The FDA continues to substitute hope for data, willful ignorance for careful risk analysis, and issues what can only be regarded as propaganda regarding both the safety and effectiveness of these products.
Both Moderna and Pfizer/BioNTech SARS-CoV-2 vaccines are contaminated with plasmid DNA fragments which have not been removed during the current manufacturing processes.
This proven fact has been acknowledged by the US FDA, Health Canada, and the European Medicines Agency. In yet another clear breach of informed consent and labeling requirements, this was not previously disclosed to physicians, public health officials, or patients.
Furthermore, the presence of highly active promoter/enhancer DNA sequences (and fragments) derived from the SV40 virus, present in the Pfizer/BioNTech product, was not disclosed and discussed with either the public or to the regulatory agencies. This has also been clearly established. Prior FDA guidance concerning the closely related DNA vaccine technology cited the presence of such highly active regulatory sequences as being of particular concern due to potential insertional mutagenesis (integration).
Despite these facts, and contrary to both federal law (21 U.S. Code § 351 – Adulterated drugs and devices) and established FDA guidance (CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act. *Direct Reference Seizure Authority for Adulterated Drugs Under Section 501(b)*), in response to reporter questioning regarding this issue, the FDA has issued a categorical denial of adulteration and risk, stating that “no safety concerns related to the sequence of, or amount of, residual DNA have been identified.”
The claim that the FDA is required to take any of the authorized or approved mRNA COVID-19 vaccines off the market is false. With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified. With regard to the FDA-approved mRNA vaccines, available scientific evidence supports the conclusion that they are safe and effective.
At best, this is willful blindness. As previously discussed at length (with peer reviewed references), such short DNA fragments (including “oligonucleotides”) are associated with a high risk of integration, otherwise known as insertional mutagenesis, which is a well characterized form of genotoxicity.
If these “vaccines” were reviewed by FDA as gene therapy products, which in fact they are, being gene therapy technology employed for the purpose of eliciting an adaptive immune response against an encoded antigen, rigorous genotoxicity (including insertional mutagenesis) studies would have been required prior to use in humans. If these were “DNA vaccines” rather than modified-mRNA vaccines, rigorous genotoxicity (including insertional mutagenesis) studies would also have been required prior to use in humans. But apparently there is something magical about inclusion of modified-mRNA together with DNA fragments in these highly active lipid nanoparticle nucleic acid delivery formulations which leads the FDA to conclude that there is no genotoxicity risk.
Of note is that there is no documentation of DNA fragment genotoxicity studies having been performed by Pfizer/BioNTech or Moderna or FDA itself to assess the risk profile of these highly active non-viral delivery formulations when co-formulated with both modified mRNA and DNA fragments. Clearly, given the established scientific literature and prior established regulatory precedent involving DNA vaccine insertional mutagenesis/integration risk, a prudent and proactive regulatory authority would have developed data to support a data-based threshold for DNA fragment contamination.
But by all appearances, no such data are available. The most well-documented risks associated with such potential insertional mutagenesis are cancer (in the case of stem and somatic cells, particularly hematopoietic lineage cells) and birth defects. As these highly active modified mRNA (plus DNA fragment) lipid nanoparticles are known to cross the placenta and to localize to ovarian tissue, the potential for birth defects would seem to be of particular regulatory interest and concern.
A COVID-19 vaccine reckoning is coming for the DOJ over federal gov mandates
The Justice Department has just posted a new jobs ad — it’s looking for eight new attorneys to defend the federal government in vaccine injury cases.
Presumably, the hiring spree is in anticipation of a surge of COVID vaccine lawsuits, as people who were forced by government mandates to take the jab, and suffered serious side effects as a result, try to extract compensation from a system that is stacked against them.
“The office is currently expanding to address workload created by an increase in cases filed under the Vaccine Act,” reads the ad posted by the Torts Branch of the DOJ on the USAJobs website.
The recruitment drive comes on the heels of a little-noticed lawsuit filed in Louisiana last month by six vaccine-injured plaintiffs against the federal government.
The suit aims to overturn the legal immunity that pharmaceutical giants like Pfizer and Moderna enjoy on their COVID shots.
Not that any of the lawyers involved expect Big Pharma to pay up, but at least if they win, it should force Congress to reform inadequate vaccine injury compensation schemes that were instituted almost 40 years ago as an alternative to suing drug companies out of existence but that have not kept up with the times.
Mandates and misery
Meanwhile, almost 13,000 Americans who claim the COVID vaccine caused them or their dead loved ones adverse reactions — such as the life-threatening heart ailment myocarditis or the debilitating immune disorder Guillain-Barre syndrome — remain in limbo after doing what they were told was “the right thing”: heeding government mandates to submit to the jab.
The unaccountable, understaffed government tribunal that presides over the so-called Countermeasures Injury Compensation Program (CICP), for vaccines administered under emergency measures, is a “kangaroo court,” says the lawsuit filed by attorney Aaron Siri, partner at New York firm Siri & Glimstad.
“The CICP is akin to a Potemkin village … an elaborate façade designed to hide an undesirable reality.
“Claims are consistently lost, ignored, denied, or caught up in the years-long purgatory of government bureaucracy. The compensation, if any, is neither timely nor adequate.”
Just six people had been compensated by October this year, of more than 12,775 COVID injury claims submitted to the CICP since Jan. 31, 2020, when the Trump administration declared a public health emergency.
Those lucky people reportedly received an average of $2,148 each.
Of the 1,800 decisions made by the CICP, just 72 have been found eligible for compensation. Another 1,728 have been denied.
That means 96 percent of claims are unsuccessful, and just 14 percent of total claims have even been adjudicated.
Tragic: 15-Month-Old Girl Dies from Organ Failure and Cardiac Arrest Two Days After Receiving Three Vaccines During Routine Visit
In a heart-wrenching incident, Melody Rain Palombi-Malmgren, a 15-month-old girl, tragically passed away two days after receiving routine vaccinations. Her mother, Katherine Palombi, recalls the shock and sorrow of losing a child who was the epitome of joy and health.
On October 17, during a routine 15-month well-visit at the Herbert Kania Pediatric Group in Warwick, New York, Melody received three vaccines, News12 Westchester reported.
Just two days later, she suddenly stopped breathing and suffered cardiac arrest despite exhibiting no warning signs.
Her grandmother, caring for her at the time, was instructed by 911 operators to perform CPR until the arrival of paramedics. Despite exhaustive lifesaving efforts at St. Anthony’s Hospital, Melody’s life couldn’t be saved.
Katherine Palombi recounts the devastating day, describing her last goodbye to Melody before leaving for work, and the harrowing call she received about her daughter’s breathing troubles.
“I just kept saying, she just had vaccines, she just had vaccines,” Palombi repeatedly thought, highlighting her immediate concern linking the vaccines to her daughter’s critical condition.
Hospital records revealed that Melody suffered liver and kidney failure, along with cardiac arrest. The Herbert Kania Pediatric Group declined to comment on the case. The CDC notes that up to 10 vaccines are recommended for 15-month-olds; Melody had received three – for varicella (chickenpox), DTaP (diphtheria, tetanus, and pertussis), and Hib (Haemophilus influenzae type b bacteria).