July 28, 2021
Get Vaccinated or Lose Your Job?
By: C-VINE NewsJuly 28, 2021
This article is in THREE parts. The first part is a letter from an organization mandating vaccines on their participants. The second part is a legal response from an unwilling participant. The third is YOUR form letter to present to someone who might not understand your civil human rights.
Know your rights. Stand your ground. This is the only way forward to restore our freedom!
Dear [REDACTED] and [REDACTED] Board of Directors,
I received your email on [REDACTED] notifying [REDACTED] members of the new Board policy that all singers be fully vaccinated with the COVID-19 vaccine in order to participate in future projects with the [REDACTED] organization.
According to Title 21, Section 360bbb-3 of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) when the Secretary of Health and Human Services grants Emergency Use Authorization, appropriate conditions must exist 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 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 the product, any alternatives to the product that are available, and of their benefits and risks.
The right to avoid the imposition of human experimentation is a fundamental human right, rooted in the Nuremberg Code of 1947, ratified by the 1964 Declaration of Helsinki and further codified in the United States Code of Federal Regulations. In addition to the United States being bound by these provisions, the FDA adopted these principles in its regulations requiring 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.[iii]
Currently, Emergency Use Authorizations have been issued for the Pfizer, Moderna, and Johnson & Johnson (Janssen) vaccines. Each Emergency Use Authorization for the Pfizer, Moderna, and Janssen vaccine was issued in conjunction with a Fact Sheet from the FDA.
For example, the Janssen fact sheet contains the following notice:
Clearly, due to the experimental nature of the Covid-19 vaccines, any attempts to force anyone to take a Covid-19 vaccine is a violation of federal law. Experimental treatment cannot be mandated.
I am writing this to notify you, as you may not be aware, that to mandate Emergency Use Authorization medical products, such as the experimental COVID-19 vaccine candidates, you may be opening up the [REDACTED] organization to lawsuits that may find you personally liable for resulting harm or vaccine injury. In addition, information about a person’s vaccination status is part of a person’s medical record and is therefore considered protected health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
According to the U.S. Department of Health and Human Services Office for Civil Rights, HIPAA’s privacy rule permits “covered entities” to use health information exchanges to disclose protected health information (PHI)…[vi]
See hhs.gov/ocr/index.html for more information.
I understand that much of the fear surrounding the pandemic has caused people to want to find ways to protect themselves and others from harm. If the [REDACTED] organization wishes to continue with requesting member vaccination and/or vaccination status, I would urge you as individuals and as an institution to comply with the FD&C Act and the terms of the Emergency Use Authorization and its accompanying Fact Sheet, as well as the HIPAA privacy act provisions, and to advise all singers of their right to accept or refuse any COVID-19 vaccine. Any other course of action is contrary to federal law.
Form Letter to Present to Employer, Board of Directors, etc.
Any compulsory Covid-19 vaccination requirement is a violation of federal law. I urge you to advise all (students) 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 following Emergency Use Authorizations have been issued for Covid-19 vaccinations:
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.
Businesses are not shielded from liability with experimental agents
While vaccine manufacturers may be shielded from liability, your institution is not protected, and neither are you.
I urge your institution to comply with the FD&C Act and the terms of the EUA and its accompanying Fact Sheet, and to advise all employees of their right to accept or refuse any Covid-19 vaccine. Any other course of action is contrary to federal law.
Thank you for your time and for protecting the best interest of your (students) .
News Posted by: C-VINE Citizen Journalists.
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