Effectiveness of monovalent XBB.1.5-containing Covid-19 mRNA vaccines in the Nordic countries

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  COMIRNATY

  Spikevax

  Vaxzevria
• Name of medicine, other:
  - Spikevax/Omicron XBB.1.5 ; - Comirnaty/Omicron XBB.1.5 ; - Comirnaty Original/Omicron BA.1 (BNT162b2) ; - Comirnaty Original/Omicron BA.4-5 (BNT162b2) ; - Comirnaty Original monovalent (BNT162b2) ; - Spikevax Original/Omicron BA.1 (mRNA-1273 [/Moderna covid19 vaccine]) ; - Spikevax Original/Omicron BA.4-5 (mRNA-1273 [/Moderna covid19 vaccine]) ; - Spikevax Original monovalent (mRNA-1273 [/Moderna covid-19 vaccine]) ; - Vaxzevria (ChAdOx1-S [/AZD1222])
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)

  DAVESOMERAN

  ELASOMERAN

  FAMTOZINAMERAN

  IMELASOMERAN

  RAXTOZINAMERAN

  RILTOZINAMERAN

  TOZINAMERAN
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN01) covid-19, RNA-based vaccine

  (J07BN02) covid-19, viral vector, non-replicating
• Medical condition to be studied:
  COVID-19

Population studied

• Short description of the study population:
  Source cohorts will consist of all individuals who are known residents in the three Nordic countries and have received at least four Covid-19 vaccine doses between 27 December 2020 and latest available date in 2024. The study cohorts will consist of individuals who are at least 65 years of age in Denmark, Finland, and Sweden and eligible to receive an XBB.1.5-containing Covid-19 vaccine as a fifth or sixth dose during the study period.
• Age groups:
  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  3100000

Study design details

• Main study objective:
  The aim of this study is to evaluate the comparative effectiveness of the monovalent XBB.1.5-containing Covid-19 vaccines in preventing severe Covid-19 outcomes among individuals aged 65 years or older.
• Outcomes:
  The outcomes of interest are Covid-19 hospitalization and Covid-19 related death.
• 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.

Documents

Study report

EMA ROC17 Option Study report.pdf