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

Biologicals 2026 Open access

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Authors: Laurence De Moerlooze, Alexander Allen, Ilaria Bartalesi, Marco Cavaleri, Miles P. Davenport, Bradford D. Gessner, Brenda Gomes, Kyla Hayford, Alane Izu, Héctor S. Izurieta, Victoria A. Jenkins, Randee Kastner
+13 more Phil Krause, Joshua Nealon, Lidia Oostvogels, Arto A. Palmu, Robert Charles Read, Carla Saénz, Dean K. Smith, Suely Tuboi, Frank Vandendriessche, Marc F.D. Baay, Danielle Craig, Pieter Neels, Kaatje Bollaert
DOI: 10.1016/j.biologicals.2026.101886
Cited by: 1
References: 77

Abstract

• 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.

Fields of Study & Subjects

Influenza Virus Research Studies Vaccine Coverage and Hesitancy Statistical Methods in Clinical Trials

Publication details

Journal / source
Biologicals
Publisher
Elsevier BV
Volume
95
Pages
101886–101886
Publication date
9 May 2026
Language
EN