Quantitative approaches for causality assessment of adverse events following immunisation for COVID-19 vaccines
Vaccine Research
; 8(1):73-80, 2021.
Article
in English
| CAB Abstracts | ID: covidwho-2026849
ABSTRACT
Vaccine safety surveillance is important to identify and manage adverse events following immunisation (AEFI) and avoid vaccine hesitancy. Currently, COVID-19 vaccines are administered to large numbers of people to try and curb the pandemic. In this paper, quantitative methods for causality assessment of AEFI are described. Qualitative methods for causality assessment involve an expert panel reviewing each AEFI report to determine whether the AEFI can be attributed to the vaccine. Each AEFI is determined to be classified as consistent, inconsistent, indeterminate or unclassifiable in terms of causality. Quantitative approaches can strengthen causality assessment outcomes. However, the potential for bias and errors should be considered for each safety signal identified. Vaccine and population specific factors may affect AEFI incidence, with a need to obtain background rates to frame safety signals identified into the local context. Several case scenarios from the vaccine safety surveillance in Brunei are used to illustrate the practical application of quantitative approaches for AEFI causality assessment (including comparison of AESI incidence to background rates and disproportionality analysis), which complement the traditional qualitative methods.
Host Resistance and Immunity [HH600]; Prion, Viral, Bacterial and Fungal Pathogens of Humans [VV210]; Mathematics and Statistics [ZZ100]; adverse effects; coronavirus disease 2019; disease incidence; human diseases; immunization; pandemics; quantitative techniques; safety; surveillance; vaccines; viral diseases; disease course; disease prevention; health protection; vaccination; immune sensitization; man; Severe acute respiratory syndrome coronavirus 2; Brunei Darussalam; APEC countries; ASEAN Countries; Borneo; South East Asia; Asia; Sunda Islands; high income countries; very high Human Development Index countries; Homo; Hominidae; primates; mammals; vertebrates; Chordata; animals; eukaryotes; Severe acute respiratory syndrome-related coronavirus; Betacoronavirus; Coronavirinae; Coronaviridae; Nidovirales; positive-sense ssRNA Viruses; ssRNA Viruses; RNA Viruses; viruses; adverse reactions; Brunei; SARS-CoV-2; viral infections; disease progression
Full text:
Available
Collection:
Databases of international organizations
Database:
CAB Abstracts
Topics:
Vaccines
Language:
English
Journal:
Vaccine Research
Year:
2021
Document Type:
Article
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