After a year in lockdown, the coronavirus vaccine has become available to select groups of the public, but President Joseph Biden promises that all American adults will be eligible for immunization by May 1st. At this point, three COVID-19 vaccinations have been granted Emergency Use Authorization (“EUA”) by the FDA: the Pfizer-BioTech vaccine, the Moderna vaccine, and the Janssen vaccine by Johnson & Johnson. The fact that the vaccinations have been granted EUA status but have not been officially approved by the FDA is extremely important in the determination of whether or not places of employment can require their employees to be vaccinated. The answer to whether or not employers can require their employees to get the COVID-19 vaccine remains unclear, however, the following information reflects part of the argument that, at this stage, the vaccine can not be mandated.
The EUA is outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act and serves as a way for drugs to be used in a time of emergency when they are not yet FDA approved. There are three main criteria for a EUA status to be established. First, it must be determined by the Secretary of the Department of Homeland Security, the Secretary of the Department of Defense, or the Secretary of the Department of Health and Human Services (“HHS”) that an emergency is occurring. Second, the Secretary of HHS must declare that the circumstances of the emergency justify the use of EUA. The Secretary of HHS made both of these declarations, classifying COVID-19 as an emergency. Third, the FDA must find that certain criteria have been met ensuring that the drug is safe enough to be disseminated to the public. Importantly, throughout this process, the FDA must weigh the risks of the vaccine with the benefits of the vaccine. All three of the EUA approved coronavirus vaccines currently being distributed were determined to have more benefits than risks. The first vaccine, Pfizer, was granted EUA status on December 11, 2020, Moderna was given EUA status on December 18, 2020, and most recently the Janssen vaccine was authorized under EUA on February 27, 2021.
Because EUA drugs are not yet officially approved, the Federal Food, Drug, and Cosmetic Act includes an important stipulation requiring the Secretary of HHS to make it clear that individuals must be aware of the “option to accept or refuse administration of the product.” In fact, when asked if vaccination can be made mandatory, Dr. Amanda Cohn of the CDC responded no, citing the EUA rules. Thus, according to the Federal Food, Drug, and Cosmetic Act, due to the emergency basis of the use of the vaccine, the COVID-19 immunization can not be mandatory. According to this EUA rule, employers may encourage their employees to become vaccinated but in no way may they coerce them. For example, many companies are providing incentives for employees to get vaccinated, such as paying them a few hours of paid time off or simply giving them a small bonus for getting their immunization.
Assuming the vaccines become FDA approved in the future, employers will be able to mandate that their employees become vaccinated. Once the vaccine is FDA approved, questions of mandatory vaccination will be subject to the Equal Employment Opportunity Commission (EEOC) and Health Insurance Portability and Accountability Act (HIPAA). The EEOC will outline exceptions to a vaccination mandate, whereas HIPAA can help people understand whether or not they must disclose their vaccination record.
First, within the EEOC, religious and medical exceptions must be considered for the COVID-19 vaccine, as well as all other mandated immunizations. Title VII of the Civil Rights Act of 1964, prohibits employers from discriminating on the basis of a number of protected classes, including religion. Because of Title VII, if a religious belief is “sincerely held” by an employee they must give them a reasonable accommodation. Once the employer is notified of this “sincerely held” belief which would create a conflict between work requirements and religion, they must give the employee reasonable accommodation unless this poses “undue hardship.” In the case of the COVID-19 vaccine, it is logical to think that a religious exemption may cause “undue” hardship on the employer and organization at large. With such an infectious disease, the person getting an exemption may be putting the other employees at risk by not getting vaccinated. In this case, a reasonable accommodation may be to ask the employee to continue to work from home instead of coming into the office. However, if the employee works from home, they may not be able to complete all of their normal tasks, which may strain the employer and still pose “undue hardship.” In the future, people seeking religious exemptions from getting the COVID-19 vaccinations may be disappointed as the costs to their place of employment may be so high that their request is not able to be honored.
Second, the EEOC protects employees who may seek an exemption from the mandatory COVID-19 vaccination if they have an underlying health condition that would make it dangerous for them to receive the immunization. The EEOC maintains that employees are protected by the Americans with Disabilities Act (ADA), which again, requires employers to provide reasonable accommodations to those who can not receive the vaccine. According to the ADA, an employer can request information about the employee’s disability, as well as requiring them to receive a note from their doctor explaining the need for an exemption. Similarly, to the religious exemption, an employer only needs to follow the request if it does not cause the organization “undue hardship.” Because of the contagious nature of the disease, having an unvaccinated employee may certainly cause “undue hardship.” The ADA rule is also interesting to consider while the vaccine is still under the EUA label rather than fully approved. Because no one knows the full extent of problems that could arise due to immunization, the vaccine could be dangerous for a person who has a preexisting condition. In this case, it would be especially important for their employer to follow the guidelines from the Federal Food, Drug, and Cosmetic Act to avoid coercing employees to get the vaccine if they have strong hesitations.
Furthermore, HIPAA will play a role in whether or not employers will be able to demand proof of vaccination from their employees. According to HIPAA, vaccination records are protected health information that can not be disclosed to any employer without the employee’s permission. Once an employee consents to share this information it can be sent from the health care provider to the employer. In the case of COVID-19, the EEOC has already declared that employers can ask their employees for proof of vaccination, but in order to avoid possible discrimination under the ADA, employers should request to only receive vaccination records with no additional medical information.
Overall, although news of the COVID-19 vaccine is exciting for many, employers must remain sensitive to the needs of all of their employees to ensure that they are continuing to provide a safe and equal workplace.