FDA responds to calls for Pfizer vaccine recall over DNA fragments.
The FDA Refuses to Recall Pfizer’s COVID-19 Vaccine Despite Concerns
The U.S. Food and Drug Administration (FDA) is standing firm in its decision not to recall Pfizer’s COVID-19 vaccine, dismissing worries about the presence of an undisclosed DNA sequence that leaves behind fragments.
According to an FDA spokeswoman, the agency has administered over a billion doses of mRNA vaccines without identifying any safety concerns related to residual DNA. The available scientific evidence supports the conclusion that these vaccines are safe and effective.
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The FDA’s refusal to recall the vaccine comes without providing any evidence to support its stance. The decision was made in response to questions regarding the inclusion of the Simian Virus 40 (SV40) DNA sequence in the Pfizer-BioNTech shot.
The Epoch Times has submitted a Freedom of Information Act query to uncover when the FDA became aware of the sequence and from whom. However, the FDA denied expedited processing for the request, claiming there is no urgent need for the information.
Several foreign agencies, including Health Canada, have confirmed the presence of the DNA sequence in the vaccine. They also noted that Pfizer did not disclose this information in regulatory filings.
Despite numerous questions, the FDA has refused to provide answers about the sequence, including when they learned about it and whether they were informed by Pfizer.
Pfizer and its partner, BioNTech, have remained silent on the matter.
The inclusion of the SV40 DNA sequence has raised concerns among scientists, including Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer. Dr. Malone believes that the vaccine is “adulterated” and should be recalled.
According to federal law, the FDA has the authority to test drugs suspected of being adulterated. If the drugs fail to meet certain standards and pose a health hazard, the FDA should advise the manufacturer to issue a recall. If the manufacturer fails to comply, seizure of the drugs can be considered.
Dr. Malone argues that the FDA has not fulfilled its responsibility in rigorously assessing the risk associated with the inclusion of the SV40 DNA sequence. He believes that the FDA’s rationale for not classifying the vaccine as gene therapy is flawed.
Why Was SV40 Included?
The European Medicines Agency (EMA) explained that specific sequences of the non-infectious parts of SV40 are commonly used in plasmids for manufacturing biological substances. The purpose is to enhance gene expression.
However, the result is residual DNA left behind, which some scientists believe could have negative effects. David Wiseman, a former scientist at Johnson & Johnson, expressed concern that the residual DNA could integrate into the human genome and disrupt gene regulation, potentially leading to cancer.
Phillip Buckhaults, a professor of cancer genomics, tested vials of Pfizer’s vaccine and detected DNA. He believes that the regulatory process allowed the DNA to be present and has urged regulators to conduct further testing.
Despite the concerns raised by scientists, the FDA remains steadfast in its decision not to recall the Pfizer vaccine.
How does the controversy surrounding the Pfizer vaccine’s undisclosed DNA sequence impact public trust in the vaccine and the FDA’s approval process?
The FDA maintains that the presence of the DNA sequence does not pose any safety risks. In a statement, the agency emphasized that the mRNA vaccines have undergone rigorous testing and evaluation before receiving emergency use authorization. The available evidence indicates that the benefits of these vaccines outweigh any potential risks.
The FDA’s decision has sparked controversy and raised concerns among the public. Some argue that the presence of an undisclosed DNA sequence is a violation of transparency and undermines trust in the vaccine. Critics point out that Pfizer’s failure to disclose this information in regulatory filings raises doubts about the company’s integrity and the thoroughness of the FDA’s approval process.
Others, however, support the FDA’s position and believe that the agency’s assessment of the vaccine’s safety is reliable. They argue that the mRNA vaccines have been extensively studied and administered to millions of people worldwide, with no significant adverse effects reported. The presence of the DNA sequence, they claim, is insignificant and does not warrant a recall of the vaccine.
The controversy surrounding the Pfizer vaccine highlights the broader issue of vaccine safety and transparency. As COVID-19 vaccines are being rolled out globally, it is essential that regulatory agencies prioritize transparency and open communication with the public. Full disclosure of relevant information, including the presence of any genetic material, is crucial in maintaining the trust and confidence of the public.
In response to the concerns raised, Pfizer has released a statement affirming the safety and efficacy of its COVID-19 vaccine. The company maintains that the presence of the DNA sequence is a byproduct of the manufacturing process and poses no safety risks. Pfizer has also committed to enhancing transparency in its regulatory filings and addressing any questions regarding the vaccine’s composition.
The controversy surrounding the Pfizer vaccine serves as a reminder of the importance of continuous monitoring and evaluation of vaccines’ safety profiles. Regulatory agencies, including the FDA, must remain vigilant in their oversight and promptly address any emerging concerns. Public health and safety should always be the top priority in vaccine development and distribution.
As more information becomes available and additional studies are conducted, it is crucial for regulatory agencies to reassess their decisions and provide updated guidance. Transparency and open communication are key in ensuring public trust and confidence in the COVID-19 vaccination efforts.
In the meantime, individuals are encouraged to consult with healthcare professionals and make informed decisions based on the available evidence. Vaccination remains a critical tool in the fight against COVID-19, and efforts should continue to promote widespread immunization while addressing any concerns or questions raised by the public.
In conclusion, the FDA’s refusal to recall Pfizer’s COVID-19 vaccine despite concerns about the presence of an undisclosed DNA sequence has ignited a debate about transparency, vaccine safety, and public trust. While the FDA maintains that the vaccine is safe and effective, the controversy underscores the need for ongoing evaluation and open communication to ensure the public’s confidence in vaccination efforts.
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