Effectiveness of bivalent Covid-19 booster vaccines in the Nordic countries

Study identification

• EU PAS number:
  EUPAS106558
• Study ID:
  106559
• Official title and acronym:
  Effectiveness of bivalent Covid-19 booster vaccines in the Nordic countries
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  The larger Nordic countries of Denmark, Finland, Norway, and Sweden, provide a unique setting for the study of Covid-19 vaccination effectiveness. The ubiquitous nationwide demography- and health registers, which includes SARS-CoV-2 immunization and surveillance registers, allows for very large study cohorts with near real-time data availability. Available evidence suggests that bivalent booster vaccinations during autumn 2022 provided additional protection against Covid-19 hospitalisations while protection against any SARS-CoV-2 infection is more modest. However, current studies only provide insight on effectiveness in follow-up periods that do not extend beyond 2-6 months and on the Omicron subvariants prevailing during the study period. The aim of this project is to evaluate the comparative effectiveness of the bivalent boosters in preventing severe Covid-19 outcomes and all-cause mortality among individuals aged 50 years or older with 1 year of follow-up.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Department of Epidemiology Research, Statens Serum Institut

Denmark

Study timelines

Date when funding contract was signed

Planned:01/08/2023

Actual:01/08/2023

Study start date

Planned:01/08/2023

Actual:01/08/2023

Date of final study report

Planned:08/01/2024

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable