Last week, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to permit the use of the first vaccine in the fight against COVID-19. The Pfizer-BioNTech COVID-19 Vaccine is one of several Coronavirus vaccines expected to be authorized in the coming weeks and months.
In an effort to protect those most vulnerable to a virus that has already taken more than 300,000 American lives and infected tens of millions more, the CDC says the Pfizer-BioNTech COVID-19 Vaccine will be administered primarily to workers in the healthcare industry with the highest exposure to the virus. However, even with Pfizer and BioNTech’s stated success rate of 95% and few signs of severe side effects, the historic rate at which this vaccine was developed has some Americans wary of taking it. This includes many doctors and nurses. Some data has shown that only 66% of New Jersey doctors said they planned to receive the vaccine, and a similar survey of nearly 13,000 nurses conducted by the American Nurses Foundation in October found that just 35% of nurses said they will voluntarily get immunized, with the rest saying they would not take the vaccine (36%) or they were unsure (31%).
The difference between EUA authorization and full vaccine approval
Following its review of all available safety, effectiveness and manufacturing quality information, the FDA determined that the Pfizer-BioNTech COVID-19 Vaccine meets the statutory criteria for issuance of an EUA, and may be distributed to the public on an emergency basis without undergoing the same review and approval process typically required for vaccines with full approval.
It’s important to emphasize that an EUA differs greatly from full vaccine approval, which will not come until there is “substantial evidence” that the vaccine is effective. At this point, the FDA has determined only that the vaccine may be effective, and that’s a key distinction. Emergency use authorizations on products are in effect only for as long as the public health emergency lasts and can be revoked at any time if a safety issue arises or it’s determined the product’s efficacy is in doubt. When a product receives full FDA approval or clearance, approvals remain in place indefinitely unless there are safety or efficacy issues, and approval is withdrawn only after a period of notice and comment.
Mandates may be enforceable, but challenges are sure to arise
This all leads to the question of whether employers, especially those in the healthcare industry, can mandate that their workers take the COVID-19 vaccine. The issue of mandatory vaccinations initially arose in connection with the smallpox vaccine more than 100 years ago (Jacobson v. Massachusetts, 197 U.S. 11 (1905)). Among other things, the ruling showed constitutional rights can be reasonably restricted when necessary to combat a public health emergency. Other cases over the last hundred years applied the Supreme Court’s reasoning in Jacobson to find that influenza vaccinations can be mandated. Although not an identical scenario to what the country faces today, this existing case law provides support for mandating a COVID-19 vaccination.
Of course, employees retain certain rights under federal and state employment laws to avoid being mandated by their employers to get vaccinated. Just this week, U.S. Surgeon General Jerome Adams said that because the vaccine hasn’t received full FDA approval, companies should not mandate it for their workforce (though this statement could be walked back depending on pressure from unions, the public or otherwise). Regardless, there are a number of factors healthcare employers should think about as the first vaccines are now being administered to nurses and doctors across the U.S. Here are four of our top considerations:
1. Employees retain certain legal rights to refuse the COVID-19 vaccine
Although it is well established in the context of flu vaccines that an employer may require a vaccination, employees may still refuse on the grounds that 1) they have Americans with Disabilities Act (ADA) disabilities or other medical reasons that prevent or contraindicate vaccination, or 2) they possess sincerely-held religious beliefs, practices or observances, which prevent vaccination (Title VII of the Civil Rights Act of 1964). These subsets of employees must be provided a reasonable accommodation, unless the accommodation would cause an undue hardship to the employer. However, “undue hardship” has a lower, “de minimis” standard for religious accommodations than for disability accommodations.
Based on case law supporting enforcement of mandatory flu vaccinations, it is possible for employers to mandate that workers also get the COVID-19 vaccination as a requirement of their employment, provided there is a legitimate business need. Yet, employees could refuse the vaccine on the grounds that there is no legitimate business need for someone working in their position to be vaccinated (i.e., a job that is not patient or customer facing). The business need to take the COVID-19 vaccine should, therefore, be included in all worker job descriptions as an essential job function. That said, making the case for mandating the COVID-19 vaccine will be different for those in the healthcare space and at long-term care (LTC) facilities versus workers in other industries.
2. Don’t expect rapid change to labor and employment law – the courts will decide the fate of any mandate
As seen in the 1905 case involving the smallpox vaccine, constitutional rights can be reasonably restricted when necessary to combat a public health emergency. However, the ADA and Title VII are well established and will not change any time soon as a result of any COVID-19 vaccine. These historical employee rights are acknowledged by the Equal Employment Opportunity Commission (EEOC) in its COVID-19 guidance, updated on December 16. In this update, the EEOC addressed employer and employee rights related to the COVID-19 vaccine, including a statement that the process of an employee receiving the vaccine won't be considered a "medical examination" for purposes of the ADA, when employers administer it or contract with a third party to provide it. EEOC also says employers can require proof that employees received a COVID-19 vaccine on their own. But, employers must be careful not to ask too many questions about an employee’s other medical information, as such inquiry may run afoul of the ADA. Employers should also note that the EEOC’s guidance is always subject to change. This is another reason why employers should create legitimate COVID-19 health and safety requirements that are job-related and consistent with business necessity and make sure to check the most recent status of the law when making decisions about the COVID-19 vaccine.
The very nature of the unprecedented COVID-19 pandemic creates a world where precedent may or may not be applicable. The Pfizer-BioNTech COVID-19 Vaccine and others to follow were developed quicker than any similar vaccine. While this is a groundbreaking scientific achievement, some have raised concerns about how carefully these companies followed protocols and how, in a race to end the pandemic, the FDA may relax its approval process. Despite some public unease, the FDA has been adamant that protocols have been followed and the EUA was issued only after a thorough review. In its public release, FDA Commissioner Stephen M. Hahn, M.D., said the EUA followed “an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure [the Pfizer-BioNTech COVID-19 Vaccine] met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”
The FDA evaluated all the available safety data for the 37,586 who were part of the study (18,801 of which received the vaccine, with the remainder receiving a placebo), it reviewed all the effectiveness data, and it followed the EUA authorization criteria. However, with the current uncertainty in this vaccine among many people across the U.S., it will likely be the courts who decide whether this vaccine can and will be mandated for employees.
Despite the case law supporting enforcement of mandatory vaccination policies, litigation remained a common occurrence well before COVID-19, especially as the EEOC has a history of aggressively enforcing or litigating cases when the Commission believes there has been a failure to accommodate a disability or a sincerely held religious belief. This will only continue – and likely increase – if COVID-19 vaccinations become employer-mandated.
It would be wise for all employers, especially those in healthcare, to engage legal counsel on what options they have to mandate immunizations and what they can expect if and when litigation arises. Already it’s clear that there will be lawsuits over administration of the COVID-19 vaccine. It will be critical for businesses to be aware of what those outcomes are and how they may impact future litigation.
3. Beware of any potential HIPAA and other privacy violations
Like any medical information, an individual’s immunizations are confidential – COVID-19 has not changed that fact. Those organizations that have not done their due diligence when attempting to conduct contact tracing appropriately have learned that fact the hard way.
Workers are free to disclose to their employer and their fellow employees that they have taken the COVID-19 vaccine, but under the Health Insurance Portability and Accountability Act (HIPAA,) healthcare providers may not disclose this information to an employer without the prior written authorization of the employee. Additionally, under various state privacy laws, employers may not disclose who among their workforce has taken the COVID-19 vaccine without the employee’s prior consent.
Additionally, while the vaccines remain authorized under EUAs only, as part of the vaccination process all recipients must be given an FDA-reviewed patient fact sheet. This fact sheet includes a QR code that will be scanned by the administrator to confirm the vaccine recipient was given the fact sheet and understands the potential side effects and the risks and benefits of taking the COVID-19 vaccine. Additionally, this code will be used as part of the recipient’s medical records and immunization information systems to show the individual has received the COVID-19 vaccine. Employment law issues could also arise surrounding how this information is shared and with whom, but the unprecedented nature of this means those questions have yet to be answered.
4. Prepare for negotiation with labor unions
For organizations that work with labor unions, different rules may apply when it comes to mandating a vaccine, even if taking it may be deemed an essential job function. Much like any broad change to terms and conditions of employment, mandating that union members receive the COVID-19 vaccine is a mandatory subject of collective bargaining. On the other side of the coin, Occupational Safety and Health Act (OSHA) laws state that employers have a duty to provide a safe workplace for their workers, and many unions could posit that a COVID-19 vaccine is a requirement an employer must offer and mandate themselves.
These additional issues require the expertise of a labor and employment attorney with specific experience in negotiating with labor unions. It’s important when working with organized labor that an employer is prepared to face unique legal hurdles.
Engaging the right counsel
The distribution of the COVID-19 vaccine is yet another challenge employers are set to face now and in the year ahead. And, while it’s a sign that the country is closer to the end of the COVID-19 pandemic, the vaccine could present the most significant number of legal challenges yet. At Buchanan Ingersoll & Rooney, our team of labor and employment attorneys is among the largest and most respected within full-service law firms. Additionally, our team of FDA attorneys are keeping a close eye on the latest vaccine EUAs, FDA updates and other related issues. Our regulatory experience in labor relations and life sciences means our team is equipped to handle any potential litigation. Having partnered with organizations of all sizes and across industries on their Coronavirus policies, we are well suited to handle this next step in the fight against COVID-19.