FDA dismisses dangerous DNA contamination of COVID vaccines after allowing Pfizer to change its manufacturing process
FDA dismisses dangerous DNA contamination of COVID vaccines after allowing Pfizer to change its manufacturing process
When a team of researchers from Ontario, Canada discovered high levels of DNA contamination in monovalent and bivalent Pfizer/BioNTech and Moderna mRNA COVID-19 vaccines, regulatory agencies around the world should have placed a moratorium on COVID-19 vaccines and investigated the serious safety signal.
However, the U.S. Food and Drug Administration (FDA) completely dismissed the findings, ignoring their own rules and regulations regarding DNA contamination of pharmaceutical products.
In the study, every vaccine contained billions to hundreds of billions of DNA fragments and therefore exceeded the DNA adulteration standard of 10 nano-grams per dose. The batches were so heavily contaminated, they exceeded FDA standards by 188 to 509 times the regulatory limit. The researchers also found fragments of DNA larger than 200 base pairs (a measure of the length of the DNA) which also exceeds FDA guidelines.
The FDA is hesitant to sound the alarm on any serious safety issues with COVID-19 vaccines. This is absolutely terrifying that regulatory agencies do NOT care about the safety of a contaminated, experimental product that has gone on to injure and kill countless people around the world.
FDA ignores own guidance on DNA contamination and cancer risk
According to the FDA’s own guidance, residual DNA adulteration is a known safety issue with vaccines that can cause insertional mutagenesis and increase cancer risk through the inhibition of tumor suppressor genes and the activation of oncogenes.
Moderna scientists acknowledged the risk of DNA contamination in vaccines and their propensity for genotoxicity and cancer. In their patent application for “HPIV3 Vaccines” Moderna wrote:
Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and/or RSV antigens. The direct injection of genetically engineered DNA (e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.
Because of these serious risks, the FDA has guidelines in place for pharmaceutical products that contain residual DNA. They advise the pharmaceutical industry:
Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.
FDA continues to defend the safety of COVID vaccines
The mRNA vaccines contain lipid nanoparticles that penetrate inside cells to efficiently deliver new instructions, forcing the cells to synthesize foreign spike proteins. By design, this experiment has the potential to damage people with untold levels of foreign DNA. The researchers who discovered the DNA contamination of COVID-19 vaccines also found that the rate of serious adverse events was higher in the Pfizer lots that contained greater levels of DNA fragments.
However, the FDA maintains that residual DNA contamination of COVID-19 vaccines is benign. The agency claims to "stand behind its findings of quality, safety and efficacy for the mRNA vaccines."
“While concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer, or changes to a person’s genetic code,” the agency maintains. Their unwillingness to investigate is a dereliction of duty.
“With over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified,” the FDA claims, adding that the agency “does not have any additional information to provide at this time.”
Pfizer changed manufacturing process after clinical trials, poisoning population with foreign DNA
The FDA has failed to conduct manufacturing oversight on the covid-19 vaccines. A journalistic investigation finds that Pfizer used a different manufacturing process for the rushed clinical trials than what was used to deliver the products into the global population. The switch from Process 1 (PCR-amplified) to Process 2 (linearized plasmid DNA) introduced plasmid DNA impurities into the final product, poisoning millions of people with cancer causing fragments. The FDA was asleep at the wheel for all of this, as Operation Warp Speed delivered the vaccines in record time.
The FDA’s review memo from November 20, 2020 suggested that testing was ongoing. “A more comprehensive comparability assessment encompassing additional lots from multiple DP manufacturing nodes is ongoing and the results will be provided to the EUA upon completion of the study.”
Three years later, the FDA deflected from questions on whether there was any human data comparing the two manufacturing processes. According to a FOIA request, there were no studies comparing the safety and immunogenicity of the two processes, as was required by February of 2021.
The FOI stated:
…in October 2020 an exploratory objective was added in the C4591001 study to describe safety and immunogenicity of vaccines produced by manufacturing “Process 1” or “Process 2” in participants 16 to 55 years of age. This exploratory objective was removed and documented in protocol amendment 20 in September 2022 due to the extensive usage of vaccines manufactured via “Process 2”. Thus, this process comparison was not conducted as part of the formal documentation within the protocol amendment. [emphasis added]
Pfizer was given a free pass to skip biological comparability studies and the FDA stayed quiet on the issue. Now the issue has been brought to light. The manufacturing processes for COVID-19 vaccines were deliberately changed before they were mass produced and pushed onto the population, and this issue could have cancer-causing consequences in people for years to come.
Sources include:
TGA.gov.au [PDF]
DMT.NEWS
via https://www.DMT.NEWS
Lance D Johnson, Khareem Sudlow
