The top U.S. public health agency identified hundreds of safety signals for the Pfizer and Moderna COVID-19 vaccines months earlier than previously known, according to files obtained by The Epoch Times.
The U.S. Centers for Disease Control and Prevention (CDC) found more than 700 signals—including acute heart failure and death—for the vaccines in May 2022, the files show.
The CDC detected many of the same signals in July 2022, The Epoch Times previously reported. The new files show that the first time the CDC conducted an analysis called Proportional Reporting Ratio on vaccine injury reports, signals were identified.
The analysis went over reports lodged between Dec. 14, 2020, and May 6, 2022.
The CDC initially claimed it did not run the reporting ratio, a data mining method, on the injury reports made to the Vaccine Adverse Event Reporting System. The CDC later claimed it started the method in February 2021, shortly after the vaccines were rolled out. Both of those claims were false, the CDC ultimately said, adding that it did not start the analyses until March 2022.
When the first analyses were done that month, CDC employees identified more than 200 signals for Pfizer’s shot and 93 signals for Moderna’s vaccine, the files show. Those analyses were done by comparing the events lodged after vaccination with one vaccine with events lodged after vaccination with the other.
The Epoch Times obtained the files through Freedom of Information Act requests.
In the reporting ratio method, the CDC compares the vaccine injury reports lodged after vaccination with one or more vaccines to the reports lodged after vaccination with one or more different vaccines.
The strongest analysis involves comparing the reports lodged after vaccination with the Pfizer and Moderna COVID-19 vaccines to the reports lodged after vaccination with all non-COVID-19 vaccines. The analysis is contained in files labeled “Table 5.”
According to the files provided by the CDC, the agency did not start that analysis until May 2022.
“The program staff advises that ‘Table 5 was only created from May 6, 2022, to July 31, 2022,'” a CDC Freedom of Information Act processer told The Epoch Times via email.
The CDC did not respond to a request for more information.
“Federal health agencies have ignored the flashing alarms of their own safety surveillance systems since early 2021. They have ignored my oversight letters and lied about what analyses they have performed. It is well past time for the American public to be told the truth,” Sen. Ron Johnson (R-Wis.), the top Republican on the Permanent Subcommittee on Investigations, told The Epoch Times via email.
The CDC and the U.S. Food and Drug Administration (FDA) co-manage the Vaccine Adverse Event Reporting System, which accepts reports from anybody but which is primarily used by health care workers. Reports to the system are analyzed and verified by health officials and contractors.
In operating procedure documents, the agencies said that officials would monitor the system to identify “potential new safety concerns for COVID-19 vaccines.” The FDA would perform one type of analysis, called Empirical Bayesian data mining, while the CDC would perform Proportional Reporting Ratio (PRR) data mining.
The latter involves comparing the incidence of a specific adverse event after a specific vaccine or vaccines to the incidence after at least one other vaccine. A signal is triggered when three thresholds are met, according to the CDC: a reporting ratio of at least two, a chi-squared statistic of at least four, and three or more cases of the event following receipt of the vaccine or vaccines being analyzed. Chi-squared tests are a form of statistical analysis used to examine data.
The agencies have portrayed the Empirical Bayesian (EB) mining as stronger. Officials have said that the CDC undertook PRR “to corroborate the results of EB data mining.”
“PRR results were generally consistent with EB data mining, revealing no additional unexpected safety signals. Given it is a more robust data mining technique, CDC will continue relying upon EB data mining at this time,” a CDC spokesperson previously told The Epoch Times.
The FDA has declined to release the results of the EB mining, though agency workers have described them in some studies and presentations.
A signal is a sign that a vaccine could cause an adverse event. Health officials say other evidence is needed to establish causality.
The CDC has pointed out that it has investigated some of the signals, confirming a handful and ruling out others. It has not provided evidence that it investigated each signal. The agency has also refused to answer what it meant when it said it expected signals such as female breast cancer, Crohn’s disease, and Bell’s palsy.
“There doesn’t seem to be any consistency in the process of what, when and how data is collected and released to public. The CDC says one thing and the newly released data shows something else. This is why transparency is needed and why we need outside investigative parties with no skin in the game to analyze and review the data,” Kim Witczak, drug safety advocate and founder of Woody Matters, told The Epoch Times via email.
Probability ‘Essentially Zero’
Norman Fenton, a professor of risk management at Queen Mary University of London, has reviewed the signals.
Fenton said that for many of the reported adverse events (AEs), the chi-squared was so high that “the true rate of the AE of the COVID vaccines is not higher than that of the non-COVID vaccines is essentially zero.”
He added, “The onus is on the regulators to come up with some other causal explanation for this difference if they wish to claim that the probability a COVID vaccine AE results in death is not significantly higher than that of other vaccines.”
Download the files below.