FDA Refuses To Provide Key COVID-19 Vaccine Safety Analyses

In accordance with the operating procedure records, the CDC intended to carry out a different kind of data mining analysis known as Proportional Reporting Ratio (PRR) mining. Now, the FDA is refusing to provide the key COVID-19 vaccine safety analyses.

FDA Refuses To Provide Key COVID-19 Vaccine Safety Analyses

US drug regulators are refusing to release crucial assessments of a COVID-19 vaccine safety database, asserting that the factual results cannot be separated by legally protected internal discussions.

The Epoch Times questioned the Food and Drug Administration (FDA) in July for all analysis conducted by the organization for the COVID-19 vaccines using a technique called Empirical Bayesian data mining, which entails trying to compare adverse events recorded after a particular COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

As per operating practices outlined by the FDA and its partner in January 2021 and February 2022 (read below), data mining would be performed “at least biweekly” to recognise adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would mine data from the Vaccine Adverse Event Reporting System (VAERS).

The FDA records office recently responded to the media by stating that it would not make any of the analyses available, even in redacted form.

The agency cited a Freedom of Information Act exempt status that allows the government to withhold memos and letters between agencies as well as within agencies “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also cited the Code of Federal Regulations, which states that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

Why the FDA was unable to provide replicas of the evaluations with non-factual information redacted is unclear. The Epoch Times has appealed the records office’s decision.

‘Unacceptable’

The FDA’s refusal to supply the analyses, according to Kim Witczak, co-founder of Woodymatters, a nonprofit organization that champions for a stronger FDA and drug safety system, was unacceptable.

Witczak, a member of one of the FDA’s external advisory panels, said: “The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety.”

“What’s the point of having VAERS if you’re not releasing it to the public?” she added.

A recent paper by Dr. Joseph Fraiman and colleagues that found a higher prevalence of serious adverse events in vaccinated participants in the original Pfizer and Moderna vaccine trials than in placebo recipients, according to Witczak, raised her concerns regarding the safety of vaccines. She pointed out that the FDA’s 2004 warning about antidepressants raising the possibility of suicidal thoughts and actions came more than ten years after the studies it was based on.

“If this data is available, shame on you for not making it known to the public,” Witczak said. “It’s as if they don’t trust the people to make their own best decision for what’s good for them and their families.”

CDC

In accordance with the operating procedure records, the Centers for Disease Control and Prevention (CDC) intended to carry out a different kind of data mining analysis known as Proportional Reporting Ratio (PRR) mining.

Up to this point, the CDC has also declined to make the findings of those analyses available.

Additionally, it has twice answered inquiries with false information.

Data mining was initially claimed to be “outside of th[e] agency’s purview” and that no PRR assessments had been performed. The agency then acknowledged that PRRs were indeed carried out, beginning in February 2021.

Later, the organization admitted that was not correct. According to a spokesperson, the agency did not start performing PRRs until March 2022.

The first response came from records officer Roger Andoh, who cited the CDC’s Immunization and Safety Office. The second response came from Dr. John Su, a representative of the CDC. Who the information came from is still a mystery.

Data Mining Reports

According to CDC scientist Dr. Tom Shimabukuro, the Empirical Bayesian (EB) method is centered on identifying disproportional numbers of adverse events. It identifies “with a high degree of confidence, adverse event-vaccine pairs reported at least twice as frequently as expected for a COVID-19 vaccine compared to the VAERS database,” he said, or a comparison of the occurrence of a particular event like kidney disease after the COVID-19 vaccine versus the occurrence of the same event after all other U.S.-licensed vaccines.

Periodic updates on the EB data mining effort have been given by the CDC and FDA.

“Importantly, there were no Empirical Bayesian data mining alerts detected for any adverse event COVID-19 vaccine pairs as of the last data mining run that the FDA performed on February 18th,” Shimabukuro told members of the FDA’s vaccine advisory panel on Feb. 26, 2021.

In a review memo (pdf) for an extension of the emergency authorization given to Pfizer’s vaccine, FDA researchers stated that data through April 16, 2021 showed just a possible signal for body temperature.

In the June 2021 issue of the journal Vaccine, FDA researchers stated that an analysis of cases of blood clotting following the Pfizer and Moderna vaccines did not indicate a safety concern. The FDA and CDC halted the Johnson & Johnson vaccine in April 2021 due to instances of blood clotting, some of which were fatal, but lifted the halt only 10 days later. The Johnson & Johnson shot was later restricted by the FDA.

FDA and CDC researchers stated in a paper published in the CDC’s quasi-journal in August 2021 that the FDA utilized EB mining to monitor events in children aged 12 to 17 after vaccination. The findings revealed a shortage of a safety signal for post-vaccination heart inflammation, or myocarditis, despite the fact that other surveillance systems had identified the problem as an adverse event.

Government scientists reported that no unfavorable health outcomes were discovered using the EB mining in a preprint study in October 2021 that was later published in The Lancet.

In a preprint published in May 2022, researchers including Su stated that EB mining analyzing data through Nov. 12, 2021, disclosed just one signal for VAERS death reports, for “vaccination failure” after receiving the AstraZeneca vaccine, which is not approved in the US.

Read the document below:

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