As most everyone has seen or heard, the first wave of vaccines targeting the COVID-19 outbreak are beginning to emerge and progress at a breakneck pace. On December 11, 2020, after months of research and development, the U.S. Food and Drug Administration (FDA) granted an “emergency use authorization” (EUA) for Pfizer’s COVID-19 vaccine. One week later, on December 18, 2020, the FDA granted a similar EUA for Moderna’s COVID-19 vaccine. Given the astronomical rise in the infection rate, employer interest in the vaccines is extremely high. Thus, employers are asking whether they can, or should, require employees to take the vaccine.
The Current State of Approval of the Vaccines
Biological products such as vaccines are typically approved and regulated by a division within the FDA. For a vaccine to be approved, the FDA must determine that it is both safe and effective, based on data from laboratory studies and clinical trials. The FDA assesses both the quality and the quantity of the data provided when determining whether a vaccine meets this standard.
While this generally is a lengthy process, the FDA has the authority to accelerate the development and review process for vaccines used to treat/prevent serious conditions or life-threatening diseases, such as COVID-19. Even under an expedited approval process, however, priority review may take up to six months or more from the time of application. In fact, the FDA previously announced the issuance of EUAs for COVID-19 vaccines will also requires at least two months of follow-up safety data after trial participants have been fully vaccinated.
The FDA’s issuance of EUAs to Pfizer’s and Moderna’s vaccines signifies that the US Department of Health and Human Services (HHS) has concluded: (1) COVID-19 is a serious or life-threatening disease; (2) it is reasonable to believe that the vaccine may be effective in treating or preventing the disease; (3) the known and potential benefits of the vaccine outweigh the known and potential risks; and (4) there is no adequate, approved, and available alternative.
Can Employers Mandate Employee Inoculation
With the impact of COVID-19 on business and the economy only continuing to intensify, many employers want to know if they can require their employees to receive one of these COVID-19 vaccines. As a threshold matter, it is important to remember that FDA approval via a EUA is different from full FDA approval. It remains somewhat unclear whether employers may require employees to be inoculated with a vaccine approved only pursuant to a EUA.
Practically speaking, some feel that the language within the EUAs could preclude employers from enforcing a requirement to take a vaccine issued under a EUA, though this issue has never been legally tested. When a vaccine is issued under a EUA, the FDA (and the vaccination provider) has an obligation to inform vaccine recipients about its potential benefits and risks, the extent to which such benefits and risks are unknown, whether any alternative products are available, and “that they have the option to accept or refuse the vaccine.” This language comes from the federal statute governing the EUA.
While this statement would seem to preclude mandatory vaccination—at least during a EUA stage—it is probable that this directive is towards government entities—in other words, prohibiting the government from forcing the public at large to receive the vaccine. It does not appear targeted towards private employers and their ability to condition an individual’s continued employment on taking the vaccine. (This analysis may be different in unionized settings governed by a collective bargaining agreement.)
Assuming that the language within the EUA is not an issue, other laws touch on the ability of an employer to mandate inoculation of its workforce.
At present, there is no OSHA standard that would mandate employers to offer a COVID-19 vaccine when one becomes available. Similarly, OSHA has not yet provided guidance on COVID-19 vaccines. There is some speculation in the legal community that OSHA may use the OSH Act’s so-called General Duty Clause to issue citations to employers that fail to offer COVID-19 vaccines. OSHA issues citations under its General Duty Clause when no specific OSHA standard applies.
In a 2009 letter of interpretation, OSHA previously said that employers that wished to require employees to receive a seasonal flu vaccine could do so, subject to certain exceptions. OSHA emphasized that employees need to be properly informed of the benefits of the vaccinations. It clarified that if employees refuse the vaccine due to a reasonable belief that they have a medical condition creating a real danger of serious illness or death (for example, a serious reaction to the vaccine), they may be protected as a whistleblower under Section 11(c) of the Occupational Safety and Health Act.
Ultimately, OSHA’s statutory authority to issue a General Duty Clause citation will depend on a variety of factors, including (1) guidance from the CDC and OSHA on use of the vaccine in the workplace, and (2) the strength of the employer’s COVID-19 safety and health program and whether it follows other guidance from public health officials.
On December 16, 2020, the EEOC updated its ongoing COVID-19 guidance with questions-and-answers specifically addressing mandatory COVID-19 vaccination policy issues. In sum, the guidance stated that employers can implement and enforce mandatory COVID-19 vaccination policies for employees, with certain exceptions and caveats.
More specifically, the EEOC stated that employers can require that employees receive the COVID-19 vaccine as a condition of returning to, or remaining in, the workplace. However, employers must attempt to accommodate employees who, due to medical disabilities or sincerely-held religious beliefs, decline or refuse to receive the vaccine. If an employer determines, based on objective evidence, that the presence of an unvaccinated employee (i.e., one who declines or refuses to be vaccinated against COVID-19 for disability or religious reasons) presents a “direct threat to the health and safety of persons in the workplace that cannot be reduced or eliminated through a reasonable accommodation,” the employer can exclude the employee from the workplace. When the employer excludes an unvaccinated employee from the workplace due to the perceived direct threat presented by his or her presence in the workplace, the employer may not automatically terminate the employee, but instead must assess whether other accommodations, such as remote work, can be provided.
According to the EEOC, administration of a COVID-19 vaccine by an employer, or by a third-party with which the employer has contracted to provide vaccinations to employees, is not a “medical examination” for purposes of the Americans with Disabilities Act (ADA). Similarly, employers can either administer the vaccine or requiring its employees to provide proof of vaccination without implicating the Genetic Information Non-Discrimination Act (GINA).
Employers with unionized workforces should be mindful of the National Labor Relations Act (NLRA) and any labor contract obligations. Absent a “legal” mandate that employees be vaccinated (by a federal, state or local government), a vaccine requirement likely would be considered a mandatory subject of bargaining that gives rise to a duty to bargain prior to implementation, unless there’s an existing labor contract that provides for a management right to implement such a decision without bargaining. Employers also should consider any labor contract language that would foreclose mandatory vaccination.
Even in a nonunionized setting, there are potential NLRA implications. Section 7 of the NLRA grants employees the right to engage in “concerted activities” for the purpose of “mutual aid and protection.” This provision may protect the rights of employees who engage in concerted activities with regard to a mandatory workplace vaccine—such as: protesting against a mandatory vaccination policy, organized office communications or flyers among coworkers concerning such a policy, or even simple coworker discussions about the vaccine.
State laws may also play a role with respect to regulation of a COVID-19 vaccine. To date, it does not appear that any state laws have been enacted regarding the COVID-19 vaccine. However, nearly all states require certain healthcare facilities to mandate, or at least offer various immunizations, such as seasonal influenza, Hepatitis B, and Measles, Mumps, Rubella (MMR), to their workers. Some states strictly limit the reasons a vaccination may be declined. At the same time, a significant number of other states—including Alabama, Kentucky and Tennessee—permit an employee to decline the influenza vaccination for any reason, so long as the employee was informed of the health risks beforehand. Therefore, before implementing any workplace COVID-19 vaccination policy, employers should consider any relevant legislative developments in their local jurisdictions.
Currently, there are more questions than answers regarding COVID-19 vaccines. Even though an employer likely can require its employees to get the COVID-19 vaccine, employers should weigh the full scope of employee relations concerns and potential legal challenges associated with doing so. While the federal government has issued projections which indicate that there may be enough vaccine to reach the vast majority of Americans who want to take it by early April 2021, initial supplies of both vaccines are expected to be limited throughout the remainder of 2020 and early 2021. As a result, widespread vaccines will not be available for most people or businesses right away, making compliance with a mandate tricky.
Employers should consider the practical impacts of a mandatory inoculation policy before mandating that employees get vaccinated, such as: the supply of available vaccines; pay or time off for the time an employee spends getting vaccinated, or who has side effects afterwards; and reimbursement or coverage of any cost for the vaccine.
You are STRONGLY encouraged to consult with your Labor & Employment counsel before designing and/or implementing any type of mandatory COVID-19 vaccination policy.