US FDA Willfully Blind on the Safety of COVID-19 Vaccination

How Our Regulatory Agency Got Out of the Way from the Beginning

When the US HHS invoked the Emergency Use Authorization and the Department of Defense offered COVID-19 vaccination to be administered by the US FDA and CDC, it was clear the FDA was going to play no role in stopping the vaccination freight train that was about to steamroll America.   A recent paper from Dr. Maryanne Demasi points out that the FDA  “checked-out” early in the COVID-19 pandemic:[i]  “Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.  Now, facing a backlog of site inspections, experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment.  The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and was then appointed as a senior adviser to the FDA commissioner in 2019-21.” 

Demasi goes on to point out the FDA suspended inspections and despite having vast resources, does not utilize their discretionary budget to protect Americans from product safety threats.  “With a total budget of $6.1bn in 2021, he [Gortler] suggests the agency needs to be leaner and more efficient, with employees interested in improving public health.” “The bottom line is that the FDA has over 18,000 full time employees, more than any other drug regulatory agency by far, so it could have retrained and retooled anybody to tackle the need for increased inspections,” he says. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.”  “The lack of full transparency and data sharing does not allow physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments,” continues Gortler, who is now a fellow at the Ethics and Public Policy Center thinktank in Washington DC.” 

The most egregious example of FDA malfeasance is the intent to withhold release of the Pfizer regulatory dossier on its COVID-19 vaccine for 55 years knowing it contained reports of 1223 deaths shortly after administration of their vaccine.  In a continued set of historic blunders, the FDA approved the COVID-19 bivalent vaccines with no randomized trials powered for clinical outcomes with Omicron, and no information on safety.  I believe Drs Demasi and Gortler are correct, the FDA is broken beyond repair, officials and staff involved in malfeasance should be named as targets in federal investigations since so many lives have been impacted by their malfeasance.

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[i] Demasi M. FDA oversight of clinical trials is “grossly inadequate,” say experts BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2628 (Published 16 November 2022) Cite this as: BMJ 2022;379:o2628