ArticleInfluenza and other respiratory viruses2020
Enhanced Passive Safety Surveillance (EPSS) confirms an optimal safety profile of the use of MF59
Article in Influenza and other respiratory viruses, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.
- Pooled it
- Coverage and appropriateness of influenza vaccination in adults ≥ 60 y: Provider contribution and adherence to Italian national recommendations.Human vaccines & immunotherapeutics · 2026Article
- Enhanced passive safety surveillance of the MF59-adjuvanted quadrivalent influenza vaccine in the elderly during the 2021/22 influenza season.Human vaccines & immunotherapeutics · 2023Article
- Three seasons of enhanced safety surveillance of a cell culture-based quadrivalent influenza vaccine.Human vaccines & immunotherapeutics · 2023Article
- [Health Technology Assessment: a value-based tool for the evaluation of healthcare technologies. Reassessment of the cell-culture-derived quadrivalent influenza vaccine: Flucelvax TetraJournal of preventive medicine and hygiene · 2022Article
- Enhanced Passive Safety Surveillance (EPSS) confirms an optimal safety profile of the use of MF59Influenza and other respiratory viruses · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Europe, the enhanced safety surveillance (ESS) of seasonal influenza vaccines is mandatory, in order to detect any potential increase in reactogenicity when the vaccine composition is updated. The MF59
objectiveOur objective was to summarize the safety data of Fluad™ over three consecutive seasons.
methodsA passive approach to ESS (EPSS) was adopted, in which reporting of spontaneous adverse events (AEs) by vaccinees and vaccine exposure was estimated, in order to generate a near real-time reporting rate. EPSS was conducted in Italy during the 2015, 2016, and 2017 influenza seasons in the primary care setting. All AEs reported within 7 days following immunization were analyzed by season, type and seriousness. Fisher's exact test was used to compare frequencies between seasons.
resultsTotal exposure accounted for approximately 1,000 doses of Fluad™ for each season. A total of 0.5% (2015), 0.7% (2016), and 0.5% (2017) individual case safety reports (ICSRs) were received, corresponding to a total of 9 (2015), 18 (2016), and 12 (2017) spontaneous AEs. The frequencies of AEs of interest were below those expected on the basis of the known safety profile of the vaccine. Most AEs were mild-to-moderate in severity. No between-season difference was found.
conclusionsOur analyses confirmed that the safety data observed were consistent with the known safety profile of Fluad™, which has been amply established over the last 20 years. No significant changes in the safety profile were observed.
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