Adverse Events Following Immunization (AEFI) Surveillance program in India

Dr Jyoti JoshiSenior Advisor-AEFI Management, vaccine safety and quality

Immunization Technical Support Unit, MoHFW

22 Aug 2015IPC Ghaziabad

Presentation Outline

1. AEFI Surveillance Program 2. Milestones

3. Program Progress

4. Initiatives Undertaken

5. Future Plans

• ~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 coverageWide Geographical variations (Kerala 82%, Haryana 72%)Polio-free for last 3 years

Immunization program in India : A Snapshot

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

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

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

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.

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.comPrivate sector paediatricians (IAP) can report AEFIs through www.idsurv.org

new

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

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)

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

NATIONAL AEFI SURVEILLANCE PROGRAM PROGRESS

12

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 20150

100

200

300

400

500

600

700

800

900

0 9 29 48 80170

219 199

303

410321

398

593

780

64

National AEFI Guidelines

Printed and Cir-culated

Trends in reporting of serious AEFIs (2001-2015)

AEFI Sect.established at

ITSU

Revised National AEFI

Guidelines circulated

Data as on 17-02-15

State trainings and sensitization on AEFI

Surveillance

A&N

ISLA

NDS

ANDH

RA P

RADE

SH

ARUN

ACHA

L PR

.

ASSA

M

BIHA

R

CHAN

DIGA

RH

CHHA

TTIS

GARH

D&N

HAV

ELI

DAM

AN &

DIU

DELH

I

GOA

GUJA

RAT

HARY

ANA

HIM

ACHA

L PR

ADES

H

JAM

MU

& K

ASHM

IR

JHAR

KHAN

D

KARN

ATAK

A

KERA

LA

0

5000000

10000000

15000000

20000000

25000000

30000000

35000000

40000000

45000000

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

1.1Lacs

209.8 Lacs

3.2Lacs

119.7 Lacs

444.2 Lacs

3.5 Lacs

116.8Lacs

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.

LAKS

HADW

EEP

MAD

HYA

PRAD

ESH

MAH

ARAS

HTRA

MAN

IPUR

MEG

HALA

YA

MIZ

ORA

M

NAG

ALAN

D

ODI

SHA

PUDD

UCHE

RRY

PUN

JAB

RAJA

STHA

N

SIKK

IM

TAM

IL N

ADU

TELA

NGA

NA

TRIP

URA

UTTA

R PR

ADES

H

UTTA

RAKH

AND

WES

T BE

NGA

L

0

10000000

20000000

30000000

40000000

50000000

60000000

70000000

80000000

0 50 32 0 1 9 1 17 4 8 9 0 61 3 10 76 0 720 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

0.2Lakh

315.7Lacs

420.2Lacs

8.5Lacs

13.7Lacs

4.2Lacs

4.6Lacs

148.2Lacs

3.7Lacs

95.7Lacs

273.2Lacs

1.8Lacs

206.2Lacs

100Lacs

274.4Lacs

702.5Lacs

109.4Lacs

238.5Lacs

Variable sensitivity in serious AEFI reporting from states.

DISTRIBUTION OF SERIOUS AEFI CASES

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

100 100

0

100 10083.33

5748

29

56

37.293729372937334.634146341463442.767295597484340.7035175879397

31.216931216931229

0 0

0

0 016.57

4352

71

44

62.706270627062764.146341463414657.232704402515859.0452261306533

68.606701940035371

% Death % Hospitalized

Data as on 10-01-15

Increased reporting of hospitalized cases in recent years indicates enhanced sensitivity of AEFI Surveillance

State Level AEFI Committee not formedState Level AEFI Committee formed

Status of State AEFI Committee formation

2013 2014

Data as on 01-12-14

Status of District AEFI Committee formation

RAJASTHAN

ODISHA

GUJARAT

MAHARASHTRA

MADHYA PRADESH

BIHARUTTAR PRADESH

KARNATAKA

ANDHRA PRADESH

JAMMU & KASHMIR

ASSAM

TAMIL NADU

CHHATTISGARH

PUNJAB

JHARKHANDWEST BENGAL

ARUNACHAL PR.HARYANA

KERALA

UTTARAKHAND

HIMACHAL PRADESH

MANIPUR

MIZORAM

MEGHALAYANAGALAND

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

NUMBER OF REPORTING DISTRICTS AND STATUS OF AEFI COMMITTEES

2011 2012 2013 2014

125142 148

209

No. of reporting districtsdistricts

Data as on 17-02-15

Fig: Map of districts reporting serious AEFIs (2014)

LegendCASES (1 Dot = One Case)Silent District

Reporting District

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 (HOSPITAL-IZED); 133;

22%

DEATH; 169; 28%

DISABILITY; 4; 1%

HOSPITAL-IZED, 253,

43%

LAMA; 1; 0%OTHERS; 1; 0%NOT MENTIONED; 2; 0%CLUSTER CASE; 38; 5%

CLUSTER CASE (DEATH); 16; 2%CLUSTER

CASE (HOSPITAL-IZED); 152;

19%DEATH; 215; 28%

DISABILITY; 1; 0%

HOSPITALIZED, 329, 42%

RECOVERED; 4; 1% NOT MENTIONED; 25; 3%

2013 (593) 2014 (780)

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

Reporting rate for serious AEFIs has almost

doubled over the last 3 years

YEAR 2011 YEAR 2012 YEAR 2013 YEAR 20140

100

200

300

400

500

600

700

800

900

321398

593

780

229289

400327

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.

Causality Assessment of reported AEFIdeaths following Pentavalent Vaccination ( 2011-14)

Data as on 15-09-2014

UNCLASSIFIABLE; 12; 22%

IN-DE-TERMI-NATE; 5; 9%

CO-IN-CIDEN-TAL; 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

• 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

INITIATIVES TO STRENGTHEN AEFI SURVEILLANCE

• 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

!OT

I

West Zone East Zone

South Zone

North Zone

LegendNorth ZoneWest ZoneEast ZoneSouth Zone

Network of National AEFI Technical Collaborating Centres

• 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

• 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

• 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

!OT

I

West Zone East Zone

South Zone

North Zone

LegendNorth ZoneWest ZoneEast ZoneSouth Zone

Network of AEFI Collaborating Centres

Quality Managemen

t Systems

• Strengthening communication around AEFI: o Establishing spokespersons at

national and state levelo 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

• 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

Thank YouReport AEFIs in India : aefiindia@gmail.com or