Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Nov 16, 2020
Date Accepted: Mar 29, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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
ABSTRACT
Background:
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.
Objective:
To determine the Relative Incidence (RI) of AEIs following seasonal influenza vaccination, and compare RIs between aTIV, quadrivalent influenza vaccine (QIV) and live attenuated influenza vaccine (LAIV).
Methods:
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 RI of AEIs associated with aTIV, QIV and LAIV. We also compared RI of AEIs for vaccinations that took place in a practice with those that took place elsewhere.
Results:
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 RI of AEIs was observed.
Conclusions:
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.
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