Vaccine Surveillance Programme

– Global & India perspective

Dr. L Machado
WHO Country Office , India

21/04/2025 Indian Pharmacopoeia Commission, Pharm

acovigilance Programme of India
Understanding Adverse Events/ADRs
following Immunisation

AEFI Secretariat
Immunisation Technical Support Unit (ITSU)
New Delhi
 Introduction

Some AEFIs are inevitable due to intrinsic property of the

vaccine or its constituents.
21/04/2025
 Global AEFI reporting systems – I
Source: Vaccine adverse events reporting system globally , Sumit Kumar et al, International Journal of Biomedical Research, IJBR (2016) 7 (03) ,ISSN: 0976-9633 (Online); 2455-0566 (Print)

United Kingdom (U.K) United States of America (U.S.A)

The Yellow Card Scheme is the UK Vaccine Adverse Event Reporting
system for collecting information on System (VAERS) is United States
suspected adverse drug reactions program for vaccine safety, co-
(ADRs) to medicines & vaccines. managed by the Centers for Disease
Yellow card was started in 1964 after Control and Prevention (CDC) and
the Food and Drug Administration
the thalidomide disaster. The scheme
(FDA). VAERS is a post-marketing
is run by the Medicines and safety surveillance program,
Healthcare Products Regulatory collecting information about
Agency (MHRA) and the Commission adverse events (possible side
on Human Medicines (CHM), and is effects) that occur after
used to collect information from both administration of vaccines
health professionals and the general
public

Indian Pharmacopoeia Commission, Pharm 21/04/2025

acovigilance Programme of India
 Global AEFI reporting systems - II

Australia Singapore
Therapeutic Goods Administration (TGA) Health Sciences Authority (HSA)
is part of the Australian Government It is the authority which uses number of
Department of Health, and is responsible post marketing risk assessment
for regulating therapeutic goods including approaches to ensure the continued safe
prescription medicines, vaccines, use of vaccine in Singapore. These include
sunscreens, vitamins and minerals, mandatory reporting from pharmaceutical
medical devices, blood and blood manufacturers, spontaneous reporting
products from healthcare professionals, literature
reviews and the exchange of regulatory
information with other national drug
regulatory bodies. HSA also contributes to
the World Health Organisation

Indian Pharmacopoeia Commission, Pharm 21/04/2025

acovigilance Programme of India
 Global AEFI reporting systems - III

Srilanka
Cosmetics, Devices & Drugs
Regulatory Authority (CDDRA)
It is the authority to ensure that
the Pharmaceutical vaccines,
available to the public meet the
required standards of quality and
are within the existing legislative
framework with respect to the
production, marketing and
dispensing of these items and for
AEFI reporting

Indian Pharmacopoeia Commission, Pharm 21/04/2025

acovigilance Programme of India
 Reporting methods in countries

Indian Pharmacopoeia Commission,

21/04/2025
Pharmacovigilance Programme of India
 AEFI MILESTONES - INDIA

04/21/2025 Indian Pharmacopoeia Commission, P

harmacovigilance Programme of Indi
 Immunization program in India : A Snapshot

~27 million new born targeted each year

~ 9 million immunization sessions held annually

( 67% outreach)

~27,000 cold chain points

Vaccines against 8 VPDs (TB, Diphtheria, Whooping

cough, Tetanus, Hepatitis B, HiB, Measles,
Polio/IPV) nationally and 2 VPDs sub-nationally

Polio SIAs since 1995, 800 million children

vaccinated each year 61 % full immunization coverage
Wide Geographical variations
Measles campaigns completed (118 M) and second
dose measles introduced. JE campaigns in endemic (Kerala 82%, Haryana 72%)
districts since 2006 Polio-free for last 4 years

Introduction of MR, Rotavirus and pneumococcal

vaccine underway
 AEFI Surveillance in India

 1988: AEFI surveillance started in India

 2005: National AEFI guidelines developed and disseminated
 2007: Onwards: State & District Level AEFI Committees formed
 2008: National AEFI Committee constituted
 2010: Guidelines revised, printed and widely circulated.
 2011: SOPs printed and circulated
 2012: Establishment of National AEFI Secretariat
 2015: National AEFI guidelines 2015 developed and
disseminated
 2016: Causality assessment for all states and UTs completed
 OBJECTIVES OF AEFI SURVEILLANCE

04/21/2025 Indian Pharmacopoeia Commission, P

harmacovigilance Programme of Indi
Pre-licensure assessment of vaccine safety

Adverse Reactions
Sample size Common Rare

Animal trials +/− −

Clinical trials

Phase I 10-100 +/− −

Phase II 100-1,000 + −

Phase III 1,000-10,000 + −

– Does not detect adverse reactions which are:

• rare, delayed, unexpected
• occur in sub-populations
• with vaccine combinations
Differences between vaccines and other
drugs:

Vaccines Other Drugs

• Prevention in healthy, • Treatment in ill,
larger population smaller population
− Lower risk tolerance − More tolerant of risk
• Limited number of • Large number of products,
products many classes
• With single dose, greater • Treatment over time: less
potential for temporal “coincidence”
“coincidence” after a single dose
 Vaccines vs drugs (continued)

Vaccines Other Drugs

• Prone to “program error” • Less prone to

administration error
• Injection “reaction”
• Less prone to
• Cold chain often critical administration “reaction”
• Biological product − • Storage/handling less
more prone to lot critical
variation and instability • Chemical product
 Vaccines vs drugs (continued )

Vaccines Other Drugs

• Mass campaigns: many • No mass campaigns −

doses in short time, “private” prescribing to
defined population less defined population
• Issues of coordination • Less Issues of coordination
public health/UIP, NRA and between health
manufacturers system/govt/NRA and
manufacturers.

Vaccines demand higher safety and more careful quality

standards and monitoring.
Objectives of AEFI surveillance
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
 TERMINOLOGY & DEFINITIONS

04/21/2025 Indian Pharmacopoeia Commission, P

harmacovigilance Programme of Indi
 Important Terminology in AEFI Surveillance

• Notification: AEFI becoming aware by the

health care system. Usually by ANM to the
MO.
• Reporting: Informing of the AEFI to the
district and documentation of the same in
the Case Reporting Form (CRF). Usually by
MO to the district.
• Investigation: Site visit and
documentation in the Case Investigation
Form (CIF) by the district AEFI committee.
• Causality Assessment: Systematic
assessment of information to determine the
likelihood of the vaccine/s causing the event.
Conducted by state/ national AEFI committee
 AEFI Case 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.
 AEFI REPORTING SYSTEM

04/21/2025 Indian Pharmacopoeia Commission, P

harmacovigilance Programme of Indi
 AEFI Organizational Structure

Immunization Division, MOHFW NATIONAL AEFI COMMITTEE

AEFI Secretariat &

Zonal AEFI Consultants Natl. AEFI Technical
Collaborating Centre
(LHMC, New Delhi)

State Immunization Office State AEFI Committee

District Immunization Office District AEFI Committee

Pvt
Practitioner

Health facilities and outreach

sessions
 Reporting of AEFIs

Immediate Direct reporting: Monthly routine reporting in HMIS

• Serious AEFIs – Death----(selected Serious AEFI)
– Death – Abscess---(selected non serious
– Hospitalization
AEFI)
– Cluster
– Disability
– Others----All other serious and
– Significant parent/community concern non serious AEFIs are reported
• Severe AEFIs new in this category
– Injection site swelling beyond nearest Minor AEFIs e.g.
joint
– Fever >102 degrees  To be recorded in Block/PHC AEFI registers

Dedicated email address: [email protected]

Private sector paediatricians (IAP) can report AEFIs through
www.idsurv.org
 Indian Academy of Pediatrics
Infectious Disease Surveillance site

04/21/2025 Indian Pharmacopoeia Commission, P

harmacovigilance Programme of Indi
AEFI reporting system, timelines & actions
• Convene district AEFI committee meeting and
District finalize action
Immunization District
•If indicated and recommended, ship specimens to
Officer appropriate labs
• Site (s) visit and investigation
• Collect additional details
 Vaccine/logistic distribution and utilization
 Other AEFI in the area
Preliminary  Other details such as pre-existing health,
Final CIF
CIF
medical and environmental condition
10 days of Notification

70 days of Notification State

State • Inform state AEFI committee & State Drug
Immunization Controller
Officer • Request for additional information if necessary
• Do a causality assessment within 100 days of
notification

DC Inform DCG(I) & senior officers in the

Immunization MoH&FW National
Division
MoHFW,
Govt.of India
Inform the Vaccine manufacturers and
review GMP
 AEFI Monthly Reporting - Data
Flow
National

State HQ

Depending on location

District HQ Urban Centres*

PHC / Block

Sub Centre

* Monthly reports to be sent to the respective district OR state HQ through the Asst Health Officer (EPI)/
Corporation Immunization Officer I/C
 AEFI REPORTING FORMATS

CRF - (Case Reporting Form)

PCIF - (Preliminary Case Investigation Form)

FCIF - (Final Case Investigation Form)

Lab investigation form

State Causality Assessment Form

Verbal autopsy form (in selected cases)

Formats – responsibility and timelines

Type of Report Responsible Time line

24 hours of
MO
CASE REPORTING notification
FORM (CRF) 48 hours of
DIO
notification

Preliminar
10 days of
INVESTIGATION

y DIO
notification
PCIF
FORMS

District/State
Final 70 days of
AEFI investigation
FCIF notification
team
 WHO cause-specific definition of AEFIs

An AEFI that is
caused or
1 2 4 5
precipitated by 3 An AEFI that is
AnVaccine
AEFI that is Vaccine
a vaccine that Immunization
Immunization
caused by
product-
caused or isquality
due to one An AEFI that is anxiety-
precipitated error-related An AEFI arising something
Coincidental
related by or more
defect-related caused by related other than the
a vaccine due quality defects reaction
Inappropriate from anxiety event
toreaction ofreaction reaction
about the vaccine
one or more the vaccine vaccine
immunization. product,
of the inherent product handling,
immunization
properties of including its prescribing or
error or
the vaccine administration administration.
immunization
product. device as
anxiety
provided by
the
manufacturer.
 Data sources for monitoring vaccine safety

Universal Immunization Pharmacovigilance Central Drugs control and

Program Program of India Standards Organization

AEFI reporting • Immediate sharing of • Monitoring of post

through any reported serious marketing safety
• Monthly report in ADRs (AEFIs) by NCC- updates from market
PvPI to AEFI authorization holder
Health Management
Secretariat and state (MAH)
Information System
immunization
(HMIS)
program
• Weekly reporting in
H002 form NPSP • Coordinated review of
• Monthly sharing of reported AEFIs with
• Direct Reporting to
reported non-serious pharmacovigilance
AEFI program
ADRs (AEFIs) stakeholders
• IAP IDSurv system
 Reporting of Serious / Severe AEFI Cases
2001-2017*
Revised National AEFI
2000 Guidelines circulated

ITSU/ AEFI Sect.

Established

1500
l a nce
il
rve
Revised National AEFI
Guidelines circulated
S u
A EFI
1000 for
di ng 1102
il
bu
National AEFI Guidelines
c i ty 580
732
Printed & Circulated
pa 553
500
Ca 413
268 237
190 185
155 88 311 345
40 35 88 181 239 247
111 113 142 136 161
0
9 29 8 45 82 64
0 0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
(n=0) (n=9) (n=29) (n=48) (n=80) (n=170) (n=219) (n=199) (n=303) (n=410) (n=321) (n=398) (n=594) (n=792) (n=891) (n=1447 (n=979)
)

Death Others
*Data as on 30-Sep-2017
 Districts Reporting AEFI, 2015-2016*
2015 2016

Increase from 2015

to 2016
62% cases
12% reporting
districts

891 cases 1447 cases

reported from reported from
261 districts Legend 291 districts
Average reporting of Cases (1 Dot = One Case) Average reporting of
cases per district: 3.4 Silent District cases per district: 5.0
Reporting District
*Data as on 30-Sep-2017
 AEFI reporting timelines Causality Assessment
Day 100
Final investigation –
district reports to state
Day 70

Preliminary investigation
– district reports to state
Day 10
District decision
on investigation
and informs state
48 hrs
Medical officer
decision on case
visit and reports
to district
24 hrs

Notification
Day 0
Onset
 AEFI – PvPI
Collaborating for vaccine safety
 Membership in AEFI committees
National Level

 National AEFI committee- Representative of IPC

 Causality assessment subcommittee- Representative of IPC

State Level

 State AEFI committee – Representative of AMCs - nodal coordinator /

Pharmacovigilance associates (proposed)

District level

 District AEFI committee-Representative of AMCs - Pharmacovigilance

associates (proposed)
 Coordination – data sharing
• Data sharing arrangement for immediate sharing of
AEF
I- serious AEFI report
PvPi

• Monthly sharing of non-serious AEFI reports received by

AEF
I- PvPI with the National AEFI Secretariat
PvPi

• AEFI Secretariat follow up with state EPI officers and

AEF
I- DIOs for investigation of reported AEFIs (Serious/severe)
PvPi
 Coordination – meetings, trainings

 Regular National AEFI committee meetings

 Monthly partners meeting between AEFI, PvPI, CDSCO
at national level
 Training of IPC members on WHO standard causality
assessment - national & regional workshops
 Induction training of technical associates
 AEFI cases reporting through PvPI
Distribution by type of AEFIs, 2015-2017*

PvPI DIRECT
YEAR (Data received as of 5 Oct REPORTING
2017 (CRF/PCIF/FCIF)

TYPE ---- SERIOUS NON SERIOUS SERIOUS SEVERE

1/5th of all
serious and non-
2017 141 (21%) 523 884 95
serious AEFIs
reported through
2016 128 (20%) 519 1326 121
the AMCs are
serious.
2015 81 (12.25%) 580 872 19

** 2017 data FY wise (Apr 2017-Sep 2017) as on 6 Oct 2017

2016 data FY wise (Apr 2016-Mar 2017) as on 1 Sep 2017
2015 data FY wise (Apr 2015-Mar 2016) as of 12 May 2017 *Data as on 30th Sep-2017
 Action points
• Be aware of adverse events following vaccinations
• On detecting such a case, report through the PvPI software
• Additionally inform case details (name, father’s / mother’s
name, age, sex, vaccine, status, address, etc.) to the District
Immunization Officer with copy to the State Immunization
Officer and [email protected]
• Ideally the district where the person was administered the
vaccine “owns the patient”
• Help with providing hospital records, residence address and
contact details
Case Notification Format for serious AEFIs
 Future avenues for convergence
Improved district level coordination
 Pharmacovigilance associate / nodal coordinator (AMC) identify serious
& severe AEFI reports to District Immunization Officer (DIO)
 Proposed: District Immunization Safety and Pharmacovigilance
Associate (DISPA ) to serve as link between PVPI and AEFI

Improved state level coordination

 Regular feedback and discussion between AMCs and state AEFI
committees and technical collaborating centres.
 Improved coordination for active surveillance of AEFIs
 Regular feedback and information sharing between PvPI and AEFI
 Proposed: State Immunization Safety and Pharmacovigilance Associate
(SISPA ) to serve as link between PVPI and AEFI
 Causality Assessment in case of ADRs
related to Vaccines

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017
India
 Objectives

Explain what is causality assessment

List the 4 steps in the revised

causality assessment scheme

Identify the scientific basis of the

causality assessment

Explain the pragmatic aspects of

causality assessment

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017
India
 Causality and causality assessment

Causality* Causality
• Is the relationship Assessment
between two events • Determining if such a
(the cause and the relationship exists
effect), where the and if so to what
second event is a extent
consequence of the
first

*A direct cause is a factor in absence of which the effect would not occur (necessary
cause).
*Sometimes, there are multiple factors that can precipitate or function as co-factors
for the effect (event) to occur.
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of
20-01-2017
India
 Why causality assessment for
AEFI?

To avoid automatically concluding that

“the event happened after vaccination,

therefore it happened because of
vaccination”…

Best evidence is
randomized trial
Unvaccinated group
comparing AEFI in
vaccinated and non
vaccinated groups.

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017 India
 Prerequisites for assessing causality for an
AEFI case

• The AEFI case investigation • Case report form,

should have been completed • Case investigation form,
• All details of the case should • Completed clinical case
be available at the time of record,
assessment • Lab report,
• There must be a “valid • Autopsy report, details of
diagnosis” field investigations,
– The valid diagnosis refers • Blank causality
to the extent to which the assessment worksheets
unfavorable or unintended
sign, abnormal laboratory
finding, symptom or
disease is defined.
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of
20-01-2017 India
 Causality assessment steps

Classificatio
n
Algorithm

Checklist

Eligibility

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017 India
 Why four steps?

Step 3: Step 4:
Step 1: Step 2:
Algorithm Classification
Eligibility Checklist

To determine To To obtain a To categorize

that the AEFI systematicall trend on the
case satisfies y review causality association
minimum available with the of the AEFI
criteria for information checklist to vaccine /
causality information vaccination
assessment

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017
India
 Step 1: Eligibility

• Ensure AEFI investigation is completed and all details of the case is available
AEFI • Retain case details in a retrievable database
case

• Identify (at least) one vaccine administered before this event

Ident
ify
vacci
ne(s)

• Select the unfavorable or unintended sign, abnormal laboratory finding,

Valid symptom or disease you want to check causality.
Diag
nosis

• Brighton Collaboration definition,

Indian standard
Pharmacopoeia literature definition, national
Commission,
Pharmacovigilance Programme
definition or other approved definition of India
Case
defin
ition

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017 India
 Creating a causality question*

Has the ____________ vaccine / vaccination caused ____________?

Vaccine name Valid Diagnosis

Examples of causality questions

• “Has the vaccine A caused hepatomegaly?” (An example of an unfavorable or
unintended sign)
• “Has the vaccine B caused thrombocytopenia?” (An example of a laboratory finding)
• “Has the patient complained that the vaccine C caused itching and redness?” (An
example of a symptom)
• “Has the vaccine D caused meningitis?” (An example of a disease).

* Should address the unfavorable or unintended sign or laboratory finding or symptom or disease.
20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of
India
 Step 2 Checklist

Y N UK NA
I. Is there strong evidence for other causes?

II. Is there a known causal association with the vaccine /
vaccination
• Relationship with vaccine ingredients

• Immunization error
• Relationship with vaccine administration

II (Time). Was the event within the time window of increased

risk?

III. Is there a strong evidence against a causal association?


IV. Other qualifying factors


Indian Pharmacopoeia Commission, Pharmacovigilance Programme of
20-01-2017
India
 Step 3 Algorithm (summary)

I A. Inconsistent III A. Inconsistent

causal causal
association to association to
immunization immunization

Yes Yes
II. Is there a
III. Is there a
I. Is there strong known causal IV. Review other
strong evidence
evidence for association with qualifying factors
against a causal
other causes? the vaccine/
association?
vaccination
Yes

Is the event No
II (Time). Was the classifiable? IV D.
event within the Unclassifiable
time window of
increased risk? Yes
Yes

II A. Consistent IV A. Consistent IV C. Inconsistent

causal causal IV B. causal
association to association to Indeterminate association to
immunization immunization immunization

Indian Pharmacopoeia Commission, Pharmacovigilance Programme of

20-01-2017
India
 Step 4: Classification

A. Consistent causal B. Indeterminate C. Inconsistent causal

association to immunization association to immunization

A1. Vaccine product-related B1. *Temporal relationship is

reaction (As per published consistent but there is
literature) insufficient definitive
Adequate evidence for vaccine causing C. Coincidental
event (may be new vaccine-
information A2. Vaccine quality defect- linked event) Underlying or emerging
related reaction condition(s), or condition(s)
available caused by exposure to
something other than
B2. Qualifying factors result in vaccine
A3. Immunization error-related
conflicting trends of
reaction
consistency and inconsistency
with causal association to
immunization
A4. Immunization anxiety-
related reaction

Unclassifiable
Adequate
information
Specify the additional information required for classification
not available

*B1 : Potential signal and maybe considered for investigation

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
 Classification - Examples

A1. Thrombocytopenia C. Coincidental

after MMR vaccination B1. Irritable bowel Child dies after DPT
A. Consistent syndrome after TT C. Inconsistent
vaccine and autopsy
vaccine (hypothetical showscausal
congenital heart
causal
A2. Paralytic polio caused
B.andIndeterminate
unproved so far) disease
association
by incomplete IPV to
inactivation
association to
immunization immunization
or
A3. Transmission of
infection by contaminated B2.
multidose vial Thrombocytopenia Fever occurs after
vaccination (temporal
after MMR vaccine association) and
A4. Vasovagal syncope in in a dengue endemic
an adolescent following malarial parasite
vaccination area isolated from blood

l e s
m p
E x a
20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
 Multiple vaccines, multiple AEFI and clusters
Multiple Vaccines in the same Multiple AEFI in the same patient
patient
Each event should be
listed separately and
Each vaccine should be specific eligibility
assessed separately question (step 1) asked
and independently
evaluated.
AEFI cluster

Each patient in the

cluster should be
separately evaluated

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Who should assess AEFI causality

• A reviewing team/ committee that should

– Be Independent
• free of real or perceived government, industry
conflicts of interest
– Have broad range of expertise
• infectious diseases, epidemiology, microbiology,
pathology, immunology, neurology, vaccine program
expertise, other…
– Have written terms of reference (ToR)

• Can make use of an existing drug

causality assessment team BUT
modify and adapt to fit vaccines.

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 What can go wrong?

Causality assessment not done, not systematic, not done by trained

personnel and/or not done timely

Information in AEFI report is so limited that causality assessment

cannot be done

Lack of expertise and/or independence of the review committee

responsible for formal causality assessment undermines credibility

Non analysis of AEFI data may delay recognition of clusters and

programme errors

Lack of communication of findings, not addressing all target audiences, or

lack of diplomacy and/or cultural sensitivity

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Follow-up

Prevent additional cases

• Immunization program, policy makers, NRA,
community, manufacturers, HCWs

Ensure/enhance safety of immunization

programs
• Immunization program, policy makers, NRA,
community, manufacturers, HCWs

Promote transparency and accountability

• Community, policy makers, immunization program

“Political and economic” implications

• Policy makers, NRA, immunization program,
manufacturers

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Causality assessment: Decision
making on follow-up

EPI advisory AEFI

committee committee

Investigation Policy
committee makers
Recommendations

Follow Up

Action may have to be initiated while investigation is on-going

20-01-2017
Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India
 Specific actions after AEFI
A. Consistent causal
association to
immunization
A1. Vaccine product-related
reaction (As per published
literature)

A2. Vaccine quality defect-

A1: Vaccine product related reaction related reaction

A3. Immunization error-related

reaction
• follow country protocols
• Inform the NRA, marketing authorisation holder, the A4. Immunization anxiety-
related reaction

procuring agency and the WHO

A2: Vaccine quality defect related reaction

• If related to a particular lot / batch: may have to

withdraw specific lot(s)
• Inform the NRA, marketing authorisation holder, the
procuring agency and the WHO

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Specific actions after AEFI
A. Consistent causal
association to
immunization
A1. Vaccine product-related
reaction (As per published
literature)

A3: Immunization error related reaction A2. Vaccine quality defect-

related reaction

• Training and capacity building A3. Immunization error-related

reaction

• Change in logistics for supply, store or handle A4. Immunization anxiety-

• Change in procedures at the health facility related reaction

• Training of health workers

• Intensified supervision
• Measure outcome of corrective action: short- and long-
term

A4: Immunization anxiety related reaction

• Vaccinating in an ambient and safe environment

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Specific actions after AEFI
B. Indeterminate
B1. *Temporal relationship is
consistent but there is
insufficient definitive
evidence for vaccine causing
event (may be new vaccine-

B1. Temporal relationship is consistent linked event)

but there is insufficient evidence for B2. Qualifying factors result in

conflicting trends of
vaccine causing the event consistency and inconsistency
with causal association to
immunization

• Input into national database to identify a

signal later

B2. Reviewing factors result in

conflicting trends of consistency and
inconsistency
• maintain details in a national database
• With additional details classification may change

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Specific actions after AEFI
C. Inconsistent causal
association to
immunization

C. Coincidental
Underlying or emerging
The information and confirmation of the findings condition(s), or condition(s)
caused by exposure to
(underlying condition or/ and the final diagnosis) something other than vaccine

need to be provided to the patients, relatives,

the care provider and the community.

Rapid sharing of this information with all

stakeholders is CRITICAL to maintain confidence
in the Immunization programme

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Specific actions after AEFI
Unclassifiable

The available information should be

placed in a repository/ electronic
database

Review database periodically for future

classification and analyse for
identifying signals.

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Follow-up actions for single cases and clusters

Immunization
error

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Follow-up actions for signals

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Causality assessment: Summary of
Follow up

Corrective
action

Education
Communication
and training

20-01-2017 Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India

 Thank You
Report AEFIs in India : [email protected]