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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - DRIVE (Development of Robust and Innovative Vaccine Effectiveness)

Teaser

Summary

Each year, up to 50 million people fall ill with seasonal influenza in the EU and up to 70.000 die from it. Vaccines are the cornerstone of preventing influenza but their effectiveness can vary from year to year and across recipient groups. The European Medicines Agency (EMA) has requested effectiveness evaluation for all individual influenza vaccine brands, a task that demands international cooperation between public health institutions and vaccine manufacturers.
DRIVE (Development of Robust and Innovative Vaccine Effectiveness) was formed to establish a sufficiently sized network to generate robust, brand-specific effectiveness estimates for all influenza vaccines used in the EU. The data generated through DRIVE is expected to increase the understanding of influenza vaccine effectiveness, lead to enhanced monitoring of influenza vaccine performance by public health institutes and allow manufacturers to fulfil the requirements of the European Medicines Agency (EMA). DRIVE also aims to develop a sustainable and transparent governance model for public-private partnerships.

Work performed

DRIVE started in July 2017. In its first two years, it has laid down the study governance needed for a multicentre evaluation of influenza vaccine effectiveness, tested this in practice during the seasonal influenza epidemics of 2017/18, and perform an actual analysis in the 2018-19 season. DRIVE has also accomplished a number of supportive tasks that enhance the studies and their governance.

The first influenza season of the project was considered primarily a pilot to see how the studies can be best coordinated. In the second season (2018-19), data on the performance of various influenza vaccine brands was gathered at a total of ten sites (three original consortium members and seven newly joined sites). DRIVE used different sources of data (for primary care and hospital test-negative design, and also for cohort studies) and these were successfully combined in a meta-analysis providing effectiveness estimates for a number of brands. An Independent Scientific Committee of prominent influenza experts was assembled to oversee the studies and provide valuable feedback to DRIVE.

To support the studies, DRIVE developed novel study protocols and statistical analysis plans. Other important accomplishments include a multi-stakeholder research agenda, guidelines for interpreting IVE results, report templates, Standard Operating Procedures, IT infrastructure for data collection & analysis, a data management plan, a report on the sources of vaccine brand data, a communications plan, and a website. A call for tenders yielded several high-quality proposals from sites willing to join DRIVE for the influenza season 2019-20.

Final results

DRIVE is expanding the network of influenza vaccine studies in the EU but also seeks to improve its quality. The protocols and statistical analysis plans aim to harmonize data collection and provide scientifically robust results. A literature review on bias and confounding factors and how to take them into account in studies allowed to finetune the protocols. DRIVE is also looking into novel and innovative ways to assess vaccine effectiveness. There is a quality control committee that supervises the quality of the procedures followed within DRIVE, as well as the data retrieved.

DRIVE is working in an unprecedented way to map the vaccine types and brands used in Europe with the aim of applying this information to ensure that all influenza vaccine types and brands available in the EU are eventually covered by the evaluation. The governance model developed over the 5 yearsâ€™ project will provide valuable suggestions for future public-private partnerships. Key performance indicators of scientific independence, integrity and transparency have been developed, and these and other metrics will be developed and applied during the course of the project.