Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report.
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| Title: | Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report. |
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| Authors: | de Moerlooze L; P95, Leuven, Belgium., Allen A; Field Epidemiology and Health Protection Units, Public Health England, London, UK., Bartalesi I; GSK, Siena, Italy., Cavaleri M; EMA, Amsterdam, Netherlands., Davenport MP; Infection Analytics Program, Kirby Institute, UNSW Sydney, Kensington, NSW, 2052, Australia., Gessner BD; EpiVac Consulting, Anchorage, AK, USA., Gomes B; Brazilian Health Regulatory Agency (ANVISA), Brasilia, Brazil., Hayford K; Vaccine Medical Affairs, Pfizer, Inc., New York, NY, USA., Izu A; South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa., Izurieta HS; Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA., Jenkins VA; Bavarian Nordic Belgium, Brussels, Belgium., Kastner R; Takeda Pharmaceuticals International AG, Zurich, Switzerland., Krause P; Bethesda, MD, USA., Nealon J; Sanofi, Lyon, France., Oostvogels L; MinervaX ApS, Frederiksberg, Denmark., Palmu AA; FVR - Finnish Vaccine Research, Tampere, Finland., Read RC; NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK; Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK., Saenz C; Department of Evidence and Intelligence for Action in Health, Pan American Health Organization, Washington, DC, USA., Smith DK; IABS North America, Canada., Tuboi S; Takeda Pharmaceuticals Brazil, São Paulo, Brazil., Vandendriessche F; Ficaja Farma, Huldenberg, Belgium., Baay M; P95, Leuven, Belgium., Craig D; Coalition for Epidemic Preparedness Innovations, P.O. BOX 123, Torshov, 0412, Oslo, Norway., Neels P; IABS, Geneva, Switzerland. Electronic address: pieter.neels@vaccine-advice.be., Bollaert K; P95, Leuven, Belgium. Electronic address: kaatje.bollaerts@p-95.com. |
| Source: | Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2026 May 09; Vol. 95, pp. 101886. Date of Electronic Publication: 2026 May 09. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Academic Press Country of Publication: England NLM ID: 9004494 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-8320 (Electronic) Linking ISSN: 10451056 NLM ISO Abbreviation: Biologicals Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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