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.
Aaron Siri is the managing partner at Siri & Glimstad LLP, a civil litigation firm with its principal office in New York City that has represented the Informed Consent Action Network, a group that campaigns against vaccine requirements. This article is not intended to provide legal advice but to offer broad and general information about the law.
Under EEOC, employers can require the COVID vaccination shot as a condition of employment. This is not forcing someone to have a shot they do not want. There are exceptions for ADA/medical and religious reasons that require accomodation such as work-from-home, if that is possible.
You are not quite correct:
K.6. If an employer requires vaccinations when they are available, how should it respond to an employee who indicates that he or she is unable to receive a COVID-19 vaccination because of a sincerely held religious practice or belief? (12/16/20)
Once an employer is on notice that an employee’s sincerely held religious belief, practice, or observance prevents the employee from receiving the vaccination, the employer must provide a reasonable accommodation for the religious belief, practice, or observance unless it would pose an undue hardship under Title VII of the Civil Rights Act. Courts have defined “undue hardship” under Title VII as having more than a de minimis cost or burden on the employer. EEOC guidance explains that because the definition of religion is broad and protects beliefs, practices, and observances with which the employer may be unfamiliar, the employer should ordinarily assume that an employee’s request for religious accommodation is based on a sincerely held religious belief. If, however, an employee requests a religious accommodation, and an employer has an objective basis for questioning either the religious nature or the sincerity of a particular belief, practice, or observance, the employer would be justified in requesting additional supporting information.
K.7. What happens if an employer cannot exempt or provide a reasonable accommodation to an employee who cannot comply with a mandatory vaccine policy because of a disability or sincerely held religious practice or belief? (12/16/20)
If an employee cannot get vaccinated for COVID-19 because of a disability or sincerely held religious belief, practice, or observance, and there is no reasonable accommodation possible, then it would be lawful for the employer to exclude the employee from the workplace. This does not mean the employer may automatically terminate the worker. Employers will need to determine if any other rights apply under the EEO laws or other federal, state, and local authorities.
Has any of the deep nasal pcr tests for the COVID-19 been a source of chemical and viral dust transmissions for patients in CA, within USA?
Are there any regulations when it comes to signing a declination form, from your employer stating that you are acknowledging & putting your self and others at risk for not taking the vaccine?
Does this apply to businesses such as airlines or cruise line companies?
Hi, I’m a educator in California. So this article that I just read states that it’s not mandatory to get the vaccine because it is not license and it’s only use for emergency. So my school district should not force employees to take it, if they refuse. They cannot fire you for it??
I was fired from my employer after years of service. My letter of termination clearly states that I refused the Covid vaccine
Contact a lawyer. As this article makes clear, that is bluntly illegal in the real world.
What Federal law protects even licensed medical procedures , treatments, etc., from being mandatory compliance by any public or private entity?Especially if those Dx are treatable?
How does manditory participation in a Tx under the constitution protect a citizen’s right to refuse said Tx?
And lastly, wouldn’t mandatory Tx, required for employment, be a coersive act perpetrated by one party upon another?
I have many people telling me that their employers are obligating employees to be vacxinated. Please help..our people dont want to be vaccinated.
All I can say is “Contact a lawyer”! That is the only way that you are going to get employers to back down here.
Truly enjoyed reading this article. It was very informative and eye opening.
Under 21 CFR § 50.24 et seq.,
it is unlawful to conduct medical research (even in the case of emergency) without a series of steps taken, one of those steps includes establishing the research with a duly authorized and INDEPENDENT institutional review board. FDA gets 75% of it’s budget from the industry, and own part of the gardasil patent. Not only that individuals within FDA who worked on the patent, get 150,000 per year in royalties. These are the division chairs! Can you explain to me how it’s legitimate for a vaccine company to be allowed to review and determine the safety and efficacy for the products of their own industry?
We’ve already been down this road with FDA, in federal registry reguarding polio vaccines FDA made the following statements: “any possible doubts, whether
or not well founded, about the safety of
the vaccine cannot be allowed to exist
in view of the need to assure that the
vaccine will continue to be used to the
maximum extent consistent with the
nation’s public health objectives.
Accordingly, because of the importance
of the vaccine and of maintaining public
confidence in the immunization program
that depends on it,”
Library of Congress, 49 Fed. Reg. (June 1, 1984).
Additional Standards for
Poliovirus Vaccine, Live,
Oral; Final Rule. Rules and Regulations 23007 Pg 255
adj. Based on sound judgment, reasoning, or evidence. FDA prohibits, will not allow, evidence which doubts the safety of the vaccine, why? Because FDA has clear conflicts of interest, carrying every financial incentive to hide harm’s, and produce research which promotes said product, reguardless of whether or not the research is done properly. FDA had already approved the polio vaccine despite being in violation of 21 CFR, and there about to violate the law again because they’ve got no liability, no oversite, and no accountability.
Excellent point – and I am not a deep student of laws regarding all of this but if i recall some of my previous research the CDC also has ownership in several if not many vaccine patents as well…and they are not a government entity. This seems like they have a financial interest in people using/taking vaccinations that they have a share of the patents.
Comments are closed.