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

06/09/2023
23/04/2024
EU PAS number:
EUPAS106558
Study
Ongoing
Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Immunocompromised

Estimated number of subjects

3400000
Study design details

Main study objective

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 9 months of follow-up.

Outcomes

Covid-19 hospitalisation and Covid-19 mortality.

Data analysis plan

We will take advantage of the unique nationwide register-data available to us, and construct country cohorts with individual-level information on dates of vaccination and dates of effectiveness end-points together with relevant covariate information. Using target trial emulation, we will compare bivalent booster dose recipients head-to-head and with unboosted individuals in matched survival analysis that provides comparative effectiveness estimates while taking into account a range of covariates.