The claim that FDA has approved the Pfizer vaccine is false as there is no Comirnaty in the United States.
Although the FDA “approved” a product labeled Comirnaty, there is no supply of this product in the United States. So, that means that all Covid-19 vaccines available in the United States are under emergency use authorization, and the executive order stating that Phizer had an approved treatment is false.
Senator Ron Johnson inquired about this and it’s critical because experimental treatments can not be mandated. EUA products are experimental and must be voluntary with informed consent.
The senator wrote to Pfizer and BioNTech, “When the FDA made its August announcement it stated ‘[a]lthough COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.’
On September 13, 2021, the National Library of Medicine within the National Institutes of Health, reported, ‘[a]t present, Pfizer does not plan to produce any product with these new [Comirnaty National Drug Codes] and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.’
On September 22, 2021, the FDA reissued the EUA for the Pfizer-BioNTech COVID-19 vaccine, with the same language regarding availability limitations for individuals 16 years of age and older. Based on these statements it appears that individuals who are required to be vaccinated under President Biden’s and the Department of Defense’s vaccine mandates may not be able to receive the fully licensed and approved vaccine.”
It is illegal to mandate an experimental drug. Children’s Health Defense outlines the applicable law.
NOTICE FOR EMPLOYERS, UNIVERSITIES AND OTHER INSTITUTIONS
MANDATING COVID-19 VACCINES
August 31, 2021
This serves as notice that the requirement for any individual to be vaccinated against COVID-19 for employment or participation at a university or other institution violates federal law. The COVID-19 vaccines manufactured by Moderna and J&J are merely authorized, not approved or licensed, by the federal government; they are Emergency Use Authorization (EUA) only. They
merely “may be effective.”
Federal law 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III) requires that the person to whom an EUA vaccine is administered be advised, “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” The reason for the right of refusal stems from the fact that EUA products are by definition experimental.
Even if the FDA approves and licenses existing COVID vaccines, they will remain experimental and thus subject to the international requirement that informed consent is “absolutely essential.”
Nuremberg Code, Article 1; Abdullahi v Pfizer, Inc., 562 F3d 163 [2d Cir 2009]. Phase III clinical trials for the Pfizer vaccine do not end until May 2, 2023; and for the Moderna vaccine until October 27, 2022. EUA products are by definition experimental and thus require the right to refuse. Under the Nuremberg Code, the foundation of ethical medicine, no one may be coerced to participate in a
medical experiment. Consent of the individual is “absolutely essential.” A federal court held that the U.S. military could not mandate EUA vaccines to soldiers. Doe #1 v. Rumsfeld, 297 F.Supp.2d 119 (2003). The court held: “…the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.” Id. at 135. No court has ever
upheld a mandate for an EUA vaccine.
The liability for forced participation in a medical experiment, including injury or death, may be incalculable. Medical and religious exemptions will be insufficient to overcome the illegality of EUA vaccine mandates. Children’s Health Defense urges U.S. employers, universities and other institutions to respect and uphold the rights of individuals to refuse EUA COVID-19 vaccines.
This information must be shared with employers and universities attempting to coerce staff and students into taking this as a condition or enrollment or employment. It must be voluntary because it is experimental. Period. It doesn’t matter what the executive orders state. A president can not create laws.