DARWIN EU® - Coverage of meningococcal vaccines in the target population in Europe

15/07/2025
23/01/2026
EU PAS number:
EUPAS1000000675
Study
Finalised
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Study identification

EU PAS number

EUPAS1000000675

Study ID

1000000675

Official title and acronym

DARWIN EU® - Coverage of meningococcal vaccines in the target population in Europe

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Germany
Spain
United Kingdom

Study description

Vaccine exposure data supports readiness for safety signal management and can inform the feasibility of vaccine effectiveness or safety studies. However, coverage data is often mostly available from MAH sales/distribution data, which does not accurately reflect actual use. Coverage data for meningococcal vaccines, which are recommended to prevent invasive meningococcal disease in children and adolescents, is scarce and of limited granularity.
This population-level drug utilisation study generated evidence on temporal trends in the coverage of meningococcal vaccines, by brand and/or vaccine composition (as available in the data sources), and by age group and dose, in 6 data sources in 5 countries (Croatia, Spain, UK, Denmark, Finland). Exposure included: MenB vaccines (Bexsero® and Trumenba®); MenC and Haemophilus influenzae type b (Hib)/MenC conjugate vaccines; MCV4 vaccines (serogroups A, C, W-135, and Y: Menveo® and Nimenrix®). As expected, countries with universal meningococcal vaccination in childhood (ES, UK) showed higher and more consistent coverage than those without this recommendation (DK, FI, HR), reflecting the different immunisation policies across Europe. Recent decrease in coverage observed in some countries may be related to the impact of the COVID-19 pandemic on vaccine availability and access to vaccination, and increased recent increasing public vaccine hesitancy.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Ivan Lam

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable