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A staged clinical development and evidence-generation framework for Group A Streptococcus vaccines
Alberto Cagigi1, Annette Kraus2, T Anh Wartel2
1International Vaccine Institute, Europe Regional Office, Solna, Sweden. alberto.cagigi@ivi.int.
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.
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