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

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

Bell’s palsy, blood clotting and death were among the signs signaled through the analysis of adverse event reports submitted to the Vaccine Adverse Event Reporting System (VAERS). The CDC, which administers VAERS with the Food and Drug Administration (FDA), describes it as “the nation’s early warning system” for vaccine problems.

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

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

CDC analysis was performed on adverse events reported from December 14, 2020 to July 29, 2022.

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

VAERS is a passive reporting system that accepts reports from anyone, but most are submitted by healthcare professionals, who were told during the COVID-19 pandemic that they were required to file reports if post-vaccination issues arose. People who submit false reports will be subject to penalties.

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

‘Onus is on regulators’

The CDC and FDA stated in operating procedures documents that officials would monitor VAERS to identify “potential new safety concerns for COVID-19 vaccines,” with the CDC performing PRR reviews. The CDC issued several false statements about data mining, but eventually acknowledged that it didn’t start carrying out the monitoring technique until 2022 – more than a year after the Pfizer and Moderna vaccines were authorized.

The PRR involves comparing the incidence of a specific adverse event following a specific vaccine to the incidence following all other vaccines. A signal is triggered when three thresholds are reached, 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 after receiving the vaccine under review. Chi-square tests are a form of statistical analysis used to examine data.

The 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, intermenstrual bleeding, lack of oxygen in the heart and even death. The high numbers, particularly the chi-square numbers, worried experts.

For many of the events, “the chi-square is so high that, from a Bayesian perspective, the probability that the actual AE rate from COVID vaccines is no higher than that from 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 less than a 0.5% probability that the rate of liver cirrhosis, for example, would be lower after vaccination with COVID-19 than with vaccination without COVID-19. For myocarditis, or inflammation of the heart, in the 12- to 17-year-old group, the probability was close to zero.

CDC results also show that a much higher proportion of events following 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 adult deaths was 15.4% after vaccination with COVID-19, much higher than the 2.5% after other vaccines.

“The onus is on regulators to come up with some other causal explanation for this difference if they want to claim that the likelihood of a COVID vaccine AE resulting in death is not significantly greater than that of other vaccines,” Fenton said.

The CDC and FDA have not yet responded to The Epoch Times’ requests for comment by press time.

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 additional unexpected safety signals.”

The agency’s records office, in a letter accompanying the results, stated that the results “generally corroborate the findings of Empirical Bayesian (EB) data mining,” a method employed by the FDA. The FDA has refused to release the EB mining results.

Photo from the times
A portion of CDC PRR results. Click to enlarge. Full results can be downloaded at the end of the article. (Screenshot from Epoch Times)

‘Must be taken seriously and investigated’

US health officials have been cautious about linking adverse events or side effects to COVID-19 vaccines. But they acknowledged 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.

Some age groups are at greater risk of myocarditis and pericarditis after vaccination than after COVID-19 infection, leading a growing number of experts to warn against vaccinating certain people.

The newly obtained PRR results returned more than 500 adverse events greater than myocarditis and pericarditis.

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

The CDC and FDA stated in their operating procedures that the safety signs would be “reviewed as appropriate.”

“The pattern or trend of PRR and data mining results over a period of time (e.g. several weeks) will be monitored before starting a clinical review. Other factors, such as clinical importance, whether AEs are unexpected, severity, and whether a specific syndrome or diagnosis is identified, rather than nonspecific symptoms, will be considered to determine whether clinical review will be performed,” the documents say.

If a clinical review was triggered, this would include reviewing reports and associated medical records about the adverse event, confirming the time from vaccination to onset of symptoms, and other work.

The FDA recently revealed that of the four signs identified for older individuals after Moderna or Pfizer vaccinations, three were ruled out with further analysis, but one – pulmonary embolism – continued to meet the criteria. Pulmonary embolism was identified as a sign in the PRR analysis for individuals aged 12 years and older.

Download the files

The analysis results are in Excel spreadsheets. The results can be downloaded from the links below. Tables one and two are not provided.

29.07.22 Table3 PRR of PTs for COVID19 Pfizer compared to Moderna

29.07.22 Table 4 PRR of PTs for COVID19 Modern compared to Pfizer

29.07.22 Table 5 PRR of PTs for mRNA of COVID19 compared to non-COVID

22.07.29 Table 3 PRR of PTs for COVID19 Pfizer compared to Moderna

22.07.29 Table 4 PRR of PTs for COVID19 Modern compared to Pfizer

22.07.29 Table 5 PRR of PTs for mRNA of COVID19 compared to non-COVID

07.15.22 Table 3 PRR of PTs for COVID19 Pfizer compared to Moderna

07.15.22 Table 4 PRR of PTs for COVID19 Modern compared to Pfizer

7.15.29 Table 5 PRR of PTs for mRNA of COVID19 compared to non-COVID

Zachary Stieber

Zachary Stieber is a senior reporter for the Epoch Times based in Maryland. It covers US and world news.

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