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Any compulsory Covid-19 vaccination requirement is a violation of federal law. I urge you to advise every one you know that they have the right to refuse or to take any COVID-19 vaccine. Any other action is contrary to federal law.
Covid-19 Vaccines are Experimental.
Covid-19 vaccines are not approved by the FDA. The Covid-19 vaccines are only approved under an Emergency Use Authorization, for investigational use only. Covid-19 vaccines lack requisite studies and are not approved medical treatment. The FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”
Title 21, Section 360bbb-3 of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) vests the Secretary of Health and Human Services with the permissive authority to grant Emergency Use Authorizations (“EUAs”) providing that appropriate conditions designed to ensure that individuals to whom the product is administered are informed:
that the Secretary has authorized the emergency use of the product;
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
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. 1
The right to avoid the imposition of human experimentation is fundamental, rooted in the Nuremberg Code of 1947, has been ratified by the 1964 Declaration of Helsinki, and further codified in the United States Code of Federal Regulations. In addition to the United States regarding itself as bound by these provisions, these principles were adopted by the FDA in its regulations requiring the informed consent of human subjects for medical research. It is unlawful to conduct medical research, even in the case of an emergency, unless steps are taken to secure informed consent of all participants.
The following Emergency Use Authorizations have been issued for Covid-19 vaccinations:
12/11/20 Moderna - FDA issued an EUA for emergency use of the Moderna mRNA COVID-19 vaccine for recipients 16 years of age or older.
12/18/20 Pfizer/BioNTech - FDA issued an EUA for emergency use of the Pfizer/BioNTech mRNA vaccine for recipients 18 years of age or older.
2/27/21 Johnson & Johnson - FDA issued an EUA for emergency use of the Johnson & Johnson COVID-19 vaccine (aka Janssen vaccine) for recipients 18 years of age or older.
Each of the above EUAs was issued in conjunction with a similar Fact Sheet from the FDA. For example, the Janssen fact sheet contains the following notice:
“INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS”
As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website to obtain the Fact Sheet) prior to the individual receiving the Janssen Covid-19 Vaccine, including:
• FDA has authorized the emergency use of the Janssen Covid-19 Vaccine, which is not an FDA approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Janssen COVID-19 Vaccine.
• The significant known and potential risks and benefits of the Janssen Covid-19 Vaccine, and the extent to which such risks and benefits are unknown.
Clearly, any attempt to force anyone to take a Covid-19 vaccine is a violation of federal law and the conditions under which the Covid-19 vaccine has been authorized for use. The law is clear, experimental medical treatment cannot be mandated.
Businesses are not shielded from liability with experimental agents.
Under the 2005 PREP Act enacted by Congress, pharmaceutical companies that manufacture EUA vaccines are shielded from liability related to injuries and damages caused by their experimental agents. However, any employer, public school, or any other entity or person who mandates experimental vaccines on any human being is not protected from liability for any resulting harm. While vaccine manufacturers may be shielded from liability, your institution is not protected, those other entities are not.
In California, 9CCR 784 states in pertinent part, "
§ 784.29. Informed Consent to Medical Treatment. (a) It is the responsibility of a physician to determine what information a reasonable person in the client's condition and circumstances would consider material to a decision to accept or refuse a proposed treatment or procedure. The disclosure of any material information and obtaining informed consent shall be the responsibility of the a physician. (b) Informed consent must include a verbal explanation by a physician of the client's right to refuse or accept medical treatment. It must include a written consent form signed by the client indicating the above information has been given. The signed consent form is to be obtained and kept in the client's record as specified in Sections 851 and 852. (c) No medical treatment may be administered to a client without informed consent except in an emergency situation as defined by Section 853 or circumstances otherwise authorized by law. (Section 853 - "An emergency exists when there is a sudden marked change in the patient's condition so that action is immediately necessary for the preservation of the life or the prevention of serious bodily harm to the patient or others, and it is impracticable to first obtain consent. ) (d) The client has the right to accept or refuse the proposed treatment, and if he or she consents, has the right to revoke his or her consent for any reason at any time. Licensed mental health professionals or licensed nursing staff shall verify that the client's health record contains documentation that the client has given informed consent to the proposed treatment or procedure. (e) This section shall not be construed to require obtaining informed consent each time a treatment or procedure is administered unless material circumstances or risks change. (f) Treatment may be initiated without informed consent if there is documentation within the client's health record that an emergency exists where there is an unanticipated condition in which immediate action is necessary for preservation of life or the prevention of serious bodily harm to the client or others or to alleviate severe physical pain, and it is impracticable to obtain the required consent, and provided that the action taken is within the customary practice of physicians of good standing in similar circumstances. (g) A general consent provision in a contract for admission shall only encompass consent for routine nursing care or emergency care. Routine nursing care, as used in this section, means a treatment or procedure that does not require informed consent as specified in this section, or that is determined by the physician not to require the disclosure of information material to the individual client. Routine nursing care includes, but is not limited to, care that does not require the order of a physician. This section does not preclude the use of informed consent forms for any specific treatment or procedure at the time of admission or at any other time. All consent provisions or forms shall indicate that the client or incapacitated client's legal representative may revoke his or her consent at any time. (h) If a client or his or her legal representative cannot communicate with the physician because of language or communication barriers, the mental health rehabilitation center shall arrange for an interpreter. (1) An interpreter shall be someone who is fluent in both English and the language used by the client and his or her legal representative, or someone who can communicate with a deaf person, if deafness is the communication barrier. (2) When interpreters are used, they shall be physically present and documentation shall be placed in the client record indicating the name of the person who acted as the interpreter and his or her relationship to the client and to the mental health rehabilitation center.