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
Concepts
•   Background
•   AEFI surveillance
•   National Guidelines
•   Case investigation
•   Recording and Reporting
•   AEFI committees
Adverse Event Following Immunization
A medical incident that takes place
after an immunization, causes concern
and is believed to be caused by
immunization
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.
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
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
AEFI Surveillance

                         AEFIs identified
                           by existing
                          surveillance



Unreported, undetected
        AEFIs
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
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
Sub-committees of
National AEFI Committee...

• Causality assessment sub committee

• Operational group sub committee

• Investigation sub committee

• Media management sub committee
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 )
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
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 )
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
AEFI Committees Status
                                                                                                                                                                                                                                                                                                   District Level
                        State Level
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          JAMMU & KAS HMIR                                                                                                                           # # #
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                                          n = 35                                                                                                                                                                                                                                                                                                                                                           n = 494
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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        #
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.
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 )
Revised AEFI
Surveillance and Response
  Operational Guidelines

 Released in September 2010

            By

 Ministry of Health and FW,
       Government of
      India, New Delhi
DIFFICULTIES ARE INTENDED TO MAKE US
               BETTER,
              NOT BITTER




Immunization Division & National AEFI Committee
Immunization Division & National AEFI Committee

AEFI Dhamija

  • 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 FollowingImmunization A medical incident that takes place after an immunization, causes concern and is believed to be caused by immunization
  • 4.
    Serious AEFI: WHO standarddefinition 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 AEFICases (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 NationalAEFI 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 NationalAEFI 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 AEFICommittee... • Causality assessment sub committee • Operational group sub committee • Investigation sub committee • Media management sub committee
  • 11.
    Members of StateAEFI 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 StateAEFI 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 # # # # # # JAMMU & KAS HMIR # # # # # # # # # # # # # # n = 35 n = 494 HIMACHAL PRADESH # # # # # # # # # # # # PUNJAB # # # # # # # # # # # # # # # # # # # # # # UTTARANCHAL # # # # # # # ## # # # # # # # ## # # # # # HARYANA # # # # # # # # # # # # # # # # # # # # # # # # ARUNACHAL PR. # # ## # # # # # # # # # # # # # # # SIKKIM # # # # # # # # # # # # # # # # # # # # # # # # ## # # RAJASTHAN UTTAR PRADE SH ASSAM # # # # # # # # # # # # # # # # # # # # # # # # # # # # ## # # ## # # # # NAG ALAND # # # # # # # # # # # # # # # # # # # # BIHAR # MEG HALAYA # # # # # # # # # # # # # # # # # # # # # # # # # ## # # # # # # # MANIPUR # # # # # # # # # # # # # # # # # # # # # # # # # # # TRIPURA # # # # # # # # # # # JHARKHAND # # # # # # # # # # GUJARAT MADHYA PRADESH MIZORAM # ## # # # # # # WEST BENGAL # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # CHHATTISGARH # # # # # # # # # # # # # ORIS SA # # # # # # # # # D&N HAVELI # # # # # # # # # ## # # MAHARASHTRA # # # # # # # # # # # # # # # # # BI A R D # # # # # # # # # GULBA R A G # # ANDHRA PRADESH BI APU R J # # # # # # # BELG M AU BAGALK OT # # # # R C HU AI R # # # GOA ## DH W # AR AD G AG AD # KOPPA L # # KARNATAKA BELLARY # # HAVER I # # UTTAR KAN NAD # DAVAN AG E ER # SHI O A M G C TRAD R A HI U G # # # U UP I D ## CH CKABA LLAPUR I # TUM U K R C KM LU HI AG R KOLAR # # # # # # A&N ISLANDS BAN ALO E ( ) G R R H # ASSA N BANG ALO E ( U R ) # # # # # DAKSH I KAN N N AD R A NAG R AM A A M D YA AN # # KO G ( C O R ) DA U O G # # # PONDICHERRY # # MYSO RE C AM AR H AJN AGAR # # # # # # ## # # # TAMIL NADU # # # # # # # # # # LAK SHADW EEP KERALA # # # # # # # # # # # # # # # # # # # # # #
  • 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 FirstInformation 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 andResponse Operational Guidelines Released in September 2010 By Ministry of Health and FW, Government of India, New Delhi
  • 19.
    DIFFICULTIES ARE INTENDEDTO MAKE US BETTER, NOT BITTER Immunization Division & National AEFI Committee
  • 20.
    Immunization Division &National AEFI Committee