Perhaps it’s time for IPAK to design The People’s Vaccine Safety Tracking System. Thoughts?
by James Lyons-Weiler, PhD, Popular Rationalism, ©2026
(Sep. 17, 2026) — A new BMJ investigation documents a preventable pharmacovigilance failure: a known masking defect, an available statistical remedy, and public reassurance built partly on the absence of alerts that the surveillance method was structurally capable of missing.
There is a profound difference between saying, “We did not detect a safety signal” and saying, “We used a system capable of reliably detecting a safety signal, and none appeared.”
Those statements are not interchangeable.
According to an investigation published September 16, 2026, in The BMJ, officials at the US Food and Drug Administration knew during the initial COVID-19 vaccine rollout that their principal statistical data-mining method could fail to detect adverse-event signals under the unusual reporting conditions created by mass COVID vaccination. An FDA physician and an internationally recognized statistician warned them. A more sophisticated method existed. Analyses using it produced signals that the routine method did not.
Yet the older method remained in use.
The BMJ investigation, by investigative journalist David Willman, relies on internal government correspondence obtained through the Freedom of Information Act and Senate investigations, along with interviews with scientists and public-health officials. The journal reports that FDA medical officer Ana Szarfman and statistician William DuMouchel warned senior officials in early 2021 that FDA’s statistical system suffered from a potentially consequential problem known as masking. The BMJ reports that Szarfman’s efforts to pursue the issue eventually drew an instruction to “cease and desist.”
This is not a story about whether every report submitted to the Vaccine Adverse Event Reporting System, VAERS, represents an injury caused by a vaccine.
VAERS cannot establish that.
This is a story about whether the surveillance machinery responsible for detecting hypotheses worth investigating was statistically fit for that purpose—and what federal officials did after experts inside the system told them that it was not.
What VAERS Is Supposed to Do
VAERS is a passive adverse-event reporting system jointly operated by FDA and CDC. Reports can come from clinicians, manufacturers, patients, caregivers, and others. Reports describe events occurring after vaccination; temporal association does not establish causation.
FDA states this explicitly. VAERS lacks the denominator structure necessary to calculate incidence rates directly, and reports can suffer from stimulated reporting, underreporting, incomplete information, duplication, and other biases.
But pointing out those limitations does not make statistical signal detection irrelevant.
It makes signal detection essential.
The purpose of a pharmacovigilance system is not to declare every report causal. Its first task is to identify unusual patterns quickly enough that better data sources, case adjudication, medical records, epidemiological studies, and active-surveillance systems can investigate them.
A signal is an alarm.
It is not the fire investigation.
Confusing those two ideas produces errors in both directions. Treating every report as causation exaggerates risk. Treating failure of an imperfect algorithm to sound an alarm as evidence that no problem exists can conceal risk.
The latter is what makes the BMJ investigation so important.
Read the rest here.
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