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Estimating Waning of Vaccine Effectiveness: A Simulation Study.

Ariel Nikas1, Hasan Ahmed2, Veronika I Zarnitsyna1

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Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
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Summary

New methods improve vaccine effectiveness (VE) waning estimation. A Cox model with time-vaccine interaction and optimized time partitioning accurately captures rapid VE decline, unlike scaled Schoenfeld residuals.

Keywords:
Cox proportional hazards modelestimating waning of vaccine effectivenessmultiscale modelingscaled Schoenfeld residualsvaccine efficacy

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Area of Science:

  • Immunology
  • Epidemiology
  • Biostatistics

Background:

  • Accurate estimation of vaccine protection is crucial for public health.
  • Existing statistical methods may inaccurately capture rapid, intraseasonal waning of vaccine-induced protection.
  • Rigorous investigation of these methods' limitations is needed.

Purpose of the Study:

  • To compare statistical methods for estimating vaccine effectiveness (VE) waning.
  • To assess the accuracy of different approaches in capturing time-varying vaccine protection.
  • To identify reliable methods for analyzing VE waning in acute viral infections.

Main Methods:

  • Generated simulated epidemic data using a multiscale, agent-based model.
  • Applied a framework for VE measures based on observational data richness.
  • Evaluated the performance of the Cox proportional hazards model and its extensions, including scaled Schoenfeld residuals and a proposed time-partitioning approach with a time-vaccine interaction term.

Main Results:

  • VE measures using hard-to-collect data (e.g., exact exposure timing) were accurate.
  • The Cox model extension with scaled Schoenfeld residuals proved unreliable for estimating the degree and functional form of VE waning.
  • Partitioning time and including a time-vaccine interaction term in the Cox model significantly improved VE waning estimation, even with rapid waning.

Conclusions:

  • Scaled Schoenfeld residuals are unreliable for quantifying VE waning, though useful for detecting it.
  • A Cox model incorporating time-vaccine interaction and optimized time partitioning offers a more reliable method for estimating VE waning.
  • These findings provide guidance for future analyses of vaccine effectiveness waning data.