PMID- 31617965 OWN - NLM STAT- MEDLINE DCOM- 20200528 LR - 20231027 IS - 1750-2659 (Electronic) IS - 1750-2640 (Print) IS - 1750-2640 (Linking) VI - 14 IP - 1 DP - 2020 Jan TI - Enhanced Passive Safety Surveillance (EPSS) confirms an optimal safety profile of the use of MF59((R)) -adjuvanted influenza vaccine in older adults: Results from three consecutive seasons. PG - 61-66 LID - 10.1111/irv.12685 [doi] AB - BACKGROUND: 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((R)) -adjuvanted influenza vaccine (Fluad) is the first and the only licensed adjuvanted seasonal influenza vaccine in Europe. OBJECTIVE: Our objective was to summarize the safety data of Fluad over three consecutive seasons. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CI - (c) 2019 The Authors. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd. FAU - Panatto, Donatella AU - Panatto D AUID- ORCID: 0000-0002-2677-0551 AD - Department of Health Sciences, University of Genoa, Genoa, Italy. AD - Interuniversity Research Center on Influenza and other Transmissible Infections (CIRI-IT), Genoa, Italy. FAU - Haag, Mendel AU - Haag M AD - Clinical Development, Seqirus Netherlands B.V., Amsterdam, the Netherlands. FAU - Lai, Piero Luigi AU - Lai PL AD - Department of Health Sciences, University of Genoa, Genoa, Italy. AD - Interuniversity Research Center on Influenza and other Transmissible Infections (CIRI-IT), Genoa, Italy. FAU - Tomczyk, Sylvie AU - Tomczyk S AD - Seqirus USA Inc., Cambridge, MA, USA. FAU - Amicizia, Daniela AU - Amicizia D AD - Department of Health Sciences, University of Genoa, Genoa, Italy. AD - Interuniversity Research Center on Influenza and other Transmissible Infections (CIRI-IT), Genoa, Italy. FAU - Lino, Maria Maddalena AU - Lino MM AD - Seqirus IT SPA, Siena, Italy. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20191016 PL - England TA - Influenza Other Respir Viruses JT - Influenza and other respiratory viruses JID - 101304007 RN - 0 (Adjuvants, Immunologic) RN - 0 (Influenza Vaccines) RN - 0 (MF59 oil emulsion) RN - 0 (Polysorbates) RN - 7QWM220FJH (Squalene) SB - IM MH - Adjuvants, Immunologic/*administration & dosage/adverse effects MH - Aged MH - Aged, 80 and over MH - Female MH - Humans MH - Influenza A virus/genetics/immunology MH - Influenza Vaccines/*administration & dosage/adverse effects MH - Influenza, Human/*prevention & control MH - Male MH - Polysorbates/*administration & dosage/adverse effects MH - Seasons MH - Squalene/*administration & dosage/adverse effects MH - Vaccination/adverse effects PMC - PMC6928029 OTO - NOTNLM OT - Fluad OT - adjuvanted influenza vaccine OT - enhanced safety surveillance OT - influenza OT - pharmacovigilance; reactogenic COIS- Mendel Haag, Sylvie Tomczyk, and Maria Maddalena Lino are full-time employees of Seqirus, a CSL company, and hold shares in CSL ltd. Donatella Panatto, Piero Luigi Lai, and Daniela Amicizia declare no conflict of interest. EDAT- 2019/10/17 06:00 MHDA- 2020/05/29 06:00 PMCR- 2020/01/01 CRDT- 2019/10/17 06:00 PHST- 2019/03/07 00:00 [received] PHST- 2019/08/06 00:00 [revised] PHST- 2019/09/18 00:00 [accepted] PHST- 2019/10/17 06:00 [pubmed] PHST- 2020/05/29 06:00 [medline] PHST- 2019/10/17 06:00 [entrez] PHST- 2020/01/01 00:00 [pmc-release] AID - IRV12685 [pii] AID - 10.1111/irv.12685 [doi] PST - ppublish SO - Influenza Other Respir Viruses. 2020 Jan;14(1):61-66. doi: 10.1111/irv.12685. Epub 2019 Oct 16.