“Moderna’s New COVID Shot Approved After Trial—But Skips Placebo Testing”

In a controversial move, the U.S. Food and Drug Administration (FDA) has granted approval to Moderna’s latest COVID-19 vaccine, mNEXSPIKE, without requiring the company to conduct placebo-controlled safety trials prior to release. Critics argue that this decision represents a serious departure from previous regulatory standards and raises new concerns over public trust, vaccine safety, and regulatory capture.

Fast-Tracking Without Full Testing

According to Moderna, mNEXSPIKE is intended for adults aged 65 and older and for individuals 11 years and older with “underlying conditions,” including those with so-called Long COVID. But instead of testing this new formulation against a saline placebo — the gold standard for evaluating safety and efficacy — the FDA allowed Moderna to compare mNEXSPIKE to an earlier version of its COVID-19 shot.

This approach directly contradicts a public promise made by the U.S. Department of Health and Human Services (HHS) to require that new vaccines undergo proper placebo-controlled clinical trials before authorization.

No such trial is expected until November 2025, and Moderna has indicated that full results from any long-term studies likely won’t be available until at least 2027.

Mounting Scientific and Medical Concerns

Dr. Peter McCullough, a cardiologist and prominent critic of the federal COVID-19 vaccine rollout, has voiced serious concerns over the safety of mRNA-based injections. Citing both clinical findings and autopsy reports, McCullough stated, “We should expect all mRNA vaccines to cause myocarditis,” noting that vaccine-derived mRNA has been detected in heart tissue weeks after injection.

A 2024 peer-reviewed study lends support to these claims. Researchers discovered lingering spike proteins and synthetic mRNA in heart muscle and plasma samples taken from vaccinated individuals — in some cases persisting for a month or more. The study also reported signs of inflammation and cardiac tissue damage in several cases.

While regulatory agencies and pharmaceutical manufacturers have downplayed these findings, insisting that adverse events are rare, critics argue that such assurances are unsubstantiated without robust, transparent safety trials.

Public Backlash and Erosion of Trust

Public skepticism surrounding mRNA vaccines has continued to grow. A recent Rasmussen survey found that a substantial percentage of Americans now believe COVID-19 shots were not adequately tested before being widely distributed, and many view the relationship between government regulators and pharmaceutical companies as compromised by financial or political motives.

“This is regulatory theater,” said one biotech industry insider who wished to remain anonymous. “The FDA is greenlighting new products with minimal independent oversight — and doing so while the public’s confidence is cratering.”

The New Variant and Convenient Timing

Just as mNEXSPIKE enters the market, a new COVID variant — NB.1.8.1 — is making global headlines. Early reports suggest it spreads rapidly and poses heightened risk to immunocompromised individuals — a group that includes many of the same patients targeted for the new vaccine.

This pattern — of variant emergence coinciding with vaccine rollout — has been noted throughout the pandemic, and some researchers are beginning to question whether repeated mRNA injections could be playing a role in immune system dysregulation.

While this theory remains controversial, data has shown that post-vaccination breakthrough infections remain common, and in some cohorts, initial mRNA injections were associated with increased short-term susceptibility to COVID-19 infection.