Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season

Cueva, Ignacio Salamanca de la; Cinconze, E.; Eckermann, Tamara; Nwoji, Ugo; Godderis, Lode; Lu, E; Martínez-Gómez, Xavier; Wang, Huajun; Yanni, Emad

doi:10.1007/s40264-021-01121-8

Cited by 6 publications

(1 citation statement)

References 12 publications

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“…In Europe, the European Medicines Agency began requiring annual enhanced safety surveillance for seasonal influenza vaccines in 2014 [ 15 ]. Following an initial feasibility study conducted in the 2015–2016 season [ 16 ], surveillance studies have been conducted for IIV4 in England in 2016–2017 [ 17 ] and 2017–2018 [ 18 ], and in Belgium, Germany and Spain in 2018–2019 [ 19 , 20 ], 2019–2020 [ 21 ] and 2020–2021 [ 22 ]. All these surveillance studies reported no safety concerns with IIV4, supporting the acceptable safety profile of the vaccine.…”

Section: Discussionmentioning

confidence: 99%

An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older

Dos Santos,

Devadiga,

Kim

et al. 2024

Drug Saf

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Introduction Seasonal influenza is associated with substantial public health burden. The objective of this study was to assess the safety of inactivated quadrivalent seasonal influenza vaccine (IIV4, Fluarix Tetra , GSK, Belgium) in subjects aged ≥ 6 months in Korea. Methods This prospective, observational, non-comparative, multi-centre post-marketing surveillance study was conducted in Korea in subjects aged ≥ 3 years for 6 years (2014–2020) and extended to subjects aged 6–35 months for 4 years (2018–2022). Subjects received IIV4 in routine clinical practice according to local prescribing information. Adverse events (AEs) were recorded over 21 days post-vaccination. Results The group aged ≥ 3 years included 701 subjects (mean 31.97 years, range 3–86 years, 46.36% male), and the group aged 6–35 months included 687 subjects (mean 16.31 months, 47.02% male). In the group aged ≥ 3 years, 98 subjects (13.98%) reported 140 AEs, of which 42 events in 34 subjects (4.85%) were adverse reactions to vaccine (ARVs). Most of the ARVs were expected, mainly administration site reactions. There were seven mild unexpected ARVs. In the group aged 6–35 months, 248 AEs were reported in 149/687 subjects (21.69%). ARVs were reported in 25/687 subjects (3.64%, 29 events); one was considered unexpected. There were five serious AEs overall, none of which were considered related. Conclusion No safety concerns were found during this surveillance study of IIV4 in subjects aged ≥ 6 months in Korea. The findings of this study suggest IIV4 is safe and well tolerated for use in all age groups with a vaccine indication. Graphical Abstract Supplementary Information The online version contains supplementary material available at 10.1007/s40264-024-01395-8.

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Section: Discussionmentioning

confidence: 99%

An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older

Dos Santos,

Devadiga,

Kim

et al. 2024

Drug Saf

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Brand-Specific Enhanced Safety Surveillance Study of GSK’s Quadrivalent Seasonal Influenza Vaccine, Conducted During the COVID-19 Pandemic, in Belgium, Germany and Spain, for the 2020/21 Season

et al. 2021

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Introduction Seasonal influenza poses a major public health burden worldwide. Influenza vaccines, updated yearly to match circulating strains based on World Health Organization (WHO) recommendations, are the cornerstone of prevention and require regular monitoring. The COVID-19 pandemic is expected to cause logistical, site access and medical staff constraints and could affect the safety profile of influenza vaccines. Methods Following European Medicines Agency guidance, an enhanced safety surveillance (ESS) study assessed the frequency and severity of predefined and other adverse events (AEs) occurring within 7 days of receiving GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4), in Belgium, Germany and Spain in 2020/21, using adverse drug reaction (ADR) cards. Results During the 2020/21 influenza season, 1054 participants vaccinated with GSK’s IIV4 were enrolled (all adults in Belgium and Germany, 30% adults/70% children in Spain); 96 eligible children received a second dose. Overall, 1042 participants completed the study. After doses 1 and 2, 98.9% and 100% of participants, respectively, returned their completed ADR card. After doses 1 and 2, 37.8% (398/1054) and 13.5% (13/96) of participants, respectively, reported at least one AE. The most frequently reported categories of AEs were “general disorders and administration site conditions” (e.g. injection site pain) and “nervous system disorders” (e.g. headache). There were no deaths or serious AEs deemed related to GSK’s IIV4. Conclusion This ESS study assessed AEs in near real time. The COVID-19 pandemic did not alter the safety profile of GSK’s IIV4. No safety signals were detected during the study, which confirms the excellent safety profile of GSK’s IIV4. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00571-y.

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Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season

de la Cueva,

Gerber,

Hastie

et al. 2024

Drug Saf

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Background Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring. Objective We assessed the frequency and severity of adverse events within 7 days of administering GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season. Methods In this enhanced safety surveillance study, adults who received GSK’s IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months–17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination. Results In total, 1332 participants (53.6% female) received at least one dose of GSK’s IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months–17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18–65 years (59.7%), followed by those aged 3–17 years (47.0%), >65 years (35.7%), and 6–35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent. Conclusions Across all age and risk groups for serious disease, no serious adverse events related to GSK’s IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK’s IIV4 across all recommended age groups. Clinical Trial Registration ClinicalTrials.gov number: not applicable. Graphical Abstract

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Safety Profile of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season

Cited by 6 publications

References 12 publications

An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older

An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014–2022) Following the Introduction of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older

Brand-Specific Enhanced Safety Surveillance Study of GSK’s Quadrivalent Seasonal Influenza Vaccine, Conducted During the COVID-19 Pandemic, in Belgium, Germany and Spain, for the 2020/21 Season

Enhanced Safety Surveillance of GSK’s Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season

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