Popular Rationalism by James Lyons-Weiler 5/13/2025
Corrected Efficacy Curves, Suppressed Risks, and Policy Recommendations. IPAK-EDU White Paper 2025-ENDEUAExecutive Summary
In December 2020, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorizations (EUAs) for the first SARS-CoV-2 mRNA vaccines—Pfizer-BioNTech and Moderna—based on interim data from large-scale Phase III trials. The legal standard under §564 of the Federal Food, Drug, and Cosmetic Act requires that a product may be authorized for emergency use only if it is “reasonable to believe” that the product “may be effective” against a life-threatening condition, that the known and potential benefits outweigh the known and potential risks, and that no adequate alternatives are available. This report demonstrates, through a rigorous retrospective analysis, that these criteria were never met.
Key Findings
Overstated Efficacy from the Outset
The widely publicized efficacy claims—95% for Pfizer and 94.1% for Moderna—were derived from case-counting methods that excluded entire categories of trial participants. These included individuals who developed symptoms shortly after vaccination but prior to a defined post-vaccination window (7 days for Pfizer, 14 days for Moderna) and symptomatic cases that were not PCR-confirmed. When these participants are included—following standard first-in-human trial principles—efficacy drops substantially. Lyons-Weiler’s dropout-inclusive recalculation yields a corrected VE of approximately 75%. Doshi’s analysis suggests it may have fallen as low as 19% under full reintegration of excluded cases.
Early Risk Period Excluded from Analysis
The period from first dose to the start of the official efficacy window—when the immune system is unprimed and biologically vulnerable—was excluded from primary analysis. This design decision effectively concealed potential early harms, including those arising from mechanisms such as antibody-dependent enhancement (ADE) or immune suppression, which are most likely to manifest during immune immaturity.
Rapid and Predictable Waning of Protection
Real-world data from 2021 and 2022 confirm that VE against infection declines rapidly. Israeli and UK datasets show efficacy against symptomatic infection falling below 40% within five months and below 20% for Omicron, even after boosters. Protection against severe disease persisted longer but also declined significantly, especially in older or immunocompromised populations. This collapse was anticipated by modeling using a 7.5% monthly exponential decay rate.
Dropout-Inclusive Models Fail to Reach EUA Thresholds
When efficacy is recalculated from a corrected base of 75%, and further adjusted for waning, variant escape, population risk factors, and untested mechanistic hazards (e.g., ADE, molecular mimicry), the resulting population-level VE never exceeds 50%. These findings are not speculative. They are consistent with observed empirical VE trajectories for Pfizer and Moderna, which, once similarly adjusted, fall below EUA-relevant efficacy thresholds within 2–4 months of full vaccination.
Suppression of Risk and Immunopathology Evidence
No ferret challenge studies were conducted to rule out ADE. No epitope exclusion or autoantibody screening was required prior to rollout. Peer-reviewed bioinformatics work published before vaccine deployment warned of widespread homology between SARS-CoV-2 proteins and human tissues. These findings were confirmed by later clinical studies showing cross-reactivity and the presence of autoantibodies in vaccine recipients. Yet these signals were not considered in the EUA process. Passive surveillance systems later revealed increases in myocarditis, thrombotic events, neurological symptoms, and autoimmune conditions—often in age groups for which the baseline risk of COVID-19 was low.
Structural Bias and Misclassification in Observational Data
Post-market surveillance systems, including the UK Office for National Statistics, misclassified vaccinated individuals as “unvaccinated” if infection occurred before the post-vaccination case-counting threshold. Fenton and Neil identified this as "case counting window bias"—a statistical artifact that artificially inflated VE estimates. These findings corroborate the structural distortions originally revealed in the Phase III trial design.
Legal and Regulatory Breakdown
The statutory threshold that a product “may be effective” was never fulfilled under a corrected efficacy assessment. Moreover, the failure to reevaluate EUA eligibility as VE collapsed in real-world conditions constitutes a breakdown in regulatory duty. The failure to revoke or re-review the EUA as Omicron rendered the original formulation increasingly ineffective reflects a lack of accountability and scientific integrity.
Conclusion
The evidence presented in this report shows that the SARS-CoV-2 mRNA vaccines did not meet the minimum statutory requirements for Emergency Use Authorization when evaluated through corrected dropout-inclusive models, adjusted real-world decay trajectories, and documented immunopathological risks. The EUA process failed—not because of a single miscalculation, but because of a cascade of exclusions, omissions, and optimistic assumptions that compounded into systemic error.
The purpose of this white paper is not simply to audit a decision. It is to confront the institutional vulnerabilities that allowed the decision to persist uncorrected despite mounting evidence of failure. What follows is a set of urgent and concrete reforms designed to restore integrity to the emergency use framework, safeguard public trust, and prevent this class of error from recurring.
Much Much More:
https://popularrationalism.substack.com/p/unqualified-how-the-mrna-vaccines?isFreemail=true&post_id=163373340&publication_id=475124&r=cjt3t&triedRedirect=true
