More to Offer Than Direct Clinical Benefit: FDA's Vaccine Licensure Process Ignores Population Health and Social Determinants of Disease.

ABSTRACT

The current US Food and Drug Administration (FDA) licensure process underestimates the potential benefits of vaccines at both the individual and population levels by considering only direct clinical outcomes of vaccination. While all approved vaccines do protect the person who takes them from poor clinical outcomes for a specific infectious disease, many vaccines also have the potential to offer measurable, direct nonclinical benefits. For example, coronavirus disease 2019 (COVID-19) vaccinations for school-aged children may prevent school absenteeism. Also, by preventing infection or reducing its length and severity, some vaccines also protect-to some extent-the patient's immediate contacts from contracting the same disease. These nonclinical and population-level benefits are not considered as part of the FDA's current vaccine approval process, but they could be. We argue that the FDA's structured benefit-risk assessment framework, used for vaccine approvals, can and should consider both clinical and nonclinical benefits of vaccination when sufficient evidence exists to make an informed assessment. Including them could incentivize vaccine developers to measure additional vaccination effects, inform population health, and address health inequalities-including inequalities in the social determinants of health.