tetano
Editor, Senior Moderator
Influenza Other Respir Viruses. 2019 Oct 16. doi: 10.1111/irv.12685. [Epub ahead of print] [h=1]Enhanced Passive Safety Surveillance (EPSS) confirms an optimal safety profile of the use of MF59[SUP]?[/SUP] -adjuvanted influenza vaccine in older adults: Results from three consecutive seasons.[/h]
Panatto D[SUP]1,[/SUP][SUP]2[/SUP], Haag M[SUP]3[/SUP], Lai PL[SUP]1,[/SUP][SUP]2[/SUP], Tomczyk S[SUP]4[/SUP], Amicizia D[SUP]1,[/SUP][SUP]2[/SUP], Lino MM[SUP]5[/SUP].
[h=3]Author information[/h] 1 Department of Health Sciences, University of Genoa, Genoa, Italy. 2 Interuniversity Research Center on Influenza and other Transmissible Infections (CIRI-IT), Genoa, Italy. 3 Clinical Development, Seqirus Netherlands B.V., Amsterdam, the Netherlands. 4 Seqirus USA Inc., Cambridge, MA, USA. 5 Seqirus IT SPA, Siena, Italy.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] In 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[SUP]?[/SUP] -adjuvanted influenza vaccine (Fluad™) is the first and the only licensed adjuvanted seasonal influenza vaccine in Europe.
[h=4]OBJECTIVE:[/h] Our objective was to summarize the safety data of Fluad™ over three consecutive seasons.
[h=4]METHODS:[/h] A 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.
[h=4]RESULTS:[/h] Total 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.
[h=4]CONCLUSIONS:[/h] Our 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.
? 2019 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.
[h=4]KEYWORDS:[/h] Fluad™; adjuvanted influenza vaccine; enhanced safety surveillance; influenza; pharmacovigilance; reactogenic
PMID: 31617965 DOI: 10.1111/irv.12685
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Panatto D[SUP]1,[/SUP][SUP]2[/SUP], Haag M[SUP]3[/SUP], Lai PL[SUP]1,[/SUP][SUP]2[/SUP], Tomczyk S[SUP]4[/SUP], Amicizia D[SUP]1,[/SUP][SUP]2[/SUP], Lino MM[SUP]5[/SUP].
[h=3]Author information[/h] 1 Department of Health Sciences, University of Genoa, Genoa, Italy. 2 Interuniversity Research Center on Influenza and other Transmissible Infections (CIRI-IT), Genoa, Italy. 3 Clinical Development, Seqirus Netherlands B.V., Amsterdam, the Netherlands. 4 Seqirus USA Inc., Cambridge, MA, USA. 5 Seqirus IT SPA, Siena, Italy.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] In 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[SUP]?[/SUP] -adjuvanted influenza vaccine (Fluad™) is the first and the only licensed adjuvanted seasonal influenza vaccine in Europe.
[h=4]OBJECTIVE:[/h] Our objective was to summarize the safety data of Fluad™ over three consecutive seasons.
[h=4]METHODS:[/h] A 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.
[h=4]RESULTS:[/h] Total 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.
[h=4]CONCLUSIONS:[/h] Our 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.
? 2019 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd.
[h=4]KEYWORDS:[/h] Fluad™; adjuvanted influenza vaccine; enhanced safety surveillance; influenza; pharmacovigilance; reactogenic
PMID: 31617965 DOI: 10.1111/irv.12685
Free full text