Posted on 07/29/2021 8:06:54 AM PDT by Enlightened1
Ever since the Food and Drug Administration granted emergency use authorization for two new vaccines, employers, schools, and other organizations are grappling with whether to require Covid-19 vaccination.
While organizations are certainly free to encourage their employees, students, and other members to be vaccinated, federal law provides that, at least until the vaccine is licensed, individuals must have the option to accept or decline to be vaccinated.
Knowing what an organization can or cannot do with respect to Covid-19 vaccines can help them keep their employees, students, and members safe and also save the them from costly and time-consuming litigation.
Even though the FDA granted emergency use authorizations for the Pfizer/BioNTech and Moderna vaccines in December 2020, the clinical trials the FDA will rely upon to ultimately decide whether to license these vaccines are still underway and are designed to last for approximately two years to collect adequate data to establish if these vaccines are safe and effective enough for the FDA to license.
The abbreviated timelines for the emergency use applications and authorizations means there is much the FDA does not know about these products even as it authorizes them for emergency use, including their effectiveness against asymptomatic infection, death, and transmission of SARS-CoV-2, the virus that causes the disease.
Given the uncertainty about the two vaccines, their EUAs are explicit that each is “an investigational vaccine not licensed for any indication” and require that all “promotional material relating to the Covid-19 Vaccine clearly and conspicuously … state that this product has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA” (emphasis added).
The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant emergency use authorization also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”
Likewise, 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 …”
In the same vein, when Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, she responded that under an EUA, “vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.” Cohn later affirmed that this prohibition on requiring the vaccines applies to organizations, including hospitals.
The EUAs for both the Pfizer/BioNTech and Moderna vaccines require facts sheets to be given to vaccination providers and recipients. These fact sheets make clear that getting the vaccine is optional. For example, the one for recipients states that, “It is your choice to receive or not receive the Covid-19 Vaccine,” and if “you decide to not receive it, it will not change your standard of medical care.”
When the FDA grants emergency use authorization for a vaccine, many questions about the product cannot be answered. Given the open questions, when Congress granted the authority to issue EUAs, it chose to require that every individual should be allowed to decide for himself or herself whether or not to receive an EUA product. The FDA and CDC apparently consider this fundamental requirement of choice important enough that even during the height of the Covid-19 pandemic they reinforced that policy decision when issuing their guidance related to the Covid-19 vaccines.
This means that an organization will likely be at odds with federal law if it requires its employees, students or other members to get a Covid-19 vaccine that is being distributed under emergency use authorization.
State law often prohibits retaliating against an employee for refusing to participate in a violation of federal law. Organizations that require Covid-19 vaccination in violation of federal law may face lawsuits under these state laws not only to block the policy but also for damages and attorneys’ fees. Such potentially costly lawsuits can be avoided by refraining from adopting policies that require vaccination or penalize members for choosing not to be vaccinated.
Organizations are free to encourage vaccinations through internal communications, through educational events, and through other measures to urge employees to be vaccinated. They can take these measures so long as: (1) they are not viewed as coercive, (2) the organization makes clear the decision regarding whether to receive the vaccine is voluntary, and (3) the measures comply with the requirements in the EUAs and the related regulations for these products.
People across the world have had their lives upended during the last year. The urgency to return to normalcy is felt deeply by many. As decision-makers at organizations decide on their Covid-19 vaccination policy, they should be careful to not let this passion lead the organization to run afoul of the law.
A lot of people opining, not a lot of lawsuits flying. The left doesn’t live by their own rules, so I have no doubt this is all just yelling at the ocean. There’s insufficient pain being felt by a majority of the population to really evince any change.
The rush for approval starts in 3..2..1..
I can’t imagine the pressure being brought to bear on the FDA to go ahead and approve these vaccines so they can be mandated.
I’m surprised they haven’t caved....yet
https://www.lawandtheworkplace.com/wp-content/uploads/sites/29/2021/07/DOJ-Vaccine-Memo.pdf
DOJ isn’t going to help you. This is the legal guidance that they just sent out to employers just before the mandates started dropping.
Another utterly unconstitutional and, thus, invalid federal law. Any unjust or invalid law is NO law, according to William Blackstone (the renowned English jurist from whom derived much of the thinking regarding today’s common law and Judeo-Christin Judicial System).
“Law” does not matter.
“Force” does.
I can. Approval is slated for September.
The requirement is attempting to side step the law by allowing “options”. Either get the vaccine or do this ....
The courts SHOULD be quashing this. But I have lost so much faith in our system that I doubt that will happen.
I’ve see trials until 2023.
P4L
My thoughts exactly.
If they approve it though, doesn’t that mean lawsuits get to go out for any malpractice?
I can see no ballots or entry to polling places for the unvaccinated.
Just another bad dream....
Law doesn’t matter here:
FLASH FLOOD WARNING! The tort bar is beginning to salivate. Roll up the pant legs; too late to save the shoes.
I had previously searched something similar to "mandatory CV19 vaccine law" and arrived at the following link, same one in OP.
21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies
Below is what I understand to be the key language in the law, and there is a problem with 3rd party explanations of the law imo.
The good news is that part (II) of the law effectively gives citizens the right to be informed about the pros and cons of the vaccine, which is not happening where problems are concerned imo, and to choose to refuse vaccine.
The bad news is that part (III) suggests that employers indoctrinated with pro-vaccine propaganda can still fire you for refusing the vaccine.
"(e) Conditions of authorization(1) Unapproved product(A) Required conditions(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—(I) that the Secretary [Secretary of Health and Human Services] 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."
VIDEO: Rand Paul Addresses the Delta Variant and Covid Misinformation (7.28.21)
Corrections, insights welcome.
Moreover,
Any mandates or coercion to make people take a vaccine is in violation of about 12 different international treaties and agreements.
Not that this matters in the US today. Every administration merely interprets the laws the way they see fit and enforces them selectively... so yeah we’re definitely like any other lawless banana republic.
But, technically speaking all of these treaties are being violated with all this mandate/mandatory crap:
-—Universal Declaration of Human Rights, of December 10, 1948.
-—American Declaration of the Rights and Duties of Man, Bogotá, 1948.
-—American Convention on Human Rights, San José (Costa Rica), from November 7 to 22, 1969.
-—International Covenant on Economic, Social and Cultural Rights of December 16, 1966.
-—The Convention for the Protection of Human Rights and Fundamental Freedoms Rome of November 4, 1950.
-—International Covenant on Civil and Political Rights of December 16, 1966.
-—Convention for the protection of human rights and the dignity of the human being with respect to the applications of Biology and Medicine of April 4, 1997, Oviedo Convention.
-—Nuremberg Code of Ethics of August 19, 1947.
-—Geneva Declaration of 1948.
-—International Code of Medical Ethics of October 1949.
-—Declaration of Helsinki adopted by the 18th World Medical Assembly, 1964.
-—Belmont Report of April 18, 1979.
-—1981 WMA Declaration of Lisbon on the Rights of the Patient.
-—Declaration of the WMA on the Independence and Professional Freedom of the Physician of 1986.
-—Madrid Declaration of the AMM on Professional Autonomy and Self-Regulation of 1987.
-—WMA Seoul Declaration on Professional Autonomy and Clinical Independence 2008.
-—Madrid Declaration of the AMM on Professional Regulation of 2009.
-—WMA Declaration on the Relationship between Law and Ethics 2003.
-—UNESCO Universal Declaration on Bioethics and Human Rights of 2005.
-—International Health Regulations 2005
You see, after WWII, with the experience of WWII and human testing, people back then made rules to PREVENT exactly those things we are trying to do today. It is considered illegal, unethical... But again, it’s the USA 2021 and not even the US Constitution matters anymore.
I’m sure that those companies that are making vaccinations a condition of employment have lawyers and are aware of the law, yet they go ahead and implement the requirement. Courts have upheld such requirements for hospitals in Texas. Maybe the law doesn’t say what people thinks it says?
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