By Conn Maciel Carey’s COVID-19 Task Force
With the availability of a safe, effective COVID-19 vaccine edging closer and closer, employers understandably have a number of questions regarding their role in the workplace – whether and when they can require a vaccination, what exceptions are required in a mandatory vaccination program, and whether they should require (as opposed to encourage and facilitate) the COVID-19 vaccine for employees once it becomes available.
This summer, the World Health Organization reported that nearly 200 potential vaccines were currently being developed in labs across the world, and as of mid-October, disclosed that more than 40 had advanced to clinical stage testing on humans. Drug manufacturers estimate that a vaccine will be ready and approved for general use by the end of this year, although logistically not ready for widespread distribution until mid-2021.
Indeed, just over the past couple of weeks, Pfizer and Moderna have made promising announcements regarding the results of their clinical trials. Namely, on Monday, November 9, 2020, Pfizer and BioNTech announced that a vaccine candidate against COVID-19 achieved success in the firm interim analysis from the Phase 3 study. The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. According to the announcement, submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) is planned for soon after the required safety milestone is achieved, which is currently expected to occur this week. Additionally, as reported by the National Institutes of Health (NIH) on November 16, 2020, there have been promising interim results from a clinical trial of a NIH-Moderna COVID-19 vaccine. An independent data and safety monitoring board (DSMB) reported that the vaccine candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%.
As the reality of a vaccination nears, employers are inquiring whether they can and should mandate the vaccine for their employees.
- Can Employers Require Employees to Take the COVID-19 Vaccine?
As a threshold matter, it should be noted that according to a member of the federal advisory panel on immunizations that will be making recommendations to the CDC on who should get the first doses, vaccines authorized under the FDA’s emergency use authority, as these COVID-19 vaccinations will be at the start, cannot be mandated. Any COVID-19 vaccine brought to market under an EUA instead of the normal non-emergency approval process will, by necessity, lack long term safety data.
In general though, outside the context of EUA vaccine, employers can require vaccination as a term and condition of employment, but such practice is not without limitations, nor is it always recommended. Although the issue is only now coming to the forefront because of COVID-19, mandatory vaccinations in the workplace are not new, and have been particularly prevalent among healthcare providers for decades. Some variability exists under federal law and among federal agencies, but for the most part, mandatory vaccination programs are permissible, as long as employers consider religious accommodation requests under Title VII of the Civil Rights Act of 1964 (Title VII) and medical accommodation requests under the Americans with Disabilities Act (ADA). Continue reading