In December 2019, an outbreak of respiratory syndromes was recorded in Wuhan, Hubei Province, China. The novel coronavirus was named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2), while the associated disease was designated COVID-19. Following the identification of SARS-CoV-2 and its global spread, major COVID-19 outbreaks occurred across Europe. In response, European countries implemented unprecedented large-scale non-pharmaceutical interventions (NPIs), such as school closures and national and international lockdowns. However, containing the pandemic caused by SARS-CoV-2 required the availability of safe and effective vaccines. By the end of 2020, the first COVID-19 vaccines received conditional marketing authorization in the European Union (EU) from the European Medicines Agency (EMA).
Despite the efficacy of COVID-19 vaccines being rigorously studied during clinical trials, it is essential to evaluate their real-world effectiveness through post-marketing observational studies. To date, clinical trials have not yet provided answers to the following questions: duration of protection and antibody titers; effectiveness against emerging variants; effectiveness against severe forms of COVID-19; effectiveness in specific risk categories, such as immunocompromised individuals, subjects with chronic pathologies or comorbidities. COVIDRIVE is a public-private partnership built on the framework of the IMI-DRIVE project, adapting its tools and structure to the specific requirements of evaluating the real-world effectiveness of COVID-19 vaccines.

Objectives

Primary Objectives: To estimate brand-specific COVID-19 vaccine effectiveness (CVE) against laboratory-confirmed SARS-CoV-2 hospitalization in patients with severe acute respiratory infection (SARI) who were vaccinated with any COVID-19 vaccine during the season of interest compared to: a) unvaccinated patients, b) subjects vaccinated with at least 1 dose of COVID-19 vaccine, c) subjects who completed a primary series with any COVID-19 vaccine, and d) patients who previously completed at least one primary series with any COVID-19 vaccine and received at least one additional dose of COVID-19 vaccine.
Secondary Objectives: To estimate brand-specific COVID-19 vaccine effectiveness (CVE) against laboratory-confirmed SARS-CoV-2 hospitalization in patients with severe acute respiratory infection (SARI) who were vaccinated with any COVID-19 vaccine during the season of interest compared to: a) unvaccinated patients, b) subjects vaccinated with at least 1 dose of COVID-19 vaccine, c) subjects who completed a primary series with any COVID-19 vaccine, and d) patients who previously completed at least one primary series with any COVID-19 vaccine and received at least one additional dose of COVID-19 vaccine.