July 28, 2021

Get Vaccinated or Lose Your Job?

By: C-VINE News
July 28, 2021

More and more American citizens are being confronted with this decision; either get the COVID-19 Vaccine or lose your job. Has this happened to you or someone you know?

We know the current administration is moving forward to see that our military, all of our healthcare workers, all businesses, schools and universities and even religious institutions, including Catholic and Evangelical churches, require full vaccination in order to participate. Their goal is for everyone to be vaccinated, but is this even legal?

Many have been the target of ‘vaccinate or lose your job.’ However, this is a violation of federal law.

Thousands upon thousands are waking up to the truth that in accordance with the FDA’s guidance on the Vaccine, the FDA is required to ensure that recipients … have the option to accept or refuse an emergency use authorization (EUA) product.

An Emergency Use Authorization product was put in place in case there was no other option to promote health, however, we know there are indeed other medications proven to aid in helping the body to heal from COVID, and that the vaccine is not necessary.

What does this mean for you or your fellow employee? Those who require the Vaccine are breaking the law and can be held liable in this Emergency Use Only status.

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!

Part 1:

Letter to Participants Requiring Forced Vaccination, or Suffer Termination

Dear [REDACTED],

At their monthly meeting on Wednesday night, our board of directors voted that [REDACTED] singers must be fully vaccinated against COVID-19 to participate in our projects for the foreseeable future.

Additionally, participating singers will be required to verify their status by showing proof of vaccination. This will be accomplished at the first rehearsal of upcoming concert projects in which you’ll be asked to show your vaccination card or other relevant vaccine documentation.

The organization also encourages mask wearing considering the state of local transmission rates, vaccination rates, hospitalizations, etc, but the decision ultimately remains with individual singers as to whether or not they choose to wear a mask when singing. We recognize that these decisions may vary depending on circumstances such as whether we are singing indoors or outdoors, the period of time for which we are assembled and singing together, and the number of singers who are participating.

Vaccinations against COVID-19 have been readily available to any adult in Washington state since April 15 and are now available for free to any Washington resident age 12 or older. When the state fully reopened on June 30, guidance on vaccination status and masking has largely been left to individual businesses and organizations like ours to decide. [REDACTED] has handled its response to the pandemic over the course of the past 16 months with great care and diligence by prioritizing the health and safety of our stakeholders. We believe this new policy continues our efforts in that vein.

We will revisit this policy when needed as more information becomes available from local, state, and national agencies. As of now, we will institute this policy for the foreseeable future, including outdoor performances scheduled for the coming months that include our participation at the [REDACTED]

[PARAGRAPH REDACTED]

Please feel free to contact us with any questions or concerns. [REDACTED] believes in the safety and efficacy of COVID-19 vaccines, and we are proud to play our role in this community to support public health initiatives to stop the spread.

Sincerely,

[REDACTED], Board President
[REDACTED], Managing Director
[REDACTED], Artistic Director

Part 2:

Letter to Organizations’ Board of Directors Educating Them on the FD&C Act

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.

While I can appreciate the concern for public health, I am equally concerned about such mandates, since the COVID-19 vaccines are currently authorized for Emergency Use Authorization for investigational use only.[i]

The COVID-19 vaccines still lack requisite clinical trials studies and are not approved medical treatment by the FDA. 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 emergency use authorization product…”[ii]

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:

1. That the Secretary has authorized the emergency use of the product
2. Of the significant known and potential benefits and risks and of the extent to which such benefits and risks are unknown; and
3. 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:

“INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS”

As the vaccination provider, you must communicate to the recipient …information consistent with the “Fact Sheet for Recipients…” (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:

· The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine, which is not an FDA approved vaccine,

· The recipient has the option to accept or refuse the COVID-19 vaccine,

· The significant known and potential risks and benefits of the vaccine, and the extent to which such risks and benefits are unknown. [iv]

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.

Under the 2005 PREP Act enacted by Congress, pharmaceutical companies that manufacture Emergency Use Authorization vaccines are shielded from liability related to injuries or 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 or shielded from liability from any resulting harm.

While vaccine manufacturers may be shielded from liability, public institutions are not protected, nor are you as individuals personally protected from liability from mandating experimental vaccines.[v]

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]

Only “covered entities” involved in a patient’s medical care are authorized to obtain any protected health information. To require proof of vaccination without having authorization to view such medical information is not permitted under the HIPAA law.

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.

Thank you for your time and for protecting the best interest of all [REDACTED] singers.

Sincerely,

[REDACTED]

Fmr Coordinator, Institutional Review Board

Human Subjects Research (2001-2010)

[REDACTED] Hospital

[REDACTED], Washington

ihttps://ca.childrenshealthdefense.org/wp-content/uploads/CDE-Superintendent-Letter0from-Childrens-Health-Defense-California-Chapter.pdf

ⁱⁱ^.https://www.fda.gov/media/97321/download

ⁱⁱⁱ^.^{21 CFR § 50.24}

^iv^.www.janssencovid19vaccine.com

^v^.https://childrenshealthdefense.org/defender/under-federal-law-can-your-employer-make-you-get-covid-vaccine/

Part 3:

Form Letter to Present to Employer, Board of Directors, etc.

Date: ____________________

To: Whom It May Concern:

Re: Covid-19 Experimental Vaccine Candidates

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 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, and neither are you.

You are hereby on notice that if you illegally or irresponsibly mandate EUA medical therapies on students, such as the experimental Covid-19 vaccine candidates, I may have no choice but to take legal action, and you may be personally liable for resulting harm.

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) .

Sincerely,

(Sign Name Here)

¹ https://ca.childrenshealthdefense.org/wp-content/uploads/CDE-Superintendent-Letter0from-Childrens-Health-Defense-California-Chapter.pdf

² https://www.fda.gov/media/97321/download

³ 21 CFR § 50.24

⁴ www.janssencovid19vaccine.com

⁵ https://childrenshealthdefense.org/defender/under-federal-law-can-your-employer-make-you-get-covid-vaccine/ ;