FDA Grants Emergency Use Authorization For COVID-19 Vaccine
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As most everyone knows by now, the Food and Drug Administration (FDA) granted emergency use authorization for Pfizer’s COVID-19 vaccine in the U.S on Friday, December 11, and the first Americans have already begun to receive the vaccine. The government is expecting an initial 2.9 million doses of the Pfizer vaccine to be distributed in the coming weeks. Authorization for emergency use for the Moderna vaccine is expected this week as well, and projections indicate that there may be enough vaccine to reach the vast majority of Americans who want to take it by early April 2021. Given the upward trajectory of the infection and death rates in the U.S., employer interest in the vaccine is extremely high. In particular, employers are asking whether they are permitted to, or should require employees to take the vaccine.
In order to understand the response, it is important to first understand the current state of affairs. Distribution of the COVID-19 vaccine has not yet been licensed under the FDA’s usual processes. The vaccine is currently available only pursuant to an EUA. The FDA’s Emergency Use Authorization (EUA), is a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.” Under this EUA, the FDA has not yet compiled all the evidence and clinical data that it would normally examine before fully approving a drug for public distribution and use. The FDA has, however, stated that the vaccine has met its “rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization” and that “its known and potential benefits clearly outweigh its known and potential risks.”
In the wake of these unique circumstances, it remains somewhat unclear whether employers may require employees to be inoculated with a vaccine approved only pursuant to an EUA. In these uncharted waters, the language for EUAs could preclude employers from enforcing a requirement to take a vaccine issued under an EUA. Given the severity of the COVID-19 pandemic, however, more guidance is anticipated, as the initial doses of the vaccine are distributed.
Once the vaccine receives full approval from the FDA, employers should have the right to require employees to receive it, subject to some limitations and subject to further guidance from the Equal Employment Opportunity Commission (EEOC). As of today, neither the CDC nor the EEOC have issued any guidance regarding the workplace law implications of requiring the COVID-19 vaccination.
Regardless of any EEOC and/or CDC guidance that will be forthcoming, employers should begin to consider how strongly they wish to encourage employees to take the vaccine when it becomes available. The date on which workers become eligible to receive the vaccine largely depends on the industry they are employed in. Those in the healthcare field or some similarly designated essential activity, will of course be the first to receive the vaccine.
Another consideration is that if employers require employees to be vaccinated, they will be subject to the almost-certain requirement to accommodate employee requests for exemptions based upon medical circumstances or sincerely held religious beliefs. Further, if an employer implements a vaccine mandate, the employer should also be prepared to articulate its job-related reason for requiring the vaccine. For example, there may be no basis for requiring an employee who is working remotely to be inoculated.
Various polls have suggested that while the public’s willingness to take a COVID-19 vaccine may be increasing, a large segment of the workforce – perhaps one third or more – will likely be skeptical of the vaccine or may even refuse to take it. As a practical matter, employers should try to anticipate how a vaccine mandate would be received by its workforce and consider how to respond if a large segment of the workforce pushes back.
Employers should also consider specifically which job classifications would be required to receive a vaccine, the logistics of delivering the vaccine or otherwise ensuring it is easily administered, and the general employee and public relations aspects of such an undertaking. Options may include offering incentives to employees to encourage them to get vaccinated, and investigating how to make it easier for workers to obtain the vaccination.
The pandemic continues to require employers to follow new developments and remain fluid in their approach to the associated challenges. The emerging availability of COVID-19 vaccines will be no different. As wider availability of the vaccine draws closer, employers must start contemplating and be prepared with at least a policy framework and a communications plan. We will continue to monitor developments related to the new vaccines and related workplace questions that arise, including any specific guidelines from the CDC or the EEOC.
