An investigation published September 16 in The BMJ reports that U.S. health officials relied on a data-mining method to screen COVID-19 vaccine safety reports even after being warned it could miss certain signals, and that an FDA medical officer who pushed for a fix was asked to "cease and desist." Within days, physicians and statisticians disputed how the journal framed those findings.
The dispute centers on the Vaccine Adverse Event Reporting System, or VAERS, the early warning database run jointly by the CDC and FDA. Both sides agree on a key technical point: a statistical problem called "masking" can hide signals. They disagree on whether officials' choices amounted to suppression or a defensible trade-off during a vaccine rollout of unprecedented size.
