ArticleBMJ open2020
Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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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.
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.
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Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia.BMC medical informatics and decision making · 2024Article
- Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia.Vaccines · 2024Article
- The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February - August 2021.The Medical journal of Australia · 2022Observational
- Article
- Observational
- Change Point Analysis for Detecting Vaccine Safety Signals.Vaccines · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo determine how soon after commencement of the seasonal influenza vaccination programme, the AusVaxSafety active vaccine safety surveillance system, currently in use across Australia, would have detected a safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies).
designSimulation study.
settingWestern Australian vaccine influenza coverage and adverse event surveillance data. OUTCOME MEASURES: Simulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years.
participantsNone.
resultsWe estimated a >90% probability of a safety signal being detected by AusVaxSafety based on solicited reports for either fever or medical attendance at or before the week ending 28 March 2010, 3 weeks after the start of vaccine distribution. Suspension of the national paediatric influenza vaccination programme as a result of the passive adverse events surveillance operating at the time did not occur until 23 April 2010.
conclusionsActive vaccine safety surveillance leading to rapid detection of a safety signal would likely have resulted in earlier suspension of Fluvax from the vaccination programme, prevention of many febrile convulsions and maintenance of public confidence in influenza vaccination for young children.
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Registered trials
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