Tuberculosis vaccine = BCG vaccine

Indications

Prevention of tuberculosis.

Composition, forms, route of administration

• Live attenuated bacterial vaccine.
• Powder for injection in multidose vial, to be dissolved with the entire vial of the diluent supplied by the manufacturer.
• For intradermal injection into the external face of the left upper arm.

Dose and vaccination schedule

• Child: 0.05 ml single dose as soon after birth as possible.
• If child is over one year old: 0.1 ml single dose.

Contra-indications, adverse effects, precautions

• Do not administer to patients with immunodeficiency such as symptomatic HIV infection, immunosuppressive therapy, and malignant haemopathy.
• Vaccination should be postponed in the event of evolutive extensive dermatosis, acute complicated malnutrition, and severe acute febrile illness; minor infections are not contra-indications.
• May cause a normal local reaction 2 to 4 weeks after injection: a papule that changes to an ulcer and usually heals spontaneously, leaving a permanent scar.
• May occasionally cause persistent ulcer with serous discharge up to 4 months after injection, non-suppurative adenitis, keloid formation, and abscess at the injection site, and exceptionally suppurative lymphadenitis or osteitis.
• Clean the injection site with boiled and cooled water and allow drying. Do not use antiseptics because of the risk of inactivation of live vaccine.
• Do not mix with other vaccines in the same syringe.
• If administered simultaneously with EPI vaccines, use different syringes and injection sites.
• Pregnancy: contraindicated.
• Breast-feeding: no contra-indication.
• Inject the vaccine in the same place for each child to make it easy to find the BCG scar subsequently.
• If the injection is correctly performed, an orange-skin papule measuring 5 to 8 mm should appear at the injection site.
• Duration of protection is not known and decreases over time.