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Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience.
- Source :
-
Expert review of vaccines [Expert Rev Vaccines] 2018 Jun; Vol. 17 (6), pp. 555-562. Date of Electronic Publication: 2018 Jun 11. - Publication Year :
- 2018
-
Abstract
- Background: India has implemented the World Health Organization's revised Causality Assessment Protocol for adverse events following immunization (AEFI). We describe the number and types of serious/severe AEFIs, including deaths.<br />Research Design and Methods: Analysis of causality classification of reported serious/severe AEFIs from 1 January 2012 to 7 January 2016 was done. Classification includes (A) consistent with causal association to immunization; (B) indeterminate; (C) coincidental association; or (D) unclassifiable. We present descriptive statistics across each category.<br />Results: Analysis of causality assessment completed for 1037 reports of serious AEFIs: 499 (48%) were causally associated, 84 (8%) were indeterminate, 323 (31%) were coincidental, and 131 (13%) were unclassifiable. Of the 499 reports in the A category, the events were causally linked to vaccine product for 189 (18%), to immunization error for 135 (13%), and to immunization anxiety for 175 (17%). Among 279 reported deaths, more than half (55%; n = 153) were coincidental events and 37% were unclassifiable.<br />Conclusions: Causality assessment of AEFI cases is an important component of vaccination programs and post-marketing surveillance of vaccines. Field reporting and investigation of AEFIs can be improved for many severe or serious reports, most of which are not causally linked to the vaccination program.
- Subjects :
- Adverse Drug Reaction Reporting Systems statistics & numerical data
Child, Preschool
Female
Humans
Immunization Programs
India epidemiology
Infant
Infant, Newborn
Male
Vaccines administration & dosage
World Health Organization
Drug-Related Side Effects and Adverse Reactions epidemiology
Immunization adverse effects
Vaccination adverse effects
Vaccines adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1744-8395
- Volume :
- 17
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Expert review of vaccines
- Publication Type :
- Academic Journal
- Accession number :
- 29865876
- Full Text :
- https://doi.org/10.1080/14760584.2018.1484285