Evidence of DNA Contamination in mRNA Shots Prompts Call for Halting Their Use

On Dec. 6, 2023, Florida’s Surgeon General, Joseph Ladapo, MD, PhD, wrote a letter to the commissioner of the U.S. Food and Drug Administration (FDA), Robert Califf, MD, requesting that an investigation be launched into the alleged DNA contamination in Pfizer/BioNTech’s Comirnaty and Moderna/NIAID’s Spikevax mRNA (messenger ribonucleic acid) COVID shots. Not satisfied with the answers he received, Dr. Ladapo followed up his letter with a Jan. 3, 2024 public call for people to stop getting the shots.^{1 2 3}

In his letter, Ladapo asked the FDA and the U.S. Centers for Disease Control and Prevention (CDC) to answer the following three key questions;

Whether or not drug companies have evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines;

If the FDA holds a current standard for an acceptable and safe quantity of residual DNA (presently known as contaminants in biological therapies) used in the lipid nanoparticle delivery system for the vaccines; and

If the risk has been evaluated—considering the wide biodistribution of ingredients of the shot in the body—beyond just the local injection site.¹

FDA Responds to Ladapo’s Questions About DNA Contaminants in mRNA COVID Shots

The FDA responded to Ladapo’s letter on Dec. 14, 2023. The FDA’s letter was written by Peter Marks, MD, PhD, director of the agency’s Center for Biologics Evaluation and Research.³ Regarding Ladapo’s first question about the risk to the human genome of residual DNA contaminants in the mRNA COVID shots, Dr. Marks wrote:

No SV40 proteins are encoded for or are present in the vaccines. On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA. Additionally, studies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine. Pharmacovigilance data in hundreds of millions of individuals also indicate no evidence indicative of genotoxicity.⁴

With respect to Ladapo’s second question about the residual DNA used in the nanoparticle delivery system for the mRNA COVID shots, Marks wrote:

The agency has taken into account the totality of the mRNA COVID-19 vaccine product, including the lipid nanoparticles, as it reviewed the manufacturers’ specifications for residual DNA fragments present. Any contamination with residual DNA fragments is monitored routinely as a product specification.⁴

As to Ladapo’s third question about the risk of possible integration of residual DNA contaminants into cells beyond the injection site, Marks wrote:

Please see the response to the first question above regarding the implausibility that the minute amounts of small DNA fragments present could find their way into the nucleus of these cells. Additionally, reproductive toxicology studies have been conducted to evaluate the mRNA COVID-19 vaccines and have found no concerns.⁴

FDA Fails to Provide Evidence No Harmful DNA Contamination in mRNA COVID Shots

The FDA’s letter, however, did not allay Dr. Ladapo’s concerns about the risk of residual DNA contaminants in the mRNA COVID shots. Notably, Ladapo pointed to the potential for DNA contaminants to be spread throughout the body by lipid nanoparticles serving as carriers for the synthetic spike protein in the shots, which some scientists believe could have the potential to cause cancer. This is a concern also recently raised by Phillip Buckhaults, PhD, professor of cancer molecular genetics at the University of South Carolina, and immunologist Jessica Rose, PhD.^{1 3 5 6 7} According to Ladapo:

The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed. Instead, they pointed to genotoxicity studies—which are inadequate assessments for DNA integration risk. In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct. 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.⁸

Ladapo added:

Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment. It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome.⁸

Ladapo then went one step further and called for use of the mRNA COVID vaccines manufactured by Pfizer and Moderna to be suspended.  On Jan. 3, 2024, he said:

I am calling for a halt to the use of mRNA COVID-19 vaccines. The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have always played it fast and loose with COVID-19 vaccine safety, but their failure to test for DNA integration with the human genome—as their own guidelines dictate—when the vaccines are known to be contaminated with foreign DNA is intolerable.⁹

Ladapo’s Call to Halt Use of mRNA COVID Shots Draws Attacks by Media

It was these comments by Ladapo—a physician with both an MD and PhD from Harvard University, a former professor of medicine at New York University and Surgeon General of the third most populous state in the United States—that have made him the target of attacks by federal health officials  and the corporate media, for which the idea of stopping the use of the mRNA COVID shots for apparently any reason is not up for public debate.

Dr. Ladapo raised legitimate safety concerns about a controversial biologic product that has been shown to be ineffective against infection and transmission of the SARS-CoV-2 virus and has been associated with numerous illnesses, injuries and deaths and for which neither government nor industry has conducted appropriate long-term safety studies. Ladapo was doing his job when he asked FDA officials for evidence to back up their contention that there is no reason to worry about DNA contaminants in a product that has been used by more than 80 percent of all Americans after determining that the FDA’s response was inadequate.

For this, federal health officials responsible for regulating vaccines and the media promoting vaccines have tried to discredit him, alleging that he is spreading “scientific nonsense” and “normalizing medical quackery.” The media has further attempted to dismiss his legitimate concerns by describing him as a “prominent anti-vaxxer.”¹⁰

Unable to resist inserting politics into the narrative about DNA contamination of mRNA COVID shots, the corporate media is also highlighting the fact that Ladapo was appointed Florida’s Surgeon General by that state’s conservative Republican governor, Ron DeSantis, who is running for President and has been a critic of Biden’s COVID-19 pandemic response policies.¹¹ An article in Britain’s The Independent noted:

This isn’t the first time Dr. Ladapo has been publicly skeptical about the efficacy or safety of the vaccine since he was appointed by Florida Gov. Ron DeSantis to serve as the state’s top health official in September 2021—or even before.¹²

A USA Today article stated:

Since taking office, he has appeared on podcasts known for having conservative listeners or hosted by anti-vaccine advocates. On the podcast ‘Liberty Lockdown,’ he called former chief White House medical advisor Dr. Anthony Fauci ‘a complete fraud when it comes to communication.’ During another appearance, he urged listeners to rely on their intuition when deciding whether or not to listen to medical doctors.¹³

The insinuation seems to be that Gov. DeSantis has consistently been wrong about the risks of COVID shots and the Biden administration’s  COVID response policies (like lockdowns) and therefore, by association, so has Ladapo, and that their positions may largely be politically motivated. In a thinly veiled attempt to frame Ladapo as some sort of kook, a Washington Post article ran the following quote from Ashish Jha, MD, MPH, former White House COVID response coordinator:

We’ve seen this pattern from Dr. Ladapo that every few months he raises some new concern and it quickly gets debunked. This idea of DNA fragments—it’s scientific nonsense. People who understand how these vaccines are made and administered understand that there is no risk here.¹⁴

For his refusal to take the word of FDA and drug company officials that the mRNA COVID shots are perfectly safe and nothing less than a “modern miracle,” for his due diligence in raising questions about the potential risks of DNA contamination of the mRNA COVID shots and his insistance on transparency from the FDA with regard to evidence and data demonstrating safety, Dr. Ladapo has been accused of offering up “anti-science and anti-vaccination disinformation, revealing a pattern of abuse of the public trust.”¹⁵

FDA’s Credibility Eroded by Conflicts of Interest and Lack Transparency

More than likely, though, it is the FDA which has been abusing the public trust. The FDA is a regulatory agency riddled with conflicts of interest with the pharmaceutical industry. It receives 75 percent of its annual funding from pharmaceutical companies.^{16 17 18 19 20 21}

A poll taken in May 2021 by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health found that only 37 percent of Americans said they had a lot of trust in the FDA. Later that year, Forbes published an article titled “How the FDA’s Lack of Transparency Undermines Public Trust.”^{22 23} The article by David Gortler, MD, former FDA medical officer and senior advisor to the FDA commissioner, noted:

[T]here has been a disturbing increasing pattern of the FDA refusing to honestly discuss its public health decisions.²³ 

This is probably at the root of what bothers Ladapo about the FDA and contributes to his skepticism about Marks’ response to a request for information about DNA contaminants in the mRNA COVID shots and about the way the FDA conducts its business in general.

It has long been known that the FDA’s reputation as the “gold standard” for evaluating drugs has eroded and that the federal health agency is sorely in need of “structural and cultural changes to bring it in line with its original mission of acting as an independent government regulator of the food and drug industries,” according to a 2022 report commissioned by the PharmedOut project of Georgetown University.^{24 25} 

Reshma Ramachandran, MD of the Yale School of Medicine and a member of the PharmedOut working group acknowledged that the FDA is not a “truly independent” regulatory agency.²⁵ Another member of the working group, John Powers, MD, of George Washington University School of Medicine, said:

The focus now in the current era seems to be more on speed of drug approvals to market and the quantity of drugs approved, with an assumption that more is better and access is better for patients, even if it’s not clear whether those interventions improve patient outcomes.²⁵

There is nothing unreasonable or unscientific about Ladapo’s call for more information regarding DNA contaminants in the mRNA COVID shots. As investigative medical reporter Maryanne Demasi wrote in an article reprinted in The Vaccine Reaction last month, “the FDA has known about the risk posed by residual DNA in vaccines.”²⁶ She cited the FDA’s own guidance to industry…

Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.²⁶

“Put simply,” Demasi wrote, “the FDA acknowledges the possibility that fragments of DNA left over by the manufacturing process can be incorporated into a patient’s own DNA, to potentially cause cancer.”²⁶

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