DOJ’s Dystopian Opinion That U.S. Citizens Can Be Coerced to Get Experimental Vaccine Injections

The Department of Justice Office of Legal Counsel has issued an opinion that public and private entities can legally mandate that employees get injected with the COVID-19 experimental vaccines as a condition of employment.

COVID-19 Vaccines are Authorized But NOT Approved by the FDA

The gravamen of the EUA standard is that the known and potential benefits of the COVID-19 vaccines when used to prevent COVID-19 outweigh their known and potential risks. The COVID-19 vaccines have not been demonstrated to be safe or effective by the FDA. The COVID-19 vaccines are authorized for use and are being monitored for safety and effectiveness.

COVID-19 Vaccines are Experimental

The safety studies are continuing during the EUA period. The COVID-19 vaccines are experimental vaccines. The COVID-19 vaccine trials are being opened up to include children as young as 6 months. All who take part in the COVID-19 vaccination program are de facto participants in a medical experiment that is being monitored for safety and effectiveness. But they are not being told this. The FDA explains the EUA vaccine program:

FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.

FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).

Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist.

Vaccines can be authorized for use in an emergency by the FDA while they are still undergoing experimental trials. Authorization for use in an emergency is not the same as approval. Such investigational vaccines are not approved by the FDA. COVID-19 vaccines are “investigational vaccines” authorized under an emergency use authorization (EUA) by the FDA. An investigational vaccine is, by definition, an experimental vaccine. Investigational vaccines being used under an EUA are “still in the testing and evaluation phase and are not licensed for use in the general public.” All manufacturers of COVID-19 vaccines explain in their information page, the EUA legal status of the COVID-19 vaccines. For example, the Moderna fact sheet states: “The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.“ Substantially similar language is found in all the COVID-19 EUA vaccine fact sheets.

Nuremberg Code Requires Informed Consent

It is unconscionable to coerce people into receiving an experimental vaccine. Furthermore, not informing a person that he is taking part in an experiment violates the Nuremberg Code, which requires that “the voluntary consent of the human subject is absolutely essential” before they take part in a medical experiment. That principle was considered authoritative and applicable when determining the application of the Alien Tort Statute. See Abdullahi v. Pfizer, 562 F.3d 163, 174-188 (2nd Cir. 2009).

The Nuremberg Code requires that the consent be knowing consent. The person must be informed that he is taking part in an experiment involving the COVID-19 vaccine that has not been demonstrated to be safe or effective. But the test subjects are not being told this. Indeed, they should be told that the vaccine manufacturers are so unsure of the safety and effectiveness of the vaccine, the test subjects will be monitored to determine if they suffer any dangerous side-effects from the experimental vaccine. But most are not being told this.

The gravamen of the Nuremberg Code has been adopted as the law in the United States under 45 C.F.R. § 46.111, et seq. and 21 C.F.R. § 50.20, et seq. Section 50.20 states:

Except as provided in §§ 50.23 and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

FDA Says Nuremberg Code Inapplicable to EUA COVID-19 Vaccines

The FDA has taken the position that Congress has exempted authorization of vaccines under an EUA from the informed consent requirements of the Nuremberg Code and the above listed federal regulations. A different statute, 21 U.S. Code § 360bbb–3, provides, in pertinent part, that when an unapproved medical product is authorized for emergency use, the product may be administered provided that the following conditions are met:

(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed

(I) that the Secretary has authorized the emergency use of the product;

(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and

(III) 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 FDA has taken the official position that compliance with the above statutory requirements is sufficient to dispense with the need to obtain informed consent from the EUA vaccine recipient. The FDA alleges:

Although informed consent as generally required under FDA regulations is not required for administration or use of an EUA product, section 564 [21 U.S. Code § 360bbb–3] does provide EUA conditions to ensure that recipients are informed about the MCM [Medical Countermeasure] they receive under an EUA.

The FDA further states:

FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website.

The FDA thinks that providing a fact sheet to the recipients of the COVID-19 vaccines is sufficient. “Therefore, FDA recommends that a request for an EUA include a “Fact Sheet” for recipients that includes essential information about the product.” 

Below are the fact sheets provided by each of the vaccine manufacturers.

Moderna COVID-19 Vaccine Fact Sheet

Pfizer-BioNtech COVID-19 Vaccine Fact Sheet

Basically, the patient is given a fact sheet from each manufacture. Notice that dodge in the Moderna COVID-19 vaccine fact sheet. The fact sheet asks the following question: “ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES MODERNA COVID-19 VACCINE?” Notice that the question only goes to prevention. There is no mention of treatment.

This is the Moderna answer to that question: “Currently, there is no FDA-approved alternative vaccine available for prevention of COVID-19. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.” Moderna does not address the question about “other choices” for preventing COVID-19. Moderna limits the response only to vaccines. There is no mention of hydroxychloroquine, ivermectin, or other safe and effective treatment and prevention alternatives. The Pfizer-BioNtech fact sheet contains the same misinformation.

The FDA is reading the statutory requirements under 21 U.S. Code § 360bbb–3 for the administration of an unapproved MCM under an EUA as a waiver of the otherwise required informed consent. The FDA’s position is presumably based on the following language in subsection (k) of 21 U.S. Code § 360bbb–3:

If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

The regulations found under found at 45 C.F.R. § 46.111, et seq. and 21 C.F.R. § 50.20, et seq regarding informed consent were enacted under the auspices of those statutes. 

Informed Consent Required for EUA COVID-19 Vaccines

Let us examine 21 U.S. Code § 360bbb–3 and see if it is in fact it provides for an exemption of an EUA from the Nuremberg Code informed consent requirements. A person receiving the COVID-19 vaccine must be informed of its dangers and consent to being vaccinated. A person cannot be compelled to take the COVID-19 vaccine. 21 U.S. Code § 360bbb–3, which is the law governing the emergency use authorizations (EUA) of experimental vaccines, requires informed consent that is more limited than in the federal regulations on informed consent for medical experiments. But the statute nonetheless requires certain information be provided to the patient prior to vaccination, and the patient has the option of withdrawing consent and refusing to be vaccinated. The statute, 21 U.S. Code § 360bbb–3(e)(1)(A)(i), requires informed consent for vaccines authorized under an EUA. That code section provides:

Appropriate conditions designed to ensure that individuals to whom the product is administered are informed
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) 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.

21 U.S. Code § 360bbb–3(e)(1)(A)(i) (emphasis added)

DOJ Reinterprets Informed Consent

DOJ focused on the language found under 21 U.S. C. § 360bbb–3(e)(1)(A)(i) that requires a recipient to be “informed … of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product.” DOJ opines that a person can either “accept or reject” the vaccine and a company can coerce the employee in making that decision as long as the company informs the employee “of the consequences, if any, of refusing administration of the product.”

DOJ claims that it reads the “option to accept or refuse” condition as merely informational and not conditional. That means that the employer only needs to tell the employee the consequences of not taking the vaccine, and then, with that information known, they can decide whether to suffer the consequences of accepting or refusing the vaccine.

DOJ opines that “These provisions all appear to require only that certain factual information be conveyed to those who might use the product.”

DOJ Opines Employment is Only a “Desirable Activity”

Thus, DOJ is saying that the information given to the potential recipient has no real effect because they really don’t have a choice. It is silly to suggest that a person has free choice of accepting or refusing the vaccine when the consequence is that he will be fired and will no longer be able to feed his family if he chooses not to be vaccinated. According to DOJ the option to accept or refuse the COVID-19 need not be voluntary.

DOJ argues that getting fired or expelled from school is only a secondary consequence of refusal. DOJ characterizes getting fired from your job as simply exclusion from a “desirable activity.” I kid you not, DOJ thinks that your ability to feed  your family is not a necessity, it is only a “desirable activity.” DOJ is twisted. If you get fired for refusing to get vaccinated, DOJ considers you to have exercised your option, and to have chosen, of your own free will, to be excluded from a “desirable activity” of employment over getting vaccinated because you were told ahead of time you would be fired. On the other hand, if  you get vaccinated because you have been threatened with being fired, DOJ considers that exercising your free choice to get vaccinated. The coercive threat of losing your job is perfectly fine to DOJ.  Your choice does not have to be voluntary, according to DOJ.

Aaron Siri’s Rebuttal

Aaron Siri, attorney for the Informed Consent Action Network wrote a rebuttal to the DOJ OLC opinion. Mr. Siri pointed out that the DOJ argument that expulsion from a job, school, and civil society are only “secondary consequences,” which does not remove the “option to accept or refuse” defies common sense. He points out that the statutory framework, and implementation of 21 U.S. Code § 360bbb-3 “all reflect that ‘the option to accept or refuse’ was intended to continue the longstanding principle that it is not permissible to coerce anyone to receive an unlicensed medical product.”

Mr. Siri points out that the principle of informed consent “was carried forward when Congress included the words ‘the right to accept or
refuse’ in Section 564 [21 U.S. Code § 360bbb-3] is reinforced by the legislative discussions surrounding the passing of Section 564 [21 U.S. Code § 360bbb-3]. He explained:

On July 16, 2003, in deliberating Section 564, Representative Hays said, without any objection, that:

[A]ny authority to actually use experimental drugs or medical devices in emergency situations has to be defined and wielded with nothing less than surgical precision. Prior informed consent in connection with the administration of experimental therapy is a basic human right, a right no one should be asked to surrender.

Similarly, on May 19, 2004, Senator Kennedy said while deliberating regarding Section 564 that “[t]he authorization for the emergency use of unapproved products also includes strong provisions on informed consent for patients.”

The statements of Representative Hays and Senator Kennedy indicate that Congress thought that the requirement in Section 564 that the patient be informed of the “significant known and potential benefits and risks of such use,” and “of the option to accept or refuse administration of the product” established a requirement of “informed consent.” Indeed, Senator Kennedy and Representative Hays were adamant that informed consent be required before anyone was subjected to the administration of an unapproved medical product of any kind when it is authorized for use in an emergency. Senator Kennedy described the language in Section 564 as constituting “strong provisions” requiring informed consent. Informed consent is a higher degree of consent, and all consent must be voluntary for it genuinely to be consent.

The American Medical Association (AMA) states that “informed consent to medical treatment is fundamental in both ethics and law.” The AMA states that when a physician is obtaining a patients informed consent, he should: “Assess the patients ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.”

The concept of informed consent for medical experiment subjects is found in every state. For example, in Virginia, the state provides that an agency must obtain the informed consent of anyone taking part in a medical experiment. The Virgina statutes states that the consent must be unconstrained by any coercion: “Informed consent” means the knowing and voluntary agreement, without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, of a person who is capable of exercising free power of choice.” 12VAC5-20-100.

Informed consent in the context of experimental vaccines requires that the patient be fully informed. But regardless of the information provided, his decision to obtain the vaccine must be the product of an unencumbered will that is free of coercion. The litigation regarding the admissibility of confessions offers guidance as to what it means for consent to be voluntary. In Culombe v. Connecticut, 367 U.S. 568 (1961), the U.S. Supreme Court stated that “[t]he ultimate test remains that which has been the only clearly established test in Anglo-American courts for two hundred years: the test of voluntariness. Is the confession the product of an essentially free and unconstrained choice by its maker?” Id. at 602. The Colombe Court explained that “The line of distinction is that at which governing self-direction is lost and compulsion, of whatever nature or however infused, propels or helps to propel the confession.” Id. at 603. The critical distinction between a voluntary and an involuntary confession is whether the confessor was compelled to confess. For example, threatening to inform the prosecutor of a suspect’s refusal to cooperate is viewed by courts to be coercive and render the resulting confession involuntary and inadmissible. See United States v. Harrison, 34 F.3d 886, 891 (9th Cir. 1994). That same concept is found in family law statutes. In Kentucky voluntary, informed consent is defined by statute, in pertinent part, as:

“Voluntary and informed consent” means that at the time of the execution of the consent, the consenting person was fully informed of the legal effect of the consent, that the consenting person was not given or promised anything of value except those expenses allowable under KRS 199.590(6), that the consenting person was not coerced in any way to execute the consent, and that the consent was voluntarily and knowingly given.

Ky. Rev. Stat. Ann. § 199.011 (West)

Getting back to Aaron Siri’s opinion letter, Siri further explains:

The FDA likewise viewed Section 564 as providing a substantive right to refuse when it explained the military exception:

[A]s a general rule, persons must be made aware of their right to refuse the product (or to refuse it for their children or others without the capacity to consent) and of the potential consequences, if any, of this choice. An exception to this rule is that the president, as commander in chief, can waive military personnel’s right to refuse this product. If the right is not specifically waived by the president for a particular product given under EUA, military personnel have the same right to refuse as civilians.

The FDA thus makes clear that Section 564 provides a substantive right to refuse, and this right does not exist in the presence of a requirement that imposes negative consequences for refusing.

Similarly, the CDC’s Advisory Committee on Immunization Practices (“ACIP”) has interpreted Section 564 as a consent provision and not merely a  requirement to inform. When responding to an inquiry regarding whether the COVID-19 vaccines can be required, the Executive Secretary of ACIP publicly stated that “under an EUA, vaccines are not allowed to be mandatory. Therefore, early in the vaccination phase individuals will have to be consented and cannot be mandated to be vaccinated.”

ACIP’s Executive Secretary then reaffirmed to the FDA’s Vaccine and Related Biological Products Advisory Committee that no organization, public or private – including hospitals – can mandate the EUA COVID-19 Vaccines:

Organizations, such as hospitals, with licensed products do have
[the] capability of asking their workers to get the vaccine. But in the setting of an EUA, patients and individuals will have the right to refuse the vaccine.

Consistent with the foregoing, the U.S. General Services  Administration’s (“GSA”) Safer Federal Workforce website, applicable to all federal employees and contractors, expressly provided that the EUA COVID-19 vaccines cannot be mandatory.

The GSA’s official position was that “COVID-19 vaccination should generally not be a pre-condition for employees or contractors at executive departments and agencies … to work in-person in Federal buildings, on Federal lands, and in other settings as required by their job duties.”

Siri reveals that the GSA changed its interpretation of the statute after DOJ released its slip opinion. Now, GSA states that a person who is unvaccinated can be required to wear a mask, physical distance, be tested, restricted from travel, and even quarantined.

The DOJ interpretation of the Section 564 (21 U.S. Code § 360bbb-3) give short shrift to the concept of freedom of choice. Option as used in the statute is defined in the dictionary as “an act of choosing; the power or right to choose: freedom of choice.  The DOJ opinion eliminates the “freedom of choice” by allowing that the choice be coerced by a threat of being fired, having to wear a mask, being tested, physical distance, etc.

Siri makes the common-sense observation that “[i]t is illogical that Congress would require that individuals be informed of a freedom of choice if that choice is illusory at the whim of any public or private entity.”

2 thoughts on “DOJ’s Dystopian Opinion That U.S. Citizens Can Be Coerced to Get Experimental Vaccine Injections

  1. I have heard speculation that the FDA will be approving this “vaccine” by Labor Day.
    I am very concerned that this will bring on tyrannical coercion at every level.
    What are your thoughts?

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