Vaccine Hesitancy: Experimentalism as Regulatory Opportunity

Ana Santos Rutschman, Saint Louis University School of Law
Timothy L. Wiemken, Saint Louis University


This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost the efficacy of each vaccine received by a child or adult.

Current regulatory approaches subsume staggering into vaccine hesitancy frameworks. The scientific literature, however, has begun to explore possible benefits of specific forms of staggering, as well as the need for the production of more information on different forms of vaccine staggering. The Essay thus argues in favor of separate treatment for vaccine staggering as opposed to vaccine refusal and further notes that the current conceptual and regulatory problems surrounding vaccine staggering point to broader systemic issues in vaccination policy and vaccine data infrastructure in the United States.

The Essay proceeds as follows. It begins with a brief background section on the evolution of vaccination schedules. Part II describes different types of behaviors that may result in departures from vaccination schedules, highlighting the disjunction between behavioral heterogeneity and the unified regulatory framework, which currently lumps together materially different behaviors under the “vaccine hesitancy” umbrella. Part III then focuses specifically on the case of vaccine staggering and advocates for a separate treatment of staggering behaviors as opposed to other types of departures from official vaccination schedules. The Essay further argues that the persistence of unitary treatments of vaccine-related behaviors increases uncertainty and promotes conflicting discourses outside scientific circles, an especially concerning phenomenon at a time in which outbreaks of vaccine-preventable disease are once again becoming more frequent. The Essay concludes by briefly pointing out that the specific problems surrounding current approaches to vaccine staggering also illustrate systemic limitations of the vaccine data infrastructure in the United States.