I am pleased to join as one of the regular contributors to the Manufacturing Law Blog. I am a labor and employment lawyer and I will be providing insights from that vantage point, which Matt Miklave has so ably contributed over the past several years. Matt is retiring from Robinson+Cole and we wish him well as he opens his own firm.

After months of countless updates on the status of the COVID-19 vaccine weaving its way through the regulatory approval process, the vaccine has arrived! Now many employers are grappling with a key question – what type of vaccination program can employers implement?

According to guidance issued by the Equal Employment Opportunity Commission (EEOC) on December 16, 2020, employers may implement a mandatory COVID-19 vaccine program for vaccines that have been authorized or approved by the Food and Drug Administration (FDA). As part of that program, employers may inquire as to whether an employee has been vaccinated and request proof of vaccination. That being said, according to the guidance, employers should review requests for reasonable accommodation from employees seeking an exemption from vaccination based on a disability or a religious reason. In reviewing such requests, employers would then determine if an unvaccinated employee would pose a “direct threat” to the health or safety of individuals in the workplace that cannot be reduced to an acceptable level by conducting a case-by-case analysis and taking an approach that is meant to limit potential risks.

In terms of administering the vaccine, the current EEOC guidance suggests that if an employer  uses a third-party, such as a pharmacy or health care provider, with which it does not have a contract, to administer the vaccine, then the third party can engage in relevant pre-screening inquiries of the employees (e.g., why haven’t you had the vaccine, are you taking any medications, etc.). While unlikely to occur at this stage, if an employer administers the vaccine itself or uses a contractor, according to the guidance, the employer would have to ensure that such inquiries are “job related and consistent with business necessity,” consistent with the Americans with Disabilities Act.

While the EEOC’s guidance provides some clarity surrounding this issue, there remain significant legal risks in implementing vaccination programs which are heightened if the employer’s program is mandatory. Arguably the most significant risk would occur if an employee suffers harm after taking the vaccine; in that case, employees may file suit against the employer, arguing that the vaccine was not safe since it was authorized under an “emergency use authorization,” rather than approved by the FDA, among other safety-related arguments; there may be support for this position in a number of agency regulations including the FDA, EEOC, OSHA, and various laws. For unionized employers, there is an additional consideration as  a mandatory vaccination program may be considered a mandatory subject of bargaining, meaning that prior to implementation, the employer would typically have to provide the union with notice and an opportunity to bargain or establish that the collective bargaining agreement permits implementation.

As manufacturers review this issue, it is important to consider whether to implement a voluntary or mandatory program or to simply encourage employees to be vaccinated, what documentation may be required to implement such a program (e.g., waiver, accommodation request form, etc.), what employee communication would be appropriate, among other considerations.

As additional guidance is published, we will keep you updated on this issue.