8.2 Universal Immunization Programme (UIP) & Child Vaccines

Universal Immunization Programme (UIP) & Vaccine Guidelines

The Universal Immunization Programme (UIP) in India is one of the largest public health interventions in the world. Originally launched as the Expanded Programme on Immunization (EPI) in 1978, it was renamed UIP in 1985. UIP currently protects children against 12 Vaccine-Preventable Diseases (VPDs):

• Nationally (9 diseases): Tuberculosis, Diphtheria, Pertussis, Tetanus, Poliomyelitis, Hepatitis B, Measles, Rubella, and Haemophilus influenzae type b (Hib) meningitis/pneumonia.
• Sub-nationally / Endemic States (3 diseases): Rotavirus diarrhea, Pneumococcal pneumonia (PCV), and Japanese Encephalitis (JE).

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National Immunization Schedule (UIP India)

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Specific Vaccine Characteristics & Clinical Nuances

1. BCG (Bacillus Calmette-Guérin)

• Strain: Live attenuated Mycobacterium bovis (Danish 1331 / Gothenburg strain).
• Reconstitution: Must be reconstituted ONLY with Normal Saline (0.9% NaCl). Never use Distilled Water, which causes local spinal tissue swelling, irritation, or micro-hemolysis.
• Dose: 0.05 mL if administered at birth up to 1 month of age; 0.1 mL if administered after 1 month up to 1 year.
• Normal Reaction: Papule forms at 2–3 weeks → Induration/Nodule → Vesicle/Pustule at 5–6 weeks → Shallow Ulceration → Permanent Punctate Depressed Scar healed by 6–12 weeks.
• Koch's Phenomenon: Accelerated BCG reaction occurring within 24–48 hours in a child already infected with Tuberculosis or previously vaccinated.

2. Polio Vaccines (bOPV & fIPV)

• bOPV: Bivalent Oral Polio Vaccine containing live attenuated Sabin strains of Types 1 and 3 (Type 2 was withdrawn globally during 'The Switch' in April 2016 to prevent circulating Vaccine-Derived Poliovirus - cVDPV2).
• fIPV: Fractional Inactivated Polio Vaccine (Salk strain). Administered intradermally at 0.1 mL (1/5th of full 0.5 mL dose) at 6 and 14 weeks. Intradermal delivery targets dermal dendritic cells, inducing systemic and mucosal immunity equal to full IM dose.

3. Measles-Rubella (MR) Vaccine

• Live attenuated lyophilized vaccine reconstituted with Sterile Water for Injection.
• Administered Subcutaneously (SC) in right upper arm.
• 4-Hour Rule: Reconstituted MR, BCG, and JE vaccines MUST be kept cold (+2 to +8°C) and DISCARDED strictly after 4 hours (or at the end of the session, whichever is earlier) due to risk of Toxic Shock Syndrome caused by Staphylococcus aureus contamination.

4. Pentavalent Vaccine

• Combines DPT + Hepatitis B + Hib in a liquid single/multi-dose vial.
• Freeze-Sensitive: Must NEVER be frozen. Freezing denatures the aluminum adjuvant, causing irreversible loss of potency and severe local sterile abscesses.

Cold Chain System, Open Vial Policy & AEFI Management

The cold chain is a continuous system of transporting and storing vaccines at recommended temperatures from the point of manufacture to the point of administration.

Cold Chain Equipment & Storage Architecture

ILR Loading Principles:

• Top Section: Holds heat-sensitive vaccines (OPV, MR, BCG).
• Bottom Section: Holds freeze-sensitive vaccines (HepB, Pentavalent, DPT, TT/Td, PCV).
• Vaccines must be placed in baskets, keeping a 2 cm air gap from the walls.

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Vaccine Vial Monitor (VVM) & Shake Test

Vaccine Vial Monitor (VVM) Stages

VVM is a thermo-chromic label printed on the vial that changes color as the vaccine is exposed to cumulative heat over time.

• Stage 1 (Usable): Inner square is much lighter than outer circle.
• Stage 2 (Usable): Inner square is still lighter than outer circle (Use this vial FIRST).
• Stage 3 (DO NOT USE): Inner square matches the color of outer circle (DISCARD!).
• Stage 4 (DO NOT USE): Inner square is darker than outer circle (DISCARD!).

   [Stage 1: Light Square]  ==>  [Stage 2: Pale Square]  ==>  [Stage 3: MATCHED]  ==>  [Stage 4: Dark Square]
         (USABLE)                      (USABLE FIRST)            (DISCARD VIAL)           (DISCARD VIAL)

The Shake Test

Used to determine if a freeze-sensitive vaccine (Pentavalent, HepB, DPT, Td, PCV) has suffered damage due to accidental freezing:

1. Take a suspected frozen vial and a control vial (never frozen) from the same manufacturer.
2. Freeze the control vial completely, then thaw it.
3. Shake both vials vigorously for 10–15 seconds and place them side-by-side on a flat surface.
4. Observation: If the suspected vial clears rapidly and a thick flocculant sediment settles to the bottom faster than the control vial, the test is POSITIVE → Vaccine frozen and damaged → DISCARD VIAL.

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Open Vial Policy (OVP)

Under India's National Open Vial Policy, opened multi-dose vials of specific vaccines can be kept and used for up to 28 days, provided:

• Expiry date has not passed.
• Vaccines are stored at +2°C to +8°C.
• VVM inner square is lighter than outer circle.
• Vaccine septum has not been submerged in water.
• Aseptic technique was maintained.

Vaccines COVERED under Open Vial Policy (28 Days)

• bOPV, fIPV, Pentavalent, DPT, Td, Hepatitis B, PCV.

Vaccines EXCLUDED from Open Vial Policy (Discard within 4 Hours!)

• Reconstituted Live Vaccines: BCG, MR (Measles-Rubella), JE, and Rotavirus (liquid/lyophilized) MUST be discarded at the end of 4 hours or session end.

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Adverse Events Following Immunization (AEFI): Anaphylaxis Protocol

An adverse event following immunization is any untoward medical occurrence following immunization.

Classification of AEFI

1. Vaccine product-related reaction: Inherent pharmacological property (e.g., mild fever after DPT).
2. Vaccine quality defect-related reaction: Manufacturing defect.
3. Immunization error-related reaction (Programmatic Error): Inappropriate reconstitution (e.g., using non-sterile diluent causing abscess/TSS).
4. Immunization anxiety-related reaction: Vasovagal syncope in older children.
5. Coincidental reaction: Illness occurring post-vaccination by chance.

AEFI Anaphylaxis Emergency Protocol

• Clinical Features: Rapid onset (within minutes to 30 mins) of bronchospasm, stridor, urticaria, facial angioedema, hypotension, and collapse.
• FIRST-LINE DRUG OF CHOICE: Adrenaline (Epinephrine) 1:1000 dilution (1 mg/mL).
• Route & Site: Intramuscular (IM) into the Anterolateral Mid-Thigh.
• Dose: 0.01 mg/kg (equivalent to 0.01 mL/kg of 1:1000 solution).
  • Infant < 2 years: 0.05 to 0.1 mL
  • Child 2–5 years: 0.15 to 0.2 mL
  • Child 6–12 years: 0.3 mL
• Repeat every 5–15 minutes if clinical response is inadequate. Keep patient supine with legs elevated.