Top officials with the U.S. Food and Drug Administration (FDA) were warned in early 2021 of a critical defect in the country’s vaccine monitoring system yet chose to rely on it anyway while assuring the public of the COVID-19 vaccines’ safety, according to a new report.
On September 16, the British Medical Journal (BMJ) published a report detailing flaws in the algorithms used to sift through the federal Vaccine Adverse Event Reporting System (VAERS) to find safety signals with the COVID shots that would require investigation.
One of those algorithms would calculate “proportional reporting ratios” (PRRs), identifying events that were reported at a higher rate than others, along with “empirical bayesian” data mining.
But according to the BMJ’s investigation, the agency’s algorithm was “mathematically compromised by the deluge of covid vaccine adverse event reports – resulting in a near total loss of signal detection sensitivity for the new mRNA vaccines made by Pfizer and Moderna.” More significantly, top officials were warned early in 2021, yet chose to keep relying on it anyway, and even “cited the absence of signals when assuring clinicians and the public of the vaccines’ safety.”
In February 2021, the Israeli Ministry of Health informed the FDA and CDC of a “a large number of reports of myocarditis, particularly in young people” after vaccination, and followed up five weeks later that two of the 77 had died. The Pentagon Defense Health Agency subsequently reported a “cluster” of myocarditis cases among male soldiers. By May, VAERS had gotten hundreds of such reports, prompting the CDC to begin alerting medical professionals.
Then-FDA Center for Biologics Evaluation & Research director Peter Marks emailed CDC director Rochelle Walensky, expressing concern that “myocarditis and pericarditis have not actually signaled … Can you help me understand why we are doing this when pediatricians and others in the community already seem to be aware?”
As VAERS reports continued to mount, health officials inquired as to why they were not receiving safety signals from the government.
“The problem arose because, in the first year of the rollout, almost all the reports coming into VAERS – more than 90% of 1.1 million – were for the mRNA covid shots, dwarfing vaccines for all other diseases,” BMJ explained. “This meant that analyzing the safety of one vaccine, for example Pfizer’s product, involved comparing it to other vaccines, which were overwhelmingly limited to Moderna’s product. But if both mRNA vaccines elevated the risk of an adverse event like myocarditis in roughly equal amounts, the ‘observed’ frequency and ‘expected’ frequency would be similar, resulting in no automated alert. The statistical phenomenon is known as ‘masking.’”
Microbiologist and immunologist Ana Szarfman, an expert in drug safety data mining who worked with the FDA for decades, emailed Marks directly with concerns about the system. Two weeks later, a video conference was held in which Szarfman’s presentation explained that the PRR analysis “Highlights almost everything,” whereas the FDA’s bayesian approach did not: “You are not getting useful information with such low counts.”
Yet Marks and his team declined to change course and urged Szarfman to “hold off on creating and sending data mining reports and analyses using covid-19 vaccine AE (adverse event) data.”
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