June 10, 2021

QUESTION:   “Can our hospital impose a requirement that all Medical Staff members get a COVID-19 vaccine?”

ANSWER:      While we are aware of some hospitals that are considering making COVID-19 vaccination mandatory for their Medical Staffs, most have not yet implemented such a policy.  We should also note that at least one health system is subject to a class action lawsuit filed by 117 of its employees because of its policy requiring employees to be vaccinated against COVID-19. Read about it here.

While the COVID-19 vaccination is proving to be remarkably effective in controlling the spread of the virus, one of the things that is holding some hospitals and health systems back is that the vaccine is currently under emergency use authorization, rather than the full vaccine authorization normally granted by the FDA.  However, at least two pharmaceutical companies are seeking full authorization from the FDA.  On May 7, 2021, Pfizer requested full approval for their COVID-19 vaccine from the FDA.  Moderna followed suit on June 1, 2021.

As noted above in Your Government at Work, the EEOC, in its updated guidance, emphasized that the federal employment equal opportunity laws do not prevent employers from requiring COVID-19 vaccinations, subject to reasonable accommodation provisions and other equal employment considerations.  But, the EEOC also notes that it is beyond its jurisdiction “to discuss the legal implications of [emergency use authorization] or the FDA approach.”

The section of the federal Food, Drug, and Cosmetic Act allowing emergency use authorization requires that individuals to whom a product subject to emergency use authorization is administered are informed of “the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”  A reasonable interpretation of this statute would give any individual the right to refuse a vaccine that has only been given emergency use authorization and thus preclude mandates.  A counter-interpretation is that an individual must be informed of the consequences of refusal to accept an emergency use authorization vaccination, such as, for example, automatic relinquishment of clinical privileges.

Nonetheless, if you do decide to move forward with a COVID-19 vaccination requirement, you want to make sure that it is consistent with your Medical Staff Governance Documents and Hospital policies.  There should not be anything to keep you from proceeding, but you will want to confirm this.  You will also want to check if your documents permit you to mandate any vaccines.  If they do, this could set the groundwork for a COVID-19 vaccine requirement.  For example, Medical Staff Bylaws often already require influenza vaccination.  Further, many Bylaws include a threshold eligibility criterion for appointment and privileges stating that an individual must complete all required health screenings and vaccinations prior to providing any patient care at the hospital and any appointment/privileges granted by the Board are conditioned on the individual’s compliance with those requirements.  If you have this threshold eligibility criterion language, it should be broad enough to include a COVID-19 vaccination requirement in a separate policy.