A staged clinical development and evidence-generation framework for Group A Streptococcus vaccines.

Abstract

Group A Streptococcus (Strep A) causes substantial global morbidity and mortality, yet vaccine development faces scientific, regulatory, and strategic challenges. We propose a platform-agnostic, staged clinical development and evidence-generation framework aligning trial feasibility with public health priorities. Laboratory-confirmed symptomatic pharyngitis could provide a feasible pivotal efficacy endpoint for initial licensure, subject to regulatory agreement. Complementary efficacy, effectiveness, and implementation studies could then generate evidence across diverse populations and outcomes.