Cargando…

Causality assessment of adverse events following immunization: the problem of multifactorial pathology

The analysis of Adverse Events Following Immunization (AEFI) is important in a balanced epidemiological evaluation of vaccines and in the issues related to vaccine injury compensation programs. The majority of adverse reactions to vaccines occur as excessive or biased inflammatory and immune respons...

Descripción completa

Detalles Bibliográficos
Autor principal: Bellavite, Paolo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7111503/
https://www.ncbi.nlm.nih.gov/pubmed/32269767
http://dx.doi.org/10.12688/f1000research.22600.2
_version_ 1783513302237708288
author Bellavite, Paolo
author_facet Bellavite, Paolo
author_sort Bellavite, Paolo
collection PubMed
description The analysis of Adverse Events Following Immunization (AEFI) is important in a balanced epidemiological evaluation of vaccines and in the issues related to vaccine injury compensation programs. The majority of adverse reactions to vaccines occur as excessive or biased inflammatory and immune responses. These unwanted phenomena, occasionally severe, are associated with many different endogenous and exogenous factors, which often interact in complex ways. The confirmation or denial of the causal link between an AEFI and vaccination is determined pursuant to WHO guidelines, which propose a four-step analysis and algorithmic diagramming. The evaluation process from the onset considers all possible “other causes” that might explain the AEFI and thus exclude the role of the vaccine. Subsequently, even if there was biological plausibility and temporal compatibility for a causal association between the vaccine and the AEFI, the guidelines ask to look for any possible evidence that the vaccine could not have caused that event. Such an algorithmic method presents several concerns that are discussed here, in the light of the multifactorial nature of the inflammatory and immune pathologies induced by vaccines, including emerging knowledge of genetic susceptibility to adverse effects. It is proposed that the causality assessment could exclude a consistent association of the adverse event with the vaccine only when the presumed "other cause" is independent of an interaction with the vaccine. Furthermore, the scientific literature should be viewed not as an exclusion criterion but as a comprehensive analysis of all the evidence for or against the role of the vaccine in causing an adverse reaction. Given these inadequacies in the evaluation of multifactorial diseases, the WHO guidelines need to be reevaluated and revised. These issues are discussed in relation to the laws that, in some countries, regulate the mandatory vaccinations and the compensation for those who have suffered serious adverse effects.
format Online
Article
Text
id pubmed-7111503
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher F1000 Research Limited
record_format MEDLINE/PubMed
spelling pubmed-71115032020-04-07 Causality assessment of adverse events following immunization: the problem of multifactorial pathology Bellavite, Paolo F1000Res Opinion Article The analysis of Adverse Events Following Immunization (AEFI) is important in a balanced epidemiological evaluation of vaccines and in the issues related to vaccine injury compensation programs. The majority of adverse reactions to vaccines occur as excessive or biased inflammatory and immune responses. These unwanted phenomena, occasionally severe, are associated with many different endogenous and exogenous factors, which often interact in complex ways. The confirmation or denial of the causal link between an AEFI and vaccination is determined pursuant to WHO guidelines, which propose a four-step analysis and algorithmic diagramming. The evaluation process from the onset considers all possible “other causes” that might explain the AEFI and thus exclude the role of the vaccine. Subsequently, even if there was biological plausibility and temporal compatibility for a causal association between the vaccine and the AEFI, the guidelines ask to look for any possible evidence that the vaccine could not have caused that event. Such an algorithmic method presents several concerns that are discussed here, in the light of the multifactorial nature of the inflammatory and immune pathologies induced by vaccines, including emerging knowledge of genetic susceptibility to adverse effects. It is proposed that the causality assessment could exclude a consistent association of the adverse event with the vaccine only when the presumed "other cause" is independent of an interaction with the vaccine. Furthermore, the scientific literature should be viewed not as an exclusion criterion but as a comprehensive analysis of all the evidence for or against the role of the vaccine in causing an adverse reaction. Given these inadequacies in the evaluation of multifactorial diseases, the WHO guidelines need to be reevaluated and revised. These issues are discussed in relation to the laws that, in some countries, regulate the mandatory vaccinations and the compensation for those who have suffered serious adverse effects. F1000 Research Limited 2020-04-14 /pmc/articles/PMC7111503/ /pubmed/32269767 http://dx.doi.org/10.12688/f1000research.22600.2 Text en Copyright: © 2020 Bellavite P http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Opinion Article
Bellavite, Paolo
Causality assessment of adverse events following immunization: the problem of multifactorial pathology
title Causality assessment of adverse events following immunization: the problem of multifactorial pathology
title_full Causality assessment of adverse events following immunization: the problem of multifactorial pathology
title_fullStr Causality assessment of adverse events following immunization: the problem of multifactorial pathology
title_full_unstemmed Causality assessment of adverse events following immunization: the problem of multifactorial pathology
title_short Causality assessment of adverse events following immunization: the problem of multifactorial pathology
title_sort causality assessment of adverse events following immunization: the problem of multifactorial pathology
topic Opinion Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7111503/
https://www.ncbi.nlm.nih.gov/pubmed/32269767
http://dx.doi.org/10.12688/f1000research.22600.2
work_keys_str_mv AT bellavitepaolo causalityassessmentofadverseeventsfollowingimmunizationtheproblemofmultifactorialpathology