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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 Dos Santos, Gaël Wang, Hao Jindal, Pooja Rybo, Maria Roul, Hélène Pallem, Sridevi Martínez Gómez, Xavier Institut Català de la Salut [Dos Santos G] GSK, Wavre, Belgium. [Wang H] GSK, Amsterdam, The Netherlands. [Jindal P] Parexel International, Chandigarh, India, C/O GSK, Rockville, MD, USA. [Rybo M] PPD, Sundbyberg, Sweden. [Roul H] Keyrus Life Science, Levallois-Perret, France, C/O GSK, Wavre, Belgium. [Pallem S] Keyrus Life Science, New York, NY, USA, C/O GSK, New York, NY, USA. [Martínez Gómez X] Vall d’Hebron Hospital Universitari, Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Vacunes antigripals Farmacovigilància COVID-19 (Malaltia) CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Vaccines::Viral Vaccines::Influenza Vaccines ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Evaluation Studies as Topic::Product Surveillance, Postmarketing DISEASES::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::vacunas::vacunas víricas::vacunas de la gripe TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::estudios de evaluación como asunto::vigilancia de productos comercializados ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus Infectious disease; Influenza; Vaccine safety Enfermedad infecciosa; Gripe; Seguridad de las vacunas Malaltia infecciosa; Grip; Seguretat de les vacunes 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. GlaxoSmithKline Biologicals SA funded this study (study number 207750) and was involved in all stages of the study, including analysis of the data. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publication of this present manuscript, including the Journal’s Rapid Service Fee. 2022-12-09T13:42:10Z 2022-12-09T13:42:10Z 2022-02 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Dos Santos G, Wang H, Jindal P, Rybo M, Roul H, Pallem S, et al. 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. Infect Dis Ther. 2022 Feb;11:463–83. 2193-6382 https://hdl.handle.net/11351/8636 10.1007/s40121-021-00571-y 34961900 000735967500001 http://hdl.handle.net/11351/8636 eng Infectious Diseases and Therapy;11 https://doi.org/10.1007/s40121-021-00571-y Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess application/pdf Springer Scientia