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.”
Hellbound and Down 