During the 2017/18 influenza season, an enhanced safety surveillance study was done in England in accordance with European Medicine Agency advice to detect any potential safety concerns connected with influenza vaccine. The primary goal was to determine the incidence rates of adverse events occurring within seven days of Fluarix Tetra immunisation. Seasonal influenza vaccine was delivered to patients in nine General Practices in accordance with local recommendations. To evaluate the incidence rates of adverse events experienced after vaccination, events following immunisation were gathered utilising customised cards in conjunction with electronic health records [EHRs].
The study lasted from September 1st until November 30th, 2017. A total of 23,939 people were vaccinated, with 16,433 of them receiving Fluarix Tetra. Fluarix Tetra had a cumulative incidence rate of 7.25 percent for occurrences reported by card alone, and 9.21 percent when paired with EHR data. The kind and frequency of reported incidents corresponded to the Fluarix Tetra Summary of Product Characteristics. The study backs up and confirms Fluarix Tetra’s safety profile.