ACIP to probe DNA contamination in Covid-19 vaccines

DNA contamination in Covid vaccines is back in the spotlight, with a peer-reviewed study now before CDC advisers just days ahead of their pivotal vote.

The CDC’s vaccine advisory body will, for the first time, confront evidence that Covid-19 vaccines may be contaminated with DNA fragments capable of integrating into the human genome and potentially triggering cancer.

The Advisory Committee on Immunisation Practices (ACIP) has formed a new Covid vaccine work group, chaired by MIT professor Retsef Levi. Its Terms of Reference, published last month, explicitly list “DNA contamination” as an issue to be addressed.

The development follows the publication of a peer-reviewed study in Autoimmunity by David Speicher and colleagues, which analysed 32 vials of the more recent XBB.1.5 Moderna and Pfizer vaccines.

Using fluorometry coupled with RNase A digestion — a method that removes interfering RNA — the researchers found every vial exceeded the permissible threshold for DNA contamination by 36–627 times.

They reported billions of DNA fragments in both vaccines, many packaged inside lipid nanoparticles (LNPs), the same carriers designed to deliver mRNA into human cells.

Contamination levels matched those seen in earlier ancestral-strain formulations, suggesting the manufacturing problem has not improved.

“Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection using LNPs,” they wrote, urging replication of their work.

It can no longer be considered ‘misinformation’

Regulators have dismissed reports of DNA contamination as “misinformation,” claiming residual DNA levels fall within acceptable limits based on qPCR assays. But Speicher’s team showed why that method is flawed.

Co-author Kevin McKernan told me their paper “demonstrates qPCR can vary 100-fold based on the amplicon you use.” The amplicon is the DNA fragment the test targets, and the choice can make contamination look far lower than it really is.

Put plainly, if you choose to look for only one fragment, you will miss the billions of other fragments left over from the DNA plasmid used in manufacturing. It’s like trying to catch a mosquito with chicken wire.

McKernan, a genomics expert, added that “Moderna’s own patents teach against its use,” yet this is the method regulators have leaned on.

Regulators have never disclosed the exact PCR conditions or protocols under which they perform their tests for residual DNA, and freedom of information requests are routinely returned heavily redacted.

FOI 5286: TGA redacted its protocol for testing residual DNA

Corroborating evidence

Similar results have been reported by multiple labs, including research conducted at the FDA’s White Oak campus in Maryland, where students working under senior scientists found DNA contamination in Pfizer vials exceeding the regulatory limit by up to 470-fold.

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Perhaps most alarming, several groups have detected SV40 promoter-enhancer sequences in Pfizer vials (red arrow in diagram of DNA plasmid map).

Pfizer’s plasmid map with SV40 promoter doi.org/10.1080/08916934.2025.2551517

This stretch of DNA acts like a passport, helping genetic material cross into the nucleus where human DNA resides. Once there, contaminant DNA could in theory stitch itself into the human genome and activate cancer-causing genes.

Pfizer misled regulators

Internal emails obtained by The Epoch Times show a senior Health Canada scientific evaluator confirmed Pfizer “apparently chose not to mention this information” to international regulators.

While Pfizer submitted the full plasmid sequence in its dossier, it did not specifically flag the SV40 promoter as a “biologically functional” element — a requirement under regulatory rules.

Health Canada later clarified: “Health Canada expects sponsors to identify any biologically functional DNA sequences within a plasmid (such as an SV40 enhancer) at the time of submission.”

The switch in manufacturing

Compounding the issue is Pfizer’s move from Process 1, a small-scale production method used in its clinical trials, to Process 2, an industrial-scale system relying on bacterial plasmid amplification.

The latter introduced new risks of residual plasmid DNA persisting in the final product (see red circles)

Levi and Guetzkow flagged this in The BMJ, pointing out that only Process 1 data underpins Pfizer’s clinical trial safety database, while the large-scale Process 2 product was not tested in humans before authorisation.

Instead, FDA’s review memo dated 20 Nov 2020 indicates that the agency accepted laboratory comparability tests and release data, leaving a major gap in the evidence base.

Now, with Levi at the helm, ACIP’s work group will have to ask whether regulators were misled into approving one product while another — potentially contaminated with DNA — was injected into billions of people.

The cancer question

Brown University oncologist and newly appointed ACIP work group member, Professor Wafik El-Deiry, has reviewed the Speicher study.

Writing on X, he said there is “clear evidence” of residual plasmid DNA in Pfizer and Moderna vaccines, along with SV40 promoter sequences in Pfizer lots, and warned that these were linked to reported injuries in FDA’s VAERS.

Prof Wafik El-Deiry, Brown University, newly appointed member of ACIP’s Covid vaccine work group

He cautioned that while LNPs deliver genetic material efficiently into cells, the “precise risks are unknown.”

“Fragments can insert in the genome and the plasmid can turn the cell into a spike protein factory,” he wrote, referring to studies showing spike protein lingering in organs months or years post-vaccination.

El-Deiry voiced concern over unusual and aggressive cancers, “including sarcoma and lymphoma at injection site and glioblastomas, colon and pancreatic cancer.”

He urged regulators to update product labels, noting that “no impurities are listed in package inserts… This is all important as people are into 5th, 6th, or 7th shot.”

Independent analysts have echoed these concerns.

Data reviewed by an analyst known as the Ethical Skeptic suggest cancer rates in young people are up by 44 per cent.

Bioscientist David Wiseman and colleagues, analysing CDC’s own records, identified cancer “safety signals” that exceeded the agency’s own thresholds but were not investigated.

In the table (highlighted in yellow), a safety signal is considered to be significant, and worthy of further investigation, if the value in the column marked PRR exceeds 2 and the value in the Chi-Square column exceeds 4.

Changing political winds?

The political climate is already shifting.

President Donald Trump, once the champion of Operation Warp Speed, last week used Truth Social to question Pfizer’s data and the program’s success.

He demanded that drug companies “justify the success” of their various Covid-19 products, writing, “Many people think they are a miracle that saved Millions of lives. Others disagree! With CDC being ripped apart over this question, I want the answer, and I want it NOW.”

This week, the peer-reviewed study by Speicher et al. was formally entered into the Congressional record during a Senate hearing of the Permanent Subcommittee on Investigations, titled “How the corruption of science has impacted public perception and policy regarding vaccines.”

Its inclusion ensures that the findings on DNA contamination in Covid-19 vaccines are now preserved as part of the official legislative record, signalling intensifying scrutiny of both regulators and manufacturers.

On September 18–19, ACIP will weigh the latest evidence before it votes.

Will the committee call for more data before recommending further use of these injections? Could it single out Pfizer over the SV40 promoter findings? Or might it take the extraordinary step of halting recommendations altogether?

Whatever the outcome, the world will be watching. That decision could mark the first real moment of accountability since the global rollout of mRNA injections.

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