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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Veröffentlicht in:	Vaccine Jg. 61; S. 127341
Hauptverfasser:	Luyten, Jeroen, van Hoek, Albert Jan
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Netherlands Elsevier Ltd 13.08.2025 Elsevier Limited
Schlagworte:	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
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Abstract	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.
AbstractList	AbstractAlthough 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. 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.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. 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. 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. 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.
ArticleNumber	127341
Author	van Hoek, Albert Jan Luyten, Jeroen
Author_xml	– sequence: 1 givenname: Jeroen surname: Luyten fullname: Luyten, Jeroen organization: Leuven Unit for HTA Research, Department of Public Health and Primary Care, Kapucijnenvoer 35, 3000 Leuven, Belgium – sequence: 2 givenname: Albert Jan surname: van Hoek fullname: van Hoek, Albert Jan organization: Rijksinstituut voor Volksgezondheid & Milieu, Antonie van Leeuwenhoeklaan 9, 3721, Bilthoven, the Netherlands
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Cites_doi	10.1002/jmv.29693 10.1016/j.jval.2023.06.014 10.1007/s40273-023-01252-z 10.1007/s40273-013-0056-3 10.1016/j.jval.2024.03.013 10.1016/j.jval.2020.07.011 10.1016/j.socscimed.2021.114523 10.1016/j.puhe.2023.07.008 10.1016/j.socscimed.2019.03.025
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Snippet	Although vaccines must adhere to the strictest safety standards in medicine, adverse events (AE) do occur occasionally. Even when clinically negligeable, these... AbstractAlthough vaccines must adhere to the strictest safety standards in medicine, adverse events (AE) do occur occasionally. Even when clinically...
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SubjectTerms	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
Title	Reasons for excluding adverse events in cost-effectiveness analyses of vaccines: A survey amongst authors
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