FDA Fully Approves Novavax COVID Vaccine Grown In Infected Insect Cells
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The U.S. Food and Drug Administration (FDA) has granted full approval to the adjuvanted COVID-19 vaccine Nuvaxovid, produced by Novavax, according to a May 16, 2025, approval letter obtained by this publication.
But while headlines tout the vaccine as a safer, more traditional alternative to mRNA injections, the FDA’s approval rests on alarmingly thin evidence—including just 14 moderate-to-severe COVID-19 cases recorded in the placebo group and zero in the vaccine group during the pivotal phase 3 trial published in the New England Journal of Medicine.
In other words, this “100% efficacy” claim against severe disease—the centerpiece of Novavax’s approval—was based on just 14 cases.
This means the entire foundation of the FDA’s approval rests on a statistically fragile outcome that could collapse with just a handful of different results—hardly a robust basis for authorizing a biologic product for mass use.
The vaccine contains recombinant spike protein produced in insect cells (from Spodoptera frugiperda, or fall armyworm) and is combined with the Matrix-M adjuvant derived from saponin extracted from tree bark.
It is now authorized for:
What the NEJM Trial Didn’t Show
While the trial boasted over 90% efficacy against mild COVID, it only followed patients for a median of 3 months, and all cases of “severe” disease occurred in the placebo arm—a tiny sample that didn’t include a single vaccinated individual over 65 experiencing severe disease.
Additional red flags:
Post-Marketing Red Flags: Myocarditis, Anaphylaxis, Menstrual Issues
Australia’s post-market surveillance study, cited in Eurosurveillance, revealed serious concerns not seen in trials:
How Nuvaxovid Is Made: Insect Cells and Engineered Viruses
Nuvaxovid (NVX-CoV2373) uses a recombinant protein vaccine platform, which is fundamentally different from mRNA vaccines—but still raises serious biological and regulatory questions.
Nearly all Sf9 cell lines are persistently infected with Sf-rhabdovirus, an RNA virus recently discovered to be nearly universal across global supplies.
1. Insect Cells as Factories
2. Genetically Engineered Baculovirus Infection
3. Protein + Adjuvant = Final Vaccine
Why This Matters
FDA Skipped Advisory Committee Review
The FDA confirmed it did not convene an advisory committee, stating the data “did not raise concerns or controversial issues.”
This despite known post-market risks of myocarditis, pericarditis, atrial fibrillation, cranial nerve damage, and cardiac failure—all requiring mandatory 15-day reporting through VAERS for the next three years.
Long-Term Risk Studies Deferred for Years
The FDA is deferring pediatric studies until 2026–2031 and requiring post-approval studies on:
Bottom Line
A genetically engineered insect-cell-based COVID shot that caused chest pain, heart inflammation, and menstrual disruption in post-market surveillance just got full FDA approval—based on 14 cases and no severe COVID cases in the vaccinated arm.
The FDA didn’t even convene an expert panel.
The public deserves to know: This was not a thorough or reassuring approval.
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