Submitted to the FDA's Vaccines and Related Biological Products Advisory Committee Docket for Public Comment (for the December 10, 2020 meeting)

Mandating Vaccines under an EUA

Under section 564(e)(1)(A)(ii)(III) of the Food, Drug and Cosmetics Act the Secretary of Health and Human Services, when providing an Emergency Use Authorization, needs to address whether mandates are permissible. Specifically, under “Required Conditions”, the act requires the Secretary

“to the extent practicable given the applicable circumstances described in subsection (b)(1), …. establish such  conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the  public health, including the following:

(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed —

(III) 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.”

While the FDA has in the past interpreted this language to prohibit mandates, we believe the language allows the Secretary discretion on whether the EUA would allow private business to mandate vaccines. We also believe that the question is an important and tricky policy question, and that the secretary should consider it. We believe VRBPAC, as an expert committee advising on an EUA, should consider and recommend on this. We hope the committee will consider, at the least, the following points in its consideration.

On one hand, it is ethically problematic to mandate a vaccine for which there is limited data, limited supply and access, and for which the full risks/benefits profile is not yet known. There may be as yet unknown risks or effectiveness limits, and workers should have a choice whether to take those risks. There are also concerns about the harms to trust, and increase in resistance, that a mandate may cause.

On the other hand, private business have suffered economic harms through the pandemic, and in some cases (for example, meat plants and nursing homes) were centers of outbreaks. Private businesses may desire to require vaccines to protect employees, consumers, and the public, and to protect their economic viability by messaging to customers and employees that they are acting for safety. If an EUA does not allow it, they do not have a choice.

These are not the only considerations, but they are some of the issues that should be on the table, and at the least, the issue should be given serious examination.

Thank you very much,

Dorit R. Reiss 
Professor of Law
UC Hastings College of the Law

Arthur Caplan
Mitty Professor of Bioethics
NYU Grossman School of Medicine

Richard N. Gottfried
Chair, NY State Assembly Health Committee

Ross D. Silverman, JD, MPH
Professor of Health Policy and Management
IU Fairbanks School of Public Health

Y. Tony Yang, ScD, LLM, MPH
Executive Director Center for Health Policy and Media Engagement
George Washington University School of Nursing

For the Vaccine Working Group on Ethics and Policy