ENFORCE (National Cohort Study of Effectiveness and Safety of SARS-CoV-2 vaccines)

The Danish COVID-19 vaccination program will include several new SARS-CoV-2 vaccines, and the programme is expected to commence in January 2021, assuming all approvals etc. are on track. According to the national vaccine plan (Udrulning af vaccination mod Covid-19), vaccination will initially be offered to people in specified risk groups, and to selected key workers in the health, elderly and social care sectors. As the development of the vaccines has been performed during a limited time period it will be important to continue to gather more information about safety and effect as they are being rolled out.

National cohort study of effectiveness and safety of SARS-CoV-2 vaccines (ENFORCE) is an equivalence trial to evaluate the effectiveness and safety of multiple new SARS-CoV-2 vaccines approved for use in the EU, and which are being offered at participating units.

The study is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

If you have further questions regarding the study, please contact study personnel via email: enforce.rigshospitalet@regionh.dk.