BEYOND THE AGGREGATE RATE: HOW GERMANY'S FORSCHUNGSDATENZENTRUM GESUNDHEIT (FDZ) WILL RESHAPE VACCINATION COVERAGE MONITORING
Author(s)
Julian Witte, PhD, Daniel Gensorowsky, PhD.
VANDAGE, Bielefeld, Germany.
VANDAGE, Bielefeld, Germany.
OBJECTIVES: Vaccination coverage monitoring in Germany is undergoing structural change. We assessed how the national monitoring landscape will evolve and characterized the prospective added value of the Forschungsdatenzentrum Gesundheit (FDZ) relative to established Robert Koch Institute (RKI) surveillance.
METHODS: We performed a structured comparative assessment of three data infrastructures—KV-Impfsurveillance (KVIS), the electronic reporting system DEMIS, and FDZ §303 SGB V claims data—across predefined dimensions: numerator completeness, denominator definition, provider coverage, timeliness, and analytical access, drawing on regulatory provisions, data-dictionary documentation, and the mapping of STIKO indication recommendations to claims-derivable indicators.
RESULTS: Complete, timely capture of the numerator is the domain of RKI surveillance: single-case reporting from all providers via the DEMIS infrastructure is being established in phases, progressively closing the limitations of today's claims-based monitoring. For the aggregate coverage rate the FDZ therefore offers no advantage. Its differentiated value lies in the denominator and in analytical depth. The FDZ links ~74 million insured cross-sectorally (ambulatory, inpatient, medications), supporting individual-level, freely definable denominators aligned with STIKO indication groups; pseudonymized practice identifiers (BSNR) attribute vaccination activity by specialty, region, and practice; co-administration and inter-vaccination intervals are measurable to the day; and investigators retain analytical autonomy in full data depth, independent of published aggregates. Realising timely monitoring requires operationalising the FDZ's legally mandated move from annual to quarterly provision (§303b SGB V; Forschungsdatenzentrum-Gesundheit-Verordnung), making each quarter available about four months after quarter-end.
CONCLUSIONS: The two infrastructures serve complementary functions: RKI/DEMIS will deliver timely aggregate coverage, and the FDZ contributes analytical depth—who is under-vaccinated, where, and how vaccine portfolios are used. Once quarterly provision is established, the FDZ is positioned to enable indication-specific, practice-level monitoring, giving manufacturers and policymakers decision-relevant evidence beyond the aggregate rate.
METHODS: We performed a structured comparative assessment of three data infrastructures—KV-Impfsurveillance (KVIS), the electronic reporting system DEMIS, and FDZ §303 SGB V claims data—across predefined dimensions: numerator completeness, denominator definition, provider coverage, timeliness, and analytical access, drawing on regulatory provisions, data-dictionary documentation, and the mapping of STIKO indication recommendations to claims-derivable indicators.
RESULTS: Complete, timely capture of the numerator is the domain of RKI surveillance: single-case reporting from all providers via the DEMIS infrastructure is being established in phases, progressively closing the limitations of today's claims-based monitoring. For the aggregate coverage rate the FDZ therefore offers no advantage. Its differentiated value lies in the denominator and in analytical depth. The FDZ links ~74 million insured cross-sectorally (ambulatory, inpatient, medications), supporting individual-level, freely definable denominators aligned with STIKO indication groups; pseudonymized practice identifiers (BSNR) attribute vaccination activity by specialty, region, and practice; co-administration and inter-vaccination intervals are measurable to the day; and investigators retain analytical autonomy in full data depth, independent of published aggregates. Realising timely monitoring requires operationalising the FDZ's legally mandated move from annual to quarterly provision (§303b SGB V; Forschungsdatenzentrum-Gesundheit-Verordnung), making each quarter available about four months after quarter-end.
CONCLUSIONS: The two infrastructures serve complementary functions: RKI/DEMIS will deliver timely aggregate coverage, and the FDZ contributes analytical depth—who is under-vaccinated, where, and how vaccine portfolios are used. Once quarterly provision is established, the FDZ is positioned to enable indication-specific, practice-level monitoring, giving manufacturers and policymakers decision-relevant evidence beyond the aggregate rate.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH152
Topic
Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Public Health
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Vaccines