https://stopwrongfulconvictions.wordpress.com/2021/11/04/there-are-no-approved-vaccines-in-the-united-states/"There are NO approved vaccines in the United States
The claim that FDA has approved the Pfizer vaccine is false as there is no Comirnaty in the United States.
P.17 of FDA LOA Oct 29, 2021 clearly states that BioNTech is not FDA approved, it is EUA. And therefore cannot be mandated.
https://t.co/mFiSqPTkmK pic.twitter.com/ZHweYB63py
— Pam Long (@PamLongCO) November 3, 2021
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."
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https://childrenshealthdefense.org/wp-content/uploads/notice-for-employers-universities-and-other-institutions-mandating-covid-19-vaccines8.31.21.pdfNOTICE 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, 20231; and for the Moderna vaccine
until October 27, 2022.2
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.
2 A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 - Full Text View -
ClinicalTrials.gov
1 Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals - Full Text View -
ClinicalTrials.gov
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The U.S. Food and Drug Administration (FDA) approved a biologics license application for the
Pfizer Comirnaty vaccine. However, there is a huge real-world difference between products
approved under EUA compared with those the FDA has fully licensed.
● All existing Pfizer vials (in the hundreds of millions), remain under the federal
Emergency Use Authorization (EUA) (meaning people have the “option to accept or
refuse”);
● The third or “booster” Pfizer shot is identical to the above and remains under the EUA
with limited use to certain categories of people;
● BioNTech received FDA approval for people ages 16 and above under the name
Comirnaty, but there are no Comirnaty doses available in the United States;
● In other words, there is currently NO FDA approved COVID-19 injection available
anywhere in the United States. Every COVID shot in America remains under the EUA
law and thus people have the “option to accept or refuse” them; and
● Even when an FDA approved COVID shot becomes available, individuals are protected
by federal law and many states laws from being forced to get these shots based on their
sincere religious beliefs or conscience rights.
The Pfizer injection is still considered experimental under U.S. law. There is a legal difference
between products approved under authorization of emergency use (EAU) compared with those
the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which
confirms they are still under EUA, are not fully approved, and has a liability shield. That means
people must be told the risks and benefits, and they have the right to decline a medication that is
not fully licensed.
It is typical for vaccines to be in clinical trials for 6-10 years before licensure3; COVID vaccines
have been in trials for a matter of months. We simply do not have long-term safety data, and the
short-term data indicate alarming injury and death rates, unprecedented for any other licensed
vaccine. 4,406 deaths and 21,537 serious injuries have been reported after COVID vaccination to
the Vaccine Adverse Event Reporting System (VAERS) between December 14, 2020 and May
21, 2021.4
COVID vaccines will remain de facto experimental for many years; courts may well require the
right of refusal, as for Emergency Use Authorization vaccines, in work and education contexts
4 The Vaccine Adverse Event Reporting System (VAERS) Request
3 Biopharmaceutical Research & Development:The Process Behind New Medicines; Available at:
http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf1227 North Peachtree Parkway, Suite 202 • Peachtree City, GA 30269 • childrenshealthdefense.org
because of this underlying reality. But even if courts were not to find these vaccines
experimental, they would still have the duty to look at any vaccine mandate policy’s necessity,
proportionality, reasonableness, harm avoidance and non-discrimination based on the U.S.
Supreme Court’s landmark decision Jacobson v Massachusetts, 197 US 11 [1905]. There is
reason to believe that some courts would find COVID vaccine mandates inconsistent with
Jacobson.
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
