The safety of vaccines with annual strains updates need continuous monitoring. The European Medicines Agency (EMA) provides guidelines so vaccine manufacturers can rapidly identify any safety concerns.

To comply with EMA guidance, this enhanced safety study was conducted to rapidly collect and assess adverse events (AEs) following routine vaccination with GSK’s inactivated quadrivalent seasonal influenza vaccine in 2018/2019, in children and adults in Belgium, Germany and Spain.

In the 1060 subjects included, 43.0% and 23.7% reported at least one AE after dose 1 and dose 2, respectively. No unexpected safety issues were found with GSK’s vaccine, which supports and confirms the acceptable safety profile of GSK’s IIV4.