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.
The relevant issue for most people is whether your employer can fire you if you refuse the vaccine, and that is something neither Consstitutional claims nor alleged treaty violations affect.
Private businesses cannot violate the Constitution, nor breach a treaty.
Where’s the ACLU?
From the DOJ guidance:
“The language of another provision of section 564 reflects the limited scope of operation of section 564(e)(1)(A)(ii)(III).
“Section 564(l) provides that ‘this section [i.e., section 564] only has legal effect on a person who carries out an activity for which an authorization under this section is issued.’
“This provision expressly forecloses any limitation on the activities of the vast majority of entities who would insist upon vaccination requirements, because most do not carry out any activity for which an EUA is issued.”
The large overreaching entities provide PPACA health care coverage that generally pays for Covid vaccination (and quite often by self-administered plans). The federal government has even claimed that mere failure to purchase health care cost coverage was an activity. The Florida Department of Health made me fill out a form in which they asked about my insurance status before each Moderna shot was given to me. Payment is a critical activity in health care in the USA, believe me.
No way....by giving approval to pharma. they can be sued for deaths and adverse reactions...no way big pharma. wants an approval...no way!
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.
This is so irritating. Any writer knows that the first time you use an acronym in an article you give the full phrase followed by the acronym in parentheses.
e.g. Three Letter Acronym (TLA).
Although emergency use authorization is mentioned in the article, it is not followed immediately by “(EUA)”. I suppose the reader is just supposed to assume that EUA means that which was mentioned earlier in the article.
I’m so glad I’ve retired and have no desire to travel outside the US - nor do I need to fly. I’ve driven from central KY to Seattle twice and South Padre Island in texas once just in the last year.
I refuse to take the mark.
Have you seen anyone actually clutching a pink slip yet?
FWIW, I think the alleged firings are scare tactics.
For now.
Government makes and enforces law.
They will never find themselves in violation...at least when it’s important to them.
There’s no discussion of consequences just that they’re going to mandate it.
My employer, a large multinational, has not put out a mandate but has stated that they will consider all sincerely held religious beliefs and health considerations, but like many have said, eventually even those will be thrown out.
From the DOJ guidance:
“virtually all such persons continue to have the ‘option’
of refusing the vaccine in the sense that there is no direct legal requirement that they receive it. See Bridges, 2021 WL 2399994, at *2 (noting that an employer’s vaccination policy was not “coercive” because an employee “can freely choose to accept or refuse a COVID-19 vaccine; however, if she refuses, she will simply need to work somewhere else”)”
The insertion of the phrase “no direct legal requirement” implies that having a direct legal requirement would be coercive.
In my opinion, there are so many indirect legal requirements such as mortgage, car payment, property tax, health care cost coverage legal continuity requirement that legal coercion effectively exists. I took out a mortgage in 1981 because my marginal tax brackets, state and federal combined, were nearing 40%.
As for the term “freely”, it can take a few weeks to get a new job, which might mean the loss of over $2,000 for a nurse, which is logically incompatible with “freely”.
Why were judges given Article III, Section 1 protections if they could simply hang out a lawyer shingle?
“Yeah, but this is different”
This is what I am thinking. Rake in 34 billion on initial sales, up to another 20 billion for the first round of boosters. Then show that it’s ineffective and that adverse reactions are in the same order of magnitude of deaths as getting corona. Get the FDA to not approve it and walk away with the upwards of 50 billion and no liability. Plus additional sales for potential therapeutics and/or treatments for any long term side effects of the vaccine.
Yep. I retired 12/31/19 and am SO GLAD.
And that was a fed gov job and it sounds like fed gov employees are being herded to the jab or face rigorous testing. Which is part of the “make not being vaxxed as uncomfortable as possibe” plan....a plan they already admitted they were gonna implement.
This makes everything else as much as a fraud.
We no longer have a republic.
If Deep State wants it enforced, the courts will rubber stamp firings.
That said, I think the jury is still out on how far Deep State is willing to go.
They’ve been caught out.
Will they settle for a loot and run on Treasury and leave after the next, hopefully honest, election....
Or are they planning to go full ChiCom on us and refuse to leave.
FWIW, I think if Deep State permits mass firings of CoupFlu vaxx refuseniks, it’ll be a sign Deep State ain’t planning on going anywhere.
And if that’s the case, pink slips will be the least of the nation’s worries.
I think that’s how it’ll work!
This was an opinion piece posted in Stat News in February.
At the time it got a lot of criticism from people familiar with the law. Since then that criticism has been proven accurate, with the EEOC issuing guidance saying employers can mandate vaccinations and various courts rejecting challenges to employers who have done so.
Well Then, the DOJ should have 100% mandatory injection compliance. Hopefully a morbidity and mortality rate to match.
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