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dc.contributor.authorClothier, H
dc.contributor.authorLawrie, J
dc.contributor.authorLewis, G
dc.contributor.authorRussell, M
dc.contributor.authorCrawford, N
dc.contributor.authorButtery, J
dc.identifier.citationClothier, H., Lawrie, J., Lewis, G., Russell, M., Crawford, N. & Buttery, J. (2020). SAEFVIC: Surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2018. Communicable Diseases Intelligence Quarterly Report, 44,
dc.description.abstractBackground: SAEFVIC is the Victorian surveillance system for adverse events following immunisation (AEFI). It enhances passive surveillance by also providing clinical support and education to vaccinees and immunisation providers. This report summarises surveillance, clinical and vaccine pharmacovigilance activities of SAEFVIC in 2018. Methods: A retrospective observational cohort study of AEFI reports received by SAEFVIC in 2018, compared with previous years since 2008. Data were categorised by vaccinee demographics of age, sex, pregnancy and Indigenous status, vaccines administered and AEFI reactions reported. Age cohorts were defined as infant (0-12 months); young child (1-4 years); school-aged (5-17 years); adult (18-64 years); and older person (65+ years). Proportional reporting ratios were calculated for signal investigation of serious adverse neurological events with all vaccines and with influenza vaccines. Clinical support services and educational activities are described. Results: SAEFVIC received 1730 AEFI reports (26.8 per 100,000 population), with 9.3% considered serious. Nineteen percent (n = 329) attended clinical review. Annual AEFI reporting trends increased for infants, children and older persons, but were stable for school-aged and adult cohorts. Females comprised 55% of all reports and over 80% of reports among adults. There were 17 reports of AEFI in pregnant women and 12 (0.7%) in persons identifying as Indigenous Australians. A possible signal regarding serious adverse neurological events (SANE) was detected, but was not supported by signal validation testing. A clinical investigation is ongoing. Two deaths were reported coincident to immunisation with no evidence of causal association. Conclusion: SAEFVIC continues to provide robust AEFI surveillance supporting vaccine safety monitoring in Victoria and Australia, with new signal detection and validation methodologies strengthening capabilities.
dc.publisherGovernment Department of Health and Ageing
dc.titleSAEFVIC: Surveillance of adverse events following immunisation (AEFI) in Victoria, Australia, 2018
dc.typeJournal Article
melbourne.affiliation.departmentMelbourne School of Population and Global Health
melbourne.affiliation.departmentPaediatrics (RCH)
melbourne.source.titleCommunicable Diseases Intelligence Quarterly Report
dc.rights.licenseCC BY-NC-ND
melbourne.openaccess.statusPublished version
melbourne.contributor.authorClothier, Hazel
melbourne.contributor.authorLawrie, Jock
melbourne.contributor.authorRussell, Melissa
melbourne.contributor.authorCrawford, Nigel
melbourne.contributor.authorButtery, Jim
melbourne.accessrightsAccess this item via the Open Access location

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