09/28/2025 / By S.D. Wells
The U.S. Food and Drug Administration (FDA) is weighing whether to independently evaluate levels of residual DNA in COVID-19 vaccines, amid growing concern from scientists, regulators, and vaccine advisers. The issue surfaced during a Sept. 19 meeting of the Centers for Disease Control and Prevention’s (CDC) vaccine advisory panel, where members unanimously recommended scaling back COVID-19 vaccine use.
Several panel members questioned whether residual DNA fragments found in vaccines exceeded regulatory limits. They also raised concerns about messenger RNA (mRNA) and spike proteins spreading beyond the injection site and persisting longer than initially described. Retsef Levi, chair of the COVID-19 immunization workgroup, argued that the mRNA platform has not consistently worked as intended, pointing to “DNA contamination” as a major issue.
Canadian officials previously confirmed that the COVID-19 vaccine contained a DNA sequence not disclosed by the company. Independent researchers, including Kevin McKernan and former Johnson & Johnson scientist David Wiseman, warned that such DNA could integrate into the human genome, potentially triggering autoimmune disorders. A recent study published Sept. 6 reported residual DNA levels in both Pfizer and Moderna shots that exceeded FDA thresholds.
FDA’s Position and Possible Action
FDA adviser Dr. Tracy Hoeg acknowledged these concerns and confirmed that discussions were underway regarding an independent evaluation. She emphasized the agency’s commitment to safety while noting that much of the data provided by manufacturers is proprietary. Previously, the FDA had stated that no safety issues tied to residual DNA had been identified across more than a billion doses administered.
Panelist Dr. Kirk Milhoan pressed why vaccines with contamination were not withdrawn, as would be standard for other biologics. Hoeg reiterated that regulatory limits had been respected based on data provided by the companies, but thanked independent researchers for raising the alarm.
Company Responses
Big Pharma defended its testing methods. Their representatives stated that their assays specifically measured residual DNA and were validated for their products. Another argued that some external testing had flaws, noting that standard release testing includes DNA detection for every vaccine lot.
However, experts like Dr. Wafik El-Deiry of Brown University highlighted that FDA limits were established for “naked DNA,” not DNA encapsulated within lipid nanoparticles as in mRNA vaccines. He suggested that impurities identified by independent researchers might exceed FDA standards when measured with more sensitive methods.
Shifts in Oversight and Next Steps
Recent leadership changes at the FDA have coincided with tighter scrutiny of vaccine safety. Emergency authorization for COVID-19 vaccines was withdrawn, though limited approval remains for certain groups. The agency is also investigating reports of child deaths post-vaccination, marking a departure from earlier reluctance to address such issues.
CDC advisers recommended that COVID-19 vaccines be administered only after individualized consultation with healthcare providers. They also urged that official information statements include warnings about potential risks, such as prolonged exposure to spike proteins and mRNA particles.
The FDA has not yet confirmed whether it will launch its own evaluation but has signaled that the matter is being taken seriously. Independent scientists continue to press for transparency, arguing that potential DNA contamination raises unresolved questions about safety and regulatory oversight.
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