Lorna Hazell, Saad AW Shakir, Andrew Finlay, Hannah Coulter, Robert S Brody and Dennis Brooks
Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza vaccine recommended for use in children aged 2 to 17 years vaccinated as part of the seasonal influenza immunisation campaign in the UK. Following a successful pilot in 2015, we report results from a second season of passive enhanced safety surveillance (ESS) for 2016.
To measure and assess the frequencies of suspected adverse drug reactions (sADRs) in children receiving Fluenz® Tetra during the early 2016 influenza season in England.
Vaccinees or parents/guardians received a Safety Report Card (SRC) to return if children experienced sADRs after vaccination with Fluenz® Tetra. At participating sites, 47 general practices and 44 primary schools in England, immunisation teams recorded numbers of SRCs distributed. The study was approved by an NHS Research Ethics Committee (Brighton and Sussex NRES Committee).
Between 24th September 2016 and 30th November 2016, 14,511 children were vaccinated at study sites, with eight different vaccine lots used. In total, 12,610 SRCs were issued for 5,501 children (43.6%) aged 2 to 4 years, 6,457 (51.2%) aged 5 to 10 years, 651 (5.2%) aged 11 to 17 years and one child (0.1%) aged outside the 2 to 17 year old licensed age-group. Of 135 SRCs returned, 112 reported at least one sADR. The most frequently reported sADRs were rhinorrhoea (n=30), pyrexia (23), headache (20) and cough (19). No serious sADRs were reported and no sADRs were reported within the immune system organ class. The pattern of sADRs in the current ESS season was similar to that reported in the 2015 season.
Reporting of sADRs via ESS remains low (~1%). No evidence from the limited data available suggests an increased frequency of minor expected events or other safety signals compared to ESS data from the 2015 season. The ESS method appears to achieve the requirement for a monitoring method to detect possible immunogenic sADRs for each year’s vaccine.
Study co-sponsored by DSRU and AstraZeneca.