COVIDRIVE Study #1: COVID-19 vaccine effectiveness (CVE) against hospitalisation

COVIDRIVE’s first study started in September 2021, and by 14th of July 2023 has recruited 10,038 patients across 17 hospitals in 5 European countries.

Study design: multi-country hospital-based case-control study with test-negative case-control design.


  • COVID-19 CVE against COVID-19 hospitalisations (primary and booster vaccination);
  • CVE by genetic variants;
  • CVE by time since last dose (duration of protection);
  • CVE in specific risk groups (immunocompromised, risk conditions, pregnant…)

Study progress
Recruitment started on Sept 8th, 2021 for AstraZeneca and Janssen. Novavax started their study in July 2022, and Valneva started theirs in April 2023.

Study outputs include thus far interim analysis reports for AstraZeneca’s COVID-19 vaccine, submitted to the EMA and the final analysis is being prepared for end of 2023; and the first and second interim analysis report for Janssen’s and we are preparing the final analysis for mid-2024. Novavax will only have one final analysis by 2024.

Map of participating hospitals in COVIDRIVE Study 1

Participating hospitals:

  • Recruiting: Spain (6 hospitals), Italy (4 hospitals), Austria (1 hospital), Belgium (3 hospitals), Germany (3 hospitals)
  • In start-up: Germany (1 hospital)
  • In feasibility assessment: Italy

Recruitment update (as of 14th July 2023):

  • 10,038 SARI (Severe Acute Respiratory Infection) patients recruited
Figure: Cumulative number of recruited SARI patients by calendar month