Evidence map›Paper›PMID 28342074›Full record

ArticleDrug safety2017

Evaluation of 'SAEFVIC', A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia.

Hazel J Clothier, Nigel W Crawford, Melissa Russell, Heath Kelly, Jim P Buttery

Abstract read
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Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Article
  3. A Qualitative Study to Assess Challenges Faced During AEFI Surveillance.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2025
    Article
  4. Nuvaxovid NVX-CoV2373 vaccine safety profile: real-world data evidence after 100,000 doses, Australia, 2022 to 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2024
    Observational
  5. Article
  6. Article
  7. Information systems for vaccine safety surveillance.Human vaccines & immunotherapeutics · 2022
    Review
  8. Article
  9. Article
  10. Article
  11. Observational
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Hazel J ClothierSAEFVIC, Murdoch Childrens Research Institute, Melbourne, VIC, Australia. hazel.clothier@mcri.edu.au.
Nigel W CrawfordSAEFVIC, Murdoch Childrens Research Institute, Melbourne, VIC, Australia.
Melissa RussellSchool of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.
Heath KellyNational Centre of Epidemiology and Population Health, Australian National University, Canberra, ACT, Australia.
Jim P ButterySAEFVIC, Murdoch Childrens Research Institute, Melbourne, VIC, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAustralia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called 'SAEFVIC' (Surveillance of Adverse Events Following Vaccination In the Community).

objectiveThe aim of this study was to evaluate Victoria's current AEFI surveillance system 'SAEFVIC' and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia.

methodsWe conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination.

resultsAEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35-3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1-58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population.

conclusionSAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia.

Indexed as

AdolescentAdultAdverse Drug Reaction Reporting SystemsAustraliaChildChild, PreschoolFemaleHumansImmunizationInfantMalePharmacovigilancePopulation SurveillanceRetrospective StudiesVaccinationVaccinesVaccines

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.