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Immune Correlates and Vaccine Immunobridging: Statistical Innovations, Challenges, and Opportunities.
Marco Carone1,2,3, Charles J Wolock4, Antonio Olivas-Martinez1
1Department of Biostatistics, University of Washington, Seattle, Washington, USA.
The Journal of Infectious Diseases
|September 19, 2025
Summary
Immunobridging uses statistical methods to approve new vaccines by comparing immune responses to licensed ones. This ensures new vaccines offer meaningful protection for specific uses.
Area of Science:
- Vaccinology
- Biostatistics
- Epidemiology
Background:
- Immunobridging is a regulatory strategy for vaccine approval.
- It relies on immunogenicity endpoints in trials comparing investigational and approved vaccines.
- Justification requires showing trial success predicts meaningful protection.
Conclusions:
- Recent statistical advancements enhance the validity of immunobridging.
- These methods support the use of immunogenicity data for vaccine approval.
- The approach ensures investigational vaccines provide worthwhile protection.
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