Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience
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 r...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2018-06-01
|
| Series: | Expert Review of Vaccines |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/14760584.2018.1484285 |
| _version_ | 1827813267274203136 |
|---|---|
| author | Awnish K. Singh Abram L. Wagner Jyoti Joshi Bradley F. Carlson Satinder Aneja Matthew L. Boulton |
| author_facet | Awnish K. Singh Abram L. Wagner Jyoti Joshi Bradley F. Carlson Satinder Aneja Matthew L. Boulton |
| author_sort | Awnish K. Singh |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T23:29:13Z |
| format | Article |
| id | doaj.art-c9fccecfaded42208437670722041aea |
| institution | Directory Open Access Journal |
| issn | 1476-0584 1744-8395 |
| language | English |
| last_indexed | 2024-03-11T23:29:13Z |
| publishDate | 2018-06-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj.art-c9fccecfaded42208437670722041aea2023-09-20T10:18:03ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952018-06-0117655556210.1080/14760584.2018.14842851484285Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experienceAwnish K. Singh0Abram L. Wagner1Jyoti Joshi2Bradley F. Carlson3Satinder Aneja4Matthew L. Boulton5National Institute of Health and Family WelfareUniversity of MichiganCenter for Disease Dynamics Economics and PolicyUniversity of MichiganKalawati Saran Children’s HospitalUniversity of MichiganBackground: 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.http://dx.doi.org/10.1080/14760584.2018.1484285adverse events following immunizationvaccinesindiacausality assessment |
| spellingShingle | Awnish K. Singh Abram L. Wagner Jyoti Joshi Bradley F. Carlson Satinder Aneja Matthew L. Boulton Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience Expert Review of Vaccines adverse events following immunization vaccines india causality assessment |
| title | Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience |
| title_full | Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience |
| title_fullStr | Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience |
| title_full_unstemmed | Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience |
| title_short | Causality assessment of serious and severe adverse events following immunization in India: a 4-year practical experience |
| title_sort | causality assessment of serious and severe adverse events following immunization in india a 4 year practical experience |
| topic | adverse events following immunization vaccines india causality assessment |
| url | http://dx.doi.org/10.1080/14760584.2018.1484285 |
| work_keys_str_mv | AT awnishksingh causalityassessmentofseriousandsevereadverseeventsfollowingimmunizationinindiaa4yearpracticalexperience AT abramlwagner causalityassessmentofseriousandsevereadverseeventsfollowingimmunizationinindiaa4yearpracticalexperience AT jyotijoshi causalityassessmentofseriousandsevereadverseeventsfollowingimmunizationinindiaa4yearpracticalexperience AT bradleyfcarlson causalityassessmentofseriousandsevereadverseeventsfollowingimmunizationinindiaa4yearpracticalexperience AT satinderaneja causalityassessmentofseriousandsevereadverseeventsfollowingimmunizationinindiaa4yearpracticalexperience AT matthewlboulton causalityassessmentofseriousandsevereadverseeventsfollowingimmunizationinindiaa4yearpracticalexperience |