A citizen petition to the U.S. Food and Drug Administration is demanding that “both Comirnaty and SPIKEVAX” COVID shots be delicensed because their makers refused to follow federal rules and regulations in creating them and selling them, for hundreds of billions of dollars.
The petition explains the labels for both shots “have been substantially revised with indication and usage restrictions, and additional warnings for myocarditis/pericarditis. These actions were warranted; however, they do not rectify the underlying mislabeling violations described herein.”
“This Petition is not arguing about the safety or efficacy of marketed COVID-19 mRNA vaccines, but rather violations of BLA labeling standards under the law. The burden is on the FDA to prove that all BLA standards were satisfied when it fully licensed Pfizer’s and Moderna’s vaccines, which it cannot do. Therefore, based on the foregoing, the undersigned ask the FDA to revoke all mRNA COVID-19 vaccine licensure based on the FDA’s continuing lack of adherence to proper BLA standards.”
It’s from the highly influential Children’s Health Defense organization, and chief Mary Holland said, “The FDA granted full licensure to these vaccines without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines. CHD is supporting the transparency and integrity at the FDA that the American people deserve — and that U.S. Health Secretary Robert F. Kennedy Jr. has promised.”
The petition is online, and so is a portal for public comments about the plan.
The Gateway Pundit commented, “CHD alleges that the Biden-era FDA broke its own laws, bypassed mandatory safeguards, ignored manufacturing violations, and labeled experimental EUA products as ‘fully licensed vaccines’ without the clinical, manufacturing, and regulatory compliance required under federal law. According to CHD, the public, including doctors, nurses, parents, service members, and anyone affected by the mandates, may now submit comments directly to the FDA docket and demand the agency follow the law. This petition could become the most consequential public challenge to COVID-19 vaccine licensure since 2020.”
“These COVID shots were manufactured under EUA standards, without clinical trials, and without continuous compliance with BLA labeling standards,” the campaign explains. “They cannot remain in interstate commerce because they are, in fact, misbranded products.”
The charges, according to the Gateway Pundit, include:
- Pfizer’s trial data cannot lawfully serve as the basis for BLA labeling because clinical-trial batches were produced through a different process than those later used for the commercial batches, and because the clinical trials had large data gaps — they lacked clear efficacy endpoints and participants were unblinded.
- Pfizer and Moderna initiated human testing before completing nonclinical assessments that, by law, must precede human dosing for novel biologics.
- The toxicology and biodistribution studies for the Pfizer and Moderna vaccines didn’t follow Good Laboratory Practices, and sometimes relied on surrogate mRNA constructs that were used as a stand-in for the final vaccine formulations.
- Moderna’s only biodistribution study was conducted exclusively on male rats, but the vaccine is approved for use in all sexes. Those studies also found statistically significant skeletal abnormalities in the offspring of animals exposed to Moderna’s vaccine — findings that merit further investigation before licensure.
- Because the vaccines were treated as EUA countermeasures rather than new products under investigation, the trials did not involve IRB oversight or the type of informed consent procedures required under U.S. law for a clinical investigation.
The shots, in fact, are known to have caused complications up to and including death.
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