Abstract

Routine infant immunization with live, oral rotavirus vaccines (LORVs) has had a major impact on severe gastroenteritis disease. Nevertheless, in high morbidity and mortality settings rotavirus remains an important cause of disease, partly attributable to the sub-optimal clinical efficacy of LORVs in those settings. Regardless of the precise immunological mechanism(s) underlying the diminished efficacy, the introduction of injectable next-generation rotavirus vaccines (iNGRV), currently in clinical development, could offer a potent remedy. In addition to the potential for greater clinical efficacy, precisely how iNGRVs are delivered (multiple doses to young infants; alongside LORVs or as a booster; co-formulated with Diphtheria-Tetanus-Pertussis (DTP)-containing vaccines), their pricing, and their storage and cold chain characteristics could each have major implications on the resultant health outcomes, on cost-effectiveness as well as on product preferences by national stakeholders and healthcare providers. To better understand these implications, we critically assessed whether there is a compelling public health value proposition for iNGRVs based on potential (but still hypothetical) vaccine profiles. Our results suggest that the answer is highly dependent on the specific use cases and potential attributes of such novel vaccines. Notably, co-formulation of iNGRVs with similar or greater efficacy than LORVs with a DTP-containing vaccine, such as DTP-Hib-HepB, scored especially high on potential impact, cost-effectiveness, and strength of preference by national stakeholders and health care providers in lower and middle income countries.

Highlights

  • The COVID-19 pandemic represents a clear example where the development of highly effective vaccines immediately led to strong use recommendations from global and national public health agencies and rapid uptake in the target populations where the vaccines were available

  • We first considered whether it was necessary to define and prioritize among specific injectable next-generation rotavirus vaccines (iNGRV) use cases, as it is possible that a single vaccine formulation may prove relevant for the various use cases discussed above

  • A high priority given to the low cost of goods (COGs) or combinability would point to the need to invest early to ensure it is possible to sufficiently optimize product manufacture or create specific formulations

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Summary

Introduction

The COVID-19 pandemic represents a clear example where the development of highly effective vaccines immediately led to strong use recommendations from global and national public health agencies and rapid (though not yet optimal) uptake in the target populations where the vaccines were available. Termed “public health value propositions”, “business or investment cases”, or “full value of vaccine assessments”, these analyses aim to inform vaccine developers, donor agencies, recommending and funding bodies, and national authorities of the potential societal value of these vaccines in the context of other, competing interventions. They would integrate perspectives not just from recognized international experts, and from healthcare providers, caregivers, and potential vaccine recipients [4].

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