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.
WHY are you calling it a “vaccine”? Because the mainstream media is, correct? You should take the higher road and call it what it is, per doctors and scientists: either an “experimental biological agent” or a “synthetic pathogen”. Calling it a “vaccine” when it is not, only confuses the public more. However, thank you for this information. If it didn’t have the word “vaccine” in it, I would share it.
Also, it should be called “Gene therapy”
Thanks, very informative. I been hearing reports that mainstream media is not talking about is those who received the vaccine are having blood disorders. This makes me wonder if it due to mRNA.
The EEOC has already sold out the American workforce and said employers can fire people who refuse the (fake) “vaccines.” So then what is the truth?
So for those of us working for a company that has already mandated the vaccine as a contingency of continued employment with deadline of May 1 2021, what would or can we do.
Very informative. Thank you.
Thank you for sharing this important information. I was extremely worried that I would be forced to receive this vac as a nurse working in a hospital. I don’t feel comfortable getting a vac we don’t know enough about. Not enough time to know what the long or short effects are. People are getting this vac for the wrong reason. They are”tired of living this way.”
While it is true that a medical facility cannot require you to get vaccinated, they can stipulate that only vaccinated staff may work in positions that require intimate physical contact with patients and other staff, and they can put staff that are not vaccinated and whose job description require such contact to be restricted to non-contact duties, or put on layoff status for the duration of the pandemic. Such restrictions will be common, and impact hiring, as well as impacting existing employees and temporary staffing. EUA is not a free pass to continue your normal job duties and avoid vaccinations, this is the same way that registered vaccination requirements work, you can choose not to be vaccinated, but if you choose not to be vaccinated your choice may well cost you your job.
Finally, I see a very informative and well written article in statnews.
I think the following tends to misled vaccine “It is your choice to receive or not receive the Covid-19 Vaccine”. It is be stated that they have the right not to receive vaccine since it is EUA.
mRNA has never been use before. One does not know the long term effect. But if the risk of dying from covid19 or getting permanent damage is higher, then it makes sense to take a risk with the vaccine.
It is a violation of the Nuremberg Code to force someone to take an experimental vaccine or medication. Since the vaccines are in Trial Phase until Jan 2023, the recipient must agree to be a test subject.
Can you please do a follow article of what is the legal rights of the people who refuse to take vaccine. Employment in the US is at will unless you have a union. So basically employer can let with go for not taking vaccine.
But getting vaccinated with mRNA is different, its safety has not been proven. Another thing is no one know the long term effect of mRNA especially on pregnant women babies.
see my response above to Jennifer Antico Vitone.
There are few, to no rights, for employees to violate health and safety requirements for staff/clients/patients and maintain their employment, and it would be malfeasance (potentially criminal malfeasance) to allow unvaccinated staff to mix with vulnerable populations in the work place, particularly as such would open owners and operating administration/management to civil lawsuits and class action suits by those subject to illness and death from this virus and the work environment which fostered that potential.
Well, well, well. As usual the FDA is always late in informing the public.
I just read in the news that some business are requiring employee to take vaccine or else change responsibility or job.
Pleas add the number, sign or link of the federal law you talk about that provides that until the vaccine is licensed, individuals must have the option to accept or decline to be vaccinated.
Becous here in israel the population is going to a second holocaust and forced to be caccinated by the goverment and all employmens, are trying legislate it by a law.
So pleas add the federal law.