Labor, Employment and Immigration Update

Final FDA Approval of Pfizer-BioNTech Vaccine Clears a Path for Employers to Mandate Vaccines

August 23, 2021

The U.S. Food and Drug Administration (FDA) today issued full approval for the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, clearing a path for more employers and other institutions to mandate vaccinations. While lawsuits challenging vaccine mandates by private employers have failed to gain much traction thus far, the mere potential for litigation over vaccine mandates when COVID-19 vaccines were available only under the FDA’s emergency use authorization complicated many employers’ decisions over whether to issue such mandates. With voluntary vaccination incentive programs having largely played out, the FDA’s full approval of the Pfizer vaccine is welcome news for employers who wish to mandate the vaccine as a means toward fulfilling their responsibilities under the Occupational Safety and Health Act (OSHA) to provide a safe work environment for their workforces.

Now that hundreds of millions of people have received and safely tolerated the mRNA vaccines produced by Pfizer and Moderna and the FDA has given the Pfizer vaccine its full imprimatur, many more employers are expected to mandate that their employees get fully vaccinated as a condition of employment. Moderna has stated publicly that it is in the process of filing its application with the FDA as well. No timeline has been announced for FDA approval of that vaccine. Johnson & Johnson has not yet filed its application, but in late April said it planned to file later this year.

To be sure, employers implementing vaccine mandates will still need to confront a number of issues. First and foremost, employers must accommodate genuine religious objections and medical conditions that prevent an employee from taking the vaccine. Employers need to be thoughtful about their communications with employees on accommodation issues and their procedures for obtaining, assessing, and evaluating accommodation requests, whether for medical or religious reasons, to ensure fair and consistent treatment and genuine need for such accommodations. Employers also will have to continue to consider how to satisfy their duties to provide a safe workplace given there may be individuals unable to become vaccinated. Such considerations may include implementation of testing, masking, and social distancing requirements, all of which may be subject to an ever-changing array of state and local rules.

Additionally, many employers planning to mandate vaccines are grappling with the decision of whether to require proof of vaccination from their employees or to operate on an honor system. While requiring proof of vaccination leads to some modest confidentiality burdens under the Americans With Disabilities Act, given that vaccination status is medical information, the potential for cheating by the vaccine-hesitant and the morale issues that an honor system may generate could lead many employers to require that employees provide proof of vaccination. In fact, some counties have already mandated that employers ascertain the vaccination status of their employees. Employers must also be aware of medical record retention rules under OSHA if they choose to ask employees for copies of their vaccine cards.

Another complication that employers will no doubt face is concerns from employees who are vaccinated themselves but who have immunocompromised family members or young children ineligible for vaccines. Such individuals may have strong objections to returning to a workplace where unvaccinated colleagues are potentially present — a concern that has gained traction in light of the “breakthrough” infections reported among vaccinated individuals as the delta variant spreads.

If you have questions about vaccine mandates or any other COVID-19 workplace concerns, please contact the Sidley Austin LLP employment team.

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