Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence – a meeting report

• Alternative methods for vaccine licensure are needed for situations when phase III clinical trials are not feasible. • From emergency use to full approval, integration of RWE alongside traditional data sources needs to be promoted. • Safe, ethically robust human infection models can generate insights into transmission biology, CoPs, and vaccine efficacy. • Pragmatic randomised trials can offer a balance between methodological rigour and real-world applicability. • Post-licensure pragmatic trials offer a regulatory pathway for confirming and/or expanding pre-licensure data.