Comparing the incidence of common adverse events of interest following influenza vaccination in the first season adjuvanted trivalent immunisation was introduced: English sentinel network annual report paper 2018/19 (Preprint)

Abstract

Vaccination is the most effective form of prevention of seasonal influenza; the UK has a national influenza vaccination programme to cover targeted population groups. Influenza vaccines are known to be associated with some common minor adverse events of interest (AEIs), but it is not known if the adjuvanted trivalent influenza vaccine (aTIV), first offered in the 2018/19 season) would be associated with more AEIs than other types of vaccines.

We aim to compare the incidence of AEIs associated with different types of seasonal influenza vaccines offered in the 2018/19 season.

We carried out a retrospective cohort study using computerised medical record data from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network database. We extracted data on vaccine exposure and consultations for European Medicines Agency (EMA)-specified AEIs for the 2018/19 influenza season. We used a self-controlled case series design and computed relative incidence (RI) of AEIs following vaccination, and compared the incidence of AEIs associated with aTIV, quadrivalent influenza vaccine (QIV) and live attenuated influenza vaccine (LAIV). We also compared the incidence of AEIs for vaccinations that took place in a practice with those that took place elsewhere.

A total of 1,024,160 individuals received a seasonal influenza vaccine, of which 165,723 individuals reported a total of 283,355 compatible symptoms in the 2018/19 season. The majority of AEIs occurred within seven days following vaccination, with a seasonal effect observed. Using aTIV as the reference group, QIV was associated with a higher RI of AEIs (RI=1.46, 95% CI 1.41-1.52), whereas LAIV was associated with a lower RI of AEIs (RI=0.79, 95% CI 0.73-0.83). No effect of vaccination setting on the incidence of AEIs was observed.

Routine sentinel network data offer an opportunity to make comparisons between safety profiles of different vaccines. Evidence that supports the safety of newer types of vaccines may be reassuring for patients and could help improve uptake in the future.