# Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA



## Becky1951 (Mar 20, 2021)

Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA

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.

*Much remains unknown about the safety and efficacy of the vaccine*

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).

*EUAs are clear: Getting these vaccines is voluntary*

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.”

*What this means in practice*

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.

https://www.statnews.com/2021/02/23...-a-covid-19-vaccine-distributed-under-an-eua/


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## Tommy (Mar 20, 2021)

While I personally support to position that getting the vaccine should be a personal choice and not mandatory, I think there may be a differing take on this matter.  Although federal law prohibits making acceptance of the vaccine mandatory, I'm not so sure that an organization is therefore required to employ or continue to employ a person who chooses to refuse it.  The last I heard, discrimination on the basis of "vaccination status" isn't constitutionally protected.


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## Jeweltea (Apr 6, 2021)

From what I read, Pfizer is applying for full FDA approval this month.

https://www.reuters.com/article/us-health-coronavirus-pfizer-fda-idUSKBN28K2Z5


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## StarSong (Apr 6, 2021)

Jeweltea said:


> From what I read, Pfizer is applying for full FDA approval this month.
> 
> https://www.reuters.com/article/us-health-coronavirus-pfizer-fda-idUSKBN28K2Z5


When and if any vaccine receives full FDA approval it may be a game changer for the military, because they could then mandate it for their troops, just as they do other vaccines. 

According to the article:
_"The Food and Drug Administration has allowed emergency use of the vaccine, so it's voluntary. But Defense Department officials say they hope that soon may change.

“We cannot make it mandatory yet,” Vice Adm. Andrew Lewis, commander of the Navy’s 2nd Fleet, said last week. “I can tell you we’re probably going to make it mandatory as soon as we can, just like we do with the flu vaccine."_


https://abcnews.go.com/Health/wireStory/thousands-service-members-covid-19-vaccine-75950930


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## Aunt Marg (Apr 6, 2021)

Becky1951 said:


> Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUA
> 
> 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.
> 
> ...


Good!

Licensed or not, I for one, and my husband for two, will NOT be told by anyone that we will be getting a vaccination of any kind, and I encourage others to stand their ground on the issue as well.

We already live in a bully world, I refuse to embrace bullying more.


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## StarSong (Apr 6, 2021)

I want to hug, kiss and spend close-up time with my (also vaccinated) friends and family, to host and attend parties, to travel internationally again, to feel reasonably well protected from catching this virus again, and to help ensure I don't infect the people in my life who cannot be vaccinated - young children and the immunocompromised.   

Nobody "wants" to get vaccinated, but for most it's the pathway for getting our lives back to some semblance of normalcy. The prospect of another 13 months of relative isolation would be very distressing indeed.


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## ohioboy (Apr 6, 2021)

Tommy said:


> Although federal law prohibits making acceptance of the vaccine mandatory, I'm not so sure that an organization is therefore required to employ or continue to employ a person who chooses to refuse it.  The last I heard, discrimination on the basis of "vaccination status" isn't constitutionally protected.



If the person is employed "at will" the termination would only be challengeable on religious grounds/Title 7. Hard fight for sure.


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## win231 (Apr 6, 2021)

StarSong said:


> I want to hug, kiss and spend close-up time with my (also vaccinated) friends and family, to host and attend parties, to travel internationally again, to feel reasonably well protected from catching this virus again, and to help ensure I don't infect the people in my life who cannot be vaccinated - young children and the immunocompromised.
> 
> Nobody "wants" to get vaccinated, but for most it's the pathway for getting our lives back to some semblance of normalcy. The prospect of another 13 months of relative isolation would be very distressing indeed.


That's often the issue - should the desire to "Get back to normal" be the reason for getting a vaccine that might be questionable?
Or, should the motivation be "Preventing an Illness."
For me, it's whether or not the vaccine protects & is safe; not "getting back to normal."  I've been in "Normal" ever since January 2020, except for masks when shopping.


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## ohioboy (Apr 6, 2021)

Becky1951 said:
			
		

> 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



In Ohio this law would be a "Public Policy" exception to employment at will, another addition to my other post. If an employee refuses to violate PP, a state statute, or other laws of similar import, if terminated on that basis, they have a Cause of Action, yes. Now, this has nothing to do with proving it, that's another matter.

https://casetext.com/case/greeley-v-miami-valley-maintenance-contrs-inc


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## win231 (Apr 6, 2021)

Things that are said to be "Required" are often not legally required.
Example:  15 years ago, I was dating a Chinese woman.  Her 11 year old son wanted to live here & when she enrolled him in 7th grade, school administrators told her a TB skin test was required.  She & her son didn't want it.
I spoke to an RN who told me it was not a requirement; but a "Suggestion."  I had the nurse print out the law & my girlfriend showed it to school administrators.  They told her it was still required.  BUT when she said she would take them to court, they changed their tune & said, "Well....uh......it's not legally required.....we just......recommend it."
They immediately enrolled him.

What's the big deal? you may ask.  I think putting TB bacteria under the skin to see if someone reacts to it to determine possible exposure is a stupid thing to do.  If the TB test is positive, it does not mean you have TB; it only means you've been exposed to it - as many of us have been. Then they'll do a chest X-Ray & put you on antibiotics for several months - which is (again) stupid, IMO.


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