The views and opinions expressed in this article are my own and do not necessarily reflect the official policy or position of any organizations with which I am affiliated.
Public confidence in institutions tied to health policy continues to erode, with a 2024 Pew Research study showing trust in news outlets at just 31%, down from 40% five years ago. The rollout of COVID-19 vaccines, once hailed as a critical defense against the pandemic, is now under scrutiny as emerging data and independent research reveal discrepancies in initial safety assurances.
In 2021, millions received the Pfizer-BioNTech vaccine amid widespread media campaigns urging vaccination to protect vulnerable populations, such as the elderly, from COVID-19 deaths. Prominent figures like MSNBC’s Rachel Maddow, whose nightly broadcasts reached millions, framed the shots as a moral imperative. Yet, data unavailable to the public at the time has since cast doubt on those claims, according to experts and subsequent studies.
Critics claim that initial trust in the vaccines stemmed from a lack of accessible data and a simplistic media narrative marked by relentless repetition of the phrase “safe and effective”. The instinct was to rely on ubiquitous messages from health officials and the media touting the reliability of mRNA vaccines. It seemed implausible that so many could mislead the public.
The Pfizer COVID-19 Vaccine Trial
Statistical principles demand rigorous evidence. Randomized, placebo-controlled trials are required to establish cause and effect, free of bias. The Pfizer vaccine’s licensure review in July 2021, conducted by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), exposed its foundational data in a public hearing. The trial reported one COVID-19 death in the vaccine group versus two in the placebo group—counts too small to attribute to anything but chance, yet 2 being 100% larger than 1 could support deceptive claims of the vaccine’s impressive ability to prevent death from COVID-19. By the same logic, the table showed a 500% increase in cardiac-related deaths and higher all-cause mortality in the vaccine arm. At face value, the small counts and truncated trial duration (The study was unblinded after 6 months, having been originally approved for 3 years) undeniably limit both claims of safety and efficacy while also prohibiting assertions that the BNT162b2 product exhibits statistically significant evidence of harm. The incomplete safety profile forces reliance on the inferior Vaccine Adverse Event Reporting System (VAERS), widely regarded as unreliable and prone to underreporting, which has documented 38,077 COVID vaccine-associated deaths at the time of this writing.
One way to interpret these results is through the Number Needed to Treat (NNT), a metric used to assess the effectiveness of medical interventions. In this case, with one additional COVID-associated death in the placebo group compared to the vaccine group (out of 21,926 participants per group), the calculated NNT to prevent one COVID-associated death is approximately 21,916. This figure should be interpreted cautiously, as the small number of events limits statistical reliability.
Further exploration into the trial and its data reveals methodological violations and apparent suppression of potential safety signals. Buried in the report based on this initial clinical trial is documentation of 5 additional deaths, all occurring after the blinded period had ended in participants who received the vaccine. See page 6 of the report.
On November 8th, 2021, an FDA committee reviewed a May 18th, 2021, Pfizer study of its COVID-19 vaccine. Once again, the results showed evidence of a reduction in COVID-19 infections among those receiving the vaccine, however, higher (24% increase) all-cause mortality was again observed among those receiving the vaccine. See page 23 of the report.
Under FDA guidelines, researchers are expected to rigorously examine all injuries and deaths among the study group to rule out the intervention (vaccine) as the cause. The dismissal of these deaths in a single sentence obscures the nature of the investigation undertaken to rule out the vaccine as the agent responsible for the 24% increase in deaths among vaccinated individuals.
Relative Risk vs. Absolute Risk
The Pfizer BNT162b2 vaccine trial defined a case as a PCR-confirmed, symptomatic COVID-19 infection occurring at least 7 days post-second dose in participants without prior SARS-CoV-2 infection. This resulted in 8 confirmed cases among 21,720 vaccine recipients and 162 among 21,728 placebo recipients, though 3,410 suspected cases were excluded due to unconfirmed PCR tests.
The trial reported a 95% relative risk reduction (RRR) in symptomatic COVID-19, a statistic that was widely reported to support efficacy claims. Examination of the raw counts, as well as a more realistic metric, namely absolute risk reduction, reveals a dramatically different assessment of the benefits of vaccination.
The absolute risk reduction (ARR) was just 0.7084% (0.007452 - 0.000368), meaning approximately 141 people need to be vaccinated to prevent one case, a modest benefit critical for assessing the risk-benefit ratio.
The relative risk reduction is a ratio of the difference in relative risk between both trial arms to the relative risk in the placebo arm. This is how the 95% figure was calculated.
The FDA emphasizes ARR over RRR in its guidance on communicating risks, noting that RRR can exaggerate benefits when baseline risks are low (0.7452% in the placebo group), as seen here, yet the media widely reported the 95% effectiveness statistic.
Exclusion of Vulnerable Populations
The Pfizer BNT162b2 mRNA COVID-19 vaccine trial explicitly excluded several vulnerable populations, including pregnant women, individuals over 85 years old, those with significant comorbidities (e.g., severe cardiovascular or autoimmune diseases), and participants with confirmed prior COVID-19 infections. The trial’s eligibility criteria, outlined in the study protocol, prioritized healthy adults aged 16–55 and a limited subset of older adults (56–85) with stable conditions, totaling approximately 43,847 participants. Exclusion criteria for the trial are listed on page 34 of the study protocol.
Notably, only 4.4% of participants (approximately 1,904 individuals) were aged 75 or older, despite over 50% of COVID-19 deaths occurring in this age group, according to CDC mortality data. Additionally, 20% of trial participants had known comorbidities, while CDC reports indicate that 95% of COVID-19 fatalities involved one or more comorbidities, such as diabetes or heart disease. These exclusions were intended to minimize confounding variables and ensure clear safety and efficacy signals. However, post-trial, the vaccine was recommended for widespread use, including for pregnant women, elderly populations, and those with prior COVID-19 infections, despite limited or no trial data for these groups.
This discrepancy raises profound ethical concerns. Extending trial results to unstudied populations assumes similar safety and efficacy profiles, a practice known as extrapolation, which can be risky without confirmatory data. For instance, pregnant women, excluded due to potential fetal risks, were later encouraged to vaccinate based on observational studies and registry data (e.g., V-safe registry), which reported no major safety signals but lacked the rigor of randomized controlled trials. Similarly, individuals with prior COVID-19 infections, who may have natural immunity, were vaccinated without trial evidence assessing the necessity or risks in this group. The CDC’s recommendation for universal vaccination, including these populations, was criticized by some experts who argued it bypassed standard scientific caution.
The ethical issue centers on informed consent. Patients and providers were not fully informed that recommendations for these groups relied on post-hoc data rather than trial evidence, potentially violating the principle of transparency. The Nuremberg Code emphasizes the right to make informed decisions based on complete information, a standard compromised when trial limitations are not clearly communicated.
Underreported Adverse Events
The initial Pfizer trial report presented a favorable safety profile, noting that serious adverse events (SAEs) were rare and comparable between vaccine and placebo groups (0.6% vs. 0.5%, respectively). However, a comprehensive dataset, released only after a Freedom of Information Act (FOIA) request by the Public Health and Medical Professionals for Transparency, revealed a higher incidence of SAEs than previously reported. The FOIA data, covering over 42,000 adverse event cases from December 2020 to February 2021, included 1,223 deaths, 9,400 hospitalizations, and numerous cases of anaphylaxis, myocarditis, and neurological disorders, as detailed in a cumulative analysis. This contrasted sharply with the FDA’s initial review, which emphasized minimal safety concerns.
A team of researchers, in their preprint analysis titled “Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials”, re-evaluated the trial data and identified a significant increase in SAEs in the vaccine group, including cardiovascular events (e.g., myocarditis, pericarditis) and neurological conditions (e.g., Bell’s palsy). They reported a 36% higher risk of SAEs in the vaccine group (18.5 vs. 13.6 per 10,000 participants) and recommended immediate suspension of the vaccine program, arguing that the risks outweighed the benefits, especially for younger populations.
The higher dropout rate in the vaccine group (311 vs. 60 in the placebo group), noted in the NEJM supplement, further suggests potential tolerability issues not fully explored in the initial report. The discrepancy in this vaguely titled exclusion category is too large to happen by chance and calls into question the reliability of the absolute and relative risk figures.
Whistleblower Brook Jackson, a former regional director at Ventavia, alleged that investigators in the Pfizer BNT162b2 vaccine trial were unblinded and falsified data, claims supported by a fivefold higher withdrawal rate for “protocol deviations” in the vaccine group (311 vs. 61 in placebo) within fourteen days of the second dose. Her accusations, detailed in a BMJ article, were followed by her dismissal within a day of reporting to the FDA. These allegations cast doubt on the trial’s integrity, amplifying concerns about the reliability of safety data. Such uncertainties have fueled ongoing debates about the vaccine’s safety profile, as evidenced by conflicting interpretations of post-marketing surveillance data.
Ongoing Debates within the Scientific Community
Mainstream sources, including the CDC, argue that post-marketing surveillance (e.g., VAERS, V-safe) confirms the vaccine’s safety, while reporting that rare events like myocarditis do occur primarily in young males at a rate of 4–5 per 100,000. Critics counter that VAERS underreporting and delays in FOIA data release obscured the true scope of risks. The debate remains polarized, with research teams and multiple physician groups calling for termination.
Such calls are contested by health authorities who tout the vaccine’s role in reducing COVID-19 mortality, a claim supported by observational studies, which can only support conclusions of correlation, not causation. The frequently referenced study in The Lancet Infectious Diseases on BNT162b2 and CoronaVac vaccine effectiveness against COVID-19 is limited by its inability to establish causality due to potential confounding variables. Factors such as improved early interventions (e.g., antivirals, better treatment protocols), milder Omicron variants, and fewer susceptible individuals (due to prior deaths or natural immunity) could explain the observed decline in COVID-19 deaths, independent of vaccination.
Independent research raised concerns about the reliability and quality of data on COVID-19 vaccine safety and efficacy, with inconsistent definitions and reporting methods contributing to ongoing scientific debates. CDC data analysis is complicated by problematic definitions, such as counting individuals testing positive within two weeks of full vaccination as “unvaccinated,” leading to overestimations of cases and deaths in this group.
Similarly, unverifiable vaccination status or mismatched records, as noted in the Washington Department of Health Report, result in misclassification as “unvaccinated,” inflating their case and death rates.
These data quality issues, including inconsistent definitions and misclassification errors, underscore the challenges in accurately assessing COVID-19 vaccine efficacy and necessitate cautious interpretation of observational studies claiming reduced mortality.
Shifting Narratives and Public Response
Expert review of the data sparked isolated efforts to challenge the “safe and effective” narrative, including limited opposition to vaccine mandates in 2021. Institutions, business owners, and private citizens overwhelmingly supported such measures, driven by public health rhetoric and a genuine desire to protect others from harm, though many now question that stance as new evidence continues to emerge.
Since 2021, perceptions have shifted. The term “breakthrough case” has vanished from use, with data showing vaccinated individuals are at least as likely to contract and spread COVID-19 as the unvaccinated, with evidence of waning efficacy of the mRNA products appearing as early as November 2021 in a large study. The CDC now classifies the virus as comparable to a common cold.
More troubling are reports of vaccine-linked injuries and deaths, detailed by renowned yet relentlessly attacked cardiologist Dr. Peter McCullough in a widely circulated video, supported by research. A longer, more robust analysis on this topic can be found in this research-driven conversation with Dr. John Campbell.
Outspoken physicians and researchers, despite impressive qualifications, faced merciless character assassination, placing a thick smokescreen between the public and the information disseminated by those willing to challenge the “safe and effective” orthodoxy. The label “anti-vaxxer” inspires a powerful response in the reader, pre-emptively disqualifying the doctor/researcher and influencing the reader to quickly dismiss their findings.
Independent Research Highlights Gaps
The CDC and similar bodies have historically been responsible for ensuring vaccine safety, yet their limited investigation into injuries post-rollout has drawn criticism. This shortfall has compelled independent researchers, often operating with constrained resources, to explore these issues. Their early findings suggest possible risks, particularly given manufacturers’ incomplete safety and efficacy data during accelerated approvals, as noted in the FDA’s Emergency Use Authorization documentation. Critics argue that the burden of proof should rest with those who developed and mandated the vaccines, not with underfunded scientists or the public.
“A Systematic Review of Autopsy Findings in Deaths After COVID-19 Vaccinations” (2023) analyzed autopsy data, reporting a potential link between mRNA vaccines and fatal myocarditis, with myocardial scarring noted as a possible factor in arrhythmias. “Serious Harms of the COVID-19 Vaccines: A Systematic Review” (2022) identified adverse events such as myocarditis and Guillain-Barré syndrome among vaccinated individuals. “High Levels of DNA Contamination in mRNA Vaccines” (2023) detected DNA levels in Pfizer and Moderna vials exceeding regulatory limits, raising questions about potential inflammation risks.
“Humanity Projects: US Disability Trends 1997-2023” (2023), published via Phinance Technologies, examined U.S. disability data, noting a rise in reported disabilities following the vaccine rollout, suggesting a possible correlation with vaccination. Similarly, “US Nursing Home Data Analysis” (2023) from the same platform analyzed mortality trends in nursing homes, observing excess deaths post-vaccination that may signal vaccine-related risks. Excess mortality analyses, such as those self-published under “The Real CDC” initiative, also point to possible underreported cardiac events following vaccination.
Together, these investigations expose the early signals of potential problems—myocarditis, neurological conditions, disability increases, excess mortality, and contamination concerns—within a landscape where traditional research has not fully addressed such outcomes. The debate underscores a broader issue: incomplete initial trials and regulatory oversight, as discussed in the Pfizer trial’s supplementary materials, have left room for these emerging observations to gain traction, with many questions still unanswered.
Ethical and Policy Implications
The flaws in the Pfizer BNT162b2 trial—early unblinding, underreported adverse events, and extrapolation to unstudied populations—have eroded the foundation of informed consent, a cornerstone of medical ethics. The public was misled by initial claims that the vaccine prevented transmission, a narrative reinforced by health officials and the media. However, in October 2022, Pfizer executive Janine Small testified before the European Parliament that the trial did not assess transmission. This admission contradicted earlier messaging, such as CDC statements implying reduced transmission, fueling public distrust.
Informed consent requires full disclosure of risks, benefits, and uncertainties, as mandated by the Declaration of Helsinki. Yet, the trial’s limitations were not adequately communicated, leaving patients and providers unaware that safety data for groups like pregnant women relied on observational studies rather than randomized trials. This opacity, combined with the FOIA-revealed adverse events, suggests a systemic failure to prioritize transparency.
The pharmaceutical industry’s immunity from liability for certain categories of injuries, enabled by the Emergency Use Authorization (EUA) and the Public Readiness and Emergency Preparedness (PREP) Act, exacerbates these concerns. These frameworks shield manufacturers from lawsuits, reducing incentives to fully disclose risks. The 1986 National Childhood Vaccine Injury Act further limits accountability for vaccine-related harms.
Public officials must protect the right to refuse experimental treatments, a principle enshrined in 21 U.S. Code § 360bbb-3 for EUAs, which mandates the option to decline. This aligns with the Nuremberg Code of 1947, which emphasizes voluntary consent without coercion. Yet, vaccine mandates and social pressures, as seen in policies documented by the Kaiser Family Foundation, undermined this right, prompting calls for legislative protections.
A Call for Transparency
In 2025, the stakes are amplified by tightening misinformation laws and platform censorship, with few exceptions. The vaccine experience highlights why access to unfiltered data matters. Early assurances from media, government, and corporate voices leaned heavily on public trust, often bypassing the fine print. As facts emerge and agendas come into focus, the lesson is clear: passive acceptance is no longer enough. Scrutiny of the numbers, not reliance on headlines, shapes the path forward.
Key References
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