1. Adverse Events
Following Immunization:
Updates and Issues
Dr. Navneet Kumar Dhamija
Asstt. Commissioner – Immunization
Ministry of Health & FW, Govt. of India
Mobiles : 8826772555, 9911220066
Office : 23062993, 23062126, 23062728
E-mail : ImmunizationAC@gmail.com

2. Concepts
• Background
• AEFI surveillance
• National Guidelines
• Case investigation
• Recording and Reporting
• AEFI committees

3. Adverse Event Following Immunization
A medical incident that takes place
after an immunization, causes concern
and is believed to be caused by
immunization

4. Serious AEFI:
WHO standard definition for drug and vaccine
adverse events is :
“Any untoward medical occurrence that results in death,
hospitalization or prolongation of hospitalization,
persistent or significant disability/incapacity, or is life
threatening”
Additional AEFIs that need systematic causality
assessment
- AEFIs that may be caused by a programme error,
e.g., a cluster of bacterial abscesses;
- Serious unexplained AEFI occurring within 30 days
after vaccination and not listed in product label;
- Events causing significant parental or community
concern.

5. Pre-vaccine
Increasing Confidence:
Disease Eradication
Coverage Loss Return (vaccination stops?)
“Incidence”
Vaccine Outbreak
Coverage
Adverse Events:
real/perceived ?
Eradication
Maturity of immunization programme
Impact of AEFI on immunization programs

6. Reported Serious AEFI Cases (1999 – 2011)
395
400
350
301
300 199
AEFI state
250 workshops
200 170
150
100 80
48 82
50 29 32
3 9 9
0 0
r)
99
00
01
02
03
05
07
08
09
10
04
06
Ap
19
20
20
20
20
20
20
20
20
20
20
20
n-
Ja
(
11
20
*data does not include serious AEFI cases reported in Japanese Encephalitis campaigns conducted in endemic states
Data as on 20th April 2011

7. AEFI Surveillance
AEFIs identified
by existing
surveillance
Unreported, undetected
AEFIs

8. Members of National AEFI Committee
• National Immunization Program Manager
(Asstt.Commissioner-Imm.) – Member Secretary
• An Eminent Epidemiologist/Public Health Specialist /
Pediatrician – Nominated as Chairman by MoHFW, GoI
• Senior Scientist from DHR / ICMR, Govt. of India
• Director – National Centre for Disease Control
• Sr. Officer from National Drug Authority ( DCGI )
• Pediatrician of Medical College
• Microbiologist of Medical College

9. Members of National AEFI Committee...
• Pathologist of Medical College
• Pharmacologist / Toxicologist of Medical College
• Neurologist of Medical College
• Forensic Medicine expert of Medical College
• National Level Cold Chain Officer
• Representative of IDSP
• Members from professional bodies like IAP/IMA
• Representatives from partner agencies can be on panel as
ex-officio members and should be invited , when required

10. Sub-committees of
National AEFI Committee...
• Causality assessment sub committee
• Operational group sub committee
• Investigation sub committee
• Media management sub committee

11. Members of State AEFI Committee
• SEPIO – Member Secretary
• Epidemiologist/Public Health Specialist
• Representative from Drug Authority
• Pediatrician ( preferably of Medical College )
• Microbiologist ( preferably of Medical College )
• Pathologist ( preferably of Medical College )
• Neurologist ( preferably of Medical College )
• Forensic Medicine expert ( preferably of Medical College )

12. Members of State AEFI Committee....
• State Cold Chain Officer
• Representative of IDSP
• Representative from local bodies like
corporation
• Members from professional bodies like IAP/IMA
• Representatives from partner agencies can be
on panel as ex-officio members and should be
invited , when required
• DIO and other Distt. AEFI Committee members
where AEFI occurred – as special invitees

13. Members of Distt. AEFI Committee
• DIO – Member Secretary
• CMO of the district
• Epidemiologist/Public Health Specialist
• Representative from Drug Authority
• Pediatrician ( preferably of Medical College )
• Microbiologist ( preferably of Medical College )
• Pathologist ( preferably of Medical College )
• Neurologist ( preferably of Medical College )
• Forensic Medicine expert ( preferably of Medical College )

14. Members of Distt. AEFI Committee …….
• Distt. Cold Chain Officer
• Representative of IDSP
• Representative from local bodies like
corporation
• Members from professional bodies like IAP/IMA
• Representatives from partner agencies can be
on panel as ex-officio members and should be
invited , when required
• Block-IO and other Block-AEFI Committee
members where AEFI occurred – as special
invitees

15. AEFI Committees Status
District Level
State Level
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JAMMU & KAS HMIR # # #
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n = 35 n = 494
HIMACHAL PRADESH #
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PUNJAB # # #
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ARUNACHAL PR.
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SIKKIM #
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RAJASTHAN UTTAR PRADE SH ASSAM # #
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ANDHRA PRADESH
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AU BAGALK OT # # #
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GOA ## DH W
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AR AD
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KOPPA L #
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A&N ISLANDS
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M D YA
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DA U O G # #
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H AJN AGAR
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TAMIL NADU
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16. State AEFI Committees
• Status…..
Capacity building workshops
State workshops
conducted (1 ½ day training JAMMU & KASHMIR
HIMACHAL PRADESH
package developed)
PUNJAB
UTTARANCHAL
HARYANA
DELHI ARUNACHAL PR.
SIKKIM
• Workshops supported with NRHM funds. RAJASTHAN UTTAR PRADESH
BIHAR
ASSAM NAGALAND
MEGHALAYA
MANIPUR
WEST BENGAL TRIPURA
GUJARAT
Technical assistance by Partners.
MADHYA PRADESH JHARKHAND MIZORAM
CHHATTISGARH
ORISSA
D&N HAVELI
• >1100 officials sensitized (state & district AEFI
MAHARASHTRA
ANDHRA PRADESH
committee). GOA
KARNATAKA
A&N ISLANDS
• Data base regularly updated at National level. PONDICHERRY
TAMIL NADU
LAKSHADWEEPKERALA
Includes data of > 970 serious cases (1998-2010).
• National Causality assessment training conducted
2009.
• Trends show improvement in reporting of serious
AEFIs.

17. Timeliness of First Information
N=199 N=294 N=87
5% 3%
38% 38% 32%
34%
61%
65%
24%
2008 Within 24 hours 2009 2010
1-7 days
No data
Based on FIR ( Date of notification; Date of completing FIR )

18. Revised AEFI
Surveillance and Response
Operational Guidelines
Released in September 2010
By
Ministry of Health and FW,
Government of
India, New Delhi

19. DIFFICULTIES ARE INTENDED TO MAKE US
BETTER,
NOT BITTER
Immunization Division & National AEFI Committee

20. Immunization Division & National AEFI Committee