Depletion-of-susceptibles bias in influenza vaccine waning studies: how to ensure robust results.

Epidemiology and Infection
Marc LipsitchBruce Fireman

Abstract

Vaccine effectiveness studies are subject to biases due to depletion-of-persons at risk of infection, or at especially high risk of infection, at different rates from different groups (depletion-of-susceptibles bias), a problem that can also lead to biased estimates of waning effectiveness, including spurious inference of waning when none exists. An alternative study design to identify waning is to study only vaccinated persons, and compare for each day the incidence in persons with earlier or later dates of vaccination to assess waning in vaccine protection as a function of vaccination time (namely whether earlier vaccination would result in lower subsequent protection compared to later vaccination). Prior studies suggested under what conditions this alternative would yield correct estimates of waning. Here we define the depletion-of-susceptibles process formally and show mathematically that for influenza vaccine waning studies, a randomised trial or corresponding observational study that compares incidence at a specific calendar time among individuals vaccinated at different times before the influenza season begins will not be vulnerable to depletion-of-susceptibles bias in its inference of waning as a function of vaccination...Continue Reading

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Sep 12, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Marc Lipsitch
Sep 12, 2018·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·G Thomas RayBruce Fireman
Oct 18, 2018·American Journal of Epidemiology·Rebecca KahnMarc Lipsitch
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Jul 28, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·G Thomas RayBruce Fireman

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Citations

Feb 25, 2021·The New England Journal of Medicine·Noa DaganRan D Balicer
Jun 17, 2021·Vaccine·Marc Lipsitch, Rebecca Kahn
Dec 21, 2021·Annals of Internal Medicine·Michael P FayDean Follmann

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