On 3 January 2024, Florida Surgeon General Joseph Ladapo called for a halt in the use of the mRNA COVID-19 vaccines after US health agencies failed to adequately address his concerns about DNA contamination in the products.

In a statement on X, Ladapo accused the FDA and CDC of always playing it “fast and loose” with COVID-19 safety, but their failure to test whether DNA fragments in the vaccine could integrate into a person’s genome was “intolerable”.

As I and others have pointed out on numerous occasions, the FDA’s own guidance on regulatory limits for residual DNA in vaccines states “there are several potential mechanisms by which residual DNA could be oncogenic [cause cancer], including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration”.

In a letter, Ladapo had also asked the two agencies if they’d carried out any risk assessment regarding the presence of the “SV40 promoter” in the vaccines, which is thought to enhance DNA integration into host cells.

But the FDA’s top vaccine official, Peter Marks, responded to Ladapo’s demand for answers with intransigence and obfuscation.

Similar to how the FDA shut down my previous enquiries into this matter, the agency failed to provide Ladapo with any evidence that it had even conducted tests to address the risk of genomic integration.

In fact, Marks had the temerity to imply that ongoing discussion about this topic was perpetuating misinformation “which results in vaccine hesitancy that lowers vaccine uptake”.

Ladapo explained;

“DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients. If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings.”

He also recommended that providers concerned about health risks of COVID-19 should prioritise patient access to non-mRNA COVID-19 vaccines and treatment.

Quick to dismiss Ladapo’s concerns was Paul Offit, director of the Vaccine Education Centre at Children’s Hospital of Philadelphia, who serves on the FDA’s vaccine advisory committee.

Offit hit back in a video published on MedPage Today saying, “It is hard to believe that Dr Ladapo actually issued that statement … [DNA fragments] can’t possibly do harm. So scaring people unnecessarily like this has been hard to watch.”

Unfortunately, Offit’s video contains a series of erroneous statements that exposes his fundamental misunderstanding of the manufacturing and regulation of COVID vaccines.

For example, Offit says it’s unlikely that DNA fragments enter the cytoplasm of cells, or survive, once they’re inside.

“Our cytoplasm hates foreign DNA and it has a variety of mechanisms, including innate immunological mechanisms and enzymes, to destroy foreign DNA,” says Offit.

“That DNA, which would never survive the cytoplasm, would have to then cross the nuclear membrane into the nucleus, which would require a nuclear access signal that these DNA fragments don’t have … So the chance that DNA could affect your DNA is zero,” he adds.

But this statement is disingenuous on multiple fronts.

Offit talked about DNA fragments as if they were not encapsulated in lipid nanoparticles, which specifically ferry the genetic material into the cell cytoplasm. Indeed, without the lipid nanoparticles, the vaccines would never have made it to market.

A recent publication in Nature found that within hours, around 7% of cells are integrated when mixed with a transfection solution containing linear pieces of DNA.

Offit also said that DNA wouldn’t cross into the cell’s nucleus, but scientists have known that foreign DNA can be delivered into mammalian cells to modify a host cell’s genetic makeup in a process called “DNA transfection”.

It also ignores the fact that the DNA fragments contain the “SV40 promoter” which includes a nuclear targeting signal (NTS) to aid its entry into the nucleus.

A full critique of Offit’s commentary was recently published by Dr Robert Malone who pioneered some of the early work into mRNA technology.

Phillip Buckhaults, a cancer genomics expert, and professor at the University of South Carolina, has confirmed the presence of DNA fragments in the vaccines after replicating the work of McKernan et al.

Buckhaults has welcomed Ladapo’s announcement.

“I’m glad Dr Ladapo is taking a firm leadership stance to protect the people under his care. I think he is taking a lot of heat over genuinely looking out for others. I think he is acting in good faith and that is to be respected,” says Buckhaults.

He also believes that Ladapo’s stance on the mRNA vaccines is “based on solid scientific reasoning” because the long-term genomic safety has not been demonstrated for fragments of DNA that are encapsulated in lipid nanoparticles.

However, rather than completely halting the vaccines, Buckhaults says he would err on the side of caution and still “recommend the vaccine to select populations who are at high risk for death from COVID-19”.

Buckhaults hopes that Ladapo can use his authority to compel the FDA to request an extra “cheap and easy step” in the processing of the vaccines to remove the vast majority of DNA from upcoming batches.

“Then we would not even need to have this argument about DNA anymore. The risk of the DNA would be essentially gone and the crisis in confidence in leadership would be addressed,” he says.

Buckhaults has testified before a South Carolina Senate hearing about his alarm over the “very real hazard” that these fragments of foreign DNA can insert themselves into a person’s genome and become a “permanent fixture of the cell.”

He has also discussed with me at length, the potential harms to people’s health caused by DNA contamination in the mRNA vaccines. Last year, Buckhaults notified the FDA of his concerns via email but never received a response.

Maryanne Demasi PhD is an investigative journalist who writes for online media and top tiered medical journals. For over a decade, she was a TV presenter for the Australian Broadcasting Corporation (ABC). Follow her work on Substack here.