Is the FDA a mutinous ship?

The “Reformed” FDA Is Still Playing the Same Old Vaccine Games

Dr Clare Craig

They promised change. They promised transparency. They promised reform. But with the FDA’s latest approval of Moderna’s mNEXSPIKE® covid jab, it is clear the only thing that has changed is the branding.

This so-called “reformed” FDA has just authorised a new mRNA vaccine — without testing it against a placebo. Instead, the comparator was Moderna’s previous product, already associated with a range of known adverse effects.

And yet, somehow, we’re meant to believe this is progress.

Meanwhile, the leaders heading up MAHA, elected on a promise to end the regulatory theatre and restore public trust, appear to be captaining a vessel still drifting in the same dangerous waters. They are on a mutinous ship and are wrestling for the wheel.

While the FDA continues to greenlight successive iterations of mRNA vaccines, other major Western nations long since reduced their ambitions:

• In the United Kingdom, the Joint Committee on Vaccination and Immunisation (JCVI) now recommends boosters only for individuals aged 75 and over, residents of care homes, and those with specific clinical vulnerabilities.
  

• France and Germany have similarly curtailed their booster programmes, focusing on high-risk populations and refraining from broad recommendations for younger, healthier demographics.

This more cautious approach is not justifiable either given the failure of these product and their safety profile. The “benefit” only ever was - and continues to be - a statistical illusion. No one should be being exposed to this unnecessary risk.

This divergence raises a critical question: How can the same body of evidence lead to such different public health policies?

Latest Inadequate Trials

The Phase 3 trial underpinning mNEXSPIKE’s approval enrolled approximately 11,400 participants aged 12 and older. While this number might seem substantial, it's important to note that only about half received the mNEXSPIKE vaccine, while the remainder received an earlier Moderna product as a comparator. There was no placebo comparison.

This sample size is insufficient to detect rare but serious adverse events - even with a placebo. Without one you can only see differences between two sets of harm.

For context, previous studies have indicated that mRNA vaccines may be associated with an excess risk of serious adverse events of special interest, estimated at approximately 15.1 per 10,000 vaccinated individuals. This is totally unacceptable for general use even in a product that has significant benefits.

Despite approval, critical safety studies are still pending. One study, assessing safety in pregnant women, is not due until 2032. Another, evaluating vaccine effectiveness for adults aged 50–64, is still in the planning stages.

Are the FDA still pretending there is an emergency to justify these rushed decisions?

A Hollow Reformation

The USA public deserves better from their officials. They are paying for this reckless approach. The question is, can those with a more precautionary, less ideological approach, wrestle the wheel of the ship and steer her to safety?