A SIMPLE AND POWERFUL TEST OF VACCINE WANING

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ID: 319378
2026
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Abstract
Determining whether vaccine efficacy wanes is important for individual and public decision making. Yet, quantification of waning is a subtle task. The classical approaches cannot be interpreted as measures of declining efficacy unless we impose unreasonable assumptions. Recently, formal causal estimands designed to quantify vaccine waning have been proposed. These estimands can be bounded under weaker assumptions, but the bounds are often too wide to make claims about the presence of waning. We propose a different approach: a formal test to assess whether a treatment effect is constant over time at the individual level. This test provides a considerable power gain over existing approaches and is valid under interpretable assumptions in vaccine trials. We illustrate the increase in power through real and simulated examples, using three different approaches to compute the test statistics. Two of these approaches are based solely on summary data, accessible from existing clinical trials. Beyond our test, we also give new results that bound the waning effect. We use our methods to reanalyze data from a randomized controlled trial of the BNT162b2 COVID-19 vaccine. While prior analysis did not establish waning, our test rejects the null hypothesis of no waning.
Reference Key
openalex_W7166875581 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Gellért Perényi, Matias Janvin, Mats Julius Stensrud
Journal american journal of epidemiology
Year 2026
DOI
10.1093/aje/kwag118
URL
https://doi.org/10.1093/aje/kwag118
Keywords Keywords not found

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