Bewaking van de vaccinveiligheid in België
Authors: Robays Jo , Hanquet Germaine , Roberfroid Dominique , Thiry Nancy 
Published: January 2025

SYNTHESE 11 -- 1 INLEIDING 11 -- 1.1 VERSCHILLENDE BENADERINGEN VAN SIGNAALDETECTIE 12 -- 1.2 DOEL VAN DE STUDIE 12 -- 2 DATABASES DIE GEGEVENS OVER DE ACHTERGRONDINCIDENTIE IN BELGIË KUNNEN -- VERSTREKKEN 13 -- 2.1 GEGEVENSBRONNEN VAN DE OVERHEID 13 -- 2.1.1 Minimale Klinische Gegevens 13 -- 2.1.2 CARENET 13 -- 2.1.3 Overlijdensregister 14 -- 2.2 SENTINELNETWERKEN 14 -- 2.2.1 Netwerken voor huisartsen 14 -- 2.2.2 Pedisurv 15 -- 3 BEREKENING VAN DE ACHTERGRONDINCIDENTIE: EEN PILOTSTUDIE 15 -- 3.1 WIEGENDOOD 15 -- 3.2 SYNDROOM VAN GUILLAIN-BARRÉ 16 -- 3.3 STUIPEN 17 -- 3.4 HAALBAARHEID EN BETROUWBAARHEID VAN DE BEREKENING VAN DE -- ACHTERGRONDINCIDENTIE IN BELGIË 17 -- 4 UITDAGINGEN EN OPPORTUNITEITEN IN VERBAND MET DE BEWAKING VAN -- VACCINVEILIGHEID 18 -- 4.1 BEWAKING VAN DE VACCINVEILIGHEID IN BELGIË 18 -- 4.1.1 Gegevensvergaring 18 -- 4.1.2 Gegevensanalyse 20 -- 4.2 TEKORTKOMINGEN EN MOGELIJKE OPLOSSINGEN 20 -- 5 VOORUITGANG? 23 -- SCIENTIFIC REPORT 24 -- 1 BACKGROUND OF THE STUDY 24 -- 2 BACKGROUND RATES IN SAFETY SURVEILLANCE: OVERVIEW OF ISSUES 26 -- 2.1 USING BACKGROUND RATES FOR SIGNAL DETECTION. 26 -- 2.1.1 Computation 26 -- 2.1.2 Signal management: prioritization and evaluation 27 -- 2.2 CHALLENGES AND OPTIONS IN PHARMACOVIGILANCE BASED ON BACKGROUND RATES 28 -- 2.2.1 Counting events 28 -- 2.2.2 Counting exposed ones 31 -- 2.2.3 Confounding 32 -- 2.2.4 Analytical issues 33 -- 2.3 CHALLENGES AND OPPORTUNITIES FOR VACCINE SAFETY SURVEILLANCE BASED ON A -- BACKGROUND APPROACH 34 -- 3 BELGIAN DATABASES FOR COMPUTING BACKGROUND RATES 37 -- 3.1 INTRODUCTION & METHODS 37 -- 3.2 DESCRIPTION OF THE DATABASES 37 -- 3.2.1 Minimal Clinical Data 37 -- 3.2.2 Carenet 38 -- 3.2.3 GP sentinel practice networks 38 -- 3.2.4 Special Solidarity Fund 39 -- 3.2.5 Increased child allowance for disabled or ill children 39 -- 3.2.6 Pedisurv 39 -- 3.2.7 Cause-specific deaths 40 -- 3.2.8 The European Mortality Monitoring Project 40 -- 3.2.9 Vaccinnet 41 -- 3.2.10 Disease reporting at regional level 41 -- 3.3 CONCLUSION 42 -- BACKGROUND RATES IN EUROPE 42 -- 4.1 GENERAL INTRODUCTION 42 -- 4.2 METHODS 42 -- 4.3 POPULATION 43 -- 4.4 OUTCOMES 43 -- 5 ESTIMATION OF BACKGROUND RATES FOR SELECTED CONDITIONS IN BELGIUM 45 -- 5.1 SUDDEN INFANT DEATH 45 -- 5.1.1 Definitions 45 -- 5.1.2 Literature review 46 -- 5.1.3 Rates of SID in Belgium 50 -- 5.1.4 Conclusions on sudden infant deaths 53 -- 5.2 SUDDEN DEATH WITH UNKNOWN CAUSE IN &#8805;1 YEAR OF AGE 53 -- 5.2.1 Rationale 53 -- 5.2.2 Definitions 53 -- 5.2.3 Literature review 55 -- 5.2.4 Rates of sudden deaths in Belgium 56 -- 5.2.5 Conclusions on sudden deaths 60 -- 5.3 GUILLAIN-BARRÉ SYNDROME 60 -- 5.3.1 Rationale 60 -- 5.3.2 Definitions 60 -- 5.3.3 Literature review 60 -- 5.3.4 Background rates of Guillain-Barré Syndrome in the literature 61 -- 5.3.5 Seasonal or temporal patterns 63 -- 5.3.6 Prediction models 63 -- 5.3.7 Belgian data on GBS from Minimal Clinical Data 63 -- 5.3.8 Conclusions on Guillain-Barré syndrome (GBS) 65 -- 5.4 SEIZURES 66 -- 5.4.1 Case definition 66 -- 5.4.2 Literature review 66 -- 5.4.3 Results 67 -- 5.4.4 Belgian data 69 -- 5.4.5 Discussion 69 -- 6 POTENTIAL DETECTION OF CASES OF SD/SID, GBS, THROMBOCYTOPENIA AND -- CONVULSIONS FROM IMMUNOGLOBULINS PRESCRIPTIONS 69 -- 6.1 IMMUNOGLOBULINS FOR EXTRAVASCULAR ADMINISTRATION (J06BA01) 70 -- 6.2 IMMUNOGLOBULINS FOR INTRAVASCULAR ADMINISTRATION (J06BA02) 71 -- 7 MINIMAL CLINICAL DATA 72 -- 7.1 GUILLAIN-BARRÉ SYNDROME 72 -- 7.2 SEIZURES. 74 -- 7.3 DEMYELINATING DISEASE 75 -- 7.4 OPTIC NEURITIS 76 -- 7.5 BELLS PALSY 77 -- 7.6 THROMBOCYTOPENIA 78 -- 7.7 GENERAL DISCUSSION ON MCD DATA 78 -- 8 PHARMACOVIGILANCE IN BELGIUM 79 -- 8.1 DATA COLLECTION 79 -- 8.2 DATA ANALYSIS 81 -- 9 GENERAL DISCUSSION AND RECOMMENDATIONS 82 -- APPENDICES. 83 -- REFERENCES 108