(265) id.DRIVE: a Public-Private Partnership for Burden and Effectiveness Studies on Infectious Diseases, Vaccines, Related Preventive Measures and Therapeutics in Europe.

Background: id.DRIVE is a unique public-private partnership of pharmaceutical companies and research organisations joining in a Consortium to facilitate the conduct of observational studies on infectious diseases, vaccines, related preventive measures and therapeutics for infectious diseases in Europe. id.DRIVE expands from COVIDRIVE initiated in 2020 to collect real world data on brand-specific COVID-19 vaccine effectiveness (CVE). COVIDRIVE itself leveraged the DRIVE influenza vaccine effectiveness platform which provided annual effectiveness estimates to the European Medicines Agency (EMA).

Objectives: To develop harmonised methodology and study operations through common data collection to facilitate pharmaceutical companies’ fulfilment of regulatory post-authorisation commitments and burden of disease studies for multiple pathogens.

Methods: The first Consortium study started in September 2021. It has a multi-country, multi-centre, hospital-based test-negative case-control design to monitor brand-specific CVE against hospitalisation due to laboratory-confirmed SARS-CoV-2 infection in severe acute respiratory infection (SARI) adult patients, including CVE by time since last dose and by SARS-CoV-2 variant (EUPAS42328). In total, 17 hospitals in Austria, Belgium, Germany, Italy, and Spain have been actively enrolling patients.

Results: On 03 January 2024, the Consortium includes 6 pharmaceutical companies (AstraZeneca, Janssen, GSK, Novavax, Valneva, Pfizer), and 2 non-industry partners as co-coordinators (FISABIO, P95). The network has 32 study sites in 13 European countries, comprising 55 hospitals, 5 primary care networks, and a nation-wide register. The id.DRIVE Consortium is open for new partners to join.
As of 04 Dec 2023, id.DRIVE has recruited 10,237 SARI patients, including 3,598 (35%) COVID-19 cases. Median patient age was 72 years (55% male); 60% of patients had ≥2 chronic conditions. Progress (Novavax) and interim (AstraZeneca, Janssen) reports have been produced and submitted by the pharmaceutical companies to the EMA. Recruitment for Janssen and AstraZeneca was completed on 28 February and 01 March 2023, respectively. Final study reports for AstraZeneca have been submitted to the EMA and are in preparation for Janssen. A sentinel SARI surveillance study for the monitoring of adult viral respiratory infections is now in set up phase.

Conclusions: The id.DRIVE platform delivers high quality epidemiological studies with shared data collection for regulatory use. It enables collaborative generation of real-world evidence through a sustainable European research network, with potential for expansion to other infectious diseases and monitoring effectiveness of vaccines, therapeutics, and related preventive measures.