FDA addresses DNA contamination in COVID vaccines.

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.

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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.

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.