CDC finds hundreds of safety signals for Pfizer and Moderna COVID-19 vaccines

the Centers for Disaster Control and Prevention (CDC) has identified hundreds of safety signals for the two most widely administered COVID-19 vaccines, according to surveillance results obtained by The Epoch Times.

Bell’s paralysis, blood clotting and death were among the signals reported by analysis of adverse event reports submitted to the Vaccine Adverse Event Reporting System (VAERS). The CDC, which operates VAERS with the Food and Drug Administration (FDA), describes it as “the nation’s early warning system” for vaccine issues.

The CDC’s primary analysis compared reports filed for specific events experienced after receiving a Moderna or Pfizer COVID-19 vaccine to reports filed after vaccination with any other vaccine, or all non-COVID-19 vaccines. The type of analysis is known as Proportional Reporting Ratio (PRR).

Safety signals mean that a condition may be linked to a vaccine. The signals require further analysis to confirm a possible link.

The CDC’s analysis was conducted on adverse events reported from December 1. from July 14, 2020 to July 29, 2022.

The Epoch Times obtained the results through a Freedom of Information Act request after the CDC refused to release the results.

VAERS is a passive reporting system that accepts reports from anyone, but most are filed by medical professionals, who were told during the COVID-19 pandemic that they were required to file reports. reports if post-vaccination problems arise. Persons who file false declarations are liable to penalties.

Reports do not prove causation or a link between an event and a vaccine. At the same time, studies show that the number of reports is often an underestimate of the actual occurrence of post-vaccination events.

“The responsibility lies with the regulators”

The CDC and the FDA have stated in Operating pleadings that officials would monitor VAERS to identify “potential new safety issues for COVID-19 vaccines,” with the CDC performing a PRR analysis. The CDC has released multiple misrepresentations about data mining, but ultimately acknowledged that he only started performing the surveillance technique in 2022, more than a year after the Pfizer and Moderna vaccines were licensed.

PRR compares the incidence of a specific adverse event after a specific vaccine to the incidence after all other vaccines. A signal is triggered when three thresholds are met, according to the CDC: a PRR of at least two, a chi-square statistic of at least four, and three or more cases of the event following receipt of the current vaccine. to analyse. Chi-square tests are a form of statistical analysis used to examine data.

Results obtained by The Epoch Times show that there are hundreds of adverse events (AEs) that meet the definition, including serious conditions such as blood clotting in the lungs, breakthrough bleeding, lack of oxygen to the heart and even death. The high numbers, especially the chi-square numbers, have experts worried.

For many events, “the chi-square is so high that, from a Bayesian perspective, the probability that the true rate of AEs of COVID vaccines is no higher than that of non-COVID vaccines is essentially zero.” Norman Fenton, professor of risk management at Queen Mary University of London, told The Epoch Times in an email after running the numbers through a Bayesian model that provides probabilities based on available information.

There was a less than 0.5% chance that the rate of liver cirrhosis, for example, would be lower after COVID-19 vaccination compared to non-COVID-19 vaccination. For myocarditis, or heart inflammation, in the 12-17 age group, the odds were close to zero.

The CDC results also show that a much higher proportion of events after COVID-19 vaccination were serious. For adults, for example, the proportion was 11.1%, compared to 5.5% after non-COVID-19 vaccines. The proportion of deaths among adults was 15.4% after the COVID-19 vaccination, much higher than the 2.5% after other injections.

“It behooves regulators to find an alternate causal explanation for this difference if they wish to assert that the probability of an AE outcome of the COVID vaccine in death is not significantly higher than that of other vaccines,” Fenton said. .

The CDC and FDA did not respond within press deadlines to Epoch Times requests for comment.

A CDC spokesperson previously told The Epoch Times in an email that the PRR results “were generally consistent with the EB data mining, revealing no other unexpected safety signals.”

Agency office records, in a letter accompanying the findings, said the findings are “generally substantiated conclusions from Empirical Bayesian (EB) data mining,” a method employed by the FDA. The FDA has refused to publish EB mining results.

“Should be taken seriously and studied”

US health officials have been cautious in linking adverse events, or side effects, to COVID-19 vaccines. But they did acknowledge that some side effects are caused by the Moderna and Pfizer vaccines, both of which use messenger RNA (mRNA) technology, including myocarditis and a related condition called pericarditis.

Certain age groups are actually at higher risk of myocarditis and pericarditis after vaccination than after COVID-19 infection, leading a growing number of experts to prevent against vaccination some people.

The newly obtained PRR results reported more than 500 adverse events larger than myocarditis and pericarditis.

“We know that the myocarditis signal is associated with something that is caused by mRNA vaccines, so it’s more than fair to say that anything with a bigger signal than myocarditis/pericarditis should be taken seriously. and studied,” Josh Guetzkow, an Israeli statistics-trained professor at Princeton University who studied VAERS data during the pandemic, told The Epoch Times via email.

The CDC and FDA said in their operating procedures that safety signals would be “reviewed as appropriate.”

“The pattern or trend of PRR results and data mining over a period of time (eg, several weeks) will be monitored before initiating a clinical review. Other factors, such as clinical significance, whether AEs are unexpected, severity, and whether a specific syndrome or diagnosis is identified rather than nonspecific symptoms will be considered in determining whether a clinical examination will be performed,” indicate the documents.

If a clinical review is triggered, this would include review of reports and associated medical records regarding the adverse event, confirmation of the time between vaccination and onset of symptoms, and other work.

The FDA recently revealed that of four signals identified in the elderly after vaccination with Moderna or Pfizer, three were ruled out with further analysis, but one – pulmonary embolism – continued to meet the criteria. Pulmonary embolism has been identified as a signal in PRR analysis for individuals as young as 12 years old.