FDA Fully Approves Novavax COVID Vaccine Grown in Infected Insect Cells—100% Efficacy Claim Based on Just 14 Placebo Cases
Decision relied on NEJM study that only followed patients for 3 months.
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.
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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:
Adults 65 and older, and
Individuals aged 12–64 with at least one underlying condition said to put them at risk for severe COVID-19.
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:
No efficacy data on Delta, Omicron, or newer variants. The trial ended before those strains emerged.
Zero measurement of transmission or infection rates—only symptomatic illness.
Effectiveness in Hispanic participants was drastically lower: just 67.3% with a confidence interval that dipped as low as 18.7%, bordering statistical irrelevance.
Post-Marketing Red Flags: Myocarditis, Anaphylaxis, Menstrual Issues
Australia’s post-market surveillance study, cited in Eurosurveillance, revealed serious concerns not seen in trials:
Pericarditis (inflammation around the heart): 19.4 per 100,000 doses.
Chest pain: 91.3 per 100,000 doses.
Anaphylaxis: 7 cases—all in women—despite no anaphylaxis in trials.
Menstrual disturbances: reported but not tracked in the trial at all.
Death temporally linked to vaccination: 4 reported, but all dismissed as unrelated without detailed investigation.
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
The spike protein in Nuvaxovid is produced inside insect cells from the Spodoptera frugiperda species (a moth), specifically a cell line called Sf9.
These cells are cultured in large bioreactors to act as biological “factories” that churn out massive quantities of protein.
2. Genetically Engineered Baculovirus Infection
The Sf9 insect cells are intentionally infected with a recombinant baculovirus—a virus that’s been genetically modified to carry the code for the SARS-CoV-2 spike protein.
Once infected, the insect cells begin producing the full-length, prefusion-stabilized spike protein, which is then harvested and purified for use in the vaccine.
Contamination from these insect cells makes it into the vaccine and therefore the vaccinated.
3. Protein + Adjuvant = Final Vaccine
The harvested spike proteins are combined with Matrix-M, a saponin-based adjuvant derived from the bark of the Quillaja saponaria tree, which is said to boost immune response.
Why This Matters
Residual DNA Contamination Risk: Even with purification steps, it's possible for fragments of insect cell DNA or baculoviral DNA to end up in the final product. This is a known issue with recombinant protein biologics and must be monitored due to theoretical risks of insertional mutagenesis or immune activation.
Genetic Modification: The baculovirus used is a genetically engineered organism (GMO). This process qualifies Nuvaxovid as a genetically modified biologic, even if it’s not based on mRNA.
Regulatory Transparency: Most people have no idea they’re receiving a product derived from insect-virus genetic engineering, raising serious informed consent concerns.
Spike Protein Concerns: The vaccine still introduces the SARS-CoV-2 spike protein—the same spike many researchers link to vascular inflammation, immune dysregulation, and long COVID–like symptoms.
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:
Myocarditis and pericarditis outcomes (due by 2032)
Atrial fibrillation and strokes (due by 2028)
Pregnancy safety outcomes (due by 2027)
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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FDA is insane! Disgusting! Lying anti-human Creeps!
Just who in the heck approved this? We need names!!
They are determined to reduce the population, they have no souls, they will not stop until they reach their goal of only 500 million people on the whole Earth and most Americans are willing sheep to the slaughter. Why do I say this? We just sit and watch like it's a sitcom and it isn't real. Between the spraying and pharma, they will reach their goals soon.
I believe this is why The Most High God told us that if he did not intervene in the last days there would be no flesh left alive on the Earth, human or animal. Yet, our Merciful God will shorten the days for the elects sake and the elect are very few in numbers, as most have turned away from their Creator.
Matthew 24:22
"If those days had not been cut short, no one would survive, but for the sake of the elect those days will be shortened."