Results, 2018/19 season
Influenza Vaccine Effectiveness estimations for the Season 2018/19 published by EU research project DRIVE
DRIVE consortium has completed a brand specific influenza vaccine effectiveness study for the 2018/19 season.
The network expanded from 5 sites in the pilot season to 13 sites in 2018/19. Studies were further harmonized, as generic protocols are in place for TND studies, minimum data requirements were defined, and several site visits were performed prior to the start of data collection to support a standardised approach. The statistical analysis plan was improved and age-and setting-stratified IVE estimates were calculated by vaccine brand, vaccine type and for any influenza vaccine.
As a result of the relatively mild influenza season, combined with the limited number vaccinated cases by brand distributed over appropriate-yet multiple strata (age, setting, and type of outcome), IVE estimates with wide to very wide confidence intervals were obtained.
Generating robust brand specific IVE estimates is expected to continue to be challenging, even in more intense influenza seasons. The use of secondary data, such as electronic healthcare databases or linked registers, could be a potential sustainable solution to the problem of obtaining sufficient sample size and warrants further exploration. Increased data sharing throughout Europe may enable the pooling of a larger number of studies.
The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project is a public-private partnership aiming to build capacity in Europe for estimating brand-specific influenza vaccine effectiveness (IVE). The DRIVE Project, which is funded by the Innovative Medicines Initiative (IMI), was initiated as a response to the new guidance on influenza vaccines by the European Medicines Agency (EMA) that came into effect in the beginning of 2017.
- Comments by the Independent Scientific Committee (here) and vaccine manufacturers (round 1, round 2)
Summary of the report