US health officials knowingly relied on flawed vaccine safety algorithm
· News-MedicalUS health officials knowingly relied on a compromised algorithm to detect signals of harm from mRNA covid-19 vaccines and silenced efforts to fix it, finds an investigation published by The BMJ today.
The findings are based on government emails released under the Freedom of Information Act and in response to US Senate investigators, as well as exclusive interviews with public health officials and other scientists by investigative journalist David Willman.
Before rolling out covid-19 vaccines in December 2020, the US Centers for Disease Control and Prevention (CDC) assured healthcare professionals and the public that its Vaccine Adverse Event Reporting System (VAERS) could quickly spot any potentially harmful reactions following vaccination.
The CDC planned to use two "data mining" techniques: "proportional reporting ratios" (PRRs) and an "empirical bayesian" method provided by the Food and Drug Administration (FDA), which operated VAERS jointly with the CDC. The two agencies planned to share and discuss results.
But according to a letter by CDC Director Rochelle Walensky, the agency did not perform PRR analyses until 2022, and both CDC and FDA "chose to rely" entirely on FDA's bayesian method.
In October 2023, the FDA's pharmacovigilance chief acknowledged in an email to colleagues that the agency knew - as the vaccines had rolled out more than two years earlier - of the detection deficiency, but did not respond to requests for comment.
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