WASHINGTON, D.C. (LifeSiteNews) — 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.”
“We understand that exploring new approaches might improve the methodology and is of interest to you,” FDA medical policy official Craig Zinderman wrote to her in May. “However, from our perspective, the approach employed during a period of intense, high-profile surveillance should be standard, predictable, and road tested. Results from adjusting parameters that raise or lower sensitivity of the alerts as the vaccination campaign is underway could lead to confusion and have unintended consequences (eg, regarding vaccine confidence).”
Szarfman complied, but in July renewed her objections. In a September 2021 email to an FDA colleague, Marks complained, “One of the CDER statisticians, Ana Szarfman, has decided on her own to do vaccine analyses using VAERS as part of her work at FDA. She is, however, not doing this in collaboration with our statisticians, and quite to the contrary, has been asked to cease and desist, because the strategy that she is using could create erroneous conflicts that feed into anti-vaccination rhetoric. This is creating an issue … This issue came up previously during the pandemic and … it seemed to go away, but it is now back. Can we catch up about this sometime?”
BMJ added that it’s “unclear” if Walensky herself “knew that the FDA’s bayesian data mining technique was unsuitable for analyzing the covid vaccines’ rollout. But emails released following a Senate subpoena, and reviewed by the BMJ, show that senior CDC staff members were informed.”
The revelations add to a large body of evidence that fears over the safety of the COVID shots were downplayed and ignored in their rush to release.
VAERS reports 39,205 deaths, 222,922 hospitalizations, 22,560 heart attacks, and 29,264 myocarditis and pericarditis cases as of July 31, among other ailments. VAERS submission are not proven cases on their own, but in 2022, CDC researchers have recognized a “high verification rate of reports of myocarditis to VAERS after mRNA-based COVID-19 vaccination,” leading to the conclusion that “under-reporting is more likely” than over-reporting.
An analysis of 99 million people across eight countries published in the journal Vaccine in 2024 “observed significantly higher risks of myocarditis following the first, second and third doses” of mRNA-based COVID vaccines, as well as signs of increased risk of “pericarditis, Guillain-Barré syndrome, and cerebral venous sinus thrombosis,” and other “potential safety signals that require further investigation.” In April 2024, the CDC was forced to release by court order 780,000 previously undisclosed reports of serious adverse reactions, and a study out of Japan found “statistically significant increases” in cancer deaths after third doses of mRNA-based COVID-19 vaccines and offered several theories for a causal link. Most recently, studies published in the International Journal of Infectious Diseases and International Journal of Medical Science raised the possibility of the shots carrying risks of not only respiratory diseases but even kidney injury.
Democrats are largely united in favor of all such vaccines, but the response among Republicans has been conflicted, largely due to the first Trump administration’s Operation Warp Speed (OWS) initiative prepared and released the COVID shots in a fraction of the time any previous vaccine had ever been developed and tested, which President Donald Trump has refused to disavow.
So far, Trump’s second administration has rolled back several recommendations for the shots but not yet pulled them from the market despite hiring several vocal critics of the COVID establishment and putting Health and Human Services under the leadership of Robert F. Kennedy Jr., America’s most prominent anti-vaccine activist. The administration has largely settled on leaving the current vaccines optional but not supporting work to develop successors and limiting recommendations to those in high-risk groups for COVID itself. But whether it gets to the bottom of the original shots and their cover-up remains to be seen.