rates from clinical trials and the observed reports in VAERS [8]. Pfizer’s clinical trial data indicated an SAE rate of 0.7%, which, when applied to the 197 million doses of COVID-19 vaccines administered in the U.S. by August 2021, would suggest approximately 1.4 million expected SAEs. However, VAERS documented far fewer cases, leading to the conclusion that only 1 in 31 deaths or serious adverse events is captured in the VAERS system due to its passive reporting nature and known underreporting challenges [8]​. This means the American death toll from COVID-19 vaccination may be 589,868 (19,028 x 31). Thus, it is our opinion that more Americans may have died of COVID-19 vaccination than from SARS-CoV-2 infection.

There are greater than 3400 peer reviewed manuscripts in the medical literature concerning fatal and nonfatal COVID-19 vaccine injuries including those recognized by regulatory agencies around the world such as myocarditis, neurologic injury, thrombosis, and immunologic syndromes. Emerging evidence from diverse global datasets indicates patterns of concerning adverse events and mortality trends associated with COVID-19 vaccination campaigns, raising critical questions about risk-benefit balance and long-term safety. Due to these significant concerns, we reviewed the literature for excess mortality, DNA contamination, and negative efficacy associated with COVID-19 vaccines, along with compiling a comprehensive list of all calls for an immediate moratorium.

Figure 1.

United StatesCOVID-19 Vaccine VAERS Adverse Event Reports. Adapted from OpenVAERS [7].

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].

Table 1.

COVID-19 Vaccine Excess Mortality.

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.

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.

Figure 2.

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.

Negative Efficacy

Multiple studies have demonstrated that COVID-19 vaccinated individuals may face a higher risk of infection compared to unvaccinated individuals. Eythorsson et al. found that individuals vaccinated with two or more doses had a 42% higher risk of reinfection compared to those with one dose or less [29]. Chemaitelly et al. estimated that the effectiveness of Pfizer-BioNTech (BNT162b2) and Moderna (mRNA-1273) vaccines against Omicron subvariants declined significantly, reaching negative effectiveness levels (-17.8% and -12.1% for Pfizer; -10.2% and -20.4% for Moderna) after seven months [30]. Shrestha et al. found a dose-dependent increased risk of COVID-19 infection, with individuals receiving more than three doses experiencing a 253% higher risk compared to unvaccinated individuals [31]. Similarly, Feldstein et al. revealed that vaccinated children aged 6 months to 4 years without prior infection were 159% more likely to get infected and 257% more likely to develop symptomatic COVID-19 compared to their unvaccinated peers [32]. These findings collectively raise serious concerns about the long-term efficacy and safety of repeated COVID-19 vaccine doses, suggesting that continued reliance on this strategy may inadvertently increase susceptibility to infection and adverse outcomes.

DNA Contamination

Studies investigating DNA contamination and potential gene integration from COVID-19 vaccines have revealed concerning findings (Table 2) [33-44]. McKernan et al. from Medicinal Genomics (USA) reported DNA levels far exceeding the safety threshold in Pfizer and Moderna vaccines, with measurements as high as 3,390 ng per dose using electrophoresis and fluorometer methods. Their findings included evidence of gene integration and SV40 sequences in cancer cells, raising concerns that were reported to the FDA and presented at the World Council for Health (WCH) [33-35]. Nitta (Japan) found minimal DNA contamination in Moderna vaccines, measuring 0.1 ng, which was deemed negligible [36]. Buckhaults (USA) demonstrated DNA integration into human epithelial stem cells, with DNA concentrations ranging from 0.6 to 18.7 ng, emphasizing the potential for adverse events [37, 38]. König and Kirchner (Germany) identified DNA contamination levels between 3,600 and 5,340 ng, with their findings submitted to German health authorities and published in a peer-reviewed journal [39]. Speicher, Rose, and McKernan et al. (Canada) discovered DNA levels up to 5,100 ng across multiple vaccine batches, raising significant concerns and presenting their findings at the WCH [40]. Speicher also reported high DNA contamination in Australian vaccine samples, with total DNA levels ranging from 451 ng to 1,420 ng after RNaseA/DNaseI treatment and up to 14.69 ng of SV40 sequences [41]. These findings were reported to the Therapeutic Goods Administration (TGA). Raoult et al. (France) analyzed Pfizer vaccine samples, reporting average DNA contamination levels of 216 ng, which further increased to 5,160 ng following treatment with Triton-X-100, raising significant safety concerns [42]. Kämmerer et al. (Germany) examined Pfizer vaccine samples and found DNA contamination levels ranging from 2,712 to 3,683 ng after treatment with Triton-X-100 [43]. Additionally, further analysis using RNaseA showed DNA levels between 32.71 and 42.09 ng, confirming DNA contamination levels exceeded regulatory limits. They demonstrated that vaccine-derived DNA could transfect HEK293 cells, raising significant concerns about gene integration and potential adverse events [43]. Wang et al. (USA) analyzed six vials from two Pfizer vaccine lots and detected significant residual DNA contamination far exceeding regulatory limits, with amounts ranging from 3,450 to 6,550 ng per dose using UV-Vis spectrophotometry (NanoDrop) and 41.4 to 109.5 ng per dose via fluorometric dsDNA quantification (Qubit) analysis [44].

Table 2.

Verifications of mRNA Vaccine DNA Contamination in the World. Red boxes indicate DNA contamination exceeding the regulatory limit of 10 ng per clinical dose. *Multiplied the value by 300 for ul. **From the description of DNA 44x10fg to mRNA 400 ng, the calculation for Moderna 1-dose as mRNA 100 ug. Credit for table creation and data extraction: Dr. Kenji Fujikawa, PhD, Institute of Medical Statistics, Information, and Communications, Japan. (@hudikaha on X)

Table 2.

Continued.

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.  However, mechanistic or epidemiological evidence directly linking this contamination to adverse health outcomes remains limited. The presence of sequences such as SV40 raises possible risks for gene integration and carcinogenicity [46, 47]. Further research is essential to clarify the potential biological implications of such contamination.

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). Doctors for COVID Ethics called for global recall of COVID-19 vaccines on March 10, 2021 [48]. In May 2021, Bruno et al. (50 authors) called for a pause in the mass vaccination program if vaccination programs worldwide do not institute independent data safety monitoring boards (DSMB), event adjudication committees (EAC), and enact risk mitigation [49]. The World Council for Health, on November 29, 2021, issued a declaration “demanding that governments and corporations cease and desist from direct or indirect participation in the manufacturing, distribution, administration or promotion of COVID-19 experimental injections” based on serious safety concerns [50]. In May 2022, the Global COVID Summit, including more than 17,000 physicians and scientists, declared that “the COVID-19 experimental genetic therapy injections must end” [51]. In October 2022, the Association of Health Professionals and Independent Researchers (APSIIN) sent a letter to the Ministry of Health in Chile to request the immediate suspension of inoculation with mRNA platforms [52]. Dr. McCullough concluded with the assent of expert panels, that complete market removal of all COVID-19 vaccines was justified based on the excess risk of death, on December 7, 2022, in the US Senate [53], and on September 13, 2023, in the European Parliament [54]. On March 21, 2023, the Association of American Physicians and Surgeons issued a factual, scientifically grounded, and consensus driven statement calling for all COVID-19 vaccines to be removed from the market based on lack of safety and efficacy [55]. The National Citizens Inquiry, a Canadian citizen-led and citizen-funded organization chartered to investigate governments’ COVID-19 policies, on September 14, 2023, called for market removal of all COVID-19 vaccines [56]. In late 2023, Americans for Health Freedom created a signable pledge calling for COVID-19 shots to be pulled off the market [57]. As of December 1, 2024, 228 elected officials, 17 County Political Committees, 2 State Political Parties, and multiple physician organizations have signed the pledge calling for COVID-19 vaccines to be removed from the market, including but not limited to Sen. Ron Johnson, Rep. Marjorie Taylor Greene, Rep. Thomas Massie, Arizona and Idaho Republican Parties, America’s Frontline Doctors, Frontline COVID-19 Critical Care Alliance, Health Advisory and Recovery Team, the Global Health Project, and the Global COVID Summit [57].On January 4, 2024, the Florida Surgeon General called for removal of all mRNA COVID-19 vaccines from human use because of contamination by cDNA fragments and the risk of genotoxicity [58]. On January 12, 2024, again Dr. McCullough called for removal of all COVID-19 booster products from the market in a US House of Representatives Panel on COVID-19 Vaccine Injuries [59]. On February 29, 2024, members from New Zealand Doctors Speaking Out with Science (NZDSOS) presented a comprehensive letter to parliament calling for the immediate withdrawal of COVD-19 vaccines due to significant safety concerns [60]. In 2024, the McCullough Foundation issued several statements on social media platforms calling for an immediate moratorium on COVID-19 vaccines due to excess death and DNA contamination concerns [61]. In July 2024, Mead et al. published a pair of extensively referenced, peer-reviewed manuscripts concluding the COVID-19 vaccines are not safe for human use and should be removed from the market [3, 62]. The HOPE Accord, an international group of healthcare professionals, scientists, academics and concerned citizens called for the immediate suspension of COVID-19 mRNA vaccines and a comprehensive reevaluation of their safety and efficacy on July 3, 2024 [63]. The accord has garnered 64,168 signatures from prominent medical experts, researchers, and concerned citizens who argue that emerging evidence suggests these novel vaccine products may be contributing to increased rates of disability and excess deaths. Legal action was filed on October 11, 2024, by VERITY France, along with scientists, citizens, and victims, before the Administrative Tribunal of Montreuil, seeking the prohibition of the prescription and distribution of the COMIRNATY vaccine by PFIZER-BioNTech and the SPIKEVAX vaccine by MODERNA, as well as their withdrawal from the market by the National Agency for the Safety of Medicines and Health Products (ANSM) [64]. On November 1, 2024, Rogers et al. published a study that found a significant breach in the safety signal threshold concerning cerebral thrombosis adverse events after COVID-19 vaccines and called for a global moratorium [65]. Also in November 2024, a study by Oldfield et al. recommended a moratorium on COVID-19 mRNA vaccines due to incomplete data, serious safety concerns, and potential long-term risks [66]. On November 25, 2024, the NORTH Group, an international group of politicians and leading medical and other professionals sent a letter of “extreme concern” to the heads of state of 11 European countries (Denmark, Estonia, Finland, Greenland, Iceland, Latvia, Lithuania, Norway, Sweden, the United Kingdom, and Ireland) calling for a suspension of modified mRNA vaccines citing serious health concerns [67]. On December 3, 2024, Kämmerer et al. published an original article that called for an immediate halt of all RNA biologicals due to DNA contamination [43]. On December 4, 2024, we were able to obtain email confirmation that 4 members of European Parliament want the COVID-19 vaccines removed from the market: Christine Anderson (Germany), Cristian Terhes (Romania), Virginie Joron (France), and Gerald Hauser (Austria). Moreover, we received confirmation that 8 current and former Australian Federal Senators and Federal Members of Parliament have called for the removal of COVID-19 vaccines, including Gerard Rennick, Alex Antic, Malcolm Roberts, Ralph Babet, Matt Canavan, Pauline Hanson, Russell Broadbent, and Craig Kelly. We also obtained confirmation that Children’s Health Defense [68] calls for the COVID-19 vaccines to be immediately removed from the market.

Figure 3.

Organizations that Called for COVID-19 Vaccine Market Withdrawal.

Table 3.

Calls for COVID-19 Vaccine Market Withdrawal.

Table 3.

Continued.

Conclusion

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.

Acknowledgments

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.

From publichealthpolicyjournal.com