A BMJ investigation has found that US health officials were aware that the algorithm used to detect safety signals from mRNA Covid-19 vaccines was not working properly.
The investigation, published by the BMJ, found that officials at the US Food and Drug Administration (FDA) knew the safety monitoring system was effectively “blind” — unable to reliably flag potential harms from mRNA Covid-19 vaccines. The findings were reported by investigative journalist David Willman.
According to the BMJ, the algorithm in question is a form of automated signal detection — software designed to scan large volumes of health data and identify patterns that might suggest a medicine or vaccine is causing harm. The investigation found that officials were aware the system was compromised yet continued to rely on it.
The BMJ’s investigation does not conclude that the vaccines caused specific harms. But it raises questions about whether the surveillance infrastructure meant to catch safety signals was fit for purpose during one of the largest vaccination programmes in history.
Willman’s reporting centres on what FDA officials knew about the system’s limitations and when they knew it.
In the UK, Covid-19 vaccine safety monitoring was carried out separately, through the Medicines and Healthcare products Regulatory Agency (MHRA), which uses its own Yellow Card reporting scheme alongside other surveillance methods. The BMJ investigation relates specifically to the US regulatory system.
Anyone in the UK with questions about vaccine safety or side effects can report concerns through the MHRA’s Yellow Card scheme or speak to their GP. For general health queries, NHS 111 is available by phone or online.
Source: @bmj_latest
FDA Officials Knew Covid Vaccine Safety System Was Flawed, BMJ Investigation Finds Quiz
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