Module 8 · Chapter 9
Operational Aspects of AEFI Surveillance
Goal, objectives, who does what at every level from ASHA to the National AEFI Committee, committee composition and quorum, technical collaborating centres, partners, police liaison, indicators and state ranking.
9.1 Goal and objectives · 9.2 Key activities
An effective system must detect and conclusively classify AEFIs in time to prevent them or reduce impact. AEFI surveillance in India began in 1988–89.
Specific objectives
- Timely detect, report and respond to AEFI
- Identify programmatic errors and correct them efficiently
- Document and promptly communicate AEFIs due to quality defects for regulatory action
- Document AEFI rates for a specific lot/brand in a region/population
- Estimate serious AEFI rates and compare with local and global data
- Identify signals of unexpected events for further analysis/studies and new hypotheses
- Sustain confidence of public, health functionaries and professionals
Key activities
- Prompt notification and reporting, rapid investigation and evaluation, effective response
- Capacity building at national/state/district levels
- Causality assessment at state and national levels and communicating results
- Signal detection — unusual rates for a vaccine, lot or brand
- Communication on vaccine safety and AEFI crises
- Convergence and information sharing with regulatory and pharmacovigilance partners
- Regular monitoring and feedback to states
- IT — U-WIN for reporting; SAFE-VAC database for investigation and analysis
- Well-defined SOPs for clarity, uniformity and no duplication
Figure 9.1 · Key players of the AEFI surveillance system
| Level | Key players |
|---|---|
| National | Additional/Joint Commissioner, Immunization Division, MoHFW; AEFI Secretariat; zonal AEFI senior consultants · National AEFI Committee · NATCC (LHMC) · CDL Kasauli & Kolkata · CDSCO, PvPI · WHO, UNICEF, UNDP · other partners |
| State | Director FW / State Immunization Officer and State AEFI consultant · State AEFI Committee · State AEFI TCC · State Drug Authority · pharmacovigilance/ADR centres · WHO, UNICEF, UNDP and partners |
| District | Chief Medical Officer / District Immunization Officer · District AEFI Committee · pharmacovigilance partners (ADR Monitoring Centre) |
| Sub-district | MO or nodal in-charge of block PHC/CHC/DH/corporation |
| Facility | Public and private primary, secondary and tertiary hospitals, clinics, institutes, medical colleges, nursing homes |
| HWC / sub-centre | Community Health Officer (CHO), ANM and health supervisors |
| Community | Frontline workers — ASHA, AWW, volunteers |
9.3.1 Community level · 9.3.2 Sub-centre level
ASHA, anganwadi workers, volunteers, frontline workers
- After the session, use the beneficiary due list cum tally sheet to follow up beneficiaries for suspected AEFIs, illness or problems needing a doctor or hospitalization.
- Immediately inform the ANM and MO by telephone.
- Help the beneficiary access care by arranging referral transport.
- Assist the investigating team.
- Help sustain community confidence in vaccines.
Table 9.1 · Key role of the ANM
| Prevent AEFIs by best practices | Manage AEFIs |
|---|---|
|
|
Health Supervisors (HS)
- Supervise and give hands-on training to ANMs — correct injection practices, correct messages, arranging referral transport and informing officials in a crisis.
- Check availability of vaccines and logistics (anaphylaxis kit, syrup paracetamol), including adrenaline expiry.
- Monitor sessions for recommended practices.
- Monitor the community for AEs during visits; liaise with community leaders; ensure beneficiary follow-up; ensure reasons for drop-out are entered in counterfoils.
- Encourage reporting; serious/severe AEFIs notified immediately.
- Analyse sub-centre reports; track health workers who have not reported any AEFI over time.
- Assist investigation teams.
9.3.3 Facility level
- All facilities — primary, secondary, tertiary, medical colleges, nursing homes, clinics, government and private — belong in the network; primary responsibility: DIO.
- DIO, with facility authorities, designates a nodal person (MO, nurse, paramedic, resident MO…) for reporting.
- In large hospitals/medical colleges, orient Paediatrics and Community Medicine; also desirable: Medicine, Obstetrics & Gynaecology, Cardiology, Neurology, Paediatric Surgery, General Surgery, Dermatology, Forensic Medicine, Pharmacology.
- Maintain an AEFI register; inform serious/severe AEFIs to the DIO immediately; keep blank CRFs with the nodal officer.
- Assist investigation and information collection for causality.
- Special emphasis on referral hospitals and medical colleges, where sick infants with serious AEFIs present.
- Use WHO-NPSN Surveillance Medical Officers or AEFI consultants to establish reporting in medical colleges.
Involving private-sector doctors
The private sector fills service gaps (timings, approachability); many practitioners give UIP vaccines for a small administration charge. Without private reporting, surveillance is incomplete — and private data cover newer and non-UIP vaccines. Advocacy through IAP, API and IMA; NPSN SMOs play a key role. Registered IAP members can report serious/severe AEFIs through the IAP app or online at www.idsurv.org; any private practitioner can contact the DIO.
9.3.4 Sub-district (planning unit) level
Planning unit = block PHC/CHC or corporation (sometimes the district hospital for district HQ). The MO in charge works in: (1) detection, (2) management, (3) reporting and (4) QMS implementation.
Detection
- Train staff to detect, manage and notify AEFIs and distinguish minor from serious/severe
- Encourage immediate reporting of serious/severe AEFIs
- Confirm frontline reports
- On case visits, ask about recent outbreaks or deaths in the community
Management
- Clinical case management and referral to the next level if needed
Reporting
- All serious/severe AEFIs to DIO within 24 h
- Record even minor events; review in weekly/monthly meetings
- ANMs give details of all AEFIs weekly
- MO verifies and signs after the last case of the week; if none, writes “No case reported” and signs
- Analyse entries monthly (antigen trends, suspected errors) and share with DIO monthly
- Keep at least 5 blank CRFs at the planning unit
- Ensure quality investigation and documentation; collect hospital records
- Track post-mortem, histopathology, toxicology and cause-of-death reports
- For programme errors (e.g. abscess) find reasons and correct
- Help DAC/DIO; share results with vaccinators and supervisors after SIO/DIO confirmation
Analysing the AEFI register (Table 9.2 sample)
Register columns: week no., sub-centre, vaccine recipient, father’s name, age, date of vaccination, vaccines given, batch numbers, AEFI noted (symptoms), category (minor/serious/severe), case seen by MO I/C (Y/N), CRF filled (Y/N). The sample shows e.g. abscess after BCG/HepB/OPV (severe), febrile seizures after Penta/OPV (severe), fever >102°F (severe), death after BCG/OPV (serious), local reactions (minor).
Three questions for the MO
- Have all serious/severe cases in the register been reported through SAFE-VAC?
- Is there an increased trend of minor AEFIs (pain, fever, swelling) with a particular vaccine batch?
- Are there specific events (e.g. abscesses) indicating unsafe administration?
- Emergency drugs (in date) and functional equipment in the PHC AEFI management kit and the ANM’s anaphylaxis kit.
- Adequate syrup paracetamol, syringes, MCP cards.
- Anaphylaxis kit with every ANM; MO certifies contents at least once a quarter — no drug expiring within three months — and an adrenaline dose chart in the kit.
- Line list of serious, severe and non-serious AEFIs at the block PHC/CHC register.
- Weekly review: ask ANMs about missed cases; sign or certify “No case reported”.
- Regular feedback to ANMs; implement QMS at PHC and session sites.
9.3.5 AEFI committees
From district level upward, committees guide surveillance. Core actions:
- Ensure national policy/standards, prompt thorough investigation of serious/severe AEFIs, no case missed.
- Review trends of non-serious AEFIs (HMIS/RI reporting) and operational status of AEFI registers.
- Investigate where indicated; monitor surveillance performance.
- Causally assess cases (national and state committees only) per the global classification.
- Respond to media and community concerns.
- Support strengthening through handholding, trainings and workshops.
- Give feedback to reporting sites; strengthen case management and closure.
9.3.5.1 Composition
Chairperson of State/District committee: preferably a paediatrician, epidemiologist or public health specialist; another person from these specialities may also be a member. The immunization programme manager (national/state/district) is the member-secretary. Prefer specialists from medical colleges to chair or join.
| Independent members | National | State | District |
|---|---|---|---|
| Paediatrician · Public health specialist · Medical epidemiologist · Medical microbiologist · Internal medicine specialist · Cardiologist · Obstetrician-gynaecologist · Pathologist · Forensic expert | ✓ | ✓ | ✓ |
| Pulmonologist/respiratory medicine · Medical pharmacologist · Neurologist | ✓ | ✓ | – |
| Virologist · Immunologist | ✓ | – | – |
| Liaison members | National | State | District |
| Drug authority representative · Professional bodies (IAP, IMA) · Partner agencies (WHO/NPSN, UNICEF — ex-officio, invited when required) | ✓ | ✓ | ✓ |
| IDSP representative · Cold-chain officer/vaccine and cold chain manager · Quality Assurance cell (special invitee) | – | ✓ | ✓ |
| Local-body MOs (municipal corporation, ULB, ESI hospital) · ADR monitoring centre representative (where available) | – | – | ✓ |
State: ≥ 7 (3 independent + 4 liaison) incl. chairperson, paediatrician, public health specialist, forensic expert, microbiologist/pathologist.
National: ≥ 10 (5 independent + 5 liaison) incl. chairperson, advisor, paediatrician, public health specialist, forensic expert and any other.
9.3.6 District level
The DIO keeps the system functional, ensures health workers know how to report, ensures the DAC meets at least once every quarter, that all serious/severe cases are in SAFE-VAC, that cases are investigated in field and hospital with complete forms (post-mortem, histochemical analysis, hospital records), and facilitates post-mortems and HPE/chemical reports in deaths.
Table 9.4 · Key district activities
| Component | Activities |
|---|---|
| Functional District AEFI Committee | Defined ToR (Annexure 15) incl. the drug inspector; no case deserving investigation ignored; investigate all serious/severe AEFIs and update state/national; implement QMS (internal and peer assessments of PHCs). |
| Documentation and data entry | Keep: committee contact list; ToR; line list of investigated serious/severe cases; case files (CRF, CIF, documents); analyses and spot maps; communications (letters, GOs, bulletins, SAC minutes, feedback, vaccine test results). Review SAFE-VAC and HMIS data; discuss AEFI in the monthly MO meeting; feedback to PHCs/CHCs and the state. |
| Coordination | ADR Monitoring Centres (ensure vaccine ADRs in their software reach the CMO/DIO and are investigated); medical colleges for specialists (neurology, forensic medicine, microbiology, histopathology); district IAP and IMA chapters; share DIO’s personal contact with all vaccinating institutions; key DAC updates reviewed at the monthly District Task Force for Immunization/District Health Society. |
| Capacity building | Disseminate guidelines and train staff; nodal officers of medical colleges/large hospitals sensitise doctors and paramedics (supported by DIOs, SMOs, state/zonal AEFI consultants); blank CRFs with DIO contacts at all facilities; state trains DIOs at least once a year. |
| AEFI response and management | Validate CRF; data entry operator enters in SAFE-VAC under DIO supervision; case ID allotted; scanned CRF uploaded — all within 48 h of notification. Timely medical management and coordination with hospitals/labs; investigate with the DAC; collect documents immediately; CIF within 21 days; coordinate labs and share results. |
A corporation may be a separate entity with its own AEFI committee; the Corporation MO (or MO in charge of immunization) acts as DIO and sends investigated cases to the state for causality.
9.3.7 State level
Director FW / State Immunization Officer, supported by the State AEFI Consultant, and the State Drug Controller.
| Component | Activities (Table 9.5) |
|---|---|
| Functional State AEFI Committee | Strategic planning; regular SAC meetings (ToR Annexure 16; meeting steps Annexure 17); review serious/severe cases and conduct causality assessment; convey results via SAFE-VAC and, if needed, present to the national sub-committee/NAC; guide district investigations; oversee QMS and push for state certification; coordinate pharmacovigilance stakeholders; facilitate workshops/trainings; support operational research. |
| Documentation and data | Committee contacts, ToR, state line list, forms, case summaries, causality reports, spot maps, GOs; review SAFE-VAC/HMIS data; feedback to GoI and districts; identify non-/under-reporting districts; review cases not investigated; monitor unusual increases by antigen or batch and inform national level; review in state/district meetings; feed back SAC recommendations and test results; track DAC meetings with a tracking tool; field visits. |
| Coordination | State Task Force for Immunization reviews SAC updates monthly; State Drug Controller inducted in SAC; corporation committees functional; coordination with state QA cell for QMS; state IMA, API, IAP chapters for private reporting; existing surveillance networks; supportive supervision; medical-college specialists; TCCs, regulators, AMCs, partners; municipal corporations/urban areas (Urban Health Mission); Immunization Division/zonal consultants/AEFI Secretariat. |
| Training and capacity building | Verify documentation of non-investigated AEFIs; disseminate guidelines, CRF and CIF and plan periodic training; DIOs have updated AMC lists and investigate AMC-reported cases; continuous capacity building of DIOs, data entry operators, MOs, HWs, FLWs. |
| AEFI response and management | In crises: special investigations, crisis communication and media management; technical/managerial support; expert team for special cases (clusters with deaths, media-highlighted cases); check other districts’ line lists; coordinate drug authorities, hospitals, labs, colleges; activate the state communication plan. Post-event: instructions to prevent recurrence of programme-error clusters; periodic training; timely SAC causality; ensure complete CIFs and records; quality causality assessment within 90 days of notification; ensure districts upload all documents. |
The State AEFI Consultant/RI consultant assists the SEPIO — coordinates SAC meetings and liaison with the medical-college TCC — and reports to the SEPIO. SAC meets at least once every quarter. SEPIO gives feedback and motivation to poorly/non-reporting districts.
9.3.8 National level
National Programme Manager for Immunization, MoHFW
- Nodal person; periodic review with the NAC and AEFI Secretariat.
- Review patterns, revise guidelines/SOPs, capacity building, national database of serious/severe cases, feedback to states.
- Periodic evaluation of the national system.
- Regular NAC and sub-committee meetings.
- Coordinate regulators, PvPI etc.
- Assess state requests for a central expert team for special investigations.
- Regular feedback to states with action points.
National AEFI Committee (NAC)
Sector-wide: paediatricians, community health experts, neurologist, cardiologist, respiratory medicine, medical specialist, obstetrician-gynaecologist, immunologists, pharmacologists, microbiologist, pathologist, forensic experts; plus CDL Kasauli, CDSCO, PvPI-IPC and professional bodies (IAP, IMA, TNAI). Meets at least once every quarter; Directors FW, SEPIOs and SAC chairs/members may be invited on rotation.
NAC terms of reference
- Technical guidance on programme, policy and implementation
- Update guidelines/SOPs; systems for quality data esp. new vaccines (COVID-19) or mass campaigns
- Strengthen states through handholding, trainings, workshops
- Review trends; suggest policy interventions
- Review and approve national causality results (sub-committee or states) and convey to MoHFW
- Assist states in field investigation on request
- Review surveillance and QMS implementation
- Integrate the private sector
- Integrate with national pharmacovigilance (CDSCO, IPC); guide signal detection
- Advise on vaccine quality, testing facilities and collaborations
- Suggest operational/implementation research and pilots
- Mechanism for regular feedback at all levels
Four NAC sub-committees
| Sub-committee | Role |
|---|---|
| Causality assessment | Causality in meetings monthly or more often; review trends; identify signals with new vaccines; quality feedback to states |
| Investigation | Field investigations on request of the Immunization Division; feedback to improve investigations |
| Laboratory | Network of national/accredited labs for vaccine and case samples; coordinate CDSCO; quality standards |
| Media | Address media at national/state level; network of spokespersons at state and district; communication curriculum and kits |
AEFI Secretariat and zonal AEFI senior consultants
Established in 2012 on NAC recommendation; hosted at the Immunization Technical Support Unit (ITSU). Activities: coordinate with Immunization Division, NRA, CDSCO, CBHI, IEC Division, NCDC, IDSP, WHO-NPSN; liaise with state/district committees, DCGI, PvPI; support quarterly NAC and monthly causality meetings; monitor timeliness/completeness and follow-up; technical assistance to states; facilitate central team visits; review state causality with the sub-committee and TCC; administer NAC activities and workshops; support QMS (NQAS-AEFI); coordinate AMCs; review the database for signals.
Zonal senior consultants (representing the Immunization Division) support allotted states: feedback on investigation quality; follow up pending documents and screen cases; field visits and special investigations; help identify TCCs; advocate with IAP, IMA, IAPSM for private participation; roll out SAFE-VAC and QMS; capacity building of SACs (esp. causality) and DIOs; coordinate with proposed pharmacovigilance officers.
9.4 Technical collaborating centres · 9.5–9.9
9.4.1 National AEFI TCC (NATCC)
Department of Paediatrics, Lady Hardinge Medical College (LHMC), New Delhi. Technical oversight and clinical expertise for causality. Activities: (1) review database for trends; (2) ascertain causality of serious/severe cases; (3) capacity building; (4) technical support — crisis and regular; (5) identify research areas.
9.4.2 State AEFI TCC
A prominent (preferably government, state HQ) medical college — department of paediatrics, community medicine or any interested department; funded through the state PIP; simple MOU. Objectives: monitoring processes and capacity building with feedback; supporting quality causality and investigation. Roles: pool of resource persons; venue for review meetings/workshops; coordinate pharmacovigilance stakeholders; review data; encourage vaccine-safety research. Institutionalises academia–public health links.
9.5 National and state regulatory authority
DCGI heads the national regulatory body; CDSCO is the NRA — marketing authorization and post-market surveillance. CDL Kasauli and CDL Kolkata (under CDSCO) do testing and batch release of vaccines and syringes. Indian Pharmacopoeia Commission hosts PvPI. AEFI surveillance is a vital NRA function. India exports vaccines to more than 200 countries, incl. through WHO prequalification. The State Drug Controller heads the state regulatory authority.
9.6 Partners
- Immunization partners (WHO, UNICEF, UNDP) support the DIO: (a) capacity building; (b) monitoring RI sessions for ANM injection practices; (c) case investigation; (d) sharing analyses at task force meetings; (e) SAFE-VAC rollout.
- Pharmacovigilance partners: (a) reporting and cross-notification — AMCs report via CNF + email + phone call; also the ADR PvPI mobile app and toll-free 1800 180 3024; (b) vaccine safety updates via PSURs; (c) signal recommendations.
9.7 Quality assurance
The Quality Improvement Division of NHSRC helped develop the National Quality Assurance Standards for AEFI Surveillance (2016) — benchmarks, checklists, scoring. SOPs developed, QMS implemented and national-level processes certified. Expected gains: standardisation, clear accountability, efficiency, better surveillance. Areas of concern at immunization site, district, state and national levels with internal, peer and external assessment (see Ch 12).
9.8 Signal management
A national Signal Review Panel (SRP) — independent — meets every two months (or earlier) and reports to the NAC and MoHFW; the AEFI Secretariat analyses and presents data and follows up recommendations (Ch 10).
9.9 Liaison with district administration and police
- Deaths/clusters may be investigated in parallel by police and administration to rule out criminal intent or negligence; police may participate in autopsies, specimen collection and testing.
- The goal of the DAC, administration and police is identical — find the cause of death.
- Committees may invite police/administration to planning meetings, joint site visits and joint specimen collection.
- Protocols differ — handle tactfully, keep partners updated.
Figure 9.2 · Responsibilities and classification status by level
| Level | Responsibilities | Classification status |
|---|---|---|
| District (HW/MO/DIO) | Detection and recording; treatment and reporting of serious/severe AEFIs to state; routine reporting and line listing; investigation; corrective action; public education; QMS | Preliminary: non-serious vs serious/severe |
| State surveillance units | Support district (investigation, clinical and lab assessment); preliminary causality; report to national committee; data analysis and search for additional cases; corrective action; monitoring/supervision/training; public education; QMS | Serious/severe AEFI — for referral to national: vaccine reaction, coincidental, unknown; for local action: immunization error, immunization anxiety |
| National programme (AEFI Secretariat, CDSCO, IPC…) | Expert support to field investigations; monitor and assess serious AEFIs; final causality (NAC); data analysis; signal detection and management; policy recommendations; feedback guidance; research; monitoring/supervision/training guidance; public education content; global expertise; QMS | Final classification of all AEFIs; repository of all cases; signal management |
9.10 Performance indicators (Table 9.6)
| Level / indicator | Formula | Benchmark |
|---|---|---|
| A · Sub-district (assessed by MO I/C) | ||
| Serious/severe AEFIs reported to district through CRF | Reported via CRF ÷ serious/severe listed in AEFI register × 100 | >90% (quarterly) |
| Sub-centre sites scoring ≥70% in internal assessment (QMS) | Sites ≥70% ÷ all sub-centre sites in PHC × 100 | 50% of sites (quarterly) |
| B · District (assessed by DIO) | ||
| District AEFI reporting rate | Serious/severe via CRF on SAFE-VAC in a year ÷ surviving infants × 10,000 | ≥ 1 per 10,000 surviving infants/yr (quarterly) |
| AEFI report completion rate | Cases with both CRF and CIF on SAFE-VAC ÷ cases initiated × 100 | >80% (half-yearly, after next quarter — Jan–Jun cases assessed in Sept) |
| Timeliness of CRF | CRF on SAFE-VAC within 48 h ÷ reported × 100 | >90% (quarterly) |
| Timeliness of CIF | CIF within 21 days ÷ reported × 100 | >80% (quarterly) |
| DAC meetings held | Held ÷ expected × 100 | 100% (≥1 per quarter) |
| DAC minutes shared with state | Shared ÷ held × 100 (tracking tool as evidence) | 100%, within a fortnight |
| PHCs scoring ≥70% internal assessment (QMS) | PHCs ≥70% ÷ all PHCs × 100 (plus district level ≥70%) | 50% of PHCs (quarterly) |
| C · State (assessed by SEPIO) | ||
| State AEFI reporting rate | Per 10,000 surviving infants/yr | >1 per 10,000 (quarterly) |
| Proportion of reporting districts | Districts reporting any serious/severe case ÷ all districts × 100 | >80% (quarterly) |
| Timeliness of CRF / CIF | 48 h / 21 days | >90% / >80% |
| State causality assessment rate | Classified and uploaded by SAC ÷ reported × 100 | >80% (half-yearly) |
| Timeliness of causality | Classified within 100 days ÷ causally assessed × 100 | >80% (half-yearly) |
| Proportion ineligible | Ineligible ÷ reviewed and classified × 100 | <20% |
| SAC meetings held · minutes shared with national | Held ÷ expected · shared ÷ held | 100% (≥1/quarter) · 100% within a fortnight |
| Districts ≥70% in peer assessment (QMS) | Districts ≥70% ÷ all districts × 100 | 50% of districts → state eligible for peer/external assessment (yearly) |
| D · National (Immunization Division/AEFI Secretariat) | ||
| National reporting rate | Per 10,000 surviving infants | ≥1 per 10,000 |
| Proportion of reporting districts | Districts reporting ≥1 serious/severe case ÷ all districts | >80% (quarterly) |
| Timeliness of CRF | 48 h | >90% |
| CIF uploaded · CIF within 21 days | ÷ reported | >80% · >80% |
| Proportion ineligible | Ineligible by national sub-committee/NAC ÷ reported | <20% |
| National causality assessment rate | Assessed and approved ÷ reported | >80% |
| NAC meetings | Meetings held in a year ÷ 4 | ≥ 1 (one per quarter) |
9.10.2 Ranking of states
The Immunization Division ranks states every quarter on three core areas — reporting, case investigation and state-level processes — each split into weighted indicators that sum to an overall score; shared with suggestions to foster competition. Also shared regularly: mismatch between deaths on SAFE-VAC (CRF) and HMIS; NAC-approved causality results; AEFI dashboards within immunization dashboards.
Chapter summary
- Goal: safe vaccines and sustained public confidence.
- Effective surveillance detects, reports and responds; corrects errors; documents lot/brand rates; finds signals.
- Activities: SOPs, capacity building, rapid notification/investigation, state and national causality, feedback.
- Many stakeholders with clear ToRs — coordination is key.
- Indicators for reporting, investigation, causality and committee meetings exist at every level.
Quick recall
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Self-test · Chapter 9
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