The document summarizes India's Adverse Events Following Immunization (AEFI) Surveillance program. It provides an overview of the program's progress and initiatives. Key points include: - The program was established in 1988 and has strengthened over time with revised guidelines, new reporting formats, and establishment of committees at national, state, and district levels. - Reporting of serious AEFI cases has increased from around 300 annually in the early 2000s to over 700 cases in 2014, indicating improved surveillance sensitivity. - Initiatives to further strengthen the program include establishing an AEFI Secretariat, appointing zonal consultants, and partnering with a technical center to provide support to states.

1. Adverse Events Following
Immunization (AEFI) Surveillance
program in India
Dr Jyoti Joshi
Senior Advisor-AEFI Management, vaccine safety and quality
Immunization Technical Support Unit, MoHFW
22 Aug 2015
IPC Ghaziabad

2. Presentation Outline
1. AEFI Surveillance
Program
2. Milestones
3. Program
Progress
4. Initiatives
Undertaken
5. Future Plans

3. • ~27 million new born targeted each year
• ~ 9 million immunization sessions held
annually( 57% outreach, 37% Health
facilities,9% in private)
• ~27,000 cold chain points
• Vaccines against 7 VPDs (T.B, Diphtheria,
Whooping cough, Tetanus, Hepatitis B,
Measles, Polio)
• Polio SIAs since 1995, 800 million
children vaccinated each year
• Measles & JE campaign completed
(measles 135 M, JE 15 M ) and second
dose measles introduced
• Hib containing Pentavalent vaccine
introduced in 12 states in 2014 (total 20
states).
• Introduction of IPV, MR and Rotavirus
vaccine approved by the NTAGI in 2014
61 % full immunization coverage
Wide Geographical variations
(Kerala 82%, Haryana 72%)
Polio-free for last 3 years
Immunization program in India : A Snapshot

4. SIGNIFICANCE OF AEFI SURVEILLANCE IN INDIA
• AEFI surveillance program demonstrates the country’s intent of delivering
quality immunization services with safe vaccines and ensure vaccine
confidence
• Globally, India is the largest developing country manufacturer of vaccines
and vaccines manufactured in India are used in all continents
• As a large consumer, leading manufacturer and exporter of vaccines, India
is expected to have a well-developed AEFI surveillance system
• With the largest birth cohort of approx. 27 million infants in the country
the immunization program administers approx. 460 million doses annually
yet reported serious AEFI are approx. 500 serious AEFIs annually

5. Milestones in AEFI Program implementation in India
5
1988 2005 2007 2008 2010 2011 2012 2015
AEFI
Program
established
National AEFI
Guidelines
District and
State AEFI
Committee
established
National
AEFI
Committee
established
Revised
National
AEFI
Guidelines
Standard
Operating
Procedures
of AEFI
issued
AEFI
Secretariat
established
at ITSU
Revised
National
AEFI
Guidelines
launched

6. Identify problems ,if any, with vaccine lots/brands leading
to vaccine reactions caused by vaccine.
Detect, correct and prevent immunization errors.
Prevent false blame arising from coincidental adverse events.
Reduce incidence of injection reactions from anxiety
or pain through education and messaging.
Maintain confidence by addressing parent/community concerns,
and raising awareness about vaccine risks.
Estimate rates of AEFI occurrence in local population
compared with trial and international data
Objectives of AEFI surveillance

7. AEFI Case Definition
Earlier used-
An adverse event following immunization is a medical incident that
takes place after an immunization, causes concern and is believed to
be caused by the immunization.
Revised Definition-
An AEFI is any untoward medical occurrence which follows
immunization and which does not necessarily have a causal
relationship with the usage of the vaccine.
The adverse event may be any unfavorable or unintended sign,
abnormal laboratory finding, symptom or disease.

8. Data sources for AEFI surveillance program
Immediate Direct reporting:
• Serious AEFIs
– Death
– Hospitalization
– Cluster
– Disability
– Significant parent/community
concern
• Severe AEFIs
– Injection site swelling beyond nearest
joint
– Fever >102 degrees
Monthly routine reporting in HMIS
– Death----(selected Serious AEFI)
– Abscess---(selected non serious
AEFI)
– Others----All other serious and
non serious AEFIs are reported
in this category
Dedicated email address: aefiindia@gmail.com
Private sector paediatricians (IAP) can report AEFIs through
www.idsurv.org
new

9. Previous forms
• FIR (First Information
Report)
• PIR (Preliminary
Investigation report)
• DIR (Detailed Investigation
Report)
• Lab investigation form
New Forms
• CRF (Case Reporting Form)
• PCIF (Preliminary Case Investigation
Form)
• FCIF (Final Case Investigation Form)
• State Causality Assessment Form
• Lab investigation form
• Verbal autopsy form
• Guidelines for conducting
autopsy in reported AEFI deaths
AEFI REPORTING FORMATS
new

10. The DIO
sends CRF
within next
24 hours and
PCIF in 10
days. The
FCIF is
submitted
within next
60 days
Immunization Division, MOHFW
NATIONAL AEFI
COMMITTEE
State Immunization Office
District Immunization Office
Health facilities and outreach
sessions
State AEFI Committee
District AEFI Committee
Report AEFI
within 24
hours of
Notification
through CRF
Pvt
Practitioner
AEFI Organizational Structure
Severe and
serious AEFI
AEFI Secretariat,ITSU
+
4 Zonal AEFI Consultants
Natl. AEFI Technical
Collaborating Centre
(LHMC, New Delhi)

11. AEFI COMMITTEES : Roles and Responsibilities
Terms of reference
(National/ State/District)
– Strengthen and validate AEFI
reporting at all levels
– Ensure implementation of
uniform standards and formats.
– Prompt & thorough
investigation of serious AEFIs
and periodic review of non
serious AEFIs
– Timely classification of cases
– Causality assessment (Brighton
Classification)
– Support spokesperson for
media interface and
management.
Composition
• Epidemiologist/Public Health Specialist
• Representative from Drug Authority
• Pediatrician, Microbiologist, Neurologist
• Pathologist, Forensic Expert, Cold Chain
officer
• Member Infectious Disease Surveillance
Program(IDSP)
• Representative from local bodies like
corporations
• Representatives from professional
bodies like IAP,IMA
• Representatives from partners agencies
Member Secretary : Imm. Program Manager

12. NATIONAL AEFI SURVEILLANCE
PROGRAM PROGRESS
12

13. 0 9 29 48 80
170
219 199
303
410
321
398
593
780
64
0
100
200
300
400
500
600
700
800
900
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
National AEFI
Guidelines
Printed and
Circulated
Trends in reporting of serious AEFIs (2001-2015)
AEFI Sect.
established at
ITSU
Revised
National AEFI
Guidelines
circulated
Data as on 17-02-15

14. 0
5000000
10000000
15000000
20000000
25000000
30000000
35000000
40000000
45000000
A&NISLANDS
ANDHRAPRADESH
ARUNACHALPR.
ASSAM
BIHAR
CHANDIGARH
CHHATTISGARH
D&NHAVELI
DAMAN&DIU
DELHI
GOA
GUJARAT
HARYANA
HIMACHALPRADESH
JAMMU&KASHMIR
JHARKHAND
KARNATAKA
KERALA
0
8
0
106
33
1
3
0
0
21
28
15
35
2
17
4
20
126
0
7
0
13
20
0
3
0
0
1
0
7
15
1
3
3
7
8
DOSES 2014 TOTAL 2014 DEATH 2014
State-wise distribution of serious AEFIs (2014)
Data as on 10-01-15
N – 772
1.1
Lacs
209.8
Lacs
3.2
Lacs
119.7
Lacs
444.2
Lacs
3.5
Lacs
116.8
Lacs
1.5
Lacs
0.8
Lakh
51.4
Lacs 4.4
Lacs
226.
Lacs
90.4
Lacs
23.2
Lacs
34.4
Lacs
120.3
Lacs
210.8
Lacs
78.6
Lacs
Variable sensitivity in serious AEFI reporting from states.

15. 0
10000000
20000000
30000000
40000000
50000000
60000000
70000000
80000000
LAKSHADWEEP
MADHYAPRADESH
MAHARASHTRA
MANIPUR
MEGHALAYA
MIZORAM
NAGALAND
ODISHA
PUDDUCHERRY
PUNJAB
RAJASTHAN
SIKKIM
TAMILNADU
TELANGANA
TRIPURA
UTTARPRADESH
UTTARAKHAND
WESTBENGAL
0
50
32
0
1
9
1
17
4
8
9
0
61
3
10
76
0
72
0
16
4
0
1
7
1
6
0
2
8
0
13
3
9
41
0
31
DOSES 2014 TOTAL 2014 DEATH 2014
State-wise distribution of serious AEFIs (2014)
Data as on 10-01-15
N – 772
0.2
Lakh
315.7
Lacs
420.2
Lacs
8.5
Lacs
13.7
Lacs
4.2
Lacs
4.6
Lacs
148.2
Lacs
3.7
Lacs
95.7
Lacs
273.2
Lacs
1.8
Lacs
206.2
Lacs
100
Lacs
274.4
Lacs
702.5
Lacs
109.4
Lacs
238.5
Lacs
Variable sensitivity in serious AEFI reporting from states.

16. DISTRIBUTION OF SERIOUS AEFI CASES
100 100
0
100 100
83
57
48
29
56
37 35
43 41
31 29
0 0
0
0 0
17
43
52
71
44
63 64
57 59
69 71
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100% 1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
% Death % Hospitalized
Data as on 10-01-15
Increased reporting of hospitalized cases in recent years indicates
enhanced sensitivity of AEFI Surveillance

17. State Level AEFI Committee not formed
State Level AEFI Committee formed
Status of State AEFI Committee formation
2013 2014
Data as on 01-12-14

18. Status of District AEFI Committee formation
RAJASTHAN
ODISHA
GUJARAT
MAHARASHTRA
MADHYA PRADESH
BIHAR
UTTAR PRADESH
KARNATAKA
ANDHRA PRADESH
JAMMU & KASHMIR
ASSAM
TAMIL NADU
CHHATTISGARH
PUNJAB
JHARKHAND
WEST BENGAL
ARUNACHAL PR.
HARYANA
KERALA
UTTARAKHAND
HIMACHAL PRADESH
MANIPUR
MIZORAM
MEGHALAYA
NAGALAND
TRIPURA
SIKKIM
GOA
A&N ISLANDS
D&N HAVELI
PONDICHERRY
LAKSHADWEEP
DELHI
CHANDIGARH
DAMAN & DIU
District AEFI Committee yet to be formed
District AEFI Committee formed
2014 (616 – 92%)2013 (502 - 75%)
Data as on 01-12-14

19. NUMBER OF REPORTING DISTRICTS AND STATUS OF AEFI COMMITTEES
125
142 148
209
2011 2012 2013 2014
No. of reporting districts
districts
Data as on 17-02-15
Fig: Map of districts reporting
serious AEFIs (2014)
Legend
CASES
(1 Dot = One Case)
Silent District
ReportingDistrict

20. REASON FOR REPORTING OF SERIOUS AEFI (2013-2014)
Data as on 17-02-15
CLUSTER
CASE, 19,
3% CLUSTER CASE
(DEATH), 11,
2%
CLUSTER CASE
(HOSPITALIZED
), 133, 22%
DEATH, 169,
29%
DISABILITY, 4,
1%
HOSPITALIZED,
253, 43%
LAMA, 1, 0%
OTHERS, 1, 0%
NOT
MENTIONED, 2,
0%
CLUSTER CASE,
38, 5%
CLUSTER CASE
(DEATH), 16,
2%
CLUSTER CASE
(HOSPITALIZED
), 152, 19%
DEATH, 215,
28%
DISABILITY, 1,
0%
HOSPITALIZED,
329, 42%
RECOVERED, 4,
1%
NOT
MENTIONED,
25, 3%
2013 (593) 2014 (780)

21. Data review for trends
Year Doses
administered
(MoHFW)
Reported
serious AEFIs
by direct
reporting
Serious AEFI
reporting rate
per 100,000
doses
2011 40,58,52,482 321 0.079
2012 42,86,76,755 398 0.093
2013 45,19,02,620 574 0.127
2014 41,01,61,680 708 0.173
Data as on 01-12-14

22. 321
398
593
780
229
289
400
327
0
100
200
300
400
500
600
700
800
900
YEAR 2011 YEAR 2012 YEAR 2013 YEAR 2014
TOTAL COMPLETE
COMPLETENESS OF REPORTING ( FIR+PIR+DIR ,2011-2014)
Data as on 17-02-15
71 %
73 %
67 %
42 %
Completeness of cases means not only submission of FIR/ PIR/ DIR, but other documents
such as hospital records, post mortem reports, lab reports, etc. and opinion regarding
causality by State AEFI Committee. Most common cause for unclassified cases is incomplete
documentation.

23. Causality Assessment of reported AEFI
deaths following Pentavalent Vaccination ( 2011-14)
Data as on 15-09-2014
UNCLASSIFIABLE,
12, 22%
INDETERMINATE,
5, 9%
COINCIDENTAL,
37, 69%
B1, 3,
60%
B2, 2,
40%
N - 54
Following detailed causality assessment by the National AEFI
Committee, none of the reported AEFI deaths have been
found to be causally related to the vaccine

24. • Changes in
– Reporting and investigation formats and timelines
– Reporting of serious and severe AEFIs. Examples of severe AEFIs –
high grade fever, extensive limb swelling post vaccination, etc.
– Reporting adverse events with any vaccines (not just pediatric
vaccines/UIP vaccines)
– weekly zero reporting formats for serious AEFI
– AEFI register at block level to report minor and severe/serious
AEFIs
– introduce new verbal autopsy formats and Guidance for
conducting specialized autopsy to investigate cause of death (for
deaths which occur at home/inadequate information
available/brought dead to hospital/ lack of medical information
regarding circumstances of death etc.)
– Action points and tools to improve communication response
during AEFI crisis and advocate for vaccines in routine
circumstances
– Use of WHO algorithm for causality assessment (state AEFI
committees)
SALIENT FEATURES OF REVISED NAT. AEFI GUIDELINES

25. INITIATIVES TO STRENGTHEN
AEFI SURVEILLANCE

26. • Establishment of AEFI Secretariat for
techno-managerial support to National
AEFI Committee and Immunization
Division, MoHFW
• 4 zonal AEFI Consultants to work closely
with states and provide support to states.
• Partnership with Lady Hardinge Medical
College as National AEFI Technical
Collaborating Centre for technical
oversight and support
• Involvement of WHO SMO network in
improving AEFI surveillance in the country
• Formation of panel of experts to support
states( technical as well as risk
communication related) for supporting
introducing pentavalent vaccine in the
country
INITIATIVES FOR HEALTH SYSTEMS STRENGTHENING
!O
Nation
al(NorthRegio
n) A
EFI Technical
CollaboratingC
entre
National
AEFI Sec
reatriat
West Zone East Zone
South Zone
North Zone
Legend
North Zone
West Zone
East Zone
South Zone
Network of National AEFI Technical
Collaborating Centres

27. • Revision of National AEFI
Guidelines based on WHO
Guidelines with improved
investigation of reported
deaths
• Training of frontline health
workers in 9 states with
WHO country office
support
• Improved reporting from
the private sector with
collaboration with IAP,
IDSurv.org portal
IMPROVED AEFI DETECTION AND REPORTING

28. • Support to states in rapid field
investigations of reported
serious AEFI(J&K, Kerala, Punjab,
Assam)
• Special Investigation Protocol for
supporting national team in
investigation of serious AEFIs
• Improving investigations for
reported AEFI deaths through
trained resource pool of experts
&verbal autopsy form for
gathering information about
reported AEFI deaths
• Training workshops for
orientation and Capacity building
of State and District officials
IMPROVED AEFI INVESTIGATIONS
Special investigation protocol
Training workshops
Supporting field investigation

29. • Timely regular meetings:
•
o National AEFI
Committee as per
calendar
o Causality Assessment
subcommittee
• Quality Management
System for AEFI Program
• Establishment of National
AEFI Technical
Collaborating Centre
IMPROVED CAUSALITY ASSESSMENT
!O
Natio
n
al(NorthRegio
n) A
EFI Technical
CollaboratingC
entre
National
AEFI Sec
reatriat
West Zone East Zone
South Zone
North Zone
Legend
North Zone
West Zone
East Zone
South Zone
Network of AEFI Collaborating Centres
Quality
Managemen
t Systems

30. • Strengthening communication
around AEFI:
o Establishing spokespersons at
national and state level
o RI & AEFI response protocol with
tools and media templates for use
at district and state level
• Revitalization of state AEFI
committees
• Greater coordination with vaccine
safety stakeholders for response to
community and media
• Feedback to states (AEFI dashboard)
for surveillance program
performance
IMPROVED AEFI FEEDBACK AND RESPONSE
AEFI Surveillance
program of National
Immunization
Program
ICSRs reported to
Indian
Pharmacopoeia
Commission (IPC)
PSURs from MAH
to Central Drug
Standards and
Control
Organization
(CDSCO)
VACCINE SAFETY
DATABASE
AEFI edition of
PvPI newsletter
Communication
Guidelines for AEFI

31. • Improved reporting of AEFIs for all vaccines (not just vaccines
used in paediatric practice or given in UIP)
• Involvement of Medical college to support State AEFI
committees in all aspects of AEFI surveillance
• Piloting of electronic database and AEFI reporting system in the
country
• Strengthening AEFI communication response
• Involvement of SMOs of NPSP in supporting AEFI program
• Research to advance vaccine safety: Pilot of a multi centric
hospital based active AEFI sentinel surveillance system,
qualitative studies
• Increased participation of the private sector in AEFI reporting –
collaboration with professional bodies such as IAP
Future plans

32. Thank You
Report AEFIs in India : aefiindia@gmail.com or