In the ongoing discourse surrounding COVID-19 vaccines, a recent pharmacovigilance study published in Scientific Reports has reignited debates over potential renal adverse events. Authored by researchers including Ji Yun Jung and colleagues (often referenced as Hwang et al. in secondary sources), the analysis draws from over 120 million reports in the WHO's VigiBase database, spanning 1967 to 2022. It identifies disproportionate reporting of acute kidney injury (AKI), glomerulonephritis (GN), and tubulointerstitial nephritis (TIN) associated with various vaccines, including mRNA-based COVID-19 shots. This has been amplified in online narratives, such as those by Nicolas Hulscher, MPH, who extrapolates these signals to suggest widespread vaccine-induced harm, including a purported 20% higher mortality risk for Pfizer recipients and an 84% increased dialysis rate in vaccinated populations. Corroborating claims point to statistician John Beaudoin's estimates of over 200,000 excess U.S. AKI deaths from 2021 to 2024, allegedly tied to vaccines and hospital protocols.
These assertions demand scrutiny. While pharmacovigilance data like VigiBase is invaluable for hypothesis generation, it is prone to biases such as underreporting, overreporting of novel events, and confounding factors like the massive scale of COVID-19 vaccinations (over 13 billion doses globally) amid a pandemic that itself causes severe kidney damage. This essay dissects the study's methodology, key findings, and broader context, evaluating the evidence for causality versus correlation.
The Scientific Reports paper employs disproportionality analysis, using reporting odds ratios (ROR) and information component lower limits (IC025), to flag potential safety signals across 120,715,116 VigiBase reports. Reports of these events surged post-2020, aligning with vaccine rollout, but the study emphasises this as a temporal correlation, not causation. Disproportionality was also noted for 14 other vaccines (e.g., influenza, HPV), suggesting renal signals are not unique to mRNA technology. Critically, VigiBase relies on voluntary reports, which capture only a fraction of events, estimated at <1% for serious adverse effects, and are skewed toward high-profile interventions like COVID vaccines.
Hulscher's summary invokes a separate, unverified "2.9 million adults" TriNetX study claiming +20% AKI risk (HR 1.20), +84% dialysis (HR 1.84), and Pfizer-specific +20% mortality (HR 1.20), allegedly after excluding early deaths to mask "immortal time" bias. However, no such study appears in peer-reviewed literature or TriNetX-sourced publications matching this scale or outcomes that I could find.
Beaudoin's work, cited for 211,805 excess U.S. AKI deaths (2021–2024), stems from CDC data analyses showing AKI mortality spiking 200–300% above baseline post-2021. He attributes this to mRNA vaccines and protocols like remdesivir under the New COVID-19 Treatment Action Plan (NCTAP), which incentivised alternative therapies. Yet, this overlooks COVID-19's direct nephrotoxicity: up to 50% of hospitalised patients develop AKI, with 30–40% mortality in severe cases, far exceeding vaccine signals. A 2024 npj Vaccines cohort of over 1 million patients found no increased AKI risk post-vaccination (adjusted HR 0.95), while infection quadrupled it (HR 4.12).
Earlier studies, like a 2022 Renal Failure analysis of VAERS reports, noted AKI clusters post-vaccination but linked most to comorbidities (e.g., sepsis in 42%) and preexisting CKD, with no causal mechanism established. A 2023 PMC review of 97 post-vaccination AKI cases found diverse pathologies (e.g., 30% crescentic GN), but incidence remained rare (~1–5 per million doses), dwarfed by COVID-19's 20–30% AKI rate.
This study, despite its limitations, adds to a growing call for renal monitoring post-vaccination, particularly in at-risk groups (e.g., CKD patients), and highlights GN as a watchpoint. We await further research and evidence.
https://www.thefocalpoints.com/p/breaking-29-million-person-study