Scientists Petition FDA to Suspend or Withdraw mRNA COVID Vaccines

They knew. They lied. People died. And now it’s all coming out.

This article originally appeared on The Defender and was republished with permission.

Guest post by Michael Nevradakis, Ph.D.

The petition, which had garnered 326 comments as of press time, cites evidence that the Pfizer and Moderna COVID-19 vaccines are unapproved gene therapies and are contaminated with DNA plasmids.

Scientists and legal experts have petitioned the U.S. Food and Drug Administration (FDA) to suspend or withdraw the Pfizer and Moderna mRNA COVID-19 vaccines, arguing they are unapproved gene therapies and citing their contamination with DNA plasmids.

According to a press release by Australian law firm PJ O’Brien & Associates, the petition “exposes alarming evidence of synthetic DNA contamination and regulatory failures that could affect millions worldwide,” shedding light on “a public health crisis.”

The Citizen Petition stated that Pfizer and Moderna misclassified their mRNA products as vaccines instead of gene therapy products, enabling the companies to avoid legally required FDA environmental assessments.

“This misclassification denied Americans transparency and informed consent, violating federal law and rendering approvals void from the start,” the press release stated.

The petition also cites several studies that “confirm synthetic DNA in these vaccines at levels 6 to 470 times above safety thresholds.”

“This biologically active DNA — detected in vials and human blood — carries SV40 [simian virus 40] sequences linked to cancer and genomic instability, posing risks of oncogenesis, hereditary changes, and immune disruption,” the press release stated.

The petition calls on the FDA to investigate its classification of the mRNA shots as non-gene therapy products, conduct independent testing of existing COVID-19 vaccine stocks, issue public guidance on contamination-related risks, and conduct studies examining the vaccines’ contamination and their health effects.

“Vetted by U.S. attorneys and hailed by MAHA [Make America Healthy Again] advisors for its rigor, this document is a clarion call to rewrite the narrative on COVID-19 vaccine safety,” the press release stated.

The petition is open for public comment. Initial signatories include:

• Attorney and lead petitioner Julian J. Gillespie

• Pharmacy consultant L. Maria Gutschi

• Kevin McKernan, chief scientific officer of Medicinal Genomics

• Immunologist and biochemist Jessica Rose, Ph.D.

• Virologist David J. Speicher, Ph.D.

In 2023, McKernan became the first scientist to identify DNA contaminants in the mRNA shots.

‘This is not just an American crisis — it’s a global reckoning’

According to the press release, the petition to the FDA “falls under the purview” of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. HHS oversees the FDA. Kennedy has until July 20 to issue a ruling on the petition.

The petition was also submitted to the U.S. Department of Justice, asking the agency to consider “potential fraud indictments against Pfizer and Moderna.”

It was also shared with the U.S. Department of Government Efficiency’s FDA initiative.

“This is not just an American crisis — it’s a global reckoning,” Gillespie said in the petition. “The synthetic DNA contamination in these vaccines, coupled with their mischaracterization as mere vaccines rather than gene therapies, threatens countless lives across every nation where these products were deployed. Governments must act now to halt further harm and support those already affected.”

Rose said, “The petition evidences potent facts that should lead to the suspension of use of these experimental nucleoside-modified RNA gene-based products.”

For McKernan, the petition is an opportunity for the FDA to regain public trust.

“How do they ever expect to regain the public’s trust?” McKernan asked. “They recently recalled some protein bars for a threat of peanut allergies, yet every American knows multiple people with COVID-19 vaccine injuries, yet the FDA is head-in-the-sand silent.”

The FDA and HHS did not respond to requests for comment by press time.

COVID shots were ‘unlawfully’ licensed

The petition cites federal regulations that require all gene therapy products under FDA consideration to include an “Environmental Assessment” or a claim of categorical exclusion.

Under the regulation, the “human environment” — including human health and safety — is part of such an environmental assessment.

Instead of classifying their mRNA COVID-19 shots as gene therapies, the petition stated, “Pfizer and Moderna sought categorical exclusions … which the FDA wrongfully and illegally granted … despite clear legal and regulatory provisions showing ineligibility for such exclusions.”

The petition notes that the FDA defines gene therapy products as those that intend “to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.”

Rose said gene therapy products are different from conventional vaccines. “A conventional vaccine uses weakened or inactivated material to trigger an immune response, while a nucleoside-modified RNA gene-based product uses a small piece of modified genetic material (spike gene) to instruct cells to produce a protein that stimulates immunity.”

According to the press release, “Had the FDA properly demanded Environmental Assessments … the American public would have been informed of the gene therapy nature” of the mRNA vaccines, “fulfilling legal obligations for transparency and enabling informed consent.”

“Without Environmental Assessments or legally valid categorical exclusions, the Biological Licence Applications for Comirnaty [Pfizer] and Spikevax [Moderna] were unlawfully approved,” and should be revoked or suspended, the press release stated.

DNA contamination in COVID shots above regulatory limits

The petition also cites “multiple independent studies” that have confirmed the presence of “excessive levels of synthetic DNA” in the Pfizer and Moderna mRNA COVID-19 shots, describing “numerous legal and regulatory failures” that led to the approval of these products despite the presence of contaminants.

It also notes that the manufacturers did not disclose contamination, violating federal regulations that require disclosure of the presence of any DNA contaminants.

This includes McKernan’s September 2023 study, which detected levels of synthetic DNA in the Pfizer and Moderna shots between 18 and 70 times above regulatory limits. The contamination included “SV40 promoter and enhancer sequences.”

SV40, a DNA virus, penetrates the barriers of human cells, increasing the risk of DNA contaminants being transported into the cell nucleus and integrating into the genome. It has been linked to cancer, lymphoma, mesothelioma and other health risks.

The petition also cited a December 2024 peer-reviewed study supervised by FDA scientists, which detected synthetic DNA contamination levels in the Pfizer and Moderna vaccines that were 6 to 470 times above regulatory limits.

“This study confirmed the synthetic DNA contamination is encapsulated and protected by the Lipid Nanoparticles (LNPs) used to encapsulate, protect, and efficiently transfect the modRNA into human cells,” the petition stated.

The petition also cites a December 2024 peer-reviewed study authored by German researchers, which found DNA contamination levels in the Pfizer COVID-19 vaccine ranging between three to four times above regulatory safety limits. The study found that this contamination included the SV40 promoter and the presence of LNPs.

Similar findings regarding DNA contamination in the Pfizer COVID-19 vaccine were found in a French study published in November 2024 and a May 2024 study by German researchers, both of which were cited in the petition.

According to the petition, the DNA contamination is potentially hazardous to human health, posing “risks of genomic instability and insertional mutagenesis, which can trigger cancers, especially leukemia.” Other risks include blood clots and immune disorders.

The petition, hosted on Regulations.gov, remains open to the public. It had garnered 326 comments as of press time.

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