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.

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.

Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain for the 2018/19 Season: Interim Analysis.

INTRODUCTION: Influenza is an important cause of morbidity and mortality in Europe. Prevention by annual vaccination is most effective but with yearly vaccine reformulation to match circulating virus strains, vaccine safety must be continuously monitored. The European Medicines Agency published guidance on safety monitoring of influenza vaccines. METHODS: An enhanced safety surveillance study of GSK's inactivated quadrivalent influenza vaccine (IIV4) was conducted in Belgium, Germany, and Spain in influenza season 2018/19. The objective was to collect adverse event (AE) reports from subjects within 7 days of vaccination. A customized AE reporting card (AERC) with predefined AEs of interest was used to rapidly detect and evaluate potential new safety concerns. Interim results are presented here. RESULTS: Between week 40 and 52, 1060 vaccinated subjects were enrolled (31.0% Belgium, 26.2% Germany, and 42.7% Spain) covering all ages for which IIV4 is indicated (32.0% aged 6 months-17 years, 33.8% 18-65 years, and 34.2% over 65 years). Pediatric subjects less than 9 years old (n = 139) received two doses. Following dose 1 and dose 2, 98.2% and 100%, respectively, returned the completed AERC recording any AEs. Following dose 1 and dose 2, 454 and 34 subjects, respectively, reported at least one AE (most frequently expected general and injection site symptoms and respiratory symptoms). CONCLUSION: All reported AEs were expected as per summary product characteristics (smPC). No safety signals that impact public health or alter the benefit-risk profile of GSK's IIV4 were identified. Subjects from all vaccinated age groups were enrolled and the use of AERCs allowed rapid monitoring and analysis of reported AEs. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03688620. FUNDING: GlaxoSmithKline Biologicals SA.

Fluarix quadrivalent vaccine for influenza.

Influenza A and B infections cause significant morbidity and mortality. Over the past 30 years, two main influenza B strains have been circulating globally. The trivalent influenza vaccine used in the last 25 years contains one B strain, with approximately 31% of B strain disease coverage over the last 10 years. Fluarix quadrivalent vaccine, containing two A and two B strains, combines the components of two existing trivalent vaccines to prevent this mismatch. This review gives an overview of the published data about Fluarix quadrivalent vaccines, showing an immunogenicity and safety profile of the vaccine comparable with the two licensed trivalent vaccines containing the same strains, but with no evidence for efficacy in the literature. Future vaccines aim for a universal influenza vaccine that will give a long-lasting protection against all influenza strains.