A new peer-reviewed paper in the Journal of American Physicians and Surgeons examines the Pfizer/BioNTech COVID-19 mRNA vaccine trial and documents two subject deaths in the vaccinated arm that were not disclosed to U.S. regulators during the 2020 Emergency Use Authorization (EUA) review. The study, authored by former WarRoom/DailyClout Pfizer Documents Project researchers, Dr. Jeyanthi Kunadhasan and Dr. Corinne Michels, is publicly available here.

The authors base their analysis entirely on Pfizer’s own internal case report forms, six-month death narratives, and adverse-event documentation released under court order. Their work focuses strictly on timelines, data accuracy, reporting completeness, and what information the FDA’s advisory committee did—or did not—receive before making its recommendation.

This investigation was made possible by the WarRoom/DailyClout research team, which examined the 450,000+ pages of Pfizer trial documents after a federal judge ordered their release. Dr. Kunadhasan and Dr. Michels’ earlier work on the WarRoom/DailyClout project, identifying subject IDs, reconstructing reporting timelines, and analyzing trial discrepancies, forms the backbone of the new peer-reviewed analysis.

Documented but Undisclosed: Two Vaccinated-Arm Deaths Missing From the EUA Review

The study identifies two clinical trial participants—both in the vaccinated arm—whose deaths occurred within the official reporting window (Jul. 27–Nov. 14, 2020) but were not disclosed to the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) during the EUA evaluation:

• Subject 11141050 (Kansas, age 63): Died Oct. 19, 2020, 41 days after Dose 2. Autopsy listed “sudden cardiac death.”

• Subject 11201050 (Georgia, age 58): Died in her sleep on Nov. 7, 2020. No autopsy performed; cause listed as “cardiac arrest.”

Both deaths were later documented in Pfizer’s six-month narrative report. But they were absent from Pfizer’s presentation to VRBPAC and from the major trial publications that regulators were relying on.

Family members notified clinical trial sites on the day each subject died, yet the official entry of the deaths into Pfizer’s system was significantly delayed. These delays contributed directly to Pfizer’s omissions in the dataset shown to regulators in December 2020 when the company was seeking EUA for its vaccine.

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What Regulators Saw—and What They Did Not

When VRBPAC met on Dec. 10, 2020, it had only 20 days to review the thousands of pages submitted with Pfizer’s EUA application. At that meeting, members were told that six total deaths had occurred during the first 20 weeks of the trial: two in the vaccinated group and four in the placebo group.

The peer-reviewed study shows that the correct number, based on Pfizer’s own documentation, was actually 11 deaths during that window: six vaccinated, five placebo.

The committee also did not request updated death information for the period between the data cutoff (Nov. 14, 2020) and the meeting date (Dec. 10, 2020). Had it done so, it would have learned that 17 subjects had died by the time the EUA was evaluated: eight vaccinated, nine placebo.

These differences stem mainly from recording delays in Pfizer’s system, overwhelmingly concentrated in the vaccinated arm and primarily before the EUA approval date.

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Six-Month Data: Patterns in Sudden Deaths and Autopsy Gaps

By the end of the six-month interim period (July 27, 2020–March 13, 2021), the trial documentation listed:

• 21 deaths in the vaccinated arm

• 17 deaths in the placebo arm

Within the vaccinated group, 10 deaths were classified as sudden or unexpected—subjects found deceased at home, collapsing without warning, or not waking from sleep. Only two of these cases received autopsies, and just one autopsy result appears in the publicly released documentation.

In several cases, investigators concluded that the deaths had “no reasonable possibility” of being related to the study drug—even when autopsy results were still pending or never obtained.

The placebo group showed five sudden deaths, with the remainder distributed among causes such as stroke, pneumonia, overdose, cancer, diabetes, or multi-organ dysfunction. COVID-19 was recorded as a secondary cause of death in five placebo subjects and one vaccinated subject.

The study makes no causal claims. It documents what is present in the trial record.

Structural Problems in Trial Data Handling

The peer-reviewed analysis identifies multiple procedural issues in Pfizer’s reporting system:

• Significant delays—sometimes more than a month—in entering death information.

• A complex, multi-step reporting chain between trial sites and Pfizer staff.

• Longer recording delays for vaccinated-arm deaths before EUA approval, compared with placebo subjects and post-authorization entries.

• Missing Serious Adverse Event reporting forms, preventing independent verification of real-time reporting timelines.

The authors note that these structural problems prevented regulators from having complete and accurate information at the time of the EUA decision.

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Historical Examples of Data-Integrity Failures

The study briefly outlines earlier, well-documented instances where trial data discrepancies came to light only after regulatory approval—such as with Merck’s Vioxx and AstraZeneca’s ticagrelor. These examples are presented as context demonstrating that data-handling failures in pharmaceutical trials are not unprecedented.

Post-Authorization Safety Signals and Regulatory Actions

The paper summarizes the documented timeline of myocarditis reports following Pfizer vaccination, including early notifications from Israel’s Ministry of Health (MoH) to the CDC in February 2021. Internal discussions at U.S. agencies continued through April and May, with public safety-label updates issued in late June 2021 after additional case reports accumulated.

Again, the study simply outlines the sequence of documented communications.

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Proposed Reforms Based on the Evidence

The authors argue that several structural reforms would improve trial oversight and public trust, including:

• Modern, real-time clinical-trial data-capture systems.

• Shorter terms and stronger conflict-of-interest protections for FDA advisory committees.

• Independent third-party reviewers with complete access to trial data before meetings.

• Continued expansion of post-marketing surveillance systems with real-time capabilities.

• Reevaluation of the EUA framework, especially the PREP Act’s compressed review timelines.

The authors conclude that the EUA process itself—by design—limited the depth of review regulators could perform.

Why These Findings Matter

For readers who have long questioned whether Pfizer’s clinical trial data were presented in full and in real time, this peer-reviewed study offers a detailed, evidence-driven analysis rooted entirely in Pfizer’s own documentation.

It does not speculate. It does not extrapolate. It simply examines the record and identifies where the record was incomplete at the moment the EUA decision was made.

The full study is available here.

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A team of neuroscientists at Australia’s Florey Institute of Neuroscience and Mental Health recently uncovered a surprising finding in mice: when male mice were infected with SARS-CoV-2 before conception, their offspring later showed signs of increased anxiety and altered brain gene activity.

The mechanism? Small non-coding RNA molecules in the sperm — tiny regulators that can influence how genes switch on and off early in embryonic development.

Though this research was conducted in rodents, not humans, it adds to growing evidence that a father’s health and environment before conception can influence the next generation’s biology.

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How the Research Was Conducted

• Male mice were infected with a lab-adapted strain of SARS-CoV-2.

• After recovery (and once the virus was cleared), they were mated with healthy, uninfected females.

• Scientists compared the offspring of infected vs. control-group fathers on multiple fronts: behavior, brain chemistry, and sperm RNA profiles.

• They also created a second generation to see whether effects might carry over again.

• To confirm causation, researchers isolated the altered sperm RNA and microinjected it into normal embryos, reproducing the same anxiety-like traits in the new mice.

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What They Found

Behavioral and Brain Changes in Offspring

• Offspring of previously infected fathers were more anxious, spending less time in open or bright spaces during standard lab tests.

• The hippocampus — a key brain region for emotion and memory — showed altered gene expression, especially in female offspring.

• Some offspring also exhibited differences in body weight and growth during early life.

Changes in Sperm Molecular Profile

• The fathers’ sperm showed disrupted levels of small non-coding RNAs, including microRNAs and tRNA fragments.

• When these altered RNAs were injected into healthy embryos, the resulting offspring again showed anxiety-like behaviors — indicating these RNAs are active messengers, not bystanders.

A Limited Transgenerational Effect

• By the second generation, the behavioral differences largely disappeared.

• Researchers did note slightly smaller litters and minor developmental differences, but no consistent anxiety-related patterns.

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What It Doesn’t Mean (Yet)

Scientists emphasize: this is an animal study. The leap from mice to humans is large and uncertain.

• Human sperm and reproductive timing differ significantly from rodents.

• Not every viral infection will produce the same molecular or behavioral outcomes.

• The study doesn’t suggest that COVID-19 infection in men necessarily affects their future children.

• Factors such as fever, inflammation, and stress during infection could play roles independent of the virus itself.

In short: this is a signal worth studying — not a definitive conclusion.

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Why This Matters

This research adds to a growing field called paternal epigenetic inheritance, which explores how a father’s experiences — illness, stress, diet, toxins — may alter the biological “software” that programs the next generation.

If similar patterns hold true in humans, it could change how scientists think about the long-term health legacy of viral pandemics. Instead of ending with infection recovery, the biological effects might echo — subtly — in future generations.

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What Comes Next

To understand whether this finding applies to humans, scientists say we need:

1. Long-term human studies tracking children conceived after paternal COVID infection.

2. Sperm RNA analysis in recovered men over time to see if changes persist.

3. Severity and timing studies — do mild vs. severe COVID cases differ in sperm impact?

4. Intervention testing — can antivirals or waiting periods before conception reduce risks?

5. Comparative research — do other infections produce similar sperm RNA changes?

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The Bottom Line

This study raises provocative questions, but it does not prove that men who’ve had COVID will pass behavioral changes to their children.

It does, however, underscore a key takeaway:

A man’s health before conception may matter more than once thought.

COVID-19, like many viral illnesses, may have effects that reach beyond the individual — potentially touching the next generation in ways science is only beginning to understand.

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Study Overview

Research Context

The study, titled "Association of SARS-CoV-2 vaccination status with risk of influenza-like illness and loss of workdays in healthcare workers," published on August 10, 2025, focuses on the SARS-CoV-2 Immunity and Reinfection Evaluation or SIREN cohort, a group of healthcare workers in the United Kingdom, and analyzes data collected between October 2023 and March 2024. The research aimed to assess the effectiveness of COVID-19 booster vaccinations in preventing influenza-like illness and associated absenteeism in a post-pandemic environment.

Methodology

The study employed a retrospective cohort design, analyzing data from 28,000 healthcare workers enrolled in the SIREN study. Participants reported their vaccination status, including whether they had received a COVID booster shot. The researchers tracked the incidence of influenza-like illness, defined as symptoms such as fever, cough, or sore throat, and recorded workdays lost due to these symptoms. Statistical models adjusted for variables like age, sex, and occupational exposure to assess the COVID vaccine impact on these outcomes.

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Key Findings

Lack of Protective Effect

The study found that COVID-19 booster vaccinations did not reduce the incidence of influenza-like illness among healthcare workers. Contrary to the researchers' expectations, the data suggested a potential temporary increase in the likelihood of symptomatic infections following vaccination. This finding strongly challenges the assumption that booster shots provide broad protection against respiratory illnesses in a post-pandemic context.

Negative Impact on Workday Loss

Another significant finding was the association between recent booster vaccination and increased workday loss. Healthcare workers who received a booster shot reported more absences due to influenza-like illness compared to unvaccinated colleagues. The study suggests this could be due to short-term immune responses or heightened symptom reporting post-vaccination.

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Implications for Healthcare Policy

Reevaluating Booster Strategies

The findings raise questions about the role of routine SARS-CoV-2 booster vaccinations in healthcare settings. Policymakers may need to reassess vaccination strategies, balancing potential short-term disruptions against long-term benefits. The study emphasizes the need for further research to understand the mechanisms behind the observed increase in infection risk and absenteeism.

Broader Public Health Context

The research highlights the complexity of vaccine efficacy in a post-pandemic world, where SARS-CoV-2 has transitioned to an endemic state. It underscores the importance of monitoring real-world outcomes to inform evidence-based public health decisions. The COVID vaccine impact on healthcare workers may differ from its effects during the height of the pandemic, necessitating updated guidelines.

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Limitations of the Study

The study acknowledged several limitations. Self-reported data on symptoms and vaccination status may introduce bias. Additionally, the study focused on influenza-like illness, which includes symptoms caused by various pathogens, not just SARS-CoV-2. The observational design also limits causal inferences, and unmeasured factors, such as underlying health conditions, could influence results.

Takeaways

The Nature study on the COVID vaccine impact provides valuable insights into the lack of effectiveness of SARS-CoV-2 booster shots in healthcare workers. The findings suggest boosters do not protect against influenza-like illness and temporarily increase infection risk and workday loss. Further research is needed to refine vaccination strategies and optimize healthcare workforce resilience in a post-COVID pandemic era.

Source: Nature Communications Medicine, August 10, 2025

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Study Background and Purpose

Pancreatic cancer is a highly lethal disease with a five-year survival rate of approximately 10-12%. As COVID-19 vaccinations became widespread, questions emerged about their effects on cancer patients. This repeated COVID-19 vaccination study, conducted in Japan, investigates whether multiple vaccine doses influence pancreatic cancer progression, focusing on immune responses mediated by IgG4 antibodies.

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Study Design and Methods

The retrospective, single-center cohort study analyzed 272 pancreatic cancer patients diagnosed between January 2018 and November 2023. Researchers examined survival outcomes, measuring serum IgG4 levels in 96 patients and spike-specific IgG4 in 79 patients with various diseases, including pancreatic cancer, from September to November 2023. Immunohistochemistry assessed Foxp3-positive regulatory T cells (a.k.a., "Tregs") in tumor tissue, which are linked to immune suppression.

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Alarming Findings

The study uncovered several concerning results:

• Reduced Survival with Multiple Doses: Patients receiving three or more COVID-19 vaccine doses had a median overall survival of 10.3 months, less than half of the 20.8 months for those with zero to two doses. This stark difference highlights a potential negative impact of repeated vaccinations.

• Elevated IgG4 Levels: Total serum IgG4 levels increased with the number of vaccine doses. Patients with high IgG4 levels (>48 mg/dL) exhibited worse survival outcomes, suggesting that elevated IgG4 may contribute to a poorer prognosis.

• Immune Suppression: Higher infiltration of Foxp3-positive regulatory T cells was observed in tumor tissue, indicating suppressed anti-tumor immunity. This immune suppression is particularly concerning, as it likely allows cancer to progress more aggressively.

• Independent Risk Factor: Multivariate analysis identified three or more vaccine doses as an independent predictor of poor prognosis, with a hazard ratio of 4.08, underscoring the strength of this association.

These findings suggest that repeated COVID-19 vaccinations may exacerbate pancreatic cancer progression by inducing immune suppression through elevated IgG4 levels and regulatory T cell activity.

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Patient Care Implications

The study’s concerning findings call for cautious evaluation of vaccination strategies in pancreatic cancer patients. The potential for repeated doses to worsen cancer outcomes necessitates tailored approaches for this population. Clinicians should weigh these risks when advising patients with pancreatic cancer, as well as fully inform patients that repeated mRNA COVID vaccines lead to survival rates that are reduced by more than half.

Limitations and Future Research

The study’s retrospective nature and single-center design limit its applicability to broader populations. The small sample size for IgG4 analysis and the lack of mechanistic clarity on IgG4’s role in cancer progression are also constraints. Future research must explore these effects in larger, diverse cohorts and across other cancer types to confirm the findings and elucidate underlying mechanisms.

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Final Thoughts

This repeated COVID-19 vaccination study highlights critical concerns about the association between multiple vaccine doses and poorer survival in pancreatic cancer patients. The observed link to elevated IgG4 levels and immune suppression underscores the urgent need for further investigation to ensure safe and effective vaccination strategies for cancer patients.

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CVXGA1 Vaccine Overview

CVXGA1 is delivered intranasally using a viral vector derived from parainfluenza virus type 5 (PIV5). Like other COVID-19 vaccines, this vaccine is designed to produce the SARS-CoV-2 spike protein in the body. CVXGA1 is intended to generate both mucosal and systemic immunity.

The Phase 1 trial enrolled 72 participants ranging in age from 12 to 53. The drug was administered in low and high doses, and the researchers indicate that they monitored safety, immune response, and evidence of viral replication in the nasal passages. However, a deeper dive into the study design shows that it was not set up to effectively detect basic safety issues.

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Core Safety Concerns

Viral Replication and Shedding

One of the primary concerns relates to the use of a replicating viral vector. Genetic material from the PIV5-based vaccine was detected in nasal samples after administration, confirming that the vaccine virus replicated in the upper respiratory tract. It is important to note that the trial did not assess whether the replicated virus could be infectious or transmitted to others through nasal secretions -- i.e., transmission through shedding. The absence of infectivity testing or RNA quantification makes it impossible to rule out environmental exposure risks through shedding, especially in households or public spaces.

Lack of Placebo Control

The trial used an open-label design and did not include an unvaccinated control group. Without a placebo comparison, a thorough evaluation of adverse events, immune responses, or potential risks in an unbiased way cannot be done. This concerning approach also limits the scientific strength of any conclusions about the vaccine’s effectiveness or tolerability.

Short-Term Follow-Up

Some experts also raised concerns that the study’s follow-up period seems too short to detect delayed adverse events, which have been observed at alarming rates in relation to mRNA COVID-19 vaccine injections, or to assess how long immune responses last. The small sample size of only 72 participants also adds to the uncertainty, as serious side effects may not emerge in such a small cohort.

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Technology and Ethical Considerations

Replicating Vector Use

The PIV5 vector’s ability to replicate causes the body to produce an immune response, but introduces a level of unpredictability. Without clear data on how long the vector persists in the body or how it behaves in different populations, the use of a live, replicating virus requires rigorous monitoring.

Financial Conflicts

Several of the researchers involved in the trial are affiliated with CyanVac, the manufacturer of the vaccine, and hold financial interests in the product; so they are not able to be completely objective in their analyses. Such a novel vaccine requires greater transparency and independent oversight in future phases of research.

Research Next Steps

According to CyanVac, the trial sponsor, larger studies are planned, with up to 10,000 participants in the next phase. Future studies must include a placebo group, extended observation periods, and dedicated analysis of shedding risks to ensure a more comprehensive safety analysis.

As the field of intranasal and spray-based vaccines expands, it is crucial to set high standards for clinical design and data transparency. This will allow unbiased, independent experts to examine and report on both study designs and their results.

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Big Pharma's Interests Are Not Consumers' Interests

The sprayable COVID vaccine CVXGA1 represents another step towards Big Pharma's ongoing pursuit of needle-free immunizations. However, its use of a live, replicating vector and limited early-stage data raises alarming safety and scientific concerns. Future research must address these gaps through stronger study design, longer-term monitoring, and independent review if this vaccine platform is to gain public trust.

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Texas’ House Bill 3441: Targeting Manufacturer Advertising

Texas has taken a significant step with House Bill 3441, passed in 2023 and effective September 1, 2025, which holds vaccine manufacturers liable for injuries caused by their products if they advertise in the state. The bill targets vaccine liability immunity by making manufacturers accountable for actual damages and court costs up to three years after an injury, particularly for products deemed “unavoidably unsafe.” Sponsored by State Sen. Bob Hall (R) and championed by medical liberty advocate and Dallas salon owner Shelley Luther, HB3441 addresses the NCVIA’s protections and aims to ensure manufacturers face consequences for defective vaccines.

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Iowa’s House File 712: Waiving Manufacturer Immunity

Iowa’s House File 712, introduced in 2025, prohibits the distribution, sale, or administration of vaccines unless manufacturers waive immunity from lawsuits for injuries caused by design defects. This bill directly challenges vaccine liability immunity under the PREP Act and NCVIA, requiring manufacturers to accept legal responsibility for harms. By mandating this waiver, HF712 aims to ensure Iowans injured by vaccines have access to legal recourse. The bill, still under consideration, responds to public concerns about vaccine safety.

New Jersey’s Senate Bill 384: Accountability for Mandates

New Jersey’s Senate Bill 384 focuses on holding entities enforcing vaccine mandates accountable for resulting injuries. The bill focuses on state agencies, employers, or institutions imposing mandatory vaccinations, requiring them to assume liability for adverse effects. By shifting responsibility to mandators, SB384 bypasses vaccine liability immunity at the federal level, aiming to discourage coercive vaccination policies. Supporters view it as a safeguard against overreach, protecting individual choice, while critics argue it could undermine public health mandates.

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New York’s SB5910: Dual Approach to Liability

New York’s Senate Bill 5910 address vaccine liability immunity holding state and local governments liable for injuries resulting from enforced vaccine mandates. It ensures accountability for policy decisions and balances public health with individual protections.

Oklahoma’s Senate Bill 801: Comprehensive Accountability

Oklahoma’s Senate Bill 801 requires both vaccine manufacturers and state entities to waive vaccine liability immunity for injuries caused by vaccines or mandates. It prohibits vaccine distribution unless manufacturers agree to liability for design defects and adverse reactions, and it holds state agencies accountable for mandate-related injuries. The bill includes a state-administered compensation fund to streamline legal processes.

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Tennessee, Arkansas, Louisiana, and Idaho: Emerging Efforts

Tennessee, Arkansas, Louisiana, and Idaho have passed legislation related to holding vaccine accountability, aligning with Texas’s approach. These states have enacted laws to reduce vaccine liability immunity, focusing on manufacturer accountability for defective vaccines. For example, Tennessee’s legislation resembles Texas’s HB3441, targeting liability for injuries, while Arkansas and Louisiana have also banned vaccine mandates, reducing scenarios where mandators could face liability. Idaho’s laws similarly limit mandates and prohibit vaccine passports, supporting accountability measures. These efforts reflect a broader movement to address public concerns about vaccine safety, though further details are needed to confirm their scope.

States Limiting Mandates: Indirect Accountability

Several states, including Texas, Florida, Montana, Arkansas, Georgia, Idaho, Indiana, North Dakota, Tennessee, Utah, Kansas, South Carolina, Missouri, and Alabama, have banned or limited vaccine mandates, indirectly reducing potential liability for injuries by minimizing forced vaccinations. For instance, Texas’s SB 29 (2023) prohibits governmental entities from mandating COVID-19 vaccines, and Florida imposes fines of $10,000 per employee violation for mandate breaches. Montana bans mandates for all employers except healthcare institutions, requiring accommodations for unvaccinated employees. These measures, while not directly addressing liability for mandate-related injuries, reduce the scenarios where state entities or businesses could face accountability for enforced vaccinations.

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Proposed Legislation in Other States

South Carolina, Missouri, Kansas, and Pennsylvania are considering legislation to hold vaccine manufacturers accountable. Some of these states have also restricted vaccine mandates, with Kansas banning mandates for all employers and South Carolina prohibiting proof of vaccination for services. These efforts suggest a legislative environment critical of vaccine liability immunity and supportive of accountability; however, their proposed laws remain in early stages.

Federal Context and Legal Challenges

The PREP Act and NCVIA pose significant barriers to state efforts, granting broad immunity to manufacturers for COVID-19 and childhood vaccines, respectively. The Countermeasures Injury Compensation Program (CICP) for COVID-19 vaccines has a very low payout rate, limiting recourse for injuries. States like Texas and Iowa are navigating these federal protections by targeting specific activities (e.g., advertising) or requiring immunity waivers, but legal challenges due to federal preemption remain a concern. Many people are frustrated with these federal shields, as can be seen across social media platforms, so that is helping to fuel state-level action.

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Implications and Challenges

These state bills reflect growing public demand to counteract vaccine liability immunity, addressing concerns about vaccine safety, mandates, and lack of recourse. By holding manufacturers and mandators accountable, they aim to increase transparency and perhaps increase trust in vaccination programs. However, federal preemption may limit their enforceability, and manufacturers will likely resist waiving immunity. Accountability measures would ensure safer products and policies, balancing individual rights with public health concerns.

Public Health Accountability Is Evolving

Texas’ HB3441, Iowa’s HF712, New Jersey’s SB384, New York’s SB5910, Oklahoma’s SB801, and laws in Tennessee, Arkansas, Louisiana, and Idaho represent a significant push to counteract vaccine liability immunity and to put Americans' freedom of choice and safety first. By targeting manufacturers and mandators, these bills seek to ensure accountability for vaccine injuries and coercive mandates. States like South Carolina, Missouri, Kansas, and Pennsylvania are exploring similar measures, while mandate bans in multiple states reduce potential liability scenarios. As these efforts progress, they will shape the national conversation on vaccine safety, individual protections, and public health policy, though their success hinges on overcoming federal legal barriers.

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What the Study Examined

The study, conducted by a team of researchers including Thorp, Rogers, Cosgrove, Hatfill, Breggin, Pinsky, and McCullough, aimed to explore whether COVID-19 vaccination and neuropsychiatric conditions are associated. Using data from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration's (FDA) Vaccine Adverse Event Reporting System (VAERS), as well as the the CDC and FDA's statistical methodology for detecting safety signals, the researchers analyzed reports of adverse events (AEs) related to neuropsychiatric issues following COVID-19 vaccination. The study compared these events to those reported after influenza vaccinations and all other vaccines over a specific timeframe.

The data spanned from January 1, 1990, to December 27, 2024, covering 420 months for all vaccines and 48 months for COVID-19 vaccines, which have only been available since late 2020. The researchers used a statistical measure called the Proportional Reporting Ratio (PRR) to identify potential safety concerns. According to CDC/FDA guidelines, a PRR of 2 or higher indicates a possible safety signal, meaning the adverse event occurs at a rate that warrants further investigation.

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Key Findings

The study identified 86 serious neuropsychiatric safety signals associated with COVID-19 vaccines when compared to influenza vaccines. These signals suggest a higher likelihood of certain neuropsychiatric conditions following COVID-19 vaccination. Below are the most significant findings:

• Psychosis: The study found that psychosis was 440 times more likely to be reported after COVID-19 vaccination compared to influenza vaccination. This is a striking figure, indicating a significant safety signal.

• Other Neuropsychiatric Conditions: The study identified safety signals for conditions such as anxiety, depression, and cognitive impairment, though specific PRR values for these conditions were not detailed in the summary.

• Comparison to Other Vaccines: When compared to all other vaccines, COVID-19 vaccines also showed elevated PRRs for neuropsychiatric adverse events.

• Statistical Significance: The safety signals were calculated with 95% confidence intervals and p-values, ensuring the findings met rigorous statistical standards. A PRR ≥ 2, as defined by the CDC/FDA, was consistently observed for the identified neuropsychiatric conditions.

These findings suggest that COVID-19 vaccination and neuropsychiatric conditions have a stronger association than previously disclosed.

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Why This Matters

The study contributes to the ongoing conversation about vaccine safety, particularly for mRNA COVID-19 vaccines, which were developed and rolled out very rapidly. Understanding the potential risks is crucial for informed consent. The identification of 86 neuropsychiatric safety signals underscores the importance of actively monitoring vaccine side effects, especially for conditions that can significantly impact quality of life.

For individuals considering vaccination or concerned about side effects, this study suggests discussing known mRNA COVID-19 vaccination risks with healthcare providers. It also highlights the value of systems like VAERS in detecting potential issues early, allowing researchers to investigate further.

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Limitations of the Study

The study has some limitations that readers should keep in mind:

• VAERS Data: As a passive reporting system, VAERS cannot confirm causation, and reports may include incomplete or inaccurate information.

• Timeframe Differences: The 48-month availability of COVID-19 vaccines compared to 420 months for other vaccines may skew comparisons.

• Complexity of Neuropsychiatric Conditions: These conditions are influenced by many factors, making it challenging to isolate vaccines as the sole cause.

Even with such limitations, the study’s rigorous methodology and use of CDC/FDA safety thresholds make it a valuable contribution to the field.

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What’s Next?

The researchers call for further studies to explore the mechanisms behind these potential associations. For example, future research could investigate whether specific vaccine components or individual health factors contribute to these adverse events. Regulatory agencies like the CDC and FDA may also use these findings to guide vaccine safety monitoring.

For the public, this study is a reminder of the importance of staying informed and engaging in open discussions with healthcare professionals. Knowing and understanding the full range of mRNA COVID-19 vaccine adverse events is essential for making informed healthcare decisions.

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Closing Thoughts

The study on COVID-19 vaccination and neuropsychiatric conditions provides important insights into potential vaccine-related adverse events. By identifying 86 safety signals, including a significant association with psychosis, it highlights areas for further research and gives patients more information for deciding whether or not to risk a gene therapy "vaccination." These findings encourage ongoing vigilance and dialogue about vaccine safety.

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What Is the Family Vaccine Protection Act?

H.R.3701, the Family Vaccine Protection Act, is a Democratic-led proposal to amend the Public Health Service Act, passed into law in 1944. It establishes the ACIP, a Centers for Disease Control and Prevention (CDC) advisory body, in statute, defining its structure and processes for vaccine recommendations. The bill requires ACIP decisions to rely on peer-reviewed scientific evidence and mandates transparency if the Secretary of Health and Human Services (HHS) deviates from ACIP’s recommendations. It also ties ACIP recommendations to vaccine access through programs like Vaccines for Children (VFC) and insurance coverage requirements.

The bill responds to actions by HHS Secretary Robert F. Kennedy, Jr., who dismissed all 17 members of the ACIP, appointed new ACIP members, and has been criticized by Democrats for not supporting the previous ACIP members' recommendations on vaccines, such as those for COVID-19 and respiratory syncytial virus (RSV). Democrats cite the 2025 measles outbreak as a reason for formalizing ACIP’s role.

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Key Provisions of the Act

The Family Vaccine Protection Act includes the following provisions:

• ACIP Codification: Establishes ACIP in law, specifying membership criteria (i.e., expertise in epidemiology, immunology, or vaccine safety) and meeting schedules.

• Evidence-Based Process: Requires ACIP to base vaccine recommendations on peer-reviewed scientific evidence, with a defined timeline for reviewing new vaccines.

• Transparency Mandate: Obligates the HHS Secretary to publish a detailed, evidence-based explanation if rejecting ACIP recommendations.

• Vaccine Access: Links ACIP recommendations to the VFC program and insurance coverage to ensure vaccine availability.

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Arguments in Favor

Democratic supporters, including the American Academy of Pediatrics and Big Pharma vaccine manufacturers, argue the bill ensures vaccine policies are based on scientific evidence. They note that vaccines have reduced diseases like measles by 99.9% in high-compliance areas, per CDC data. The bill’s focus on ACIP’s independence is said to protect programs like VFC, which affect over 40 million children in 2024, and maintain public access to vaccines.

Arguments Against

Critics, including some advocacy groups, argue the bill will limit flexibility in vaccine policy, as well as cite concerns that the act’s $2.8 million annual ACIP budget could favor pharmaceutical interests. Others contend the bill’s strict criteria for ACIP members will exclude alternative viewpoints on vaccine safety. Opponents point out that mandating adherence to ACIP recommendations restricts HHS’s ability to address unique public health scenarios.

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Potential Effects

If enacted, H.R.3701 could formalize the vaccine recommendation process, tying it to federal programs and insurance. GovTrack.us estimates a 10% chance of passing committee and a 2% chance of enactment, indicating legislative challenges. Debates will likely focus on balancing ACIP’s role with HHS oversight and addressing public concerns about vaccine policies. The Democratic-driven Family Vaccine Protection Act reflects ongoing discussions about public health governance.

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Study Methodology

The study encompassed a diverse set of European countries, including Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Researchers collected data from reputable sources such as the Institute for Health Metrics and Evaluation, Our World in Data, the World Bank, and the CIA World Factbook. Additional datasets included the Global Settlement Layer and a Zenodo archive.

To analyze the relationship between mask usage and excess mortality, the study employed both bivariate and multivariate regression analyses, adjusting for confounders such as vaccination rates, socioeconomic indicators, and the intensity of COVID-19 waves. Statistical analyses were performed using R (version 4.1.0) and JASP, ensuring robust and transparent data processing. Multiple sensitivity analyses were conducted to confirm the consistency of the findings, enhancing the reliability of the results.

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Key Findings

The study’s results revealed a significant positive correlation between mask usage and excess mortality. Countries with higher mask-wearing rates experienced elevated levels of age-adjusted excess mortality, as indicated by the bivariate Spearman correlation coefficient of 0.477 (p = 0.018) and the multivariate standardized coefficient of 0.52 (p = 0.0012).

Notably, the study found no significant association between mask usage and COVID-19 case rates (bivariate Spearman coefficient = -0.108), challenging the assumption that masks effectively reduce viral transmission at the population level. These findings were consistent across various sensitivity analyses, reinforcing the study’s conclusions.

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Discussion, Hypotheses, and Limitations

The study aligns with prior research, such as a systematic review by Jefferson et al., which found no clear evidence that masks significantly reduce the risk of viral infections. The researchers propose several hypotheses to explain the positive correlation between mask usage and excess mortality. One theory suggests that prolonged mask-wearing may lead to adverse effects, such as the re-inhalation of viral particles or other physiological impacts. Other potential explanations include socioeconomic factors, healthcare system disparities, or the varying severity of COVID-19 waves across countries.

The authors emphasize the limitations of the observational study design, which precludes establishing causality. Unknown confounders, such as differences in public compliance with other non-pharmaceutical interventions or variations in testing protocols, may have influenced the results. This acknowledgment underscores the complexity of interpreting population-level data in public health research.

Why It’s Important to Study Excess Mortality

This study is particularly noteworthy for its use of excess mortality as an endpoint, which provides a broader measure of the pandemic’s impact compared to COVID-19-specific mortality rates. Excess mortality accounts for both direct and indirect deaths related to the pandemic, offering a more comprehensive perspective on public health outcomes. This approach highlights the study’s contribution to understanding the multifaceted effects of public health interventions during a global crisis.

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Conclusion and Going Forward

In conclusion, despite what public health “experts” and policymakers recommended to the general public during the COVID-19 pandemic, the study suggests that mask usage did not prevent COVID-19 transmission at the population level and may be associated with adverse health effects, as evidenced by the correlation with excess mortality. These researchers advocate for further randomized controlled trials to elucidate the impact of mask-wearing on public health outcomes and to inform evidence-based policymaking. This work underscores the complex relationship between mask usage and excess mortality, emphasizing the need for rigorous scientific inquiry to guide future public health strategies.

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The Advisory Committee on Immunization Practices (ACIP) is a pivotal entity within the U.S. public health framework, established to provide expert guidance to the Centers for Disease Control and Prevention (CDC) on vaccine use and immunization policies. Comprising medical and public health professionals, the ACIP typically consists of 17 voting members, including physicians, epidemiologists, and other specialists, who serve four-year terms. The committee meets three times annually to review scientific data on vaccine safety, efficacy, and public health needs, issuing recommendations that influence vaccination schedules for children and adults, federal vaccine programs, and insurance coverage mandates. Established in 1964, the ACIP has historically played a key role in addressing vaccine-preventable diseases, such as measles and polio, and its decisions carry significant weight in clinical practice nationwide.

Secretary Kennedy's Decision to Dismiss ACIP Members

On June 9, 2025, Robert F. Kennedy Jr., newly appointed as Secretary of Health and Human Services (HHS) under the Trump administration, announced the immediate dismissal of all 17 ACIP members. Kennedy, a prominent environmental lawyer, cited pervasive conflicts of interest among the committee members as the driver for his decision. He noted that many members had financial or professional ties to pharmaceutical companies, such as Pfizer and Moderna, or had participated in approving vaccines they later evaluated, compromising their impartiality. Kennedy framed the dismissals as a necessary step to rebuild public trust in vaccine science and federal health agencies. This decision aligns with his long-standing advocacy for greater transparency and his claims that industry influence has skewed public health priorities.

Who Are the New Members?

Following the dismissals, Kennedy appointed eight new members to the ACIP on June 11, 2025, significantly changing its composition. The appointees bring a mix of credentials and perspectives.

• Martin Kulldorff, a Harvard-trained epidemiologist and biostatistician, co-authored the Great Barrington Declaration in 2020, advocating for targeted protection of vulnerable populations during the COVID-19 pandemic rather than broad lockdowns. His inclusion signals an important shift toward alternative public health strategies.

• Vicky Pebsworth, PHD, RN, holds dual doctorates in public health and nursing, and has over 35 years of experience in healthcare. She has been an ICU nurse, health policy analyst, administrator, and research scientist. Her work has centered on public health policy, pediatrics, patient safety, and vaccine safety. Dr. Pebsworth served as a consumer representative on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) since 2008, and contributed to CDC-related vaccine safety working groups (e.g., NVAC and the H1N1 Vaccine Safety Risk Assessment WG).

• Cody Meissner, MD, a pediatric infectious disease expert from Tufts University, brings extensive experience in vaccine development and evaluation. Recognized by peers, including Paul Offit, for his expertise, Meissner’s appointment has been viewed as a solid addition to the ACIP.

• Joseph R. Hibbeln, MD, a psychiatrist and neuroscientist with expertise in immune regulation and neurodevelopment.

• Retsef Levi, PhD, a professor of operations management at the Massachusetts Institute of Technology (MIT) and an expert in healthcare analytics, risk management, and vaccine safety.

• Robert W. Malone, MD, a biochemist and expert in mRNA vaccine technology. He has served in advisory roles for the U.S. Department of Health and Human Services and the Department of Defense

• Cody Meissner, MD, a pediatrician and Professor of Pediatrics at Geisel School of Medicine at Dartmouth. He is a nationally recognized expert in pediatric infectious diseases and vaccine policy and was previously a voting member of both the CDC’s ACIP and the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).

• James Pagano, MD, a board-certified emergency medicine physician with over 40 years of clinical experience in emergency medicine. Secretary Kennedy said Dr. Pagano is “a strong advocate for evidence‑based medicine.” His extensive frontline experience in emergency medicine equips him to assess real‑world implications of vaccine-preventable disease outbreaks and vaccination outcomes in acute care settings.

• Michael A. Ross, MD, Clinical Professor at George Washington University and Virginia Commonwealth University. He served on the CDC’s Advisory Committee for the Prevention of Breast and Cervical Cancer and contributed to national strategies for cancer prevention, including HPV immunization efforts.

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Reactions and What These Appointments Mean Going Forward

The overhaul of the ACIP has elicited polarized responses from the public health community. Critics, such as Dorit Reiss, a vaccine policy expert at the University of California Law — San Francisco, argue that the dismissals and appointments reflect an anti-vaccine bias. Reiss speculates that a committee skeptical of established vaccine science could delay critical recommendations, thus increasing the risk of outbreaks of diseases like measles. Other prominent public health policy professionals echo concerns that the move could erode public confidence in vaccines at a time when trust in health institutions is already fragile.

Supporters applaud the decision as a bold correction to a compromised system. They argue that the new members bring fresh scrutiny to vaccine policy, addressing legitimate concerns about industry influence and safety oversight. Paul Offit, a vocal vaccine proponent and co-inventor of the rotavirus vaccine, offered a nuanced view, praising Meissner’s expertise while expressing reservations about the committee’s overall direction under Secretary Kennedy’s leadership.

The implications extend beyond immediate policy. The ACIP’s recommendations influence billions of dollars in vaccine purchases and shape global perceptions of U.S. public health leadership. A shift in its approach could ripple through federal programs like Vaccines for Children, private insurance coverage, and international health initiatives.

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What’s Next for the ACIP?

As of mid-June 2025, the ACIP remains in limbo. With only eight members appointed, it lacks the quorum of 12 required to hold official votes or issue binding recommendations. This shortage threatens to disrupt its next scheduled meeting on June 25-27, 2025, where topics like influenza vaccine strains and potential updates to COVID-19 booster guidelines were slated for discussion. The CDC and HHS have not yet indicated when additional members will be appointed or how interim vaccine guidance will be handled.

Kennedy’s actions are part of a broader agenda to reform federal health agencies, consistent with his and the Trump administration’s focus on reducing perceived overreach and industry entanglement. The ACIP overhaul has reignited debates about balancing scientific integrity with public skepticism, with its long-term impact on U.S. immunization policy and public health outcomes still unfolding.

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Mr. Berkovich submitted a FOIA request to the Centers for Disease Control and Prevention (CDC) stating, “I request emails sent by and received by Dr. Rochelle P. Walensky, Sherri A. Berger, and Kevin Griffis (all of whom are CDC personnel) on dates beginning February 1, 2021 through May 31, 2021, containing the word myocarditis.” DailyClout reported on the subsequent FOIA productions, which first revealed the CDC’s delayed action:

• August 29, 2023: “472 Pages FOIAed from CDC Leaders, 2021, Reveal Lengthy Comms Re: ‘Myocarditis,’ Massive Redactions. CDC Hiding April 2021 Monthly Safety Report on Pfizer’s Vaccine and Myocarditis/Pericarditis.”

• September 20, 2023: “46 Pages FOIAed Emails Between CDC Leaders, Dr. Fauci, Dr. Collins, and White House, NIH, HHS, Show They Knew About Vaccine-Induced Myocarditis and Thrombotic Thrombocytopenia, a Blood Clotting Disorder. Emails Over 80% Redacted.”

• October 18, 2023: “FOIA’d Emails Reveal Highest-Level Leaders at White House, HHS, CDC, NIAID, AAP All Knew COVID Vaccines Linked to Myocarditis, Yet Publicly Covered Up Findings.”

• November 2, 2023: “FOIA’d CDC Emails Reveal Disturbing Myocarditis Timeline Warranting Investigation: Different Messaging Internally Vs. Publicly About COVID-19 Vaccines and Myocarditis.”

This WarRoom/DailyClout reporting revealed publicly for the first time:

• CDC Internal Awareness of Myocarditis: The FOIA-obtained emails show that CDC officials knew about COVID-19 mRNA vaccine-associated myocarditis as early as February 19, 2021, less than three months after the vaccines became publicly available.

• Health Alert Not Issued: The CDC had internal deliberations regarding issuing a health advisory alert via its Health Alert Network (HAN) and ultimately did not issue one.

• Public Communication Delay: Despite months of internal discussions about cases of myocarditis associated with mRNA COVID-19 vaccines, the CDC's public acknowledgment of myocarditis risk occurred on May 27, 2021, three months after the CDC first became aware of it.

For the first time, the full list of the 111 people, including the 100 government employees, involved in the communications related to the myocarditis cover-up, is publicly available. The job titles and hyperlinks included were all accurate and active as of November 2024.

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White House:

• Ian Sams, former Health and Human Services [HHS] Deputy Assistant Secretary for Public Affairs, COVID Response and current Special Assistant to the President and Senior Advisor and Spokesman for the White House

• Grace Kwak, White House Advisor to the Deputy COVID-19 Response Coordinator

• Benjamin Wakana, Deputy Director of Strategic Communications and Engagement, COVID and Health Care Outreach Lead on the Biden-Harris Transition Team

• Andrew Slavitt, White House (Biden) Senior Advisor for the Covid Response

• Kate Berner, Principal Deputy Communications Director at the White House

• Kevin Munoz, Assistant Press Secretary at The White House

• Max Lesko, JD, Chief of Staff, Office of the Surgeon General; White House COVID-19 Response Team

• Subhan N. Cheema, Senior Strategic Communications Advisor, White House COVID- 19 Response Team

• Mariel S. Sáez, Director of Broadcast Media, White House

• Cameron Webb, MD, Senior Advisor for Equity to the White House COVID-19 Response Team

• Marissa Sanchez-Velasco, Associate Director of Communications and Digital Director, White House COVID-19 Response Team

• Nikki Jo Romanik, then CDC Senior Public Health Analyst and now White House Special Assistant to the President, Deputy Director, and Chief of Staff

• Marissa Padilla, Senior Vice President, Communications & Public Affairs at Global Strategy Group and former Biden-Harris Transition Team Volunteer; former Principal Deputy Assistant Secretary for Public Affairs, HHS

COVID-19 Task Force:

• Jennifer Byrne, MPH, Task Force Liaison (TF LNO) Team Lead, Health Department Section, State, Tribal, Local & Territorial Support Task Force, COVID-19 Emergency Response

• Ramona (“Mona”) Byrkit, Lead, Health Department Section, State, Tribal, Local and Territorial Support Task Force, COVID-19

• Anita Pullani, Team Lead COVID-19 Response Task Force

• Marcella Nunez-Smith, MD, COVID-19 Health Equity Task Force Chair

• Courtney M. Rowe, Director of Strategic Communications and Engagement, COVID- 19 Response Team

NIH:

• Francis Collins, MD, PhD, Director, National Institutes of Health

• John Burklow, Acting Chief of Staff in the Office of the Director of the National Institutes of Health

• Renate Myles, Acting Associate Director for Communications and Public Liaison NIH Office of Communications and Public Liaison

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CDC:

• Tom Shimabukuro, MD, MPH, MBA, Vaccine Safety Team, CDC COVID-19 Vaccine Task Force

• John T. Brooks, MD, Chief Medical Officer, CDC COVID-19 Response

• Thomas A. Clark, MD, CDC Deputy Division Director of Division of Viral Diseases

• Dana Meaney-Delman, MD, CDC Lead, Maternal Immunization; CDC Chief of Infant Outcomes Monitoring Research and Prevention Branch, Fellow of the American College of Gynecology

• Denise Cardo, MD, CDC Director of the Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)

• Kimberley Fox, MD, Director of the Division of Bacterial Diseases (DBD) within CDC’s National Center for Immunization and Respiratory Diseases (NCIRD)

• Rebecca Greco Krone, CDC Co-Lead, Vaccine Task Force, COVID-19 Response

• Ann Schuchat, MD, Former Deputy Director of the CDC and GAVI Board Member

• Rochelle Walensky, MD, MPH, CDC Director and ATSDR Administrator

• Henry Walke, MD, MPH, CDC Director of the Office of Readiness and Response

• Nicole Coffin, CDC Senior Advisor, Strategic Policy, Communications, and Partnerships

• Seth Kroop, CDC Associate Director for Policy, Division of Healthcare Quality Promotion

• Abbigail Tumpey, former Associate Director for Communication Science for CDC’s Public Health Infrastructure and now Vice President, Institute Communications at the Georgia Institute of Technology

• Melinda Wharton, MD, MPH (CAPT, USPHS), CDC Associate Director for Vaccine Policy and Clinical Partnerships (NCIRD) and ACIP Executive Secretary

• Sarah Mbaeyi, MD, MPH, CDC staff member and doctor at Children’s Healthcare of Atlanta

• Barbara Mahon, Director (acting), Coronavirus and Other Respiratory Viruses Division (proposed), CDC; Senior Advisor, CDC; and former Senior Program Officer at the Bill & Melinda Gates Foundation

• Demetre Daskalakis, MD, COVID CDC Response Role: Senior Lead, Equity in COVID Data and Engagement and Director of CDC Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

• Christa Capozolla, CDC Global Health Center (GHC) Deputy Director for Strategy, Policy, and Communication

• Michael J. Beach, PhD, Principal Deputy Incident Manager, CDC COVID-19 Emergency Response; CDC Spokesperson; and Mahoning County (Ohio) Public Health Associate Director for Healthy Water, National at the Center for Emerging, Zoonotic, and Infectious Diseases

• Manish M. Patel, MD, CDC Influenza Division

• Laurie E. Markowitz, MD, Medical Officer, CDC

• Kristen Nordlund, Health Communication Specialist at CDC

• David L. Fitter, MD, CDC Director, Division of Global Migration and Quarantine

• John Su, MD, PhD, MPH, Vaccine Safety Team, CDC COVID-19 Vaccine Task Force

• Paul Fulton, CDC Press Officer

• Lynn Gershman, Executive Assistant to the CDC Director

• Nikki Jo Romanik, then CDC Senior Public Health Analyst and now White House Special Assistant to the President, Deputy Director, and Chief of Staff

• Leslie Harrison, MD, CDC Epidemiologist

• Margaret (“Peggy”) Honein, PhD, MPH, CDC Director, Division of Preparedness and Emerging Infections

• Athalia Christie, Acting Principal Deputy Director, CDC Global Health Center (GHC)

• Dale Rose, PhD, MSc, Deputy Director, CDC Division of Bacterial Diseases

• Christopher M. Jones, CDC Deputy Director, National Center for Injury Prevention and Control

• Kerry Caudwell, Senior Policy Analyst, CDC/Office of the Chief of Staff

• Tiffany Brown, then CDC Deputy Chief of Staff

• Sherri Berger, CDC Chief Operating Officer

• Jason McDonald, CDC Spokesperson for Rochelle Walensky

• Amanda Cohn, MD, CAPT, USPHS Director, Division of Birth Defects and Infant Disorders

• Kerri Moran, then Healthcare Communications Specialist

• Jessica Schindelar, Associate Director for Communications, Division of Healthcare Quality Promotion (DHQP)

• Cecilia Joshi, Health Scientist and Associate Director for State Strategy, Division of Healthcare Quality Promotion (DHQP)

• Sam Posner, PhD, then Acting Director, National Center for Immunization and Respiratory Diseases (NCIRD); now Director, Office of Science and CDC Chief Science Officer

• Nicole Fehrenbach, Deputy Division Director, Division of Congenital and Developmental Disorders

• Jo Stryker, Chief, Prevention Communication Branch, Division of HIV/AIDS Prevention at Centers for Disease Control and Prevention

• Nora Kelly Holton, Associate Director for Communication

• Katherine T. Hoffman, then Health Communication Specialist; now Digital Strategist for CDC’s National Center for Chronic Disease Prevention and Health Promotion

FDA:

• Peter Marks, MD, Director, Center for Biologics Evaluation and Research (CBER) at FDA

• Lorrie McNeill, Director, FDA Office of Communication, Outreach and Development

• Stephanie Caccomo, then FDA Media Relations Director

• Janet Woodcock, MD, then Acting Commissioner of Food and Drug Administration (FDA) and now FDA Principal Deputy Commissioner

• Julia (Julie) Tierney, JD, Chief of Staff of the FDA

• Richard Forshee, PhD, then Associate Director for Research; now Deputy Director, Office of Biostatistics and Pharmacovigilance, FDA/CBER; http://www.richardforshee.org/

• Steve Anderson, Director, Office of Biostatistics and Epidemiology, FDA/CBER

• Sarah Walinsky, JD, then Chief of Staff

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HHS:

• Xavier Becerra, HHS Secretary

• Admiral Rachel Levine, MD, Assistant Secretary for Health, HHS

• Vice Admiral Vivek Murthy, MD, MBA, U.S. Surgeon General, Health and Human Services

• Max Lesko, JD, Chief of Staff, Office of the Surgeon General; White House COVID-19 Response Team

• Adam Beckman, Special Advisor to the Surgeon General, Health and Human Services

• Kristen Allen, National Press Secretary (COVID Response), Health and Human Services

• Sherice Perry, Senior Advisor, COVID-19 Equity Task Force, Health and Human Services

• Bill Hall, Deputy Assistant Secretary for Public Affairs, Health and Human Services

• David Kessler, MD, Chief Science Officer for COVID-19 Task Force, HHS

• Loyce Pace, MPH, HHS Assistant Secretary for Global Affairs

• Sean Mccluskie, HHS Chief of Staff

• Lisa Barclay, HHS Deputy General Counsel

• Sarah Boateng, MHA, HHS Principal Deputy Assistant Secretary for Health

• Kimberly Espinosa, HHS Deputy Assistant Secretary for Legislation

• Sarah Despres, HHS Counselor for Public Health and Science

• AJ Pearlman, HHS Chief of Staff, COVID-19 Response

• Stephen Cha, Counselor to HHS Secretary Becerra

• Perrie Briskin, Senior Advisor to the Chief of Staff at HHS

• Clare Pierce-Wrobel, Senior Advisor to the Chief of Staff, HHS Office of the Secretary

• Adam Beckman, Special Advisor, U.S. Surgeon General

• Alexandria Phillips, Communications Director, U.S. Surgeon General

NIAID:

• Anthony Fauci, MD, National Institute of Allergy and Infectious Disease Director, White House COVID Task Force

• Courtney Billet, Director, Communications and Government Relations, National Institutes of Allergy and Infectious Disease

• Patricia Conrad, NIAID Special Assistant to the Acting Director

Pfizer:

• Patrick Caubel, Chief Safety Officer at Pfizer

Children’s Hospitals and Organizations:

• Matt Oster, MD, Director, Children’s Cardiac Outcomes Research Program at Sibley Heart Center (CORPS) at Children’s Healthcare of Atlanta, Cardiology (Emory University School of Medicine, Emory Rollins School of Public Health)

• Jane W. Newburger, MD, Associate Cardiologist-in-Chief for Academic Affairs at Children’s Hospital Boston

• James Baumberger, Senior Director, Federal Advocacy, American Academy of Pediatrics

• Mary Beth Son, MD, Section Chief, Rheumatology Program; Director, Samara Jan Turkel Clinical Center; Director, Services and Outreach and Associate Professor of Pediatrics, Harvard Medical School

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Committees:

• Sara Elizabeth Oliver, MD, MSPH, Medical Officer, National Center for Immunizations and Respiratory Diseases (NCIRD) and Lead for the COVID-19 Vaccines ACIP Work Group

• Paul Offit, MD

Other:

• Céline Grounder, MD, ScM, FIDSA, CEO/Founder, Just Human Productions; Host/Producer, American Diagnosis and Epidemic podcasts; Medical Analyst, CNN; Clinical Assistant Professor of Medicine and Infectious Diseases at NYU School of Medicine and Bellevue Hospital

• Jeremy Faust, MD, MS MA, Emergency Physician at Brigham and Women’s Hospital; Instructor at Harvard Medical School; cohost of FOAMcast

• Megan L. Ranney, MD, MPH, Dean of Yale School of Public Health and C.-E. A. Winslow Professor of Public Health (Health Policy) and Professor of Emergency Medicine

• Dana Ohannessian, Massachusetts Department of Health

• Wassim Choucair, MD

• "Larry"

With 100 federal employees involved in internal discussions that were kept from public view, the American public now knows they are funding a government that does not prioritize serving and protecting its citizens. Transparency and honesty are the cornerstones of public trust, especially in matters of health. As more details come to light, the American people deserve answers and accountability from those in charge.

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Dr. Naomi Wolf

CEO, DailyClout.io

A recent pre-print study by Manniche et al. analyzing national health data from the Czech Republic has identified a notable association between COVID-19 vaccination and reduced birth rates among women of reproductive age. The research, which has not yet been peer-reviewed, examined pregnancy outcomes for approximately 1.3 million women aged 18 to 39 over 27 months. It found that birth rates were approximately 30% lower among women vaccinated prior to conception, compared to their unvaccinated counterparts.

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The study assessed completed pregnancies and categorized the data by COVID-19 vaccination status at the time of conception. Among unvaccinated women, monthly birth rates remained consistently above six births per 1,000 and peaked at over ten births per 1,000 between August and December 2021. However, from February 2022 — by which time the majority of women had been vaccinated — the birth rate among vaccinated women remained about 30% lower for at least a year, through March 2023.

This analysis backs up the findings of several earlier investigations, including WarRoom/DailyClout “Report 52: Nine Months Post-COVID mRNA “Vaccine” Rollout, Substantial Birth Rate Drops in 13 European Countries, England/Wales, Australia, and Taiwan” by Robert Chandler, M.D., examining national birth trends in relation to COVID vaccination status. The authors suggest that the findings may help explain the sudden and sustained decline in birth rates observed in countries with high levels of COVID-19 vaccine uptake among women of childbearing age.

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During the clinical trials for its COVID-19 vaccine, pharmaceutical giant Pfizer appears to have hidden two deaths — including one in Kansas — which researchers allege would have revealed potentially dangerous side effects to the vaccines.

Over the last year and a half, a team of researchers — volunteering for The Daily Clout, a non-profit news outlet — including physicians, a businessman, and a former United States Army Intelligence officer poured through thousands of pages of documents relating to the study and found that Pfizer had failed to report the deaths of two women — one in Kansas and one in Georgia — during the trial.

Not only did they fail to report them, but they had—in fact—apparently actively covered them up.

According to Dr. Jeyanthi Kunadhasan, an anesthetist and perioperative physician in Australia; who was part of the team, the study protocol required that any “death or serious adverse effect” had to be reported within 24 hours. In the Kansas case that did not happen for 37 days.

The Kansas case was a 63-year-old woman who had her first dose of the Pfizer mRNA vaccine on August 18, 2020, and a second dose on September 8, 2020. She died on October 19, 2020, and her emergency contact immediately informed the clinical site — Alliance for Multispecialty Research LLC, in Newton, Kansas. Thirty-seven days later, on November 25, 2020 — 11 days after the data reporting cutoff date — the death was finally recorded in a “case report form.”

Five days after the emergency use application was submitted to the Food and Drug Administration by Pfizer.

The participant’s death was not reported in the trial results in the prestigious New England Journal of Medicine or to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which approved the EUA.

According to a letter Kunadhasan sent to Kansas Attorney General Kris Kobach — who is suing Pfizer over the vaccine — an autopsy recorded the cause as “sudden cardiac death,” and Pfizer physicians ruled her death was not related to the vaccine, citing “risk factors” for heart disease to include hypertension and obesity.

However, according to Kunadhasan, the patient was hardly obese but rather mildly overweight, at approximately 5 feet 4 inches tall and 163 pounds.

“To be eligible for inclusion in this clinical trial, participants had to be deemed healthy based on medical history, physical examination (if required), and the clinical judgment of the investigator. The protocol allowed healthy participants with pre-existing stable disease – defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the six weeks before enrolment – to participate in the clinical trial,” Kunadhasan wrote. “This patient was medicated with two different antihypertensives and had encountered clinical trial personnel at least three times with no mention of any worryingly high blood pressure readings. In fact, I cannot find any blood pressure reading in her publicly available case notes. Consequently, I can only assume the patient’s high blood pressure, from which she had suffered since January 1st, 2010, was well-controlled when she was admitted to the trial.

The patient was 165cm tall and weighed 74.1kg. Hence, her BMI (body mass index) of 27.2 put her in the overweight category, not obese.

The second hidden death was a 58-year-old woman in Georgia.

She received her first dose on August 4, 2020, and a second on August 27, 2020. The woman died in her sleep on November 7, 2020, and her husband immediately informed the clinical site. The death was not added to the data for 26 days and first followed up on December 3, 2020 — again well after the Nov. 14 data cutoff date.

The woman had taken a muscle relaxer and valium for chronic back pain prior to going to bed, but both were medications “previously used by the subject.”

In a letter to Texas Attorney General Ken Paxton, who — like Kobach — is suing Pfizer, Kunadhasan notes that there was no autopsy — a coroner was simply called to pronounce death — and the trial investigator simply declared there was “no reasonable possibility that the cardiac arrest was related to the study intervention.”

However, without an autopsy, how can anyone know?

Why do two deaths matter?

Dr. Chris Flowers, a member of the team and retired professor of Radiology who has worked clinical trials for more than 40 years, said even these two deaths out of the just over 44,000 participants should have been a signal to stop the trial immediately until they could be sure the vaccine was not the reason for the death. Flowers said an example would be the swine flu vaccine trial in which a participant got Guillain Barre Syndrome, and the trial was stopped.

“So if you put it in context, yes, there’s a small number of deaths,” Flowers said. “But any death that may be due to the intervention that you’re doing — the medication you’re giving — is extremely important, and normally the FDA calls a stop to those clinical trials until further investigation is done. And in many cases, is sort of the death knell of that clinical trial.”

The fact that both participants died of heart attacks becomes more important when other studies showed risks of myocarditis and pericarditis — particularly after a second shot and particularly in young men under 25, but among other patients as well.

Moreover, the reports shown to VRBPAC and in the New England Journal of Medicine stated there were only six deaths in the trial, four in the placebo group and two in the vaccinated group, supposedly showing that the vaccine worked and reduced the risk of death.

However there were actually four in each group.

“Nonetheless, the September 2023 Pfizer-BioNTech data released by the FDA introduced a document named “125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf,” which included information revealing that Pfizer-BioNTech was, in fact, informed of two additional deaths in the BNT162b2 arm of the trial well before the EUA data cut-off date, and that Pfizer-BioNTech did not disclose those deaths to the FDA,” Kunadhasan’s letter to Paxton reads. “If the deaths had been disclosed in the EUA submission, they would have shown that the BNT162b2 mRNA COVID vaccine intervention did not reduce deaths.”

The bottom line? Kunadhasan believes Pfizer knew the vaccine didn’t work and could cause heart problems — even before it was approved.

“There was a cardiovascular signal that we found in the data from the deaths,” Kunadhasan said.

In further stories, the Sentinel will explore additional problems with the way the study was conducted and its failure to show real clinical benefit.

Patrick Richardson has been a working journalist since 1992 at community papers across Kansas and for the last 10 as an editor for papers in Southeast Kansas, Northeast Oklahoma, and Southwest Missouri. As a freelancer, he has also broken major stories for national outlets like PJ Media and The Daily Caller. Richardson was born in Wichita and raised in Southwest Kansas and currently lives in extreme SE Kansas, with his wife, two Great Danes, English Bulldog and 10 grandchildren.

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Anaesthetist and Perioperative Physician

Pfizer Documents Analysis Project – Team 3

DailyClout

P.O. Box 24

Millerton, New York 12546

The Honourable Kris Kobach

Attorney General of Kansas

120 SW 10^th Ave, 2^nd Floor

Topeka, Kansas 66612

4th December 2024

RE: Undisclosed Vaccinated Death from Kansas in the C4591001 Trial at the Vaccine and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020

Dear Attorney-General Kobach:

My name is Dr. Jeyanthi Kunadhasan, and I am an anesthetist and perioperative physician in Australia. I am also a member of the DailyClout team of volunteers who are investigating the data, released on the Public Health and Medical Professionals for Transparency website[1], which formed the basis of the Food and Drug Administration’s Emergency Use Authorization (EUA) of Pfizer-BioNTech’s BNT162b2 mRNA COVID-19 vaccine. Additionally, I am Treasurer of the Australian Medical Professionals Society.[2]

I co-wrote the WarRoom/DailyClout Pfizer Documents Analysis reports 42[3] and 76[4], available on dailyclout.io. I am also a coauthor of “Forensic Analysis of the 38 Subject deaths in the 6-Month Interim Report of the Pfizer-BioNTech BNT162b2 mRNA Vaccine Clinical Trial,”[5] which is the first analysis of the Pfizer-BioNTech BNT162b2 mRNA vaccine original trial data by a group unaffiliated with the clinical trial sponsor.

I note with interest your lawsuit against Pfizer. I would like to draw your attention to an undisclosed participant death from Kansas that occurred the BNT162b2-vaccinated arm of Pfizer’s clinical trial as originally reported in War Room/DailyClout Report 89, 'Researchers Find Pfizer Delayed Recording Vaccinated Deaths at Critical Juncture of EUA Process. Improper Delays in Reporting Deaths in the Vaccinated Led FDA to Misstate Vaccine’s Effectiveness, Influenced EUA Grant Decision.'[6]

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As you are aware, the findings of the clinical trial C4591001 reportedly supporting the safety and efficacy of the BNT162b2 mRNA vaccine, have been published twice. Polack et al. first published findings on December 10, 2020, one day prior to the FDA’s issuance of EUA, entitled, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine”[7]. Then, on September 15, 2021, Stephen J. Thomas, MD, et al. published, “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months.”[8] The Polack NEJM publication stated, "All the trial data were available to all the authors, who vouch for its accuracy and completeness and for adherence of the trial to the protocol, which is available with the full text of this article at NEJM.org. An independent data and safety monitoring board reviewed efficacy and unblinded safety data.” (Polack et al., 2020)

The Polack paper disclosed six deaths — two in the BNT162b2 arm, and four in the Placebo arm. In the journal article and the EUA approval documentation[9], the six deaths covered the period of July 27, 2020, through November 14, 2020. This letter will demonstrate that Pfizer-BioNTech possessed records showing that eight deaths, four in the BNT162b2 arm and four in the Placebo arm, should have been disclosed by Pfizer to the FDA. In addition, the two undisclosed deaths presented a cardiac event signal in the clinical trial's BNT162b2 recipients. One of the undisclosed deaths in the vaccinated arm of the trial occurred in Kansas.

Pfizer’s clinical trial protocol required that serious adverse events (SAE) be reported immediately upon awareness, and under no circumstances to exceed 24 hours, to Pfizer Safety on the Vaccine SAE Reporting Form.[10] The protocol required site investigators to record into the patient’s Case Report Form (CRF) all directly observed, and all spontaneously reported adverse events and serious adverse events reported by the participant. In the case of a death, the next of kin/emergency contact was relied upon to inform a clinical trial site of a participant’s death, unlike the self-reporting of other adverse events. Prompt notification to the trial sponsor, by the clinical trial site investigator, of an SAE was essential to meet legal obligations and ethical responsibilities regarding the safety of participants and the safety of a study intervention under clinical investigation. The sponsor, in this case BioNTech, had a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of the study intervention under clinical investigation. The sponsor was required to comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, Independent Review Boards (IRBs)/Ethics Committees (ECs), and investigators.

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When we look at the table below, which is adapted from the “Forensic Analysis of the 38 Subject deaths in the 6-Month Interim Report of the Pfizer /BioNTech BNT162b2 mRNA Vaccine Clinical Trial”) (Michels et al., 2023), we can see, up to the data cutoff date of November 14, 2020, there were 11 deaths (six deaths in the Vaccinated arm of the study and five in the Placebo arm) in contrast to the six deaths publicly disclosed at the VRBPAC meeting and in the Polack article. There was seemingly a capture rate of 33% (two reported deaths out of six deaths) in the Vaccinated arm versus an 80% capture rate in the Placebo arm (four reported deaths out of five deaths).

To determine how the discrepancies in reported deaths occurred, my fellow researchers and I started with the premise that, as of November 14, 2020, Pfizer-BioNTech was not informed of any deaths during the trial. The only way in which that could be validly disproved was demonstrating, through publicly available records, that Pfizer-BioNTech had knowledge of the deaths. By painstakingly going through each of the patient’s notes released by the FDA and publicly available on the Public Health and Medical Professionals for Transparency (PHMPT) website, we identified the six dead subjects, whose deaths were reported in the initial Polack publication as well as at the VRBPAC meeting on December 10, 2020. They are vaccinated subjects 11621327 and 10071101, as well as the unvaccinated subjects 11521085, 12313972, 10661350, and 10811194. Their deaths occurred prior to November 14, 2020, and there was documentation of their deaths prior to November 14, 2020, in their respective CRFs.

The two BNT162b2 subjects whose deaths were included in the EUA submission:

The four placebo subjects whose deaths were included in the EUA submission:

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Having established that Pfizer-BioNTech used the data entry of the notification of death in the CRF as the only data point that determined whether a death was reported, our investigation of the public records at that time could not provide answers as to why the other deaths were not reported.

However, the September 2023 Pfizer-BioNTech data released by the FDA provided a document titled, “125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf”[11] which included information showing that Pfizer-BioNTech was, in fact, informed of two additional deaths in the BNT162b2 arm of the trial well before the EUA data cutoff and that those deaths were not disclosed to the FDA. If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths.

Subject 11141050, a then 63-year-old female subject, signed up for the Pfizer vaccine trial (C4591001) at the Alliance for Multispecialty Research LLC, in Newton, Harvey County, 67114 Kansas. The Principal Investigator at this site was Dr Richard Glover.[12]

Subject 11141050 was mildly overweight, with a BMI of 27. She was postmenopausal, had depression, hypertension, osteoporosis, rheumatoid arthritis and sleep apnoea. Her medications included trazodone (since 01 January 2005) and sertraline (since 01 July 2020) for depression; pregabalin (since 01 January 2005) and baclofen (since 01 January 2018) for degenerative disc disease; as well as amlodipine (since 01 January 2010) and hydralazine (since 01 February 2020) for hypertension.[13]

After completing the screening process and appropriate tests, she received her first dose of BNT162b2 on the 18^th of August 2020 and the second dose on the 8^th of September 2020. She presented for the one-month follow-up, post dose two, on 7^th of October 2020 and had appropriate follow-up tests done then.[14] There is no documentation of any untoward clinical events during these visits.

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She died 41 days after receiving BNT162b2 dose 2 on the 19^th of October 2020, and only 12 days after her planned follow-up visit. The emergency contact informed the clinical site of the death on October 19^th, 2020.[15]

This subject’s death was not disclosed in the Polack NEJM publication (Polack et al., 2020), nor at the VRBPAC meeting on December 10, 2020.[16] Pfizer-BioNTech’s own clinical trial protocol indicated that it should have been disclosed.

The death happened well before the data cutoff date of November 14, 2020. In the patient narratives (Pfizer, 2023, p. 71), one can see that the emergency contact confirmed on the day of death (19^th October 2020) that the subject had died. The narrative documents further state that the subject had an autopsy, from which the cause of death was determined to be “sudden cardiac death.”

When I reviewed this subject’s Case Report Form (CRF), I found the particular diagnosis “sudden cardiac death” had been mentioned on December 9, 2020.[17] On page 71 of this subject’s CRF, the date of notification of death is November 25, 2020. Since the clinical site had been informed by the emergency contact on the day the patient died, we see that there was a 37-day delay in recording this death into the CRF, in contravention of Pfizer’s trial protocol. As this death occurred well before the data cutoff date of November 14, 2020, and was known on November 25, 2020, there was ample opportunity to disclose this subject’s death, and possibly the autopsy results, at VRBPAC's December 10, 2020, meeting.

Per the autopsy, the patient died from ‘sudden cardiac death,’ with her known risk factors of hypertension and obesity putting her at high risk of cardiac-acute myocardial infarct. The clinical site staff entered the specific diagnosis of “sudden cardiac death” into her notes on December 9th, 2020, the day before the VRBPAC meeting on December 10th, 2020, which suggests that this hidden death also had autopsy results available at the critical juncture of consideration of the vaccine's Emergency Use Authorization.

https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf, p. 71.

https://phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf#page=128, p. 128.

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To be eligible for inclusion in this clinical trial, participants had to be deemed healthy based on medical history, physical examination (if required), and the clinical judgment of the investigator. The protocol allowed healthy participants with pre-existing stable disease – defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the six weeks before enrolment – to participate in the clinical trial. This patient was medicated with two different antihypertensives and had encountered clinical trial personnel at least three times with no mention of any worryingly high blood pressure readings. In fact, I cannot find any blood pressure reading in her publicly available case notes. Consequently, I can only assume the patient’s high blood pressure, from which she had suffered since January 1st, 2010, was well-controlled when she was admitted to the trial.

The patient was 165cm tall and weighed 74.1kg. Hence, her BMI of 27.2 put her in the overweight category, not obese. Without reviewing autopsy results, it will be difficult to believe that such anthropometric readings put a person at high risk of sudden cardiac death.

https://www.phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf, p. 10.

Further inquiry is needed into the clinical sponsor’s conclusion that this undisclosed death in the Vaccinated arm was not due to the vaccine. On what basis was this determination made? This patient has an autopsy result that is still not publicly available. This autopsy was not disclosed at the most critical juncture, prior to the drug's authorisation. The results of this autopsy need to be made public for scrutiny by independent experts.

It is extremely important to know

• When the clinical site 1114 received notification of death, and whether there was timely notification to the clinical trial sponsor, Pfizer-BioNTech.

• When the autopsy was done, and who was informed of the results of sudden cardiac death and when.

• Why this death (which occurred well within the reporting period) and the autopsy results were not disclosed publicly at the December 10^th, 2020, VRBPAC meeting.

Below is a simple schematic diagram highlighting the important dates for this trial subject.

I further scrutinised the deaths and autopsies performed overall in the trial. The Vaccinated arm had 21 deaths, and only three of them (subjects 11141050, 11271112, and 11351033) had autopsies done.[18] One autopsy resulted in the diagnosis of sudden cardiac death (subject 11141050), and the other two reports are still not available. Ten of the 21 deaths in the vaccinated subjects occurred in those who were found dead or suffered sudden adult death.[19] Of those 10, only two (subjects 11141050 and 11271112) had autopsies done, with only one autopsy result provided (subject 11141050 - sudden cardiac death). The result of the autopsy for vaccinated subject 11271112 is still pending. There were 17 deaths in the placebo group, and only four (subjects 11521085, 11561124, 11681083, and 12314987) had autopsies. Of these, two (subjects 11561124 and 11681083) listed a cause of death. The other two results are still not available.

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The autopsies, or rather lack of autopsies, in this trial become more pertinent considering the recently published systematic review of autopsy findings in deaths after COVID-19 vaccination. It found 73.9% of deaths were independently adjudicated as directly due to the vaccination, of which the primary cause of death included sudden cardiac death in 35%. [20]

I also want to highlight another undisclosed death of a vaccinated subject. Subject 11201050, from Meridian Clinical Research LLC, Savannah, Georgia, died on November 7, 2020. The patient narratives explicitly state that the clinical site received notification of the subject’s death on November 7, 2020, from her husband (Pfizer 2023, p. 75). This information is further supported by documentation found in that patient’s CRF clearly stating that the death notification occurred on November 7, 2020.[21]

During the December 10, 2020, VRBPAC meeting, one reason cited for vaccine approval was the known and potential benefits of the vaccine outweigh the known and potential risks of the vaccine when used for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older (Vaccines and Related Biological Products Advisory Committee, 2020). Notably, the omission of the deaths and autopsy report from the vaccinated arm of the study at this critical juncture of EUA issuance raises substantial concerns about the overall safety reporting of Pfizer’s clinical trial. Patients who volunteered for the clinical trial likely did so, at least in part, in service of humanity. The failure to disclose the patients' deaths, despite timely notification by loved ones, constitutes a betrayal of their altruism and trust and deserves further investigation. It also raises considerable doubt about the reporting methods overall. These methods have led to medico-financial expenditure never seen in the world, and possibly on incorrect premises entirely.

Sincerely,

Dr Jeyanthi Kunadhasan

MD (UKM) MMed (AnaesUM) FANZCA MMED (Monash)

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[1] “Pfizer 16+ Documents.” Public Health and Medical Professionals for Transparency, Food and Drug Administration, 17 Feb. 2021, phmpt.org/pfizer-16-plus-documents/.

[2] “Australian Medical Professionals’ Society: A Society for Australian Medical Professionals.” AMPS, AMPS, amps.redunion.com.au/. Accessed 31 Dec. 2023.

[3] Kunadhasan, Jeyanthi, et al. “Report 42: Pfizer’s EUA Granted Based on Fewer than 0.4% of Clinical Trial Participants. FDA Ignored Disqualifying Protocol Deviations to Grant Eua.” DailyClout, DailyClout, 26 Sept. 2022, dailyclout.io/report-41-the-170-clinical-trial-participants-who-changed-the-world-pfizer-ignored-protocol-deviations-to-obtain-emergency-use-authorization-for-its-covid-19-mrna-vaccine/.

[4] Kunadhasan, Jeyanthi, and Ed Clark. “Report 76: Pfizer Had Data to Announce Its COVID-19 Vaccine’s Alleged ‘Efficacy’ in October 2020. Why Did Pfizer Delay the Announcement until November 9, 2020, Six Days after the 2020 U.S. Presidential Election?” DailyClout, DailyClout, 10 July 2023, dailyclout.io/report-76-pfizer-had-necessary-data-to-announce-its-covid-19-vaccines-alleged-efficacy-in-october-2020-why-did-pfizer-delay/.

[5] Michels, Corinne, et al. “Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/Biontech Bnt162b2 Mrna Vaccine Clinical Trial.” International Journal of Vaccine Theory, Practice, and Research, International Journal of Vaccine Theory, Practice, and Research, 17 Oct. 2023, ijvtpr.com/index.php/IJVTPR/article/view/86.

[6] https://dailyclout.io/fda-granted-pfizer-eua-based-on-misrepresented-data/

[7] Polack, Fernando, et al. “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine.” New England Journal of Medicine, nejm.org, 10 Dec. 2020, www.nejm.org/doi/full/10.1056/NEJMoa2034577.

[8] Thomas, Stephen J., et al. “Safety and Efficacy of the BNT162B2 Mrna Covid-19 Vaccine through 6 Months.” New England Journal of Medicine, nejm.org, 15 Sept. 2021, www.nejm.org/doi/full/10.1056/NEJMoa2110345.

[9] Naik, Ramachandra, et al. “Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum.” FDA, fda.gov, 20 Nov. 2020, www.fda.gov/media/144416/download, p. 19.

[10] Pfizer. “A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS.” Public Health and Medical Professionals for Transparency, PHMPT.org, 1 Mar. 2022, phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf, p. 74.

[11] Pfizer. “125742_S1_M5_5351_c4591001-Interim-Mth6-Narrative-Sensitive.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 Sept. 2023, phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf.

[12] https://phmpt.org/wp-content/uploads/2021/11/5.2-listing-of-clinical-sites-and-cvs-pages-1-41.pdf#page=18.

[13] https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf, p. 69.

[14] https://phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf, p. 23.

[15] https://phmpt.org/wp-content/uploads/2023/09/125742_S1_M5_5351_c4591001-interim-mth6-narrative-sensitive.pdf, p. 71.

[16] Vaccines and Related Biological Products Advisory Committee. “Vaccines and Related Biological Products Advisory Committee December 10, 2020, Meeting Announcement.” U.S. Food and Drug Administration, fda.gov, 10 Dec. 2020, www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement.

[17] Pfizer. “125742_S1_M5_CRF_c4591001-1114-11141050.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 May 2023, phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1114-11141050.pdf, p. 128.

[18] https://dailyclout.io/wp-content/uploads/Follow-up-letter-Professor-Anthony-Lawler_17_5_24.pdf

[19] Michels, Corinne, et al. “Forensic Analysis of the 38 Subject Deaths in the 6-Month Interim Report of the Pfizer/Biontech Bnt162b2 Mrna Vaccine Clinical Trial.” International Journal of Vaccine Theory, Practice, and Research, International Journal of Vaccine Theory, Practice, and Research, 17 Oct. 2023, ijvtpr.com/index.php/IJVTPR/article/view/86.

[20] Science, Public Health Policy and the Law. 2024. “A Systematic review of autopsy findings in deaths after COVID-19 Vaccination - Science, Public Health policy.” November 17, 2024. https://publichealthpolicyjournal.com/a-systematic-review-of-autopsy-findings-in-deaths-after-covid-19-vaccination/.

[21] Pfizer. “125742_S1_M5_CRF_c4591001-1120-11201050.Pdf.” Public Health and Medical Professionals for Transparency, phmpt.org, 1 May 2023, phmpt.org/wp-content/uploads/2023/05/125742_S1_M5_CRF_c4591001-1120-11201050.pdf, p. 74.

Dear DailyClout Community,

It’s the holiday season, and we at DailyClout want to express our deepest gratitude for your support. Because of supporters like you, we’ve accomplished so much this year, and with your help, we can achieve even more.

Over the past year, we’ve grown from a small, independent news site into a trusted voice in the fight for truth. Here are just a few of our accomplishments:

• Election Integrity Reporting: Our Election Transparency, Accountability, and Inclusion Act: Model Law has helped pave the way for election transparency in the US. DailyClout also facilitated the creation of a private portal where citizens may upload photos of their ballot (in states that allow it) to shed light on process irregularities, maintain ballot records, and push for stronger safeguards against election fraud.

• Release of a Historic Book: We proudly published The Pfizer Papers, a groundbreaking work praised by Dr. Peter McCullough as, "... a comprehensive, organized, and compelling presentation of vaccine safety data that has accumulated after mass and indiscriminate administration of the Pfizer mRNA COVID-19 vaccines." True Crime Author John Leake praised The Pfizer Papers as "...one of the most impressive works of investigative scholarship in history." This book has quickly become a must-read for anyone seeking clarity in chaotic times.

• Press Release: After reviewing COVID-19 vaccine-related emails and other documents a DailyClout volunteer attorney obtained under the Freedom of Information Act, U.S. Sen. Ron Johnson (R-Wis.), ranking member of the Permanent Subcommittee on Investigations, called on the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), and Centers for Disease Control and Prevention (CDC) to immediately preserve all records referring or relating to the development, safety, and efficacy of the COVID-19 vaccines.

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A serious flu-like respiratory disease began to spread in early Fall 2019 with Wuhan, China, as “ground zero.” By December, worldwide spread of the disease was underway. Images of hapless pedestrians suddenly falling dead in the streets; overwhelmed hospitals in Lombardy, Italy; government-imposed lockdowns; and nonstop coverage of worldwide COVID deaths fanned the flames of fear surrounding this unknown disease. It was not enough to be symptom-free. People demanded the development of a test to detect silent carriers of the infectious agent.

Only the genome sequence of SARS-CoV-2 was known at the time, and the only available testing method used polymerase chain reaction, a.k.a. PCR. Despite many known contraindications, RT-PCR widespread testing for COVID-19 began. According to Dr. Trish M. Perl, an epidemiologist at Johns Hopkins and past president of the Society of Health Care Epidemiologists of America, blind faith in the results of technically complex molecular tests results in “pseudo-epidemics.”  [https://www.nytimes.com/2007/01/22/health/22whoop.html] The COVID-19 pandemic was one of those.

Even Kary Mullis, the Nobel Prize-winning inventor of PCR, would not have approved. PCR revolutionized the life sciences, especially molecular biology. This extraordinary biochemical tool facilitated all manner of techniques that were close to impossible without it. Unfortunately, demonstrating the presence of a VIABLE infectious agent is not within PCR’s skill set. Although Mullis was talking about HIV, the following quote is still appropriate for COVID-19. “[PCR] doesn’t tell you that you are sick, or that the thing that you ended up with was going to hurt you or anything like that.” Mullis continues, “It allows you to take a minuscule amount of anything and make it measurable and then talk about it.” [https://off-guardian.org/2020/10/05/pcr-inventor-it-doesnt-tell-you-that-you-are-sick/]

In the end, it was not the PCR technique that was the problem, but the fraudulent analysis of the results. To quote Mullis, “I don’t think you can misuse PCR. [It is] the results; the interpretation of it. If they can find this virus in you at all – and with PCR, if you do it well, you can find almost anything in anybody.” [https://off-guardian.org/2020/10/05/pcr-inventor-it-doesnt-tell-you-that-you-are-sick/] The FDA, which approved commercial RT-PCR test kits for COVID-19 and developed the first kits, should have been aware of the potential for misuse. It was their responsibility to put in place guardrails to prevent misuse. The CDC should have been informed as well. The fact that the FDA kept silent, or allowed it to happen, speaks volumes.

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What is PCR?

PCR is a molecular copy machine capable of producing trillions of copies of a short section of a DNA molecule. It relies on features of the DNA synthesis machinery revealed by decades of research, for which many have received Nobel Prizes.

• PCR uses a special thermostable DNA polymerase, the enzyme that synthesizes DNA, that can withstand heating to temperatures of 92^oC to 98^o

• DNA polymerase makes copies of a “template” DNA molecule. It requires a template, and it cannot start synthesizing DNA just anywhere along a DNA template. It moves along one strand of the DNA template, adding one nucleotide (base) at a time. The newly inserted nucleotide base is “complementary” to the base on the template strand. Complementary pairs of nucleotides are as follows. A is complementary to T, and G is complementary to C.

• Single strands of DNA have chemically distinct ends referred to as the 5’ and 3’ ends. DNA polymerase can only synthesize the new DNA strand by attaching to a free 3’ end. In PCR, the free 3’ end is provided by a short single strand of nucleotides, about 12 to 20 nucleotides in length, called a “primer.” DNA polymerase starts synthesizing DNA by attaching to the 3’-end of the primer.

• PCR uses pairs of primers to make multiple copies of the section of DNA between the primers. The two primers define the ends of the section to be copied. The sequence of the primers must be carefully determined to be complementary to unique sequences on opposite strands of the template DNA. Recognition of unique sequences by the primers is how PCR distinguishes among the other closely related human coronaviruses endemic in the population and SARS-CoV-2.

• At 37^oC to 65^oC, primers pair up with their complementary sequence, a process called “annealing.” The accuracy and stringency of primer annealing are dependent on the length of the primer, its G/C content, and the annealing temperature used. The higher the annealing temperature, the more stringent the sequence complementarity required between the primer and the target site. The proper annealing temperature for high stringency pairing is easily calculated for each primer.

• At temperatures of 92^oC to 98^oC, double-stranded DNA separates into single strands, called “melting.”

• DNA synthesis starting at the 3’end of the primer is called “primer extension” and occurs at 72^o.

A typical PCR reaction mix contains (1) thermostable DNA polymerase that can withstand temperatures up to 92^oC to 98^oC; (2) the pair of primers; (3) the target DNA; (4) all four nucleotides (A, T, C, G) bases, and (5) buffers and salt solutions. The PCR reaction mix is placed in a very small, conical-bottom plastic tube capable of holding only 10 or fewer drops of reaction mix.

This tube is inserted into the thermoblock of a PCR thermocycler. A typical thermoblock is about 7 centimeters square and one to two centimeters thick. It contains multiple “wells,” holes whose size perfectly fit the conical-bottom plastic tubes used for the PCR reactions. A typical number of wells is 96 arranged in eight rows of 12. The thermoblock is placed into the PCR thermocycler “temperature bath,” and all of the tubes are sealed in place.

The thermocycler rapidly raises and lowers the temperature of the thermoblock/reaction tubes in a matter of seconds. This is computer-controlled and is input by the technician. Temperature and times of each cycle will vary. Each PCR cycle consists of the following series of temperature changes and takes only a few minutes.

1. The temperature is raised to allow all of the DNA strands to separate into single strands.

2. The temperature is lowered to the desired annealing temperature to allow the primers to pair to their unique complementary sequence.

3. The temperature is raised to 72^oC to allow the thermostable DNA polymerase to extend the primer and produce a strand of DNA complementary to the target DNA template.

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Reverse Transcriptase

SARS-CoV-2 is a single-stranded RNA that functions as a messenger RNA (mRNA) for protein synthesis when it infects a cell. PCR needs a DNA target. Thus, to use PCR to detect the presence of SARS-CoV-2, this RNA must first be copied into DNA. This is done using a special DNA polymerase called “reverse transcriptase” which uses RNA as the template to synthesize a complementary DNA strand.

RT-PCR Test Procedure

Step 1: Extract RNA from the nasal swab. This will include any SARS-CoV-2 RNA plus host RNA and other nasal contaminants.

Step 2: Reverse transcriptase is used to synthesize a DNA complement to a specific section of SARS-CoV-2 RNA. In the diagram, the RT-primer for this step (in green) is complementary to a unique sequence in the untranslated region found at the 3’-end of SARS-CoV-2, just next to the N gene. The DNA strand produced will only extend a few hundred bases into the N gene. It will not include the Spike gene or any other genes of this almost 30,000-nucleotide-long genome. This is an important point! Only the presence of the N gene is being tested. (Other regions of the SARS-CoV-2 RNA could be tested as long as a unique RT-primer sequence is used.)

Step 3: Raise the temperature to separate the short DNA strand from the SARS-CoV-2 RNA.

Step 4: Lower the temperature to allow Primer 1 (in red) of the PCR mix to pair up (anneal) to the N gene DNA strand. Primer 1 is complementary to a unique short sequence that is inside the boundary of the N gene.

Step 5: Raise the temperature to about 72^oC to allow the temperature-stable DNA polymerase to synthesize the DNA complementary strand, called primer extension.

Step 6: Raise the temperature to separate the DNA strands.

As long as the primers used pair with sequences that are unique to SARS-CoV-2 RNA, the RT-PCR test will detect only SARS-CoV-2 RNA. If, for any reason, the sequence of the primers is incorrectly decided upon, the test will be flawed and give incorrect results. [Borger, Pieter, Malhotra, Rajesh Kumar, Yeadon, Michael, Craig, Clare, McKernan, Kevin, Steger, Klaus, … Kämmer, Ulrike. (2020). External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results. http://doi.org/10.5281/zenodo.4298004]

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Step 1 produces an RNA/DNA hybrid of the N gene section of SARS-CoV-2 RNA. PCR cycle 1 produces one double-stranded fragment of DNA copied from the region between the primer pair. Cycle 2 produces two copies of this fragment; Cycle 3 produces four copies; and so forth. The amount of double-stranded DNA produced is quantified easily using different methods and can be done in the heating blocks real-time thermocyclers.

Based on one starting copy, 25 cycles will produce 335,543,936 copies, and 45 cycles will produce 3,474,749,302,776 copies. If there is more than one copy in the starting reaction mix, these numbers will be reached after fewer cycles. In other words, the fewer number of cycles needed to detect a fragment, the higher the number of input copies.

DNA-binding “probes” release a fluorescent dye molecule each time a DNA fragment is copied. When a minimum number of dye molecules are released, the PCR reaction mix begins to fluoresce. The florescence of each reaction tube is monitored by the thermocycler, and the number of cycles is recorded.  See a typical plot of RT-PCR results.

Where RT-PCR Testing Went Wrong

PCR requires specialized equipment and training not only to perform the procedures properly but also to analyze the results correctly. By February 3, 2020, the U.S. Centers for Disease Control and Prevention (CDC) had developed the first RT-PCR test kit. Dozens of other commercially produced RT-PCR testing kits were soon developed. So, what could go wrong? Tons of things! Just a few of the most significant are listed below. [https://dailysceptic.org/2020/11/30/the-pcr-false-positive-pseudo-epidemic/]

• As stated in the CDC’s instruction document for its RT-PCR test kit, [it] is intended for use by laboratories designated by CDC as qualified and “to be limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) that meet the requirements to perform high complexity tests”. [https://www.fda.gov/media/134922/download] This, of course, was true for all of the RT-PCR testing kits. Billions of PCR tests were run at tens of thousands of sites, most of which were not CLIA-certified. This is comparable to taking your Ferrari 12 Cilindri for an engine tune-up by your local garage mechanic. The explosion of the number of testing sites increased the probability of testing mistakes.

• The most important take-home message from the diagram above is that the RT-PCR test does not discriminate between the whole virus and fragments of the viral RNA genome. It is ONLY capable of demonstrating the presence of SARS-CoV-2 fragments. It cannot be used as an indicator of the presence of infectious (encapsulated) viral particles in the swab. Misinterpretation of RT-PCR test results explains the “asymptomatic carrier,” the claims that so many people hospitalized for other reasons were declared to have COVID-19, and why so much of the lockdown frenzy we went through was entirely needless. There was a “pandemic of testing!”

• Patient sampling errors due to variations in “swabbing techniques” and in the efficiency of RNA purification techniques can lead to 1,000 to 10,000-fold differences in the amount of RNA in the sample tested. This translates to differences of up to 10 to 13 PCR cycles. [Michael Yeadon, “The PCR False Positive Pseudo-Epidemic.” https://lockdownsceptics.org/the-pcr-false-positive-pseudo-epidemic/]

• Test protocols should have included positive and negative control samples in each sample series. These controls would serve as indicators of technique errors and contamination. RNA is easily degraded, and poor extraction methods lead to false negative results. Contamination is a major problem in PCR because of its extreme sensitivity and sloppy technique can lead to false positive results. [https://www.thelancet.com/action/showPdf?pii=S2213-2600%2820%2930453-7]

• A significant source of analysis error in the RT-PCR test was the omission of a cut-off number of cycles at which a sample was to be considered positive or negative. Documentation for the testing kits referred to the RT-PCR test as “qualitative.” The simple addition of a standardized sample carrying a known number of copies of the DNA target would have easily allowed quantification. This is obvious from the dilution series shown in the Amplification figure above. If this had been done, a cut-off of about 25 cycles would have been sufficient to demonstrate a viral load sufficient to indicate a true infection. Testing centers rarely reported the number of cycles they were using to call a sample “positive,” but reports indicated that 45 to 47 cycles were commonly used. This number of cycles is capable of detecting insignificant nasal contaminants rather than a true infection. [https://www.journalofinfection.com/action/showPdf?pii=S0163-4453%2820%2930675-7]

• Extremely high concentrations of the primers were used in some kit protocols, which could have contributed to aberrant annealing to sites in coronavirus strains other than SARS-CoV-2.

• The annealing temperature for a primer pair is critical and must be carefully set. Different RT-PCR kits from different commercial providers used different primer pairs and, thus, would require different annealing temperatures. If a testing site used different commercial kits, it would have been critical that the thermocycler equipment temperatures be appropriately set for each kit type.

• SARS-CoV-2 spread was accompanied by accelerated production of hundreds of variants. The multitude of sequence changes accumulated throughout the length of the viral genome including the N gene. For a visualization of this, see the screenshot below from the NextStrain site entitled, “Genomic epidemiology of SARS-CoV-2 with subsampling focused globally over the past 6 months” (https://nextstrain.org/ncov/gisaid/global/6m)

  

• To keep pace with constant sequence variation, continued updating of the primer sets for a particular RT-PCR kit is necessary. Some but not all commercial kits were updated. Without appropriately updated primers, the frequency of false negative test results would increase, and individuals sick with a new SARS2-CoV-2 variant would be misdiagnosed by the reputed “gold standard” test for COVID-19.

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In November 2023, the Acon Flowflex COVID-19 Antigen Home Test became the first of dozens of at-home rapid antigen tests approved by the U.S. Food and Drug Administration (FDA) for identifying COVID-19 infection. Antigen test kits detect the presence of SARS-CoV-2 N capsid protein, an essential protein involved in packaging the viral RNA into the virus particle. These tests are used in the first one to five days of symptoms and are clear indicators of an active infection.

The availability of antigen home tests ended the frenzy of RT-PCR testing for the general public. More importantly, they ushered in the end of the pandemic frenzy and “contact tracing” frenzy. Hospitals and doctor offices continued to use the RT-PCR test, likely because administrators demanded this cash cow of government money.

RT-PCR testing for COVID-19 infection was a monstrous fraud imposed on a trusting populous. The COVID pandemic was really the Pandemic of Testing! It was used to lock Americans down, isolate us from friends and family, create rampant fear, and make us willing to vaccinate with an experimental vaccine. Government and public health entities succeeded once because the public was naive. They will continue to use the same ploy with the newest flavor of the month viral disease. Next time, reason, not irrational fear, will keep us free.

Corinne Michels, PhD, is an internationally recognized molecular geneticist studying the regulation of gene expression in the model eukaryote Saccharomyces cerevisiae, baker’s and brewer’s yeast. Her research was consistently funded by grants from the US National Institutes of Health and the National Science Foundation. She authored of over 75 research journal articles, review articles, and book chapters in scientific publications. Dr. Michels’ textbook, Genetic Techniques for Biological Research: A Case Study Approach (John Wiley & Sons), is widely used in both the classroom and research laboratory.

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This article is the writer’s opinion. Freedom of speech is one of America’s most important freedoms.

Centers for Disease Control and Prevention (CDC) emails and documents provide reasonable suspicion to investigate identifiable CDC personnel for committing the state law crime of reckless endangerment during the February through May 2021 phase of the COVID-19 vaccination campaign and beyond. A county attorney or state attorney general could lawfully file a criminal charge in the name of his or her state against a federal official in any case meeting the legal threshold required to file. This article, written to be accessible to both general readers and legal professionals, posits a prosecution for reckless endangerment, discusses applicable legal standards and statutes, precedent for state-level prosecution of federal officials, Supremacy Clause immunity, jurisdiction, venue, removal, statute of limitations, “small potatoes” concerns, related subjects, and broaches an alternative to retributive justice. I acknowledge some legal theories herein are novel.

While I support calls for and efforts toward large-scale international- and federal-level investigations and prosecutions if supported for COVID-19-era wrongdoing, I invite aligned readers to consider “thinking small” in the meantime and starting somewhere, that is, to consider investigative and prosecutorial undertakings not dependent on difficult-to-obtain political control of the power levers required to undertake international- and federal-level efforts by perhaps unwieldy or compromised coalitions. Though I base my discussion mostly in the law of one state and one federal circuit, the notions herein are intended to stimulate action by aligned persons in all states with similar laws (and accessible grand jury systems), including county attorneys, state attorneys general, legislators in states having legislative investigative powers (which can yield evidence supporting referrals for prosecution), and sheriffs.

As stated in my first article on this subject, co-authored with Amy Kelly, “FOIA'd CDC Emails Reveal Disturbing Myocarditis Timeline Warranting Investigation: Different Messaging Internally Vs. Publicly About COVID-19 Vaccines and Myocarditis.” - DailyClout, I do not rush to judgment, because I recognize facts which raise questions often have innocent explanations, investigations are intended to investigate, they can serve to dispel suspicion as effectively as to confirm it.  Also, I would be the first to advocate for defending the constitutional rights of any accused person against the slightest hint of unfairness in any forthcoming criminal proceedings.

All dates below are in 2021 unless otherwise indicated. Rather than inserting hyperlinks after every factual assertion supported by primary source documents or other content linked in the first article, I cite by the date in the chronology provided there, under which the supporting link or citation is provided. For example, when I assert, “[i]n late February and early March personnel at the Israeli Ministry of Health (IMOH) contacted CDC about ‘a large number of reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine[,]’” the reference herein will be “(March 4)” which is the date in bold font in the first article under which the supporting link or citation appears. Exceptions are my citation to the published work of Dr. Karl Jablonowski and Dr. Brian Hooker, any citation to content not included in the first article, and to correct one mis-citation there. While this posited hypothetical considers Dr. Tom Shimabukuro, (Tom Shimabukuro | Blogs | CDC), CDC’s “vaccine safety team lead on the CDC COVID-19 Vaccine Task Force” (March 4), I do not single him out: identified further below are additional CDC personnel and still others whose emails suggest either possible reasonable suspicion to investigate them for reckless endangerment, to dispel or confirm suspicion, or that interviewing them could yield information relevant to determining whether there is reasonable suspicion to investigate others.

Below, I recite facts supporting reasonable suspicion to investigate Dr. Shimabukuro for the crime of reckless endangerment, describe the reasonable suspicion standard, and apply those facts and that standard to that crime’s definition, then proceed from there. Again, investigations may dispel or confirm reasonable suspicion.

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Facts to Decide If Reasonable Suspicion Exists

In late February and early March, personnel at the Israeli Ministry of Health (IMOH) contacted CDC about “a large number of reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine.” (March 4) By early March, at the latest, Dr. Shimabukuro participated in intra-CDC dialogue about responding to IMOH and began “working with FDA [U.S. Food and Drug Administration] to respond” to IMOH.  Id.  CDC emails show a Zoom meeting between IMOH and CDC personnel was arranged, during which IMOH personnel shared their myocarditis data. Id.

Around that time, an undated CDC Word memorandum titled “Summary of VAERS Report of myocarditis, pericarditis and myopericarditis following vaccination with mRNA COVID-19 vaccines” (March 4) was drafted by an unidentified author, stating in part: “This memo responds to questions posed from [IMOH] to the FDA and CDC. They are investigating a safety signal of myocarditis[]/myopericarditis in a younger population (16[]-30 years old) following administration of Pfizer-BioNTech Covid-19 vaccine.” Id. (emphasis added). And “[IMOH] reports” “around 40 cases of this adverse event.” “A search of [VAERS]” “on February 23, 2021[,] revealed 27 cases (6 cases of myocarditis, 7 cases of myopericarditis, 14 cases of pericarditis).” Id. The memo discusses search criteria used, review and categorization methodology, and inclusion and exclusion methodology, further stating: “[T]he reporting rate of myopericarditis following administration of the mRNA COVID-19 vaccines was low and estimated to be 0.7 per million doses of vaccine administered. However, the limitations of passive surveillance such as under-reporting, lack of a control group, missing and incomplete data make it challenging to assess causation. Thus, FDA has not made a final determination regarding the causality between myopericarditis and the mRNA COVID-19 vaccines. I will continue to monitor this outcome in active and passive surveillance.” Id.

On March 8, Dr. Shimabukuro received an email from a Western Australia public health official asking if he had “information on background rates” about reports of both “myocarditis and appendicitis following COVID-19 vaccines.” (March 8)  As part of multi-recipient email discussions spanning through April 1, Dr. Shimabukuro provided the Australians with a draft manuscript of an article under review at Vaccine; information in an email, which takes up two-thirds of a page when printed, to be kept “close hold[,]” all of which is redacted from Freedom of Information Act (FOIA) responsive documents; and attachments comprised of “some ACIP [Advisory Committee on Immunization Practices] COVID-19 vaccine safety technical subgroup presentations” to be “treat[ed]” “as confidential[.]” Id.

On April 1, John R. Su, MD, PhD, MPH, Vaccine Safety Team CDC COVID-19 Vaccine Task Force, sent an email with “RE: VAERS Review of Myocarditis/Myopericarditis for DoD [Department of Defense] Discussion Tomorrow” in the subject line, with an attachment titled “VAERS myopericarditis Vaccine 2021.pdf,” one recipient of which was Dr. Shimabukuro. (April 1).

On April 6, Dr. Shimabukuro sent the agenda items for the “USG [US Governors’] vax safety coordination call[.]” The five agenda items included these three: “DoD myocarditis case series preview[,]” “VSD [Vaccine Safety Datalink] and VA [Veterans’ Affairs] efforts for signal refinement for PE [pulmonary embolism] and AMI [acute myocardial infarction][,]” and “CDC update on CVST [cerebral venous sinus thrombosis] epi and CVST reports to VAERS[.]” (April 6).

On April 12, Dr. Shimabukuro likely received an email with a slide deck in PDF format attached, the subject of which was “Monday’s VaST [Vaccine Safety Technical Work Group] presentation on Myocarditis following COVID-19 Vaccination[.]” (April 11, 12) Like in the first article, I stand by using “appears,” “likely,” and “suggests” because I am making reasonable surmisals from the emails’ content and context in FOIA records heavily redacted in places. I am open to challenge on my surmisals.

On April 15, Dr. Shimabukuro, replying to an email from a Tufts University medical doctor, acknowledged “[t]here have been reports of myocarditis following mRNA vaccines.” (April 15)

Also, Dr. Shimabukuro states he was among those monitoring for myocarditis from the beginning of the COVID-19 vaccine rollout: “I have been monitoring myocarditis/pericarditis as a VAERS [Vaccine Adverse Event Reporting System] adverse event of special interest from the beginning.” (April 19) Since he acknowledges he was using VAERS, id., it is reasonable to infer he knew what VAERS data was showing, specifically, by February 19 VAERS reports “implicat[ed] myocarditis [as] causally connected to the COVID-19 vaccine in young males with greater than 95% confidence – the typical threshold beyond reasonable doubt.” Jablonowski KD, Hooker B, Delayed Vigilance: A Comment on Myocarditis in Association with the COVID-19 Injections. International Journal of Vaccine Theory, Practice, and Research, 2(2), 651.1–651.4, View of Delayed Vigilance (Delayed Vigilance); see also, Jablonowski KD, Hooker B, et al., Lock the Doors: The Myocarditis Disaster and a call for the broad examination of the CDC and FDA | Medical Research Archives. And by the week of April 2: “VAERS [had received] enough serious adverse event reports implicating a causal connection between the COVID-19 vaccine and myocarditis in young males with a 99.9% confidence.” (Delayed Vigilance).

At a minimum it is fair to impute to Dr. Shimabukuro direct knowledge of those facts about myocarditis incidence after COVID-19 vaccination, except for the content of both the Word memorandum and the PDF slide deck about “Myocarditis following COVID-19 Vaccination[.]” For those two exceptions, it is reasonable provisionally to infer he knew the content of both those documents because he was CDC’s vaccine safety team lead on CDC’s COVID-19 Vaccine Task Force. I say “[a]t a minimum” because I am working from two heavily redacted FOIA productions, both of which are linked frequently in the first article.

Yet, on April 19, when Dana Meaney-Delman, MD, MPH, FACOG, then Chief, Infant Outcomes Monitoring Research and Prevention Branch, CDC, sent an email at 9:42 AM to Dr. Shimabukuro and others with “Pericarditis and Mrna [sic] vaccines” in the subject line, stating: “Ann S[chuchat] is on the deputies call with WH [White House] right now and is asking if there has been any signal with pericarditis and mRNA vaccines[,]” (April 19) he emailed back, stating: “DoD and the Israel MOH think they have a signal for myocarditis with mRNA vaccines, but there is potentially a lot of ascertainment bias in the DoD data. I don’t have any evidence to suggest a signal or a safety problem for myocarditis or pericarditis with mRNA vaccines from VAERS and VSD surveillance and FDA and VA have not detected any signals in their monitoring.” (April 19) (emphasis added).

There was nothing “think” about “Israeli MOH think they have a signal for myocarditis[,]” (April 19) (emphasis added) because, according to CDC’s own Word memorandum titled “Summary of VAERS Report of myocarditis, pericarditis and myopericarditis following vaccination with mRNA COVID-19 vaccines[,]” (March 4), IMOH was “investigating a safety signal[,]” meaning there was a safety signal, and IMOH was investigating it: “They are investigating a safety signal of myocarditis[]/myopericarditis in a younger population (16[]-30 years old) following administration of Pfizer-BioNTech Covid-19 vaccine.” Id. The Israelis certainly thought so: “We are seeing a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine.” (March 3) (emphasis added).  Also, because of heavy redactions in the FOIA productions, I don’t know what the data the Israelis provided to CDC and its vaccine safety team lead on CDC’s COVID-19 Vaccine Task Force showed about myocarditis incidence.

Maybe there will be later semantic disagreement about what constitutes a “safety signal,” though it is clearly defined by Health and Human Services (HHS) in its “Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.” Objective statisticians may have something to say about what constitutes a safety signal, but Dr. Shimabukuro’s stating, “[w]e don’t have any evidence to suggest” “a safety problem for myocarditis or pericarditis with mRNA vaccines” simply is not a supportable statement, in light of the foregoing.

Then, 41 minutes later, Dr. Shimabukuro emailed: “I reviewed the VSD RCA [Rapid Cycle Analysis] data this morning and discussed the DoD data. We have substantial doses administered in younger age groups in VSD and don’t have a hint of a signal; it’s actually protective in the vaccinated concurrent comparator. We aren’t really sure why DoD thinks they have a signal[.]” (CDC FOIA 23-00756 CDC responsive records.pdf - Google Drive, 309) (emphasis added).

In that email, Dr. Shimabukuro omitted mentioning IMOH data. In both 41-minute-apart emails, he omitted mentioning the Western Australian communications about myocarditis.

The facts above are gleaned from the un-redacted pages of the two heavily redacted FOIA productions cited in the first article. Given the search criteria for at least one of those FOIA productions was for CDC emails containing only one word—myocarditis—it is reasonable infer when those emails and their attachments are produced un-redacted there may be more facts and information about post-COVID-19 vaccination myocarditis incidence reasonably imputable to Dr. Shimabukuro and others.

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The Reasonable Suspicion Legal Standard

Law enforcement personnel “may detain and question an individual when the officer has reasonable, articulable suspicion that the person has been, is, or is about to be engaged in criminal activity.” State v. Markland, 2005 UT 26, ¶ 10, State v. Markland (utcourts.gov) (for all citations to Markland herein, any internal quotation marks and citations to other authority therein are omitted). “[T]o justify such a detention, the officer’s suspicion must be supported by specific and articulable facts and rational inferences.” Id. “A determination that reasonable suspicion exists need not rule out the possibility of innocent conduct.” Id. This is the lowest legal standard in criminal law, “it falls considerably short of satisfying a preponderance of the evidence standard[,]” id., a standard that “requires demonstrating that the proposition is more likely true than not true[,]” (preponderance of the evidence | Wex | US Law | LII / Legal Information Institute (cornell.edu), sometimes thought of “as requiring a finding that at least 51  percent of the evidence favors the [disputed proposition].” (Evidentiary Standards and Burdens of Proof in Legal Proceedings | Justia). Importantly, when deciding reasonable suspicion, “courts must view the articulable facts in their totality and must avoid the temptation to evaluate them in isolation.” Markland, id.

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The Crime of Reckless Endangerment

Reckless endangerment defined:

An actor commits reckless endangerment if, under circumstances not amounting to a felony offense, the actor recklessly engages in conduct that creates a substantial risk of death or serious bodily injury to another individual.

Utah Code § 76-5-112(2), Utah Code Section 76-5-112.

“Conduct means an act or omission” to act.

Utah Code § 76-1-101.5(5), Utah Code Section 76-1-101.5.

Reckless endangerment does not require death or serious bodily injury to occur, it only requires the reckless conduct to create a substantial risk of one of those things. (Even if it did, victims would not be hard to find, via word of mouth or organizations like React19, Home - React19.

Utah Code § 76-5-112(2), Utah Code Section 76-5-112.

“[S]erious bodily injury means bodily injury that creates or causes serious permanent disfigurement, protracted loss or impairment of the function of any bodily member or organ, or creates a substantial risk of death.”

Utah Code § 76-1-102.5(17), Utah Code Section 76-1-101.5.

Myocarditis, which impairs or can impair the function of the heart organ or creates a substantial risk of death (both really), meets the “serious bodily injury” definition.

Reckless endangerment is a class A misdemeanor, punishable by a fine of $2,500 and a jail term of 364 days when committed by a person, as opposed to an entity. Entity investigation and prosecution if supported under state law is a separate subject.

Utah Code §§ 76-3-301(1)(c), Utah Code Section 76-3-301 (fine); 76-3-204(1), le.utah.gov/xcode/Title76/Chapter3/76-3-S204.html?v=C76-3-S204_2019051420190514 (jail).

For any readers apoplectically thinking “What! 364 days? That’s all?” keep reading to the “Small Potatoes” section.

Applying the Law to the Facts

So, under the language of the reckless endangerment statute, do the facts above and the rational inferences from them support by considerably less than a more likely than not standard, by a considerably less than 51% evidence in support of the proposition standard, that Dr. Shimabukuro “recklessly engage[d] in conduct[,]” that is, omitting to inform Dana Meaney Delman and others about the evidence of myocarditis incidence after COVID-19 vaccination, knowledge of which can reasonably be imputed to him, so she could have relayed that to Anne Schuchat in the White House deputies meeting (April 19), where Anne Schuchat could have shared that information with those discussing the issue? And did his act of omission “create[] a substantial risk of death [from myocarditis] or serious bodily injury [myocarditis] to another individual[,]” as in Americans who were lining up to get vaccinated at rate of over 1.1 million per day, every day, during the identified period, exposing themselves to a myocarditis risk they might not have taken had they been told? The opposite conclusion, that is, there is no reasonable suspicion to investigate (“nothing to see here, move along”) strains credulity, in light of the facts above. (The 1.1 million per day figure is based on the 112,000,000 number in Delayed Vigilance).

The same analysis applies to Dr. Shimabukuro’s affirmative acts, his affirmative representations that: “I don’t have any evidence to suggest a signal or a safety problem for myocarditis[.]” (April 19) And: “We…don’t have a hint of a signal[.]” (CDC FOIA 23-00756 CDC responsive records.pdf - Google Drive, 309).

By way of understatement, it is fair to impute to Dr. Shimabukuro and others at CDC knowledge that a national vaccination campaign was underway during the February through May 2021 time frame (and beyond) and that millions of people were lining up to get COVID-19 vaccinations.  In terms of the reasonable suspicion standard’s analytical principle that facts must be viewed in their totality, I emphasize the information Dr. Shimabukuro and others had received from external entities about post-COVID-19 vaccination myocarditis incidence came from presumptively reliable sources: public health departments in two developed countries (Australia and Israel) and DoD. CDC also had the VAERS data as identified in Delayed Vigilance.

Also, for the time being, we taxpayers are not privy to the data DoD and IMOH provided CDC. Are we supposed to take CDC’s word for it? And why not mention the Australian communications and the content of the materials he sent them, which he wanted the Australians to keep “close hold” and “confidential[?]” (March 8) And why the equivocal “potentially a lot of ascertainment bias[?]” (April 19) (emphasis added) Given the IMOH data was provided to CDC in March, likely a month before the April 19 White House deputies meeting, there was time to determine that with more specificity; because, given the largest national vaccination campaign in history was underway, the strength or weakness of the myocarditis data coming to CDC is something CDC’s vaccine safety team lead would want to check into. And, since Dr. Shimabukuro was among those “monitoring myocarditis/pericarditis as a VAERS adverse event of special interest from the beginning[,] (May 14) was that or was that not significant enough to disclose?  These are all reasonable questions, the answers to which could dispel or confirm reasonable suspicion.

Whether there is reasonable suspicion to detain Dr. Shimabukuro for questioning for the crime of reckless endangerment to dispel or confirm suspicion doesn’t appear to be a close question. As stated above, I do not single him out. The following persons’ emails suggest either possible reasonable suspicion to investigate them for reckless endangerment, to dispel or confirm suspicion, or that interviewing them could yield information relevant to determining whether there is reasonable suspicion to investigate others, in alphabetical order by surname: John Brooks, MD (May 11, 14, 21); Patrick Caubel (May 22); Grace Lee, MD (April 6); Peter Marks, MD (May 13 (on or about); Elaine Miller (April 20, 26); Jay Montgomery, MD (April 11); Jane Newburger, MD (May 14); Kristen Nordlund (May 14, 27); Ann Schuchat, MD (May 23); John Su, MD (April 1, May 14); Abbigail Tumpey (April 28, May 24, 25); and Rochelle Walensky, MD (May 14, 21, 23, 24, 29). Separately, current CDC Director Mandy Cohen, MD, MPA, Director | About CDC | CDC, regarding ongoing CDC COVID-19 vaccination recommendations.

I emphasize this list is derived from what can be gleaned from documents in two FOIA productions heavily redacted, except in current Director Cohen’s situation. When the documents are eventually produced unredacted, that might provide grounds to dispel suspicion or confirm it.

This is not even to mention individuals holding memberships on various COVID-19-vaccine authorizing, approving, and recommending boards and committees within CDC and FDA who voted to make such authorizations, approvals, and recommendations after a certain date in the COVID-19 narrative, even though knowledge of the endangerment associated with COVID-19 vaccination can reasonably be imputed to them.

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Probable Cause and Reasonable Likelihood of Conviction at Trial

The U.S. Supreme Court has defined “probable cause” as “mean[ing] facts and circumstances within [an] officer's knowledge that are sufficient to warrant a prudent person, or one of reasonable caution, in believing, in the circumstances shown, that the suspect has committed, is committing, or is about to commit an offense.” Michigan v. DeFellipo, 443 U.S. 31, 37 (1979), Michigan v. DeFillippo, 443 US 31 - Supreme Court 1979 - Google Scholar. For the reasonable likelihood of conviction at trial standard, I borrow from the United States Department of Justice Principles of Federal Prosecution, 9-27.220, Justice Manual | 9-27.000 - Principles of Federal Prosecution | United States Department of Justice, which reads in part: “[A] prosecutor may commence or recommend federal prosecution only if he/she believes that the person will more likely than not be found guilty beyond a reasonable doubt by an unbiased trier of fact and that the conviction will be upheld on appeal.” Id.  And, “it should be noted that, when deciding whether to prosecute, the government attorney need not have in hand, at that time, all of the evidence upon which he/she intends to rely at trial, if he/she has a reasonable and good faith belief that such evidence will be available and admissible at the time of trial.” Id.

Assuming a state law enforcement agency investigation, assisted by a law-enforcement-retained statistician and having benefit of un-redacted FOIA productions, yielded unsatisfactory or incriminating answers or additional facts, meeting the standard to file a charge or charges, how could such a case be expected to go?

Precedent for County Attorney Prosecution of Federal Officials and Supremacy Clause Immunity

Wyoming v. Livingston, 443 F.3d 1211 (10^th Cir. 2006), Wyoming v. Livingston, 443 F. 3d 1211 - Court of Appeals, 10th Circuit 2006 - Google Scholar, provides some insight. There, a county attorney’s office charged a U. S. Fish and Wildlife official and a federal contractor with the state law crimes of trespassing and littering on private land while engaged in wolf management activities.

If a CDC official were charged with reckless endangerment in state court, their attorney likely would assert the CDC official is immune from state law prosecution under the doctrine of Supremacy Clause immunity. The U.S. Constitution’s Supremacy Clause has been interpreted to grant immunity to federal officials for “conduct facially violative of a state’s criminal code[,]” Kentucky v. Long, 837 F.2d 727, 744 (6^th Cir. 1988), Com. of Ky. v. Long, 837 F. 2d 727 - Court of Appeals, 6th Circuit 1988 - Google Scholar, but that immunity has limits: “[A] federal officer is not entitled to Supremacy Clause immunity [for conduct facially violative of a state’s criminal code] unless, in the course of performing an act which he [or she] is authorized to do under federal law, the agent had an objectively reasonable and well-founded basis to believe that his [or her] actions were necessary to fulfill his [or her] duties.” Livingston, 443 F.3d at 1222.

Examples where Supremacy Clause immunity protected a federal official from state prosecution for violating a state’s criminal code are where a deputy United States marshal shot and killed a man he thought was about to pull out a gun and shoot the Supreme Court justice the marshal was protecting, after which the marshal was charged with murder, In re Neagle, 135 U.S. 1 (1890), In re NEAGLE, 135 US 1 - Supreme Court 1890 - Google Scholar, and where a special agent for the Bureau of Narcotics and Dangerous Drugs killed a person during a drug raid, after which the agent was charged with second degree murder and involuntary manslaughter. Clifton v. Cox, 549 F.2d 722 (9^th Cir. 1977); Clifton v. Cox, 549 F. 2d 722 - Court of Appeals, 9th Circuit 1977 - Google Scholar.

Whether Dr. Shimabukuro and other CDC personnel withheld post-COVID-19 vaccination myocarditis incidence information from their superiors and, thus, the public (April 19, 28, May 21, 23) is a fact question. If they did, whether they were performing “an act which [they were] authorized to do under federal law[,]” Livingston, 443 F.3d at 1222, appears doubtful on its face, considering CDC self-describes as “the nation’s leading science-based, data-driven, service organization that protects the public’s health[,]” (About CDC | About | CDC) which uses “the Vaccine Adverse Event Reporting System (VAERS) [as] a national early warning system to detect possible safety problems in U.S.-licensed vaccines[.]” (VAERS – About Us (hhs.gov) (emphasis added). Similarly, one would be hard-pressed to conceive “an objectively reasonable and well-founded basis to believe [their] actions were necessary to fulfill [their] duties[,]” Livingston, id., for the same reason. It appears the opposite happened.  Thus, it is doubtful Supremacy Clause immunity would apply. Livingston, a fact-intensive case, held the defendants were entitled to immunity because the record supported “the suspicion that the [Wyoming] prosecution” “was not a bona fide effort to punish a violation of Wyoming trespass law” “but rather an attempt to hinder a locally unpopular federal [wolf management] program.” Id. at 1231.

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Jurisdiction

The actions and omissions by CDC personnel were likely made in Atlanta, Georgia, at CDC headquarters. Other persons of interest were likely in other states when they acted. Still, a complaining state may have jurisdiction over persons whose out-of-state actions or omissions affect residents within the complaining state. An example for determining whether a state has jurisdiction when part of a crime is committed in another state goes like this: If X is standing 20 feet inside Wyoming’s border with Utah, and X unlawfully shoots Y who is standing 20 feet inside Utah, the county in Utah where Y was standing when shot may lawfully assert jurisdiction and prosecute X for the crime charged (so can Wyoming), because at least one element of the crime (injury, serious body injury, substantial bodily injury, or death) happened within Utah:

(1) A person is subject to prosecution in this state for an offense which he commits, while either within or outside the state, by his own conduct or that of another for which he is legally accountable, if:

(a) the offense is committed either wholly or partly within the state;

(b) the conduct outside the state constitutes an attempt to commit an offense within the state;

(c) the conduct outside the state constitutes a conspiracy to commit an offense within the state and an act in furtherance of the conspiracy occurs in the state; or

(d) the conduct within the state constitutes an attempt, solicitation, or conspiracy to commit in another jurisdiction an offense under the laws of both this state and the other jurisdiction.

Utah Code § 76-1-201 (jurisdiction of offenses) (emphasis added), Utah Code Section 76-1-201, see also, Rios v. State, 733 P.2d 242 (Wyo. 1987), Rios v. State, 733 P. 2d 242 - Wyo: Supreme Court 1987 - Google Scholar (discussing subject matter jurisdiction for extra-territorial acts having intra-territorial effects).

And:

(2) An offense is committed partly within this state if either the conduct which is any element of the offense, or the result which is an element, occurs within this state.

Id. (subsection (3) omitted).

And related but not necessary for the posited hypothetical:

(4)(a) An offense which is based on an omission to perform a duty imposed by the law of this state is committed within the state regardless of the location of the offender at the time of the omission.

Id.

Thus, a Utah state court could have jurisdiction over a person whose out-of-state omission to act recklessly endangered Utah residents. Same goes for other states having analogous jurisdictional statutes.

The U.S. Code of Military Justice does not shield CDC personnel in this context. See 10 U.S.C. § 802(a)(8), 10 U.S. Code § 802 - Art. 2. Persons subject to this chapter | U.S. Code | US Law | LII / Legal Information Institute.

Venue and Removal

In criminal cases, venue is the location where a case will be prosecuted, usually the county where the crime happened, which, in this hypothetical, would be the county or counties where people were recklessly endangered.

But when a federal official is prosecuted by a state prosecution agency, like a county, the defense can seek to “remove” (transfer) the case to federal court. “[F]ederal officer removal statutes” “provide federal officers with a federal forum for the entire trial, including determinations of guilt or innocence as well as the applicability of official immunity. This protects against the possibility of a hostile state forum, which might arise when the federal officer is enforcing a locally unpopular national law.” Livingston, 443 F.3d at 1222.

If a county filed a criminal charge against CDC personnel, the defense likely would try to remove the case from state court to federal court. Removal would not be fatal to the prosecution. A federal judge would preside over the case, and guilt or innocence would be decided by a jury drawn from a larger pool of prospective jurors, instead of being presided over by a state court judge and decided by a jury drawn from a countywide pool.

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Statute of Limitations

The time limit within which to file reckless endangerment, a class A misdemeanor, is two years, Utah Code § 76-1-302(1)(b), Utah Code Section 76-1-302, which has already expired for conduct occurring from February through May 2021. Any defendant charged under my hypothetical would argue that it’s too late to file a case. I have three responses.

First and easiest, Wyoming has a reckless endangerment statute, WY Stat § 6-2-504, Title - 6.docx (wyoleg.gov) (1997) and Wyoming has no statute of limitations for crimes. So, Wyoming county attorneys could file such cases if supported anytime.

Second and more attenuated, “[t]he period of limitation does not run against any defendant during any period of time in which the defendant is out of the state following the commission of the offense.” Utah Code § 76-1-304(1), Utah Code Section 76-1-304. So, arguably, assuming CDC personnel and others have not spent two years in Utah or another state with a two-year statute of limitation since the February through May 2021 time frame, any forthcoming prosecution is not time-barred.

At first blush that argument may seem to violate the absurd results doctrine relating to statutory interpretation. See, e.g., State v. Jeffries, 2009 UT 57, ¶ 8, State v. Jeffries (utcourts.gov) (“Where a statute's plain language creates an absurd, unreasonable, or inoperable result, we assume the legislature did not intend that result.”). The absurd result putatively being a class A misdemeanor could be prosecuted many years after it was committed, running counter to the public policies underlying statutes of limitation. See generally, Paul H. Robinson & Tyler Scott Williams, Mapping American Criminal Law 184-185 (Praeger 2018).  The alternative interpretation is that the tolling provision above (“does not run” when “the defendant is out of the state following the commission of the offense”) does not mean what it says. Relatedly, “statutes of limitation” “are also controversial” “and there exists a trend toward lengthening the limitation periods and increasing the number of offenses that are altogether exempt.” Id. at 181.

Third, CDC recommendations for COVID-19 vaccination have been unrelenting, Timeline: COVID-19 Vaccines and Myocarditis | The Epoch Times, up through at least June 27, 2024. CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season | CDC Online Newsroom | CDC (“Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated,” said [CDC Director] Mandy Cohen, M.D., M.P.H. “Make a plan now for you and your family to get both updated flu and COVID vaccines this fall, ahead of the respiratory virus season.”). So have FDA approvals, up through at least August 22, 2024. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants | FDA. These dates are well within statutes of limitation and these recommendations and approvals have been made notwithstanding data about elevated risk of myocarditis after COVID-19 vaccination, for example, Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting | New England Journal of Medicine (nejm.org), and other post-vaccination adverse events, Vol. 3 No. 1 (2023): Injuries, Causes, and Treatments, Part 1 | International Journal of Vaccine Theory, Practice, and Research (ijvtpr.com), including in children, Number of Children Who Died After COVID Shots Much Higher Than VAERS Reports Indicate, Analyst Says • Children's Health Defense (childrenshealthdefense.org). Recently, FDA authorized a COVID-19 vaccine without human clinical data. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants | FDA (“For today’s approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines.”).

'Small Potatoes' Concerns

As stated above, reckless endangerment is a class A misdemeanor, punishable in Utah by a fine of $2,500 and a jail term of 364 days when committed by a person (as opposed to an entity). That may seem a small sanction for the conduct and consequences at issue. But, considering the possibility of one count of reckless endangerment for every person recklessly endangered or who actually sustained serious bodily injury from myocarditis, the theoretical number of chargeable reckless endangerment counts is high. That, plus the possibility of consecutive 364-day jail sentences, opens the theoretical possibility of substantial jail sentences for federal officials and others, including but not limited to members of various COVID-19-vaccine authorizing, approving, and recommending boards and committees who continue to vote to authorize, approve, and recommend COVID-19 vaccines in light of extant data and studies showing adverse event rates. They may want to think twice about blithely undertaking their actions, recently without clinical data, as cited above, and consider whistle blowing instead. As stated above, even if courts were to rule a victim is needed to prove a reckless endangerment case, numerous such victims would not be hard to find, via word of mouth or organizations like React19, Home - React19.

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Related Subjects

Whether post-COVID-19 vaccination myocarditis is rare has been debated. One thing is certain: when incidence rates of myocarditis occurring after non-COVID-19 vaccines administered in the pre-COVID-vaccination era are compared with incidence rates of myocarditis occurring after COVID-19 vaccination, post-COVID-19 vaccination myocarditis incidence is anything but rare, as the hockey stick graph near the end of the first article shows. It would likely be a jury question whether that context and distinction supports the “substantial risk” element of reckless endangerment. That context and distinction should be presented and argued to any future jury. Relatedly, see SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database - ScienceDirect (“In the Japanese population, SARS-CoV-2 mRNA vaccination was significantly associated with the onset of myocarditis/pericarditis.”), reported on here: Study Finds 9.6% Fatality Rate Among People Who Reported Myocarditis or Pericarditis After an mRNA COVID Vaccine • Children's Health Defense (childrenshealthdefense.org) (“A 9.6% case fatality rate for a vaccine side effect largely in young healthy men is astronomical and clinically unacceptable[.]”)

For any aligned line-level prosecutors or others reluctant to discuss in their workplace the prospect of such an investigation and prosecution, Anderson v. McCotter, 3 F. Supp. 1223 (D. Utah 1998), Andersen v. McCotter, 3 F. Supp. 2d 1223 - Dist. Court, D. Utah 1998 - Google Scholar, may be useful for gauging the extent to which such discussions would enjoy First Amendment protection. This paragraph does not constitute legal advice. Readers are responsible for their such discussions.

For investigative personnel in a complaining state to question, let alone detain, CDC personnel in Atlanta presents obvious challenges; and any such personnel would likely decline to speak with state law enforcement from a complaining state (or their own state) and assert their right to silence and to a lawyer, which are their rights, which I support. Though, it’s possible the threshold to file a charge or charges could be met from un-redacted emails, documents, and interviews with others. For that, state statutes regarding subpoena powers in aid of criminal investigations, for example, Utah Code § 77-22-1 et seq., le.utah.gov/xcode/Title77/Chapter22/77-22-S2.html?v=C77-22-S2_2019051420190514, and the Uniform Interstate Depositions and Discovery Acts, for example, Utah Code § 78B-17-101 et seq., le.utah.gov/xcode/Title78B/Chapter17/78B-17.html?v=C78B-17_1800010118000101, of which Georgia is a member state, GA Code § 24-13-114 (2022), Georgia Code § 24-13-110 (2022) - Short Title :: 2022 Georgia Code :: US Codes and Statutes :: US Law :: Justia, could be explored as ways to get currently redacted emails and documents in un-redacted form. Alternatively, an aligned Member of Congress could request the FOIA productions be made public in unredacted form. Office of Information Policy | FOIA Update: OIP Guidance: Congressional Access Under FOIA (justice.gov).

Above, I discussed only one serious adverse event, myocarditis. Another avenue for investigative and prosecution efforts if supported includes the “serious bodily injury[,]” meaning the “impairment of the function of any bodily member or organ[,]” Utah Code § 76-1-102.5(17), Utah Code Section 76-1-101.5, related to female infertility or impairment of fertility occurring after COVID-19 vaccination.

Relevant questions would include: what authorizations, approvals, and recommendations for COVID-19 vaccination were made? And what was the state of the knowledge of the risk to fertility—that is, the risk of impairment of the function of any reproductive bodily member or organ—posed by the COVID-19 vaccines imputable to federal officials and other persons on boards and committees when they voted for authorizations, approvals, and recommendations, to determine if their acts of voting could constitute reckless endangerment. Relatedly, see (1) BREAKING: Israeli Study Explains How Pfizer-BioNTech mRNA Shot Causes Menstrual Irregularities (substack.com), Report 69: BOMBSHELL - Pfizer and FDA Knew in Early 2021 That Pfizer mRNA COVID "Vaccine" Caused Dire Fetal and Infant Risks, Including Death. They Began an Aggressive Campaign to Vaccinate Pregnant Women Anyway. - DailyClout, and Report 37: Pfizer, FDA, CDC Hid Proven Harms to Male Sperm Quality, Testes Function, from mRNA Vaccine Ingredients - DailyClout.

Additional subjects to later explore include determining whether sufficient facts exist to support either legislative inquiry into the actions of state and county health department officials, or investigations of them for violations of state official misconduct statutes, some of whom appear to still be acting as unquestioning pass-through conduits for CDC policy, itself a captured agency, according to its former Director Robert Redfield, who recently wrote “Kennedy is right: All three of the principal health agencies suffer from agency capture. A large portion of the FDA’s budget is provided by pharmaceutical companies. NIH [National Institutes of Health (NIH) | Turning Discovery Into Health] is cozy with biomedical and pharmaceutical companies and its scientists are allowed to collect royalties on drugs NIH licenses to pharma. And as the former director of the Centers for Disease Control and Prevention, I know the agency can be influenced by special interest groups.” Donald Trump Has a Plan to Make America's Children Healthy Again. It's a Good One | Opinion - Newsweek.

For example, currently the Utah Department of Health and Human Services (UDHHS) website, Immunize | Immunize (utah.gov) provides a link for Adults Immunization Recommendations | Immunize (utah.gov), incorporating by reference CDC’s vaccination recommendations, with a radio button titled “Centers for Disease Control & Prevention Immunization Schedules[,]” which returns “The page you're looking for was not found.”  UDHHS provides no warning to prospective COVID-19 vaccinees, even now, notwithstanding the amount of extant adverse event information. Also, currently the Salt Lake County Health Department’s (SLCOHD) similar “Recommended Immunizations[,]” Immunizations | Salt Lake County, has a radio button titled “Adult Immunization Schedule[,]” which returns a redirect to CDC’s current vaccination recommendations, Recommended Adult Immunization Schedule for ages 19 years or older; 2024 U.S. (cdc.gov), the first entry of which is “COVID-19 vaccine[.]” SLCOHD provides no warning to prospective COVID-19 vaccinees, even now, notwithstanding the amount of extant adverse event information. (websites linked in this paragraph accessed 10/13/24).

As an aside, in recent U. S. Senate testimony Dr. Redfield stated: “[T]here was not appropriate transparency from the beginning about the potential side effects of these [COVID-19] vaccines[,]” one component of which induces “a very strong pro-inflammatory response, which is problematic.” Risky Research: Oversight of U.S. Taxpayer Funded High-Risk Virus Research - Committee on Homeland Security & Governmental Affairs (senate.gov) beginning @ 1:20:00. And: “I do think one of the greatest mistakes that was made, of course, was mandating these vaccines. They should have never been mandated. It should have been open to personal choice. They don’t prevent infection. They do have side effects.” Id.

State medical board members’ actions against physicians for prescribing effective alternative medications or employing effective alternative treatments could either be subject to legislative inquiry or scrutinized under state official misconduct statutes, Dr. Meryl Nass Rejects Maine Medical Board’s Conditions for Reinstating Medical License • Children's Health Defense (childrenshealthdefense.org). Similarly regarding school district officials’ actions, cf., Health Freedom Defense Fund, Inc. v. Carvalho, 104 F.4th 715 (9th Cir. 2024), 22-55908.pdf (uscourts.gov).

If COVID patients have been kept against their will in hospitals, hospital personnel actions could be scrutinized under state unlawful detention statutes, and where hospital personnel have administered dangerous protocols resulting death, negligent homicide statutes could be considered.

For the above suggestions about additional subjects and actions to be considered, explored, inquired about, and scrutinized, I reassert my cautionary statement about not rushing to judgment.

I leave it to others to explore the possibilities for investigation and prosecution if supported for commission of felonies, though my discussion of applicable legal standards, precedent for state prosecution of federal officials, Supremacy Clause immunity, jurisdiction, venue, statute of limitations, and at least some of the related subjects would apply to investigations and prosecutions if supported of state law felony crimes.

Again, I acknowledge the novelty of some legal theories herein and invite constructive criticism of them. I also invite readers to build on these ideas, including by suggesting articles, studies, and evidence documenting post-COVID-19-vaccination harms that should put any reasonable official, person, or entity on notice of the endangerment associated with any COVID-19 vaccine recommendations and mandates they may make. I also invite aligned readers to bring these ideas to the attention of their county attorneys, state attorneys general, legislators in states having legislative investigative powers (which can yield evidence supporting referrals for prosecution), and sheriffs.

The election season provides an opportunity to send this article to candidates for county attorney, state attorney general, and state legislatures, incumbents and contenders alike, and to raise this subject at town hall and similar candidate meetings. For any who so choose, I suggest printing this article and mailing it, to distinguish it from the flow of easily-dismissible digital information traffic, as well as emailing it, and suggest non-lawyers include in their cover letter language to the effect: “I’m not a lawyer, so I don’t know if the article has legal merit, but if it does, I encourage you to explore the possibilities it discusses.”

What to Do When There Are So Many to Investigate or Interview

There is no shortage of government personnel to investigate or interview related to COVID-era actions, at international, federal, state, county and local levels of government, and in corporations, other entities, hospitals, and workplaces. Is the best solution to spend years investigating and prosecuting? Or is there another way?

In broaching an alternative to retributive justice, I turn to Linda G. Mills, Violent Partners (Basic Books 2008), and ask readers to withhold judgment. In so doing, I do not claim Mills supports either this article’s content or applying her thinking to its content.

In Violent Partners, when discussing alternatives to retributive justice for domestic violence offenders, Mills recounts how “[w]hen apartheid was abolished in South Africa, Archbishop Desmond Tutu knew” “retributive justice” would not work. Id. at. 206. “And so he set up the” “the largest Truth and Reconciliation Commission,” (TRC) “founded on the principle that reconciliation depends on forgiveness and that forgiveness can only take place if gross violations of human rights are fully disclosed.” Id. (internal quotation marks omitted) “Although some victims’ families objected to the exchange of truth for amnesty, the vast majority of black South Africans supported this process.” Id. I emphasize this was not blanket amnesty, not an “oh well” approach, it was an exchange of truth, offenders telling the truth about their wrongdoing, all of it, in exchange for amnesty. Victims’ families also received “the opportunity to find out what really happened to their loved ones[,]” “financial support for their families by garnering [sic] the wages of the perpetrators, and they received apologies.” Id. (emphasis added). Neither remorse nor forgiveness were required. Id. at 247, 250. In exchange, perpetrators were spared jail. Mills acknowledges how unpalatable such notions can be in certain circumstances: “sickening to contemplate[.]” Id. at 249.

“Those who did not come forward” “risk[ed] prosecution for their crimes. Over several years, scores of South Africans testified about their role in the murder, imprisonment, and torture of their fellow citizens, and thousands of survivors told their stories.” Id. at 247.

That brief account does not do justice to Mills’ powerful writing on this subject, including her discussion of the partial healing that comes from hearing the truth about wrongdoing from offenders. Before dismissing those ideas as applied to COVID-19-era wrongdoing, I commend skeptical readers to pp. 205-206, 241-252 of Mills’ book, still readily available, and to consider the merit of what she says there.

There may be some who’ve engaged and are engaging in questionable COVID-era-related conduct who will not acknowledge wrongdoing, period. Others may be unlikely to come forward and fully disclose their wrongdoing unless they know they risk being held accountable in the criminal justice system. Still others may wish they had acted differently, more courageously, more knowledgeably, and may want to come forward. TRCs and the prospect of them could encourage that. Make it easier for people to cross over, even now. I hope to develop these nascent thoughts about TRCs and a “thinking small” approach to them in a later post.

There are signs some in the public health establishment may be open to non-narrative perspectives: “I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later[,]” wrote Paul A. Offit, M.D. in the New England Journal of Medicine in January 2023. Bivalent Covid-19 Vaccines — A Cautionary Tale | New England Journal of Medicine (nejm.org).

For those who resist accountability and responsibility, I suggest the preceding ideas related to county- and state-level investigation and prosecution if supported and to pursue such efforts for as long as it takes to achieve justice as appropriate on a case-by-case basis.

*Amy Kelly at dailyclout.io contributed the content suggesting infertility or impaired fertility occurring after COVID-19 vaccination as bodily injury, other supporting links, and editing. I thank her (and for a lot more than that).

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This article is the writer’s opinion. One of America’s most important freedoms is free speech.