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Prevention of AEFI (Adverse Events Following Immunization)
(Park's Textbook of Preventive and Social Medicine)
Definition
An AEFI is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the vaccine. It may be an unfavourable or unintended sign, abnormal laboratory finding, symptom, or disease.
CIOMS/WHO 2012 Classification (Cause-Specific)
| Type | Prevention relevance |
|---|
| Vaccine product-related reaction | Inherent to vaccine; minimised by pre-screening contraindications |
| Vaccine quality defect-related reaction | Prevented by Good Manufacturing Practice (GMP) and cold chain |
| Immunization error-related reaction | Entirely preventable - inappropriate handling, prescribing, or administration |
| Immunization anxiety-related reaction | Prevented by counselling and observation period |
| Coincidental event | Not causally related; detected by surveillance |
The most important category for prevention is immunization error-related reaction, as it is by its nature preventable.
Prevention of AEFI - Key Strategies
1. Pre-Vaccination Screening (Contraindication Check)
- Screen all recipients for contraindications and precautions before each vaccination.
- Do not vaccinate if true contraindications exist (e.g., anaphylaxis to previous dose, severe immunodeficiency for live vaccines).
- Note that most conditions labeled as contraindications in the past (mild fever, mild illness, breastfeeding, etc.) are false contraindications - they should NOT prevent vaccination.
- True contraindications include: history of severe allergic reaction to a vaccine component, encephalopathy within 7 days of a previous pertussis vaccine dose.
2. Proper Vaccine Handling and Cold Chain Maintenance
- Maintain the cold chain strictly: most vaccines stored at +2°C to +8°C; OPV and varicella at -20°C.
- Vaccines should never be frozen if they are freeze-sensitive (e.g., DPT, hepatitis B, Td, liquid Hib).
- Discard vaccines that have been frozen inadvertently (use Shake Test or Freeze indicator).
- Use Vaccine Vial Monitor (VVM) to check heat exposure; do not use vaccines with VVM at or past discard point.
- Use cold boxes and ice packs properly - vaccines must not come in direct contact with ice packs (to avoid freezing).
- Follow First Expiry First Out (FEFO) principle for stock rotation.
3. Correct Injection Technique and Administration
- Use correct site, route, dose as specified for each vaccine:
- BCG - intradermal, right deltoid
- DPT/DT/TT/Hepatitis B/IPV - intramuscular (anterolateral thigh in infants)
- Measles/MMR - subcutaneous
- OPV - oral
- Use sterile, single-use auto-disable (AD) syringes for every injection.
- Never reuse needles or syringes.
- Reconstitute vaccines with the correct diluent provided by the manufacturer only.
- Discard reconstituted vaccines after 4 hours (opened multi-dose vials in field conditions) or as per multi-dose vial policy.
- Do not inject into the gluteal region (risk of sciatic nerve injury and reduced immunogenicity for some vaccines).
4. Avoiding Immunization Error (Programme Errors)
Programme errors are responsible for a significant proportion of preventable AEFI. They include:
- Using wrong vaccine or wrong diluent
- Non-sterile injection technique (contamination of vaccine or multi-dose vials)
- Injecting into wrong site or by wrong route
- Incorrect dosage
- Vaccine not properly reconstituted
- Vaccine stored improperly before use
Prevention: Adequate training of health workers, supervision, standard operating procedures (SOPs), and regular refresher training.
5. Post-Vaccination Observation and Management
- All vaccinees should be observed for at least 15-30 minutes after vaccination to detect and manage:
- Anaphylaxis or severe allergic reactions
- Vasovagal syncope (fainting)
- Health facilities must have an anaphylaxis emergency kit (adrenaline 1:1000, steroids, antihistamines).
- Ensure the vaccinee is seated or lying down during/after vaccination to prevent injury from fainting.
6. Health Worker Training and Supervision
- Regular training of immunization staff on:
- Correct vaccination techniques
- Cold chain management
- Recognition and management of AEFI
- Reporting and recording of AEFI
- Supervision and quality audits of vaccination sessions.
7. AEFI Surveillance and Reporting System
- A robust AEFI surveillance system helps detect signals early and take corrective action.
- All serious AEFI must be reported promptly to district/state/national health authorities.
- Events that MUST be reported include: anaphylaxis, severe local reactions, seizures, encephalopathy, paralysis, death.
- Investigating AEFI clusters: a cluster is two or more cases of the same adverse event related in time, place, or vaccine administration.
8. Communication and Counselling
- Inform recipients/parents about:
- Expected common minor reactions (local pain, swelling, fever) and their management
- Warning signs requiring medical attention
- Importance of completing the immunization schedule
- Address vaccine hesitancy through proper communication to maintain trust.
9. Safe Injection Safety and Waste Disposal
- Safe disposal of used syringes and needles in puncture-proof containers (hub-cutters, safety boxes).
- Prevents needle-stick injuries and re-use of discarded syringes.
Summary Mnemonic: "CCTISH"
- C - Contraindication screening before vaccination
- C - Cold chain maintenance
- T - Training of health workers and correct technique
- I - Injection safety (AD syringes, sterile technique)
- S - Surveillance and reporting system
- H - Health education and post-vaccination observation
Important Points for Exam
- Immunization error-related AEFI is the ONLY fully preventable category - previously called "programme error."
- The Shake Test is used to detect freeze-damaged vaccines.
- Auto-disable (AD) syringes are mandatory in national immunization programmes.
- Anaphylaxis is the most serious immediate AEFI - epinephrine is the drug of choice.
- India's AEFI surveillance is integrated under the UIP (Universal Immunization Programme) - AEFI is reported monthly via IDSP.
Source: Park's Textbook of Preventive and Social Medicine, pp. 127-130 (AEFI section, Block 2)