Emails show FDA declined to monitor certain COVID-19 vaccine injuries from specific manufacturers

Emails recently unearthed from the U.S. Food and Drug Administration (FDA) have highlighted inconsistencies in monitoring injuries related to COVID-19 vaccines.

While there were frequent alerts for the Janssen vaccine, similar scrutiny appears lacking for Pfizer and Moderna vaccines. This revelation has raised pressing questions about the transparency and effectiveness of the FDA’s safety monitoring efforts.

The Vaccine Adverse Event Reporting System (VAERS) has logged over 1.4 million reports of adverse events. Yet, the FDA failed to identify well-documented risks such as myocarditis and pericarditis associated with mRNA vaccines. This oversight has fueled concerns about the federal government’s commitment to transparency and accountability in vaccine safety monitoring.

Emails obtained through a Freedom of Information Act lawsuit by Children’s Health Defense (CHD) reveal that the FDA’s data monitoring, conducted from January 12, 2021, to July 5, 2022, consistently flagged serious adverse events linked to the Janssen vaccine.

These events included deep vein thrombosis and even death. However, similar alerts were conspicuously absent for Pfizer and Moderna vaccines, despite numerous reports of myocarditis and pericarditis.

For instance, the FDA noted an alert for “death” related to the Janssen vaccine on March 8, 2022, and continued to do so in subsequent assessments. By contrast, only a few administration-related issues were highlighted for Pfizer and Moderna vaccines, such as “mechanical urticaria.” This discrepancy is notable given the thousands of myocarditis and pericarditis cases reported for mRNA vaccines during the same timeframe.

Ray Flores, a senior outside counsel for CHD, criticized the FDA’s monitoring strategy, 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.”*

The Centers for Disease Control and Prevention (CDC) also faced scrutiny over its role in vaccine safety monitoring. Together with the FDA, the CDC had pledged to use two complementary data analysis methods: Proportional Reporting Ratios (PRR) and Empirical Bayesian (EB) mining. However, the CDC admitted in 2022 that it had not conducted the PRR analysis as outlined in its Standard Operating Procedures.

When the CDC eventually conducted the PRR analysis in mid-2022, the results were starkly different from those of the FDA. A May 6, 2022, PRR analysis flagged 777 symptoms, including serious events like cardiac arrest and stroke, associated with 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, expressed alarm at the discrepancies, 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 growing criticism for their handling of vaccine safety data. Despite numerous FOIA requests and legal actions, these agencies have yet to release key records, including data-mining runs that did not result in alerts and follow-up investigations into detected signals.

The delays in releasing this information have been attributed to court-ordered stays, with the FDA citing resource constraints due to other litigation. This lack of transparency has fueled concerns about accountability, especially considering the rapid development and authorization of COVID-19 vaccines.

Health freedom advocates argue that the government’s failure to rigorously monitor and address vaccine injuries undermines public trust in the vaccination program. They contend that this constitutes a breach of basic medical ethics and scientific integrity, raising questions about the overall handling of vaccine safety during the pandemic.

The controversy surrounding vaccine safety monitoring is likely to continue as more information becomes available. The public and health professionals alike are eager for transparency and reassurance that vaccine-related risks are being adequately addressed.

Trust in public health institutions depends on their ability to not only detect but also respond to potential safety signals with urgency and integrity.