Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection

In influenza vaccination studies assessing vaccine efficacy (VE), both specific and non-specific endpoints (outcomes) are used. We present a formula for the relationship between VE against influenza-related outcomes (VEO), specific and non-specific, and that against influenza infection (VEI). In its...

Full description

Saved in:
Bibliographic Details
Main Authors: Jozef Nauta, Walter EP Beyer, Erna PJA Kimp
Format: Article
Language:English
Published: Milano University Press 2022-03-01
Series:Epidemiology, Biostatistics and Public Health
Online Access:https://riviste.unimi.it/index.php/ebph/article/view/17439
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849761392907780096
author Jozef Nauta
Walter EP Beyer
Erna PJA Kimp
author_facet Jozef Nauta
Walter EP Beyer
Erna PJA Kimp
author_sort Jozef Nauta
collection DOAJ
description In influenza vaccination studies assessing vaccine efficacy (VE), both specific and non-specific endpoints (outcomes) are used. We present a formula for the relationship between VE against influenza-related outcomes (VEO), specific and non-specific, and that against influenza infection (VEI). In its simplest form, the formula comprises two additional parameters: the influenza attack rate among unvaccinated subjects, and the relative risk of the outcome for influenza infected subjects versus non-infected subjects. Both parameters may show large between-seasonal variation, which translates to a large between-seasonal variation of  VEO estimates. With the full form of the formula it can be shown that, contrary to popular believe, VEO may be greater than VEI. We argue that interpreting VEO estimates in terms of “low” or “high” is not possible without taking the costs of an outcome case into account. We conclude that the decision to use a non-specific endpoint as surrogate for influenza infection should be taken in the awareness of these limitations.
format Article
id doaj-art-6938bf6ff02e403a83339958d7b62c18
institution DOAJ
issn 2282-0930
language English
publishDate 2022-03-01
publisher Milano University Press
record_format Article
series Epidemiology, Biostatistics and Public Health
spelling doaj-art-6938bf6ff02e403a83339958d7b62c182025-08-20T03:06:02ZengMilano University PressEpidemiology, Biostatistics and Public Health2282-09302022-03-0114410.2427/12367Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infectionJozef Nauta0Walter EP Beyer1Erna PJA KimpAbbott Established Pharmaceuticals Division Weespjos.nauta@abbott.comIn influenza vaccination studies assessing vaccine efficacy (VE), both specific and non-specific endpoints (outcomes) are used. We present a formula for the relationship between VE against influenza-related outcomes (VEO), specific and non-specific, and that against influenza infection (VEI). In its simplest form, the formula comprises two additional parameters: the influenza attack rate among unvaccinated subjects, and the relative risk of the outcome for influenza infected subjects versus non-infected subjects. Both parameters may show large between-seasonal variation, which translates to a large between-seasonal variation of  VEO estimates. With the full form of the formula it can be shown that, contrary to popular believe, VEO may be greater than VEI. We argue that interpreting VEO estimates in terms of “low” or “high” is not possible without taking the costs of an outcome case into account. We conclude that the decision to use a non-specific endpoint as surrogate for influenza infection should be taken in the awareness of these limitations.https://riviste.unimi.it/index.php/ebph/article/view/17439
spellingShingle Jozef Nauta
Walter EP Beyer
Erna PJA Kimp
Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection
Epidemiology, Biostatistics and Public Health
title Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection
title_full Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection
title_fullStr Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection
title_full_unstemmed Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection
title_short Toward a better understanding of the relationship between influenza vaccine efficacy against specific and non-specific endpoints and vaccine efficacy against influenza infection
title_sort toward a better understanding of the relationship between influenza vaccine efficacy against specific and non specific endpoints and vaccine efficacy against influenza infection
url https://riviste.unimi.it/index.php/ebph/article/view/17439
work_keys_str_mv AT jozefnauta towardabetterunderstandingoftherelationshipbetweeninfluenzavaccineefficacyagainstspecificandnonspecificendpointsandvaccineefficacyagainstinfluenzainfection
AT walterepbeyer towardabetterunderstandingoftherelationshipbetweeninfluenzavaccineefficacyagainstspecificandnonspecificendpointsandvaccineefficacyagainstinfluenzainfection
AT ernapjakimp towardabetterunderstandingoftherelationshipbetweeninfluenzavaccineefficacyagainstspecificandnonspecificendpointsandvaccineefficacyagainstinfluenzainfection