Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000043

EU PAS number

EUPAS1000000043

Study ID

1000000043

Official title and acronym

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

DARWIN EU® study

No

Study countries

Denmark
Finland
Sweden

Study description

The aim of this project 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. The study objectives include assessing vaccine effectiveness for preventing severe Covid-19 outcomes, evaluating waning effectiveness, and examining the impact of coadministration with influenza vaccines. We conduct nationwide register-based cohort analyses in Denmark, Finland, and Sweden from October 2023 to the latest available date in 2024. Source cohorts comprise known residents who received at least four Covid-19 vaccine doses between December 27, 2020, and the latest available date in 2024. Study cohorts include individuals aged 65+ eligible for an XBB.1.5-containing Covid-19 vaccine as a fifth or sixth dose. Outcomes of interest are Covid-19 hospitalization and death. Covariates include demographic factors, comorbidities, and previous Covid-19 vaccinations. We aim to include at least 3.1 million vaccine recipients across the three Nordic countries, utilizing all available data and ensuring statistical power reflected in 95% confidence intervals. Target trial emulation compares vaccinated individuals with controls in matched survival analyses, providing comparative effectiveness estimates while considering various covariates.

Study status

Finalised
Research institution and networks

Institutions

Swedish Medical Products Agency

Contact details

Anders Hviid

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Updated protocol

EMA_ROC17 Option_Study protocol .pdf

English (662.84 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable