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By James Lyons-Weiler, PhD

What Has to Happen Before mRNA Vaccines Are Pulled: Why RFK Jr. Hasn’t—and Why He Might Soon

Legal and regulatory options and requirements point to the pathway to freedom

The continued use of mRNA vaccines in the United States remains one of the most politically and medically contentious issues of our time. As public awareness grows around adverse event profiles and the questionable regulatory processes that ushered these products into global use, many are now asking an urgent question: why hasn’t HHS Secretary Robert F. Kennedy Jr. acted to revoke them?

To the untrained observer, Kennedy’s hesitation might appear as political caution or betrayal of his vaccine-critical roots. But the reality is far more complex. Pulling a product authorized under Emergency Use Authorization (EUA) or granted full Biologics License Application (BLA) approval is not a matter of executive decree. It requires a coordinated, multi-agency reckoning with evidence, policy, and law. And the legal scaffolding built to protect vaccine manufacturers—particularly under the Public Readiness and Emergency Preparedness (PREP) Act—was designed precisely to prevent the kind of abrupt retraction the public is demanding.

Yet the fortress is beginning to crumble.

The Nature of the Authorizations

Most Americans believe the mRNA vaccines are "approved." In fact, the vaccines administered to the majority of the population have remained under EUA, not full licensure. The FDA granted BLAs to Comirnaty (Pfizer) and Spikevax (Moderna), but those exact products are often not available in the U.S. commercial supply chain. This bait-and-switch has significant legal implications, particularly around informed consent and product liability.

Under 21 U.S.C. § 360bbb-3, EUA requires that the Secretary of HHS determine that there is a public health emergency, that no adequate approved alternatives exist, and that the known and potential benefits outweigh the known and potential risks. But what happens when emerging data calls that balance into question?

What It Has Taken to Pull Vaccines Before

History tells us that only under grave circumstances does the FDA pull a vaccine. The Cutter Incident in 1955, in which live polio virus in inactivated vaccine batches caused paralytic disease and death, is one example. RotaShield, pulled in 1999 after being linked to intussusception in infants, is another. Pandemrix, used during the 2009 H1N1 pandemic, was withdrawn in Europe after post-vaccine narcolepsy cases.

But unlike those cases, mRNA vaccine injuries are statistically diffuse, often delayed, and obscured by passive surveillance systems with notorious underreporting.
The Collapse of Confidence: What the Data Are Saying

The CDC’s V-safe program, made public only after legal action, revealed that over 7% of vaccine recipients sought medical care after vaccination. The Vaccine Adverse Event Reporting System (VAERS) has registered more deaths, heart attacks, strokes, and permanent disabilities post-COVID vaccine than all other vaccines combined over 30 years. Independent reanalyses of the original clinical trial data (e.g., Fraiman et al.) have shown more serious adverse events in the treatment group than in the placebo group.

Myocarditis risk in young males, stroke risk in older populations, menstrual disruptions, and autoimmune relapses have all been documented across peer-reviewed studies. A special case involves the discovery of plasmid DNA contamination in mRNA vaccine vials by McKernan et al., raising questions about the adequacy of manufacturing quality control.

The Peter Marks Problem

For years, the man sitting at the nexus of vaccine authorization has been Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research (CBER). No individual has done more to uphold the facade of unassailable safety and effectiveness surrounding the mRNA platform. Under his leadership, concerns over myocarditis were minimized, booster authorizations were rushed, biased testing drove us to the brink of collapse, and product labeling was never updated to reflect new risk profiles,

Marks, reportedly resistant to any form of transparency regarding the V-safe and VAERS data, remained a blockade to reform. He was the final bulwark of the pharmaceutical status quo—“the last person on Earth who would ever take action,” as one insider put it.

His resignation earlier this year, amid rising tensions with Secretary Kennedy, was not only overdue—it was pivotal. Read more here.