Awnish K Singh1,2, Abram L Wagner3, Jyoti Joshi4,2, Bradley F Carlson3, Satinder Aneja5, Matthew L Boulton3,6. 1. a National Technical Advisory Group on Immunization Secretariat , National Institute of Health and Family Welfare , New Delhi , India. 2. d Former Immunization Technical Support Unit , Public Health Foundation of India , New Delhi , India. 3. b Department of Epidemiology, School of Public Health , University of Michigan , Ann Arbor , MI , USA. 4. c Center for Disease Dynamics Economics and Policy , New Delhi , India. 5. f Kalawati Saran Children's Hospital , Lady Hardinge Medical College , New Delhi , India. 6. e Department of Internal Medicine, Division of Infectious Diseases , University of Michigan Medical School , Ann Arbor , MI , USA.
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. 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. 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. 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.
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. 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. 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. 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.
Entities:
Keywords:
Adverse events following immunization; India; causality assessment; vaccines
Authors: Tânia Cristina Barboza; Rafael Alves Guimarães; Fernanda Raphael Escobar Gimenes; Ana Elisa Bauer de Camargo Silva Journal: Rev Lat Am Enfermagem Date: 2020-06-19