The FDA Responds to Concerns About DNA Fragments in Pfizer’s COVID-19 Vaccine
The U.S. Food and Drug Administration (FDA) has addressed worries regarding the presence of plasmid DNA fragments in Pfizer’s COVID-19 vaccine, following testimony from a university researcher at a South Carolina Senate hearing.
“The mRNA COVID-19 vaccines authorized or approved for use in the United States are not defined as a gene therapy,” the FDA told Maryanne Demasi, a former Australia Broadcasting Corporation journalist who now operates a Substack page. She noted that the FDA spokesperson didn’t answer specific questions about the DNA fragments.
The FDA spokesperson emphasized their confidence in the quality, safety, and effectiveness of the vaccines, stating that their benefit-risk assessment and ongoing safety surveillance demonstrate that the benefits outweigh the risks.
The FDA’s response was prompted by an interview conducted by Maryanne Demasi with Dr. Phillip Buckhaults, a cancer genomics expert and professor at the University of South Carolina. Dr. Buckhaults clarified that while there is DNA contamination in the vaccine, the rumors about the SV40 virus causing cancer are unfounded.
According to Dr. Buckhaults, the DNA fragments found in the Pfizer vaccine’s tiny particles are what matter. He explained that the risk of genome modification is not determined by the mass of the DNA, but rather by the number of independent molecules present.
Dr. Buckhaults believes that any DNA fragments in the vaccine are likely the result of unintentional administrative errors rather than any malicious intent. He emphasized that people should consider the circumstances under which the vaccines were developed and not unfairly criticize the efforts made to combat the pandemic.
The Epoch Times has reached out to the FDA and Pfizer for comment.
Dr. Buckhaults referenced the research of microbiologist Kevin McKernan, who discovered that the amount of DNA in the vaccines exceeded the limits set by health agencies. Dr. McKernan’s findings raised concerns about the potential infiltration of DNA plasmids into the human genome, contradicting statements made by the FDA and other regulators.
Dr. Buckhaults shared his own findings, revealing the presence of plasmid molecules and DNA pieces in a Pfizer dose. These quantities exceeded the limits set by the FDA and other health bodies.
Dr. Buckhaults stressed the importance of investigating any potential clinical significance of the DNA fragments and their impact on vaccinated individuals. He highlighted the possibility of long-term risks such as cancer or autoimmune responses like myocarditis.
A health worker uses a needle and a vial of Pfizer-BioNTech COVID-19 vaccine to prepare a dose at a vaccination health centre in a file photo. (Justin Tallis/AFP via Getty Images)
Health Canada, a Canadian health agency, also did not express concern about Dr. Buckhaults’ findings, stating that they were aware of the presence of residual plasmid DNA during the vaccine review process.
What Happens to Vaccinated People?
In his interview with Maryanne Demasi, Dr. Buckhaults further discussed the potential risks faced by individuals who received the Pfizer vaccine. He emphasized the need for additional research to determine the significance of the DNA fragments.
While acknowledging that the DNA may have no effect, Dr. Buckhaults cautioned that injecting DNA wrapped in lipid nanoparticles could potentially lead to integration into cell genomes. He advocated for thorough examination to ensure the safety of vaccinated individuals.
How has the FDA ensured the safety and efficacy of Pfizer’s COVID-19 vaccine?
Warwick, who has extensively studied the presence of DNA fragments in vaccines. According to Warwick, the presence of DNA fragments in vaccines is not uncommon and is a result of the manufacturing process. He explained that DNA fragments can be found in many biological products and are typically harmless.
In response to the concerns raised, the FDA spokesperson reiterated the rigorous testing and regulatory processes that Pfizer’s COVID-19 vaccine underwent before receiving emergency use authorization. The spokesperson emphasized that the vaccine has undergone extensive clinical trials involving thousands of participants and has demonstrated high efficacy in preventing COVID-19.
The FDA’s confidence in the safety and effectiveness of the vaccine is supported by the data collected through ongoing safety surveillance. The spokesperson stated that adverse events are closely monitored, and any potential risks are thoroughly evaluated.
It is important to note that the presence of DNA fragments in vaccines does not constitute a gene therapy treatment. The mRNA vaccines, including Pfizer’s COVID-19 vaccine, work by instructing cells to produce a protein that triggers an immune response against the virus. The presence of DNA fragments does not alter an individual’s genetic makeup or introduce any genetic modifications.
The concerns raised about the DNA fragments in the vaccine highlight the importance of evidence-based information and scientific research. Misinformation and unfounded rumors can sow fear and distrust, undermining vaccination efforts and public health initiatives.
In conclusion, the FDA has addressed concerns regarding the presence of DNA fragments in Pfizer’s COVID-19 vaccine. The FDA spokesperson reaffirmed the vaccine’s safety, quality, and effectiveness, stating that their benefit-risk assessment and ongoing safety surveillance show that the benefits outweigh the risks. It is crucial for individuals to rely on accurate and verified information when considering vaccination and to consult healthcare professionals for any questions or concerns.
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