national overview AEFI survillance program

1. AEFI Surveillance System

2. Significance of AEFI surveillance
Demonstrates the country’s intent of delivering quality
immunization services with safe vaccines and ensure
vaccine confidence
Ensures global confidence that vaccines manufactured in
in India are safe
As a large consumer, leading manufacturer and exporter
of vaccines, India is expected to have a well-developed
AEFI surveillance system

3. Objectives of AEFI surveillance
•Maintain confidence by addressing parent/community concerns, and raising awareness about
vaccine risks.
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.
Identify problems, if any, with vaccine lots/brands leading to vaccine reactions caused by
vaccine.
Estimate rates of AEFI occurrence in local population compared with trial and international
data
Identify potential vaccine safety signals for further assessment leading to appropriate
programmatic and/or regulatory action

4. Scope of AEFI surveillance
• All vaccines for prevention
– private and public sector
– can report on suspicion that vaccine caused event
– no timeline between vaccination and onset
– Routine and in campaigns
• Passive surveillance
• Minor (AEFI registers-non-electronic); serious and severe AEFIs (online
reporting-SAFEVAC)
• Largest annual birth cohort - 26 million; ~ 700 million doses; ~ 1500
serious AEFIs reported annually

5. AEFI Organizational Structure
The DIO
sends CRF
within next 24
hours and CIF
in 10 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
Practitione
r
Severe and
serious AEFI
AEFI Secretariat, ITSU
+
4 Zonal AEFI Consultants
Natl. AEFI Technical
Collaborating Centre (LHMC,
New Delhi)
NRA partners
The State AEFI
Committee
completes
causality
assessment
within 100 days.

6. Stakeholders in AEFI surveillance
Government bodies
• Immunization Division;
• Drug Controller General (India); Central Drug Standards Control Organization (CDSCO);
• Pharmacovigilance Programme of India and partner institutions, others
Academic institutions
• AEFI technical collaborating centers have been established in states
• As national trainers for causality assessment and AEFI surveillance
• Extend support for AEFI case investigations in states
• Research in vaccine safety
Private sector
• Reporting of AEFIs through IAP’s mobile application and IDSurv – IAP’s infectious disease
reporting network

7. Data sources for monitoring vaccine safety
AEFI reporting
through
• Monthly report in
Health Management
Information System
(HMIS)
• Weekly reporting in
H002 form NPSP
• Direct Reporting to
AEFI program
• IAP IDSurv system
Pharmacovigilance
Program of India
• Monitoring of post
marketing safety
updates from
market
authorization
holder (MAH)
• Coordinated review
of reported AEFIs
with
pharmacovigilance
stakeholders
Universal Immunization
Program
Central Drugs control
and Standards
Organization
• Immediate sharing of
any reported serious
ADRs (AEFIs) by
NCC-PvPI to AEFI
Secretariat and state
immunization
program
• Monthly sharing of
reported non-serious
ADRs (AEFIs)

8. AEFI Surveillance Operational Guidelines, 2015
• AEFI case definition, types of AEFIs by severity and causality
• Types of vaccines, safety profiles
• Processes – reporting, investigations, causality assessments,
communication, conducting post mortems, etc.
• Human resources, stakeholders – roles and responsibilities
• Formats, timelines, indicators
• Communication
• Signal management
• Quality Management System for AEFI Surveillance
Link to download:
https://nhm.gov.in/New_Updates_2018/NHM_Components/Immunization/Guildelines_for_immunization/AEFI_S
urveillance_and_Response_Operational_Guidelines_2015.pdf

9. 0
9
29
8
45
82 64 111 113 142 136 161 181 239 315 356 412 427 478
326
187
309
40
35
88
155
88
190
268
185
237
413
553
583
1105
1242
2562
2332
1043
781
1381
0
500
1000
1500
2000
2500
3000
3500
2001
(n=0)
2002
(n=9)
2003
(n=29)
2004
(n=48)
2005
(n=80)
2006
(n=170)
2007
(n=219)
2008
(n=199)
2009
(n=303)
2010
(n=410)
2011
(n=321)
2012
(n=398)
2013
(n=594)
2014
(n=792)
2015
(n=898)
2016
(n=1461)
2017
(n=1654)
2018
(n=2989)
2019
(n=2810)
2020
(n=1369)
2021
(n=968)
2022
(n=1690)
Death Others
*Data as on 31-Dec-2022 (as per DOV)
Annual reporting of serious and severe AEFIs
(2001 to 2022*)
National cohort of 26 million infants - at least 2600 serious and severe
AEFIs expected.
---------------------------------------------------------------------------------------------------------------------------------------------------
Expected minimum reporting of serious and severe AEFIs is
10 per 100 000 surviving infants a year (Global Vaccine
Action Plan, 2016)

10. Communication
• Communication Guidelines around
Vaccine Confidence (2013)
• AEFI Media Communication Protocol
(2015)
• Media response template
• Renuka, the Health Worker – film (6
languages
• Spokespersons’ trainings – Officials from
20 states trained in four workshops
• Film for health workers on use of inj.
Adrenaline for managing Anaphylaxis-
(English and Hindi)

11. Quality Management System for AEFI Surveillance
• National Quality Assurance Committee formed (2014)
• Quality Policy and Quality Objectives approved (2015)
• Quality manual developed
• SOPs for national level processes developed
• National Quality Assurance Standards for AEFI
Surveillance Programme
• Training and implementation of SOPs for national level
processes
• QMS-AEFI is being implemented in ten states

12. Implementation Status of Quality Management System- QMS
RAJ AS THAN
LADAKH
OD ISHA
GU JAR AT
MAHARASHTRA
MADHYA PRADESH
BIHAR
KAR NATAKA
UTTAR PRADESH
ASSAM
TAMIL NAD U
TELAN GANA
AND HRA PRADESH
PUNJ AB
JHARKHAND
WEST BENGAL
ARU NAC HAL PR.
HAR YANA
KERALA
JAM MU & KASH MIR
HIMACHAL PRAD ESH
MANIPUR
MIZORAM
SIKK IM
A&N ISLANDS
D&N HAVELI
CHHATTISGAR H
UTTARAKHAND
MEGH ALAYA
NAGALAN D
TRIPURA
GOA
DELHI
CHANDIGARH
DAM AN & DIU
PONDIC HERR Y
LAKS HADW EEP
Phase-1 (FY:2021-22) Phase-2 (FY:2022-23)
ASSAM A&N ISLANDS
BIHAR CHHATTISGARH
CHANDIGARH DAMAN & DIU
GOA D&N HAVELI
GUJARAT DELHI
HARYANA LAKSHADWEEP
HIMACHAL PRADESH MANIPUR
KARNATAKA MIZORAM
KERALA NAGALAND
MEGHALAYA PUDUCHERRY
ODISHA SIKKIM
TELANGANA TAMIL NADU
WEST BENGAL TRIPURA
State/UT selected for 1st
Phase (FY-2021-22) QMS
State/Ut selected for 2nd
Phase (FY-2022-23) QMS *Provisional data as of Nov 2022

13. Changes for COVID 19 vaccination
• CoWIN-SAFEVAC - reporting by vaccinators, including minor AEs
• Widened reporting network to non-paediatric doctors /
specialists
• Reduced timelines for investigations, causality
assessments, formats for adults, post mortem guidelines,
verbal autopsy in adults
• Medical specialists, cardiologists, neurologists, obst-gyn.
in AEFI committees
• Causality assessment trainings for state and national
committees
• Hiring of extra staff at national and state levels
• Rapid review system, expedited causality assessments,
signal management capacity built
• Communication plans and advisories
• Sharing data on global platforms
• Active AEFI surveillance system set up

14. Thank You