Self-study guide · MoHFW, Government of India
Adverse Event Following Immunization: Surveillance and Response — Operational Guidelines 2024
A complete, chapter-by-chapter study companion to the 2024 national AEFI guidelines (15 chapters + 25 annexures). Every module has structured notes, exam pearls, tap-to-reveal recall cards and an instantly-graded self-test. Finish with the mock exam.
How to use this guide
- Read the module notes. Section numbers mirror the guideline (e.g. 4.3 = Chapter 4, section 3).
- Exam pearls (amber boxes) flag the facts most likely to be tested; red boxes flag common traps or discrepancies inside the guideline itself.
- Quick recall: answer in your head, then tap “Show answer”.
- Self-test: MCQs with instant feedback and explanation. Use “Reset” to retake.
- When all modules are done, sit the final mock exam.
Forewords and messages — key facts
27.4 million
children (birth cohort) and 30 million pregnant women are covered by the UIP every year — the largest cohort in the world.13.6 million
immunization sessions a year across the country (Joint Secretary’s foreword).2.2 billion+
COVID-19 vaccine doses given in the world’s largest vaccination campaign (launched 2021) using indigenously manufactured vaccines.IMI 3.0 · 4.0 · 5.0
Targeted catch-up campaigns held in 2021, 2022 and 2023 to restore routine coverage during COVID-19.- Secretary (Apurva Chandra), 6 Jan 2024: India is one of the largest manufacturers and the largest consumer of vaccines; strengthening AEFI surveillance demonstrates that vaccines made, used and exported are safe. CoWIN recorded every beneficiary’s vaccination; for the first time India has an electronic AEFI database with minor AEFIs and a dedicated signal management system for vaccines.
- AS & MD-NHM (L S Changsan): initiatives — Mission Indradhanush, Gram Swaraj Abhiyan, Intensified Mission Indradhanush; new vaccines (rotavirus, pneumococcal, measles-rubella). AEFI system strengthened by SAFE-VAC software for serious/severe AEFIs, a quality management system for AEFI surveillance and ranking of states through key performance indicators.
- Joint Secretary (Dr P Ashok Babu): changes since the 2015 guidelines — vaccinators may give one dose of injection adrenaline at the session site for anaphylaxis; syrup paracetamol instead of tablets for infants with fever; SAFE-VAC reporting; reporting of AEFIs after adult vaccines; QMS expanded to states and districts.
- Additional Commissioner (Dr Pawan Kumar), preface: CoWIN showed that minor AEFIs can be reported by vaccinators and serious/severe AEFIs by doctors and vaccine recipients; post-mortem guidelines updated; AEFI committees expanded to include physicians, obstetrician-gynaecologists, neurologists and cardiologists (for adult vaccination); new chapters on signal management, new-vaccine/future-pandemic preparedness and adult AEFI surveillance; DIOs must reach clinicians in public and private tertiary hospitals (incl. medical colleges) and collaborate with IAP, IMA and API.
Chapter 1 · Introduction
Why AEFI surveillance?
- Vaccines protect against vaccine-preventable diseases (VPD), reducing incidence and severity and saving lives. Vaccinations under the UIP in India are voluntary.
- Goal of immunization: protect the individual and the public from VPDs by ensuring every individual receives all due vaccines at the appropriate age.
- Vaccines are safe, but no vaccine is entirely without risk; adverse reactions will occasionally occur. Benefits far outweigh real or perceived risks.
- Before approval a vaccine undergoes rigorous pre-clinical assessment + three phases of clinical trials, then may be licensed by the regulator (CDSCO in India). Trials involve limited volunteers and may miss rare adverse events — a strong AEFI surveillance system monitors safety across millions of beneficiaries.
- Immunization safety spans vaccine manufacturing, regulation, safe administration, waste disposal and AEFI surveillance.
- India’s AEFI system captures events after any vaccine — not only UIP or paediatric vaccines: e.g. rabies, influenza, geography-specific vaccines (Kyasanur Forest Disease vaccine), travel vaccines (yellow fever), age/gender-specific vaccines (HPV).
Objectives of the AEFI surveillance system (Ch 1)
- Promptly detect, report and respond to AEFI.
- Expeditiously identify unusually high rates of AEFI related to a specific vaccine lot/brand.
- Promptly address programmatic errors through corrective measures.
- Estimate serious AEFI rates in the population and compare with local and global data.
- Identify signals of unexpected adverse events and generate new hypotheses, to be confirmed by planned studies and laboratory investigations.
Through surveillance the vaccine safety profile is monitored so regulators and programme managers can act, continuously conduct benefit–risk assessments, inform policy and sustain public confidence. Causality assessment distinguishes a coincidental event from a true vaccine-related event. All health-care providers should be prepared to respond appropriately and timely to public concerns.
India, as a major vaccine manufacturer, has a greater responsibility to implement critical control functions (including vaccine pharmacovigilance) competently and independently — giving other countries confidence in Indian vaccines.
History of the guidelines
- National AEFI Guidelines 2005 → revised 2010 and 2015.
- 2017: WHO assessed India’s AEFI system during the periodic NRA assessment and declared it robust.
- The COVID-19 mass vaccination campaign was used to further strengthen the system.
Intended users
Health workers and medical officers at all facilities; programme managers at PHC, district and state level; AEFI committee members at all levels; partner agencies including drug regulators; state AEFI technical collaborating centres in medical colleges; faculty and students of medical colleges; other public and private stakeholders responsible for vaccine safety and quality.
What changed in 2024
Key changes to the system since 2015
- Digital recording software (SAFE-VAC, U-WIN) to increase reporting of all AEFIs incl. minor; HMIS reporting changes; fewer CIFs; CIF timeline increased from 10 to 21 days (Ch 4).
- Vaccinators may give one IM dose of adrenaline in suspected anaphylaxis; syrup paracetamol replaces tablets at session sites for minor AEFIs (Ch 3).
- Updated post-mortem guidelines for adults and children; new verbal autopsy form for adults (Ch 6).
- QMS for AEFI surveillance expanded to states, districts, PHCs and session sites (Ch 12).
- Physicians, neurologists, cardiologists, respiratory-medicine specialists and obstetrician-gynaecologists added to AEFI committees; bigger role for state AEFI committees and state technical collaborating centres in medical colleges (Ch 9).
- Strengthening for adult vaccination, new UIP vaccines and EUA vaccines as pandemic preparedness (Ch 15).
- Signal management processes for vaccines (Ch 10).
New content in these guidelines
- New vaccine platforms (adenovector, DNA); updated safety profiles of COVID-19, non-UIP and non-paediatric vaccines (Ch 2–3).
- AEFI surveillance in adults — expanded network, revised formats, adult safety profiles (Ch 3, 4, 5, 14).
- Number of vials to send to CDL Kasauli for new vaccines (Ch 7).
- Changes to the causality process, checklist, summarising reasons, underlying mechanisms and limitations (Ch 8).
- DIO roles expanded (private and public hospitals), collaboration with Quality Assurance teams, updated monitoring indicators (Ch 9).
- Data-sharing between pharmacovigilance partners and regulators, incl. signal recommendations for regulatory action (Ch 13).
- Social media for vaccination messaging and crisis response (Ch 11).
Must-know numbers & timelines (cheat sheet)
| What | Value | Where |
|---|---|---|
| MO fills CRF (sections A–D) and sends to DIO | Within 24 h of notification | 4.3, 5.3 |
| DIO reviews CRF, fills section E, generates Case ID, enters & uploads in SAFE-VAC | Within 24 h of receiving CRF — i.e. not later than 48 h of notification | 4.3, 5.3, Table 9.4 |
| CIF + documents uploaded in SAFE-VAC | Within 21 days of notification (earlier 10 days) | 4.3, 5.3 |
| Window for pending reports (complete PM, lab results) | Up to 45 days after notification | 4.3 |
| Causality assessment by state AEFI committee | 100 days of notification (4.3 B, indicator) · 90 days (8.7, Table 9.5) | see trap below |
| Post-mortem in AEFI death | Best within 72 h; Annexure 12: begin ideally within 2 h of death | 5.3.6, Ann 12 |
| Observation after vaccination | 30 minutes | 3.3.4, 8.6 |
| Reconstituted BCG / measles-containing vaccine | Discard after 4 h; JE after 2 h; all leftovers at session end | 3.3.3 |
| Open vial policy | Use up to 4 weeks after opening (if conditions met) | 3.3.3 |
| Used vials after session | Keep in cold chain 48 h or till next session; never discard if AEFI reported | 5.3.1, 7.2.3 |
| Anaphylaxis kit check by PHC MO | Once a quarter; no drug expiring in the next 3 months | 3.3.4, 9.3.4 |
| Paracetamol syrup | 125 mg/5 ml; 10–15 mg/kg every 4–6 h, max 4 doses/24 h; only if fever | 3.3.4, Ann 4 |
| CDL Kasauli (vaccines) / CDL Kolkata (syringes, vitamin A) results | ~30 days / ~60 days | 7.2, 7.3 |
| District / state / national AEFI committee meetings | At least once a quarter; minutes shared within a fortnight | 9.3, Ann 15–16 |
| National causality sub-committee · Signal Review Panel | Monthly (or more) · every 2 months | 9.3.8, 10.3 |
| Expected reporting rate | ≥ 1 serious/severe AEFI per 10,000 surviving infants per year (= 10 per 100,000) | Table 9.6, Ann 15 |
| Quorum: district / state / national | 5 (2+3) / 7 (3+4) / 10 (5+5) — independent + liaison | 9.3.5.1 |
| Proportion of ineligible cases (target) | <20% | Table 9.6 |
| PSURs (New Drugs & CT Rules 2019) | 6-monthly for 2 yrs, then annual for 2 yrs; due within 30 days; serious unexpected ADR within 15 days | 13.2.1 |
Trap · internal discrepancySection 4.3 (state level) and the state indicator use 100 days for state causality assessment, while section 8.7 and Table 9.5 say 90 days. If an exam quotes 8.7 it expects 90; if it quotes the reporting process/indicator it expects 100.
Module map
| Module | Guideline coverage |
|---|---|
| 2 · Immunity & vaccines | Innate/adaptive, active/passive, herd immunity, vaccine types incl. COVID-19 platforms, excipients, contraindications vs precautions |
| 3 · AEFI basics | Definition, frequency categories, minor vs serious vs severe, rate tables, cause-specific types, immunization errors, ITSR, open vial policy, coincidental deaths, COVID-19 AEFIs, management |
| 4 · Recording & reporting | Who informs, immediate vs routine reporting, SAFE-VAC, HMIS rows, CRF/CIF processes, clusters, cross-notification, private sector, ADR centres |
| 5–6 · Investigation & deaths | Investigation steps, EPID number, cluster logic, verbal autopsy, post-mortem guidance |
| 7 · Specimens | Biological tests, NIV labs, CDL Kasauli quantities and packing, CDL Kolkata |
| 8 · Causality | Bradford Hill criteria, 4-step WHO method, checklist, algorithm, classification, actions, state/national operations |
| 9 · Operations | Roles at every level, committees, TCCs, police liaison, indicators, state ranking |
| 10–11 · Signals & communication | Signal management, SDR methods, SRP; risk and crisis communication, media protocol |
| 12–15 · QMS, NRA, adults, new vaccines | NQAS-AEFI, CDSCO/CDL/PvPI, PSURs, adult and pregnancy vaccination, active surveillance |
| Annexures | All 25 annexures summarised — forms, schedules, dose charts, ToRs |
Quick recall
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