FDA approves Novavax COVID vaccine grown in moth cells — 100% efficacy claim based on just 14 placebo cases, raising serious safety concerns

While the mainstream media touts Novavax’s Nuvaxovid as a “safer, more traditional” alternative to mRNA vaccines, the truth behind its FDA approval is far more unsettling. The agency green-lit this genetically engineered, insect-cell-derived vaccine based on shockingly weak evidence — just 14 moderate-to-severe COVID cases in the placebo group, with zero in the vaccinated group. This flimsy foundation allowed Novavax to claim 100% efficacy, a statistical illusion that crumbles under scrutiny.

Worse, the FDA bypassed its own advisory committee, ignored post-market reports of heart inflammation, menstrual disruptions, and even deaths, and deferred long-term safety studies for years. The public is being sold a dangerous illusion of safety while regulators and corporations collude to push another experimental product onto an unsuspecting population.

Key points:

• The FDA granted full approval to Novavax’s Nuvaxovid despite its efficacy claim resting on just 14 placebo cases — a statistically meaningless sample size.
• The vaccine is produced using genetically modified moth cells infected with a baculovirus, raising contamination and informed consent concerns.
• No severe COVID cases occurred in vaccinated participants — not because the vaccine worked flawlessly, but because the trial was too small and short (only 3 months).
• Post-market data from Australia revealed alarming rates of myocarditis, pericarditis, anaphylaxis, and menstrual disturbances — none of which were properly studied before approval.
• The FDA skipped advisory committee review, dismissing known risks while deferring critical safety studies for up to a decade.

The illusion of “100% efficacy”

The FDA’s approval hinges on a New England Journal of Medicine (NEJM) study that followed participants for a mere three months, with only 14 moderate-to-severe COVID cases in the placebo group. This microscopic sample size allowed Novavax to claim 100% efficacy against severe disease — a marketing triumph, but a scientific farce.

Dr. Peter Doshi, senior editor of The BMJ, has long criticized such statistical sleight of hand, pointing out that small, short trials are designed to inflate efficacy while hiding long-term risks. In this case, the trial didn’t even include a single vaccinated senior citizen with severe COVID — meaning the claim of protection for high-risk groups is pure speculation.

How Novavax’s vaccine is made: A Frankenstein science experiment

Unlike mRNA shots, which instruct the body to produce spike proteins, Novavax’s vaccine pre-manufactures the spike protein inside moth cells. Here’s how it works:

• Genetically modified baculovirus infects moth cells – Scientists insert the SARS-CoV-2 spike protein gene into a baculovirus, which is then used to infect fall armyworm (Spodoptera frugiperda) cells.
• Insect cells become spike protein factories – The infected moth cells mass-produce the spike protein, which is then harvested and purified.
• Adjuvant boosts immune response – The spike proteins are mixed with Matrix-M, an immune-stimulating adjuvant derived from tree bark.

But there’s a catch: nearly all Sf9 moth cell lines are contaminated with Sf-rhabdovirus, an RNA virus that could theoretically end up in the final product. The FDA has no long-term data on how these contaminants — or the spike protein itself — might affect human biology.

Post-market red flags: Heart damage, menstrual chaos, and ignored deaths

While the NEJM study reported mild side effects, real-world data tells a darker story:

• Myocarditis & pericarditis – Australia documented 19.4 cases per 100,000 doses, with chest pain occurring at 91.3 per 100,000 doses.
• Anaphylaxis – Seven cases (all in women) emerged post-approval, despite zero cases in clinical trials.
• Menstrual disturbances – Women reported sudden, severe changes in their cycles—a phenomenon ignored in trials.
• Deaths – Four fatalities were dismissed without investigation, despite occurring shortly after vaccination.

Instead of convening an independent advisory committee to scrutinize these risks, the FDA fast-tracked approval, claiming the data “did not raise concerns.” Yet, buried in the fine print, the agency mandated post-approval studies on myocarditis, strokes, and pregnancy outcomes—due between 2027 and 2032.

This means millions of people are being used as guinea pigs while regulators wait a decade to confirm if the vaccine is safe. Novavax’s vaccine is not the “natural” alternative it’s marketed as. It’s a genetically engineered, insect-cell-derived product with serious post-market risks and no long-term safety data. The FDA’s approval is a betrayal of public trust, prioritizing corporate profits over informed consent.

The question isn’t whether Novavax works — it’s whether anyone truly knows the long-term cost.

Sources include:

JonFleetwood.substack.com

FDA.gov

NEJM.org