Reasons for excluding adverse events in cost-effectiveness analyses of vaccines: A survey amongst authors

Although vaccines must adhere to the strictest safety standards in medicine, adverse events (AE) do occur occasionally. Even when clinically negligeable, these AE can still have health-economic implications, affecting the cost-effectiveness of vaccines. A review revealed that only 25 % of recent hea...

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Bibliographic Details
Published in:Vaccine Vol. 61; p. 127341
Main Authors: Luyten, Jeroen, van Hoek, Albert Jan
Format: Journal Article
Language:English
Published: Netherlands Elsevier Ltd 13.08.2025
Elsevier Limited
Subjects:
Adverse events
Allergy and Immunology
childhood
Children
Cost analysis
Cost effectiveness
Cost-Benefit Analysis
Data collection
Decision making
Drug-Related Side Effects and Adverse Reactions - economics
Economic evaluation
Economics
Guillain-Barre syndrome
HTA
Human papillomavirus
Humans
Immunization
medicine
Response rates
Rotavirus
Side effects
surveys
Surveys and Questionnaires
Vaccination
Vaccination - adverse effects
Vaccination - economics
Vaccines
Vaccines - adverse effects
Vaccines - economics
Viruses
Europe
Side effects
HTA
Cost-effectiveness
Vaccination
Economic evaluation
ISSN:0264-410X, 1873-2518, 1873-2518
Online Access:Get full text
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Summary:Although vaccines must adhere to the strictest safety standards in medicine, adverse events (AE) do occur occasionally. Even when clinically negligeable, these AE can still have health-economic implications, affecting the cost-effectiveness of vaccines. A review revealed that only 25 % of recent health-economic studies on childhood vaccines incorporated AE. In this study, we reached out to all corresponding authors of the reviewed articles who excluded AE to understand their rationale for exclusion (response rate 40 % (27/67)). The predominant reasons for not including AE were (1) that these were deemed too rare and insufficiently relevant (17/27, 65 %), (2) analysts adhered to previous methodologies that excluded AE (10/27, 35 %) and (3) there was a lack of sufficient data (9/27, 33 %). We argue that AE deserve more attention from analysts and that more efforts are needed to develop conceptual methods and collect data that enable meaningful incorporation in CEAs. •AE are excluded from most economic evaluations of (childhood) vaccines.•We investigated the reasons behind exclusion in a sample of authors of recent studies.•The most important reason stated was that AE were deemed to be irrelevant for cost-effectiveness.•We argue that AE can be an important factor of cost-effectiveness and must be analysed.•More research is needed to collect better data to enable a meaningful quantification of AE.
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ISSN:0264-410X
1873-2518
1873-2518
DOI:10.1016/j.vaccine.2025.127341