✅ Name:
BCG Vaccine (Bacillus Calmette–Guérin) – As Licensed
📄 Description:
BCG (Bacillus Calmette–Guérin) vaccine is a live attenuated bacterial vaccine derived from a strain of Mycobacterium bovis. It is used primarily to provide protection against tuberculosis (TB), particularly severe forms like TB meningitis and miliary TB in children.
💊 Prescription/Use:
- Indication:
- Prevention of tuberculosis, especially in newborns and young children.
- Given at birth as part of national immunization schedules.
- Route of Administration:
- Intradermal injection, usually in the left upper arm.
- Dosage:
- 0.05 mL for infants (<1 year)
- 0.1 mL for children >1 year and adults
- Schedule:
- Single dose at birth or as early as possible till 1 year of age.
🔬 Nature:
- Type: Live attenuated bacterial vaccine.
- Form:
- Lyophilized (freeze-dried) powder for reconstitution.
- Requires mixing with a sterile diluent before administration.
- Strain used: Danish 1331, Tokyo 172, or other WHO-prequalified strains depending on manufacturer.
🌟 Advantages:
- Provides protection against severe TB forms in infants and children.
- Long-term immunity against TB meningitis and disseminated TB.
- In countries with high TB prevalence, it reduces childhood TB-related mortality.
- Part of Universal Immunization Program (UIP) in many countries including India.
📦 Common Packaging:
- Supplied in multi-dose vials (e.g., 1 mL or 3 mL vials containing 10–20 doses).
- Includes separate ampoule of diluent (usually 1–2 mL sterile sodium chloride).
- Pack contains vaccine vial, diluent, product insert, and labeling with expiry and lot number.
🧊 Storage:
- Store between 2°C to 8°C (Refrigerated).
- Do not freeze.
- Once reconstituted, must be used within 4–6 hours and kept on ice/cold during use.
- Protect from direct light and heat.
⚠️ Precautions:
- Do not administer to:
- Individuals with immunodeficiency (e.g., HIV-positive infants with symptoms).
- Patients receiving immunosuppressive therapy.
- Infants with congenital immunodeficiency.
- Perform only intradermally – not subcutaneously or intramuscularly.
- Ensure correct dosage to avoid local ulceration or lymphadenitis.
- Check for vaccine vial monitor (VVM) and expiry date.
👩⚕️ Patient Advice:
- A small red swelling may appear at the injection site within 2–3 weeks, which may form a pustule and heal with a scar — this is normal.
- Do not apply ointment or squeeze the swelling.
- Mild fever or localized swelling is normal — consult a doctor if severe pain, pus discharge, or lymph node swelling occurs.
- BCG vaccine does not protect against all forms of TB, but prevents severe childhood forms.
- Keep the vaccination card safe as proof of immunization.
- No booster dose is recommended.