Brand-Specific Enhanced Safety Surveillance of GSK’s Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season

Abstract

Introduction Seasonal influenza causes numerous deaths worldwide each year. Annual vaccination for disease prevention is crucial. Seasonal vaccines are updated each year to closely match circulating strains. Objective To comply with European Medicines Agency (EMA) guidance, an enhanced safety study was conducted to rapidly collect and assess adverse events (AEs) within 7 days following vaccination with GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in 2018/2019. Methods A customised AE reporting card (AERC) and standardised electronic data reporting application were used in Belgium, Germany and Spain in adult and paediatric subjects in this study. Results In 2018, 1060 subjects vaccinated with one dose of GSK's IIV4 were enrolled (all subjects in Belgium and Germany were adults, and 75% and 25% of subjects in Spain were children and adults, respectively). In Spain, 139 eligible children later received a second dose. Overall 1035 subjects completed the study. After dose 1 and dose 2, 98.3% and 100% of subjects, respectively, returned the completed AERC. Over the study period, 43.0% (456/1060 post dose 1) and 23.7% (33/139 post dose 2) of subjects reported at least one AE within 7 days after immunisation. The most frequently reported categories of AEs were General and Administration Site (e.g. injection site pain, swelling, erythema) and Respiratory Disorders (e.g. rhinorrhoea, cough, nasal congestion). There were no deaths and no serious AEs deemed related to GSK's IIV4. Conclusion In compliance with EMA guidance, this study design allowed for near real-time assessment of AEs. No safety signals were detected at any point during the study period. The study supports and confirms the acceptable safety profile of GSK's IIV4. ClinicalTrials.gov identifier NCT03688620.

Facial Paralysis Following Influenza Vaccination: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System Database

“…A similar pattern has also been seen for Guillain–Barre syndrome, wherein VAERS database analysis has shown possible association [ 9 ], but not a recent nested case–control study [ 12 ]. Also, the data from the surveillance studies differ from our study data [ 19 – 22 ]. While about 5% of the facial paralysis events were associated with Guillain–Barre syndrome in our study, no cases of Guillain–Barre syndrome were reported in the surveillance studies.…”

“…While about 5% of the facial paralysis events were associated with Guillain-Barre syndrome in our study, no cases of Guillain-Barre syndrome were reported in the surveillance studies. Most of these studies were conducted in the United Kingdom, but a recent surveillance study of 1060 vaccinated individuals from Belgium, Germany and Spain also showed similar findings [22]. Hence, if an association between facial paralysis and influenza vaccine does actually exist, the risk is likely to be very low.…”

“…The recent passive surveillance and cohort studies have failed to show an increased risk of facial paralysis [18][19][20][21][22]. Apart from the study by Zhou et al [13], the VAERS database has not been specifically studied for facial paralysis possibly due to influenza vaccine, although the adverse effects of influenza vaccine, in general, have been studied [28].…”

“…However, based on the findings of two subsequent wellconducted studies, the Institute of Medicine's Committee to Review Adverse Effects of Vaccines concluded that there was no causal relationship of inactivated influenza vaccine with Bell's palsy [14]. Subsequent studies have shown conflicting results [15,16], with most of the recent follow-up studies showing no increased risk [17][18][19][20][21][22].…”

Adverse Events of Interest Vary by Influenza Vaccine Type and Brand: Sentinel Network Study of Eight Seasons (2010-2018)

“…Interestingly, we did not find any signal about differences in AEIs from the enhanced surveillance we conducted for GSK in that year. The practices who took part were excluded from this analysis as we felt they might have increased their AEI awareness and recording [37]. It is possible that the EMA goals might be better achieved through systematic data collection across sentinel networks.…”