• Newly released FDA emails reveal inconsistent monitoring of COVID-19 vaccine injuries, with frequent alerts for the Janssen vaccine but few for Pfizer and Moderna.

• Despite over 1.4 million adverse event reports in VAERS, the FDA failed to detect widely recognized risks like myocarditis and pericarditis for mRNA vaccines.

• The CDC and FDA relied solely on one data analysis method, ignoring another that flagged hundreds of potential safety signals.

• Critics argue the agencies’ oversight was inadequate, raising concerns about transparency and accountability in vaccine safety monitoring.

FDA’s data monitoring: a tale of two vaccines

In the first 18 months following the rollout of COVID-19 vaccines, the U.S. Food and Drug Administration (FDA) detected consistent safety alerts for the Janssen vaccine but largely overlooked similar risks for Pfizer and Moderna shots, according to newly released emails. These records, obtained through a Freedom of Information Act (FOIA) lawsuit by Children’s Health Defense (CHD), reveal a troubling pattern of oversight gaps in the federal government’s monitoring of vaccine injuries. Despite over 1.4 million adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), the FDA’s data analysis failed to flag widely recognized risks like myocarditis and pericarditis for mRNA vaccines. The revelations raise critical questions about the adequacy of the government’s safety monitoring and its commitment to transparency during the pandemic.

The FDA emails, posted on the agency’s website, detail weekly data mining of VAERS reports from January 12, 2021, to July 5, 2022. The analysis, known as Empirical Bayesian (EB) data mining, showed consistent alerts for serious adverse events linked to the Janssen vaccine, including deep vein thrombosis and death. However, the same analysis yielded almost no alerts for Pfizer and Moderna vaccines, even for well-documented risks like myocarditis and pericarditis.

For example, the FDA noted an alert for “death” associated with the Janssen vaccine on March 8, 2022, and in every subsequent email. In contrast, the agency flagged only a handful of administration-related issues for Pfizer and Moderna shots, such as “mechanical urticaria” and “exposure via breast milk.” This discrepancy is striking, given that VAERS received over 15,000 myocarditis reports and 10,000 pericarditis reports for mRNA vaccines during the same period.

Ray Flores, senior outside counsel to CHD, criticized the FDA’s approach, stating, “The emails are further evidence of the federal government’s failure to make good on its promises to use VAERS as an ‘early warning system’ to detect and act on risks associated with the new vaccines.”

CDC’s role in the fraud and the controversy over proportional reporting ratios

The CDC and FDA had pledged to use two complementary data analysis methods—Proportional Reporting Ratios (PRR) and EB mining—to monitor vaccine safety. However, the CDC admitted in 2022 that it had not conducted PRR analysis as outlined in its own Standard Operating Procedures (SOP). Instead, the agency relied solely on the FDA’s EB mining, which critics argue is less effective at detecting safety signals.

When the CDC finally conducted PRR analysis in mid-2022, the results were starkly different from the FDA’s findings. For example, a May 6, 2022, PRR analysis flagged 777 symptoms, including 171 serious events like cardiac arrest and stroke, for mRNA vaccines. In contrast, the FDA’s EB mining on May 10 detected only three clinical outcomes for the same vaccines.

Brian J. Hooker, Ph.D., CHD’s chief scientific officer, called the discrepancy “alarming,” stating, “The results of these two methods are simply not ‘generally consistent,’ and a pharmacovigilance system that detects a mere three clinical outcomes while failing to detect the most serious adverse events certainly does not qualify as a ‘gold standard.’”

The FDA and CDC have faced mounting criticism for their handling of vaccine safety data. Despite repeated FOIA requests and lawsuits, the agencies have yet to disclose key records, including data-mining runs that did not result in alerts and follow-up investigations into detected signals. The delays have been attributed to court-ordered stays, with the FDA citing resource constraints due to other litigation.

The lack of transparency has fueled concerns about accountability, particularly in light of the unprecedented speed at which COVID-19 vaccines were developed and authorized. Health freedom advocates argue that the government’s failure to rigorously monitor and address vaccine injuries undermines public trust in the vaccination program and constitutes a breach of basic medical ethics and scientific integrity.

Sources include:

ChildrensHealthDefense.org

FDA.gov

Wonder.cdc.gov