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Development of Robust and Innovative Vaccine Effectiveness

Periodic Reporting for period 3 - DRIVE (Development of Robust and Innovative Vaccine Effectiveness)

Reporting period: 2019-07-01 to 2020-06-30

Influenza is a major public health problem: 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.
DRIVE started in July 2017. In three 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 actual analyses in the 2018-19 and 2019-2020 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 could 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. During DRIVE third season (2019-2020) a total of 14 sites from 8 different countries participated in the IVE studies.

To support the studies, DRIVE developed novel study protocols and statistical analysis plan. 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 new call for tenders yielded several high-quality proposals from sites willing to join DRIVE for the influenza season 2020-21 and will contribute to the constant expansion of DRIVE research platform in the coming season.
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 fine-tuning of 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 years’ 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.