PMID- 36991538
OWN - NLM
STAT- MEDLINE
DCOM- 20230331
LR  - 20230508
IS  - 1750-2659 (Electronic)
IS  - 1750-2640 (Print)
IS  - 1750-2640 (Linking)
VI  - 17
IP  - 3
DP  - 2023 Mar
TI  - Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in 
      Germany and Spain (2021/2022 season) using an electronic patient-reported outcome 
      system for vaccine safety remote monitoring.
PG  - e13098
LID - 10.1111/irv.13098 [doi]
LID - e13098
AB  - BACKGROUND: Seasonal influenza epidemics are managed through vaccination each 
      winter in the European Union, to prevent infections, complications, and deaths. 
      As circulating virus strains vary unpredictably, vaccines are reformulated 
      annually, and their safety monitored rapidly and continuously at the start of 
      each season, following European Medicines Agency guidelines.Seasonal influenza 
      epidemics are managed through vaccination each winter in the European Union, to 
      prevent infections, complications, and deaths. As circulating virus strains vary 
      unpredictably, vaccines are reformulated annually, and their safety monitored 
      rapidly and continuously at the start of each season, following European 
      Medicines Agency guidelines. METHODS: This enhanced safety surveillance study 
      assessed pre-specified and other adverse events (AEs) occurring within 7 days of 
      GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in children and 
      adults in Spain and Germany. As the study was conducted during the COVID-19 
      pandemic (2021/2022 season), data were collected electronically, using a web 
      portal or call center. RESULTS: Safety was assessed in 737 participants (median 
      age 49 and 9 years in Germany and Spain, respectively, 19.3% with a chronic 
      medical condition). After Dose 1 and Dose 2, respectively, 332 (45.1%) and 5 
      (26.3%) participants reported at least one AE, primarily pre-specified AEs. The 
      most common AEs after Dose 1 (adults and children) were injection site pain, 
      swelling or erythema, headache, and fatigue. After Dose 2 (in children), the most 
      common AEs were injection site pain, rhinorrhea, fatigue, and decreased appetite. 
      No new or unexpected safety issues were identified. CONCLUSION: This study 
      supports and confirms the safety profile of GSK's IIV4 in all age groups with a 
      vaccine indication. The new electronic safety reporting method (with response 
      rates of 75.4% following Dose 1 and 100% following Dose 2) provides an 
      alternative for future studies to reduce the burden on sites or in case site 
      visits are not feasible.
CI  - (c) 2023 GlaxoSmithKline Biologicals SA. Influenza and Other Respiratory Viruses 
      published by John Wiley & Sons Ltd.
FAU - Dos Santos, Gael
AU  - Dos Santos G
AUID- ORCID: 0000-0001-8623-3478
AD  - GSK, Wavre, Belgium.
FAU - Eckermann, Tamara
AU  - Eckermann T
AD  - Hausarztpraxis Heimeranplatz, Munich, Germany.
FAU - Martinez-Gomez, Xavier
AU  - Martinez-Gomez X
AUID- ORCID: 0000-0003-4583-9734
AD  - Hospital Universitari Vall d'Hebron, Barcelona, Spain.
FAU - Parra, Jose
AU  - Parra J
AUID- ORCID: 0000-0002-5152-4715
AD  - GSK, Wavre, Belgium.
FAU - Nwoji, Ugo
AU  - Nwoji U
AUID- ORCID: 0000-0002-2946-703X
AD  - GSK, Rockville, Maryland, USA.
FAU - Salamanca de la Cueva, Ignacio
AU  - Salamanca de la Cueva I
AUID- ORCID: 0000-0003-0561-9913
AD  - Instituto Hispalense de Pediatria, Sevilla, Spain.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Influenza Other Respir Viruses
JT  - Influenza and other respiratory viruses
JID - 101304007
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Child
MH  - Adult
MH  - Humans
MH  - *Influenza Vaccines
MH  - *Influenza, Human/prevention & control/epidemiology
MH  - Spain/epidemiology
MH  - Seasons
MH  - Pandemics/prevention & control
MH  - *COVID-19/epidemiology
MH  - Germany/epidemiology
MH  - Patient Reported Outcome Measures
PMC - PMC10040952
OTO - NOTNLM
OT  - influenza
OT  - post-marketing surveillance
OT  - safety
OT  - vaccination
COIS- Gael Dos Santos is employed by GSK and holds shares in GSK. Tamara Eckermann 
      declares that her institution received payment from GSK for the conduct of the 
      study. Jose Parra and Ugo Nwoji were employed by GSK at the time of the study. 
      Xavier Martinez-Gomez declares having received payment from GSK for slide 
      materials and from AstraZeneca for lecture, outside of the submitted work. 
      Ignacio Salamanca de la Cueva declares that his institution received payment from 
      GSK for the conduct of the study, by contract approved by the corresponding 
      ethical committees and health authorities, and outside of this study, for other 
      trials from other vaccine manufacturers. He has also received grants/honoraria as 
      a consultant/advisor/speaker for attending conferences and practical courses from 
      GSK and other vaccine manufacturers. The authors declare no other financial and 
      non-financial relationships and activities.
EDAT- 2023/03/31 06:00
MHDA- 2023/03/31 06:41
PMCR- 2023/03/26
CRDT- 2023/03/30 00:03
PHST- 2022/12/14 00:00 [received]
PHST- 2023/01/10 00:00 [accepted]
PHST- 2023/03/31 06:41 [medline]
PHST- 2023/03/30 00:03 [entrez]
PHST- 2023/03/31 06:00 [pubmed]
PHST- 2023/03/26 00:00 [pmc-release]
AID - IRV13098 [pii]
AID - 10.1111/irv.13098 [doi]
PST - ppublish
SO  - Influenza Other Respir Viruses. 2023 Mar;17(3):e13098. doi: 10.1111/irv.13098.