AEFI Surveillance & Role of Partners

Dr Deepak Polpakara

Senior Team Lead, AEFI Secretariat, ITSU

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NRA-WHO Global Benchmarking Tool for Vaccines

10^th-14^th April 2023, TISRD, Telangana

Disclaimer

The thoughts, views and opinions expressed in this presentation belong solely to the author and do not necessarily represent the opinion of the ITSU/MOHFW

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Conflict of Interest: Nothing to Disclose

Contents

• Overview of AEFI surveillance
• Partners and roles
• Status and areas for improvement
• Group work

Immunization Technical Support Unit

• Set up in 2012 to provide techno-managerial support for scaling up the Universal Immunization Programme (UIP), innovate, demonstrate and document best practices in routine immunization

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• AEFI Secretariat housed within ITSU with the objective of having a group of dedicated personnel at the national level, focusing only on strengthening AEFI surveillance and monitoring vaccine safety

Role of AEFI Secretariat

• Conduct National AEFI Committee meetings, causality assessment meetings

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• Manage AEFI surveillance database – analysis, documentation

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• Capacity building activities

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• Coordinate with CDSCO, PVPI, CDL Kasauli, academic and research institutions, professional bodies, other partners at national level

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• Support states and districts in improving AEFI surveillance, case investigations

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• Revise AEFI guidelines, support MOHFW in policy decisions

Need for Adverse Events Following Immunization (AEFI) surveillance

• To ensure vaccine safety and build vaccine confidence.
• To capture rare, serious AEFIs undetectable during clinical trials.
• To recognise, correct and prevent immunization programme errors and take corrective actions.
• To investigate known coincidental events causing concern and prevent false blame.
• Document and convey the cause to parents/community.
• Estimate rates of occurrence of AEFI in the local population.

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AEFI Surveillance Activities

• Reporting

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• Investigations

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• Causality assessments

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• Signal management

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• Action taking
• Training, sensitization, monitoring / supervision
• Changes to policies / guidelines
• Communication and advisories
• Recommendations for regulatory action

Reaching Impact, Saturation, and Epidemic Control (RISE)

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

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• Passive surveillance

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• Minor (AEFI registers-non-electronic); serious and severe AEFIs (online reporting-SAFEVAC)

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• Immunization Division, DCGI/CDSCO, pharmacovigilance partners, others

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Adverse Events Following Immunization (AEFI)

• An adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine

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• The adverse event may be any unfavorable or unintended sign (e.g. Abscess following vaccination), abnormal laboratory finding (e.g. Thrombocytopenia following measles vaccination) symptom or disease (e.g. Disseminated BCG infection following BCG vaccination).

AEFI as per severity

Minor

Severe

Serious

Usually occur within a few hours of injection.

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Resolve after short period of time and pose little danger.

Can be disabling and, rarely life threatening

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Most do not lead to long-term problems

Must be reported

Death

Inpatient hospitalization

Results in persistent/significant disability

AEFI cluster

Parent/Community / media concern

Congenital anomalies / birth defects

WHO cause specific definition of AEFIs

This is utilized for causality Assessment by State and National AEFI Committees

Channels of reporting AEFI

1. Universal Immunization Program

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• AEFI surveillance system:
• Primary reporting of AEFI cases from rural & urban areas: ANM, MO-PHC
• Medical colleges, private practitioners, media reports
• Immediate reporting of all severe/serious AEFI cases through CRF, CIF into SAFE-VAC /Co-WIN SAFE-VAC
• HMIS Report:
• Monthly reporting of all AEFIs (numbers only) through HMIS (Death, Abscess and Others column)
• VPD Surveillance:
• Weekly reporting (severe & serious cases) from all reporting unit in form of VPD H002 & its compilation in D001 forms

Channels of reporting AEFI

2. Pharmacovigilance Program of India (PvPI)

• Individual Case Safety Report (ICSRs) generated by ADR Monitoring centres established as a part of PvPI
• Case Notification Formats for reporting details of serious and severe AEFIs to immunization programme

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3. Central Drugs control and Standards Organization
1. Monitoring of post marketing safety updates from market authorization holder (MAH)

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4. IAP’s http://www.idsurv.org/ portal for private Paediatricians

AEFI Organizational Structure

• Prepared in 2005, revised in 2010 and 2015
• Revised AEFI case definition and algorithm for causality assessment
• Reporting, investigation and causality assessment formats improved and timelines reduced
• AEFI reporting following non UIP vaccines

National AEFI Surveillance Operational Guidelines

Serious/Severe AEFI Cases �(formats and timelines)

SAFE-VAC�(Surveillance and Action For Events following Vaccination)

• Web based application
• Case-based information of AEFI cases is submitted
• Scanned copies of the documents can be uploaded
• Submitted at district level, can be viewed at state and national level
• Other features: Automated reminder emails, data dashboard, key performance indicators, downloadable charts and line-lists
• Secure data
• hosted on government server
• can be accessed by authorized users
• IT security and safety guidelines followed

*Data as on 28-Feb-2023 (as per DOV)

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National cohort of 26 million infants - at least 2600 serious and severe AEFIs expected

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Expected minimum reporting of serious and severe AEFIs is 10 per 100 000 surviving infants a year (Global Vaccine Action Plan, 2016)

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AEFI Committees

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.

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Composition

• Epidemiologist/Public Health Specialist
• Pediatrician, physician, cardiologist, neurologist, respiratory medicine, obstetrician-gynaecologist, microbiologist, pathologist, forensic medicine, Cold Chain officer
• Representative from drug authority
• Nodal officer/Technical Associate, AMC
• Member Integrated Disease Surveillance Program(IDSP)
• Representative from local bodies like corporations
• Representatives from professional bodies like IAP, IMA
• Representatives from partners agencies

Member Secretary: Immunization Programme Manager

National AEFI Committee

• Reconstituted in June 2013; expanded in April 2014; revised in April 2017

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• Revised and expanded in 2020 before Covid-19 vaccination – included cardiologist, neurologist, respiratory medicine expert, Obstetrician & gynaecologist

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• Four sub-committees
• Causality
• Media
• Laboratory
• Investigation

Quality Management System

• Guidelines for National Quality Assurance Standards for AEFI Surveillance Programme developed (2016)

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• Quality certification received for national level processes of AEFI Surveillance

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• Budgetary norms for state, district and PHC/session site activities, eligibility criteria for assessments and certification (2019)

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• Implementation initiated in 10 states in 2021-22 including Goa

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Communication

• Communication Guidelines around Vaccine Confidence (2013)

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• AEFI Media Communication Protocol (2015)

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• Media response template

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• Renuka, the Health Worker – film (6 languages)

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• Spokespersons’ trainings – Officials from 20 states trained in four workshops

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Academicians and private sector

Involvement of academicians in AEFI

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• AEFI technical collaborating centres have been established in states (Bihar, Madhya Pradesh, Andhra Pradesh, Karnataka, Kerala)

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• As national trainers for causality assessment and AEFI surveillance

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• Extend support for AEFI case investigations in states

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Private sector

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• IDSurv – IAP’s infectious disease reporting network includes AEFI reporting

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AEFI Surveillance: Partnerships on vaccine safety

Pharmacovigilance Partners

Data Sharing Arrangements

• PVPI
• ICSR – monthly anonymized linelists of minor, serious /severe AEFIs from AMCs
• ICSR and Case Notification Format (CNF) immediately for serious and severe AEFIs

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• AEFI Secretariat
• Weekly limited line list of serious and severe AEFI
• Monthly detailed line list of serious and severe AEFIs
• Causality assessment results with vaccine batch details

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• CDSCO
• SmPC, PSURs, RMPs

AEFI: Organizational Structure

National AEFI Committee

Immunization Division, MOHFW

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AEFI Secretariat, ITSU

Signal Management Team

Recommendations of previous NRA Assessment

• Specific plans to target silent districts; state AEFI committees to use surveillance data, monthly reports to guide districts; training district AEFI committee members; Create objective evidence for measuring training effectiveness in districts

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• Additional manpower and IT support for document management system.

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• Improve quality of case investigations and verbal autopsy formats using simulation exercises

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Recommendations of Previous NRA Assessment

• Improve timeliness of causality for completion within a few weeks, systematic literature review – share with all levels

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• Signal detection – VigiBase; link AEFI and PVPI databases; Active surveillance systems

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• Ensure manufacturers report immediately to the NRA all new and relevant data concerning quality, efficacy and safety of vaccines which may have impact on the benefit risk ratio - CDSCO

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Areas of improvement

• Strengthen coordination mechanisms
• Institutional Development Plan
• Effective partners coordination meetings

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• Review data sharing mechanism among PV Partners
• Sharing of PSURs, RMP, updated PI/SmPCs
• Unified database - Validation of vaccine ICSRs by AEFI Secretariat/CDSCO

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Summary

• Identification, reporting and investigation of AEFI cases is important to capture rare, serious AEFI;

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• Build vaccine confidence in the community

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• National AEFI Operational Guidelines (2015) – formats, timelines, guidance, etc. for different components of AEFI surveillance

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• Defined roles and responsibilities of partners

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• Coordination and data sharing mechanisms require revision

Thank you!

Questions

Resource Material Link:

https://itsu.org.in/adverse-event-following-immunization-resource-materials-ri/

Group work

Group work

• Each group should have atleast one representative from all partners
• A list of data to be shared between partners is prepared
• The existing data sharing mechanism is studied by the group and updated
• Timelines and mode of sharing should be defined

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