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

ABSTRACT: 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.

SUBMITTER: Bellavite P

PROVIDER: S-EPMC7111503 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Bellavite Paolo P

F1000Research 20200309

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 l ...[more]

PMID: 32269767

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Project description:BackgroundWith over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana's Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system's performance in meeting its objectives.MethodsA case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC's Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system's attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews.ResultsIn all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated "fear of being victimized" as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics.ConclusionThe AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.

Project description:PurposeThis meta-epidemiological study aimed to systematically review case reports regarding sports nutrition supplements and adverse events (AEs), specifically addressing the issue of causality assessments.MethodsThrough a systematic literature search we identified all published case reports of AEs associated with sports nutrition supplements between 1 January 2008 and 1 March 2019. Data regarding AEs, suspected supplements, relevant causality assessment factors and the reporting of clinical reasoning and/or systematic causality assessment methods were extracted.ResultsIn all, 72 publications were included, reporting 134 supplements and 37 different AEs in 97 patients (85% males; median age: 30 years [range: 14-60]). Information regarding previous health and regular prescription drugs was not presented in 30% (29/97) and 46% (45/97) of cases, respectively. In 23% (22/97) of the cases, no alternative cause was mentioned. Clinical reasoning was identified in 63% (61/97), and in 13% (8/61) of these, a systematic causality assessment method was applied. In cases with clinical reasoning, a theoretic rationale (92% vs 78%, P = 0.05), a description of previous cases (90% vs 72%, P = 0.021) and body fluid analysis (18% vs 3%, P = 0.027) were reported to a greater extent. Among cases with clinical reasoning, the application of a systematic causality assessment method captured additional important aspects: use of medication (100% vs 55%, P = 0.015), alcohol use (88% vs 43%, P = 0.020) and illicit drug use (88% vs 40%, P = 0.011).ConclusionsIn published case reports where sports nutrition supplements were suspected to have caused AEs, essential factors for causality assessment were left out in a non-negligible proportion. Clinical reasoning was identified in most cases whereas a systematic causality assessment method was applied in a minority. Factors of importance for causality assessment were reported to a greater extent in cases including clinical reasoning, and the application of a systematic causality assessment method captured additional aspects of importance.

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

Publications

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

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