The paper is published in Journal of Angiology & Vascular Surgery, an outlet of Herald Scholarly Open Access, a publisher that appears on Beall’s list of potential predatory publishers and is not indexed in the usual scientific databases.
It was accepted 11 days after submission (24 April → 5 May 2025), an interval barely long enough for routine peer‑review.
The senior author, Richard M. Fleming, is a cardiologist‑turned‑activist who lost his medical licence after felony health‑care‑fraud convictions and is currently debarred from FDA‑regulated research. Lead Slovak co‑author Peter Kotlár holds a political appointment investigating his country’s COVID response. None of these biographies, or their obvious interests in vaccine controversy, appear in the conflict‑of‑interest statement.
Those red flags would make most editors skeptical, but they are secondary if the data themselves are solid. Below is where the work falters on its own technical terms.
Nobody knows how the vials were handled
The authors never document how the Moderna and Pfizer lots were stored or shipped before analysis. Were they kept continuously at –20 °C/–80 °C, parked in a domestic freezer, or bounced around at room temperature? Without that record, we cannot distinguish genuine manufacturing variability from nucleic‑acid degradation (or aggregation) that occurred after the vials left the factory. In plain language: nobody knows where these samples had been rolling around.
Their “28 % variability” cannot coexist with their own qPCR plots
Early in the Results the paper’s scatter plots show qPCR signals spanning two to three orders of magnitude - a 100 % to 1 000 % spread.
Yet the Conclusion claims “a 28 % difference in nucleic‑acid content between lots.” These two claims cannot both be right: variability is either about 28 % or it is 100‑1.000 %, but never both at once.
If the assay really produced ten‑fold swings, referring to them as “28 %” is a mathematical mismatch. Conversely, if genuine lot‑to‑lot variability were only 28 %, the ten‑fold points must be laboratory artefacts.
The extraction protocol was probably saturated
Commercial mRNA vaccines are formulated at roughly 100 µg RNA mL⁻¹. The kit the authors used - the Qiagen AllPrep DNA/RNA Mini is rated by the manufacturer for a maximum binding capacity of 100 µg total nucleic acid per column and is considered linear only up to about 50 µg. A direct 0.5 mL load therefore feeds ~50 µg of RNA (plus any DNA) onto a membrane that is already at the top of its specification. Once a column sits near saturation, small differences in clogging or breakthrough liquid can masquerade as big lot‑to‑lot swings even when the true input is identical. The paper shows no spike‑recovery or dilution‑linearity test to confirm that the extraction remained quantitative.
RT‑qPCR reaction was likely saturated
The one‑step RT‑qPCR step was almost certainly overloaded, not merely close to the ceiling. Each extraction began with 500 µL of vaccine (≈100 µg RNA mL⁻¹, i.e. ~50 µg total), which the Qiagen column eluted in just 50 µL an effective ten‑fold concentrate of about 1 µg RNA per microlitre. The authors then pipetted 4 µL of this eluate into a 20 µL reverse‑transcription reaction, delivering roughly 4 µg RNA to an enzyme mix whose linear range usually tops out near 1 µg. Such template overload can inhibit reverse transcriptase and eventually underestimate RNA concentrations.
No positive or negative controls
The study ran without the single most critical control in extraction‑based quantitation: a positive spike‑in of known copy number. Standard practice is to add a defined amount of synthetic RNA or plasmid to every vial before extraction; the recovered Cq then shows instantly whether the column, wash steps, or enzyme mix lost 2 % or 40 %. Given that the authors report variation spanning orders of magnitude, the absence of a spike‑in makes it impossible to tell whether the spread comes from the vaccine or from the workflow itself. A simple positive control would have flagged column saturation, pipetting loss, or RT inhibition and put hard bounds on true lot‑to‑lot variability.
The paper also omits routine negative controls, blank extractions and non‑template PCR wells, which would have exposed background DNA or primer‑dimer fluorescence. But the real show‑stopper is the missing spike‑in: without it, any large differences between vials could just be artefacts introduced during handling. Leaving out such a basic safeguard is highly unusual in quantitative molecular biology and undermines the credibility of the numerical claims.
qPCR cannot prove the plasmids are intact
Quantitative PCR amplifies short 100–150 bp stretches. It cannot tell whether those stretches were on a full 4 kb plasmid or on a broken fragment. Demonstrating intact plasmid requires DNase‑control digests, sizing gels, or sequencing - none of which the paper provides.
Even the worst‑case number is within the legal limit
The highest DNA value reported (≈10⁹ copies mL⁻¹) converts to about 2 ng DNA per 0.5 mL dose. International guidelines for injectable biologics allow up to 10 ng residual double‑stranded DNA per dose. The regulatory limit applies to total residual DNA—intact or fragmented—so the measured 2 ng is still a comfortable five‑fold below that threshold.
Bottom line
The study combines missing chain‑of‑custody information, an extraction method likely beyond its capacity, an internal contradiction between 28 % and 1 000 % variability, and an unsupported claim about “intact plasmids.” Even the authors’ own worst‑case number falls well inside existing regulatory limits. Publishing such insufficiently‑vetted data in a venue with minimal peer‑review is irresponsible because it can be weaponised to erode public confidence, delay vaccination, and ultimately cost lives.
Zooming out, the broader evidence base shows that the very Moderna and Pfizer vaccines scrutinised here have been administered billions of times and remain among the most closely monitored medical products in history. Every commercial lot is tested for potency, purity, and residual DNA before release; pharmacovigilance systems track adverse events batch‑by‑batch. No pattern of DNA integration, mutagenesis, or vaccine‑linked cancer has been detected. On the contrary, rigorous clinical trials and multiple real‑world studies confirm high efficacy against severe COVID‑19 and a clear net benefit that has already saved millions of lives. Claims of hidden genetic danger therefore run counter not only to regulatory chemistry data but to the accumulated clinical outcome data as well.
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