– 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

Dosage 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 (symptomatic HIV infection, immunosuppressive therapy, etc.) and malignant haemopathy.
– Vaccination should be postponed in the event of evolutive extensive dermatosis, acute complicated malnutrition (vaccine should be given just before the child is discharged from the nutrition centre) and severe acute febrile illness (minor infections are not contra indications).
– May cause:
• normal local reaction 2 to 4 weeks after injection: papule which changes to an ulcer, that usually heals spontaneously (dry dressing only), leaving a permanent scar;
• occasionally: persistent ulcer with serous discharge up to 4 months after injection, non-suppurative adenitis, keloid formation, abscess at the injection site;
• exceptionally: suppurative lymphadenitis, osteitis.
– Clean the injection site with boiled and cooled water and allow drying. Do not use antiseptics (risk of inactivation of live vaccine).
– Do not mix with other vaccines in the same syringe (inactivation of vaccines).
– If administered simultaneously with EPI vaccines, use different syringes and injection sites.
– 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 5-8 mm in diameter, should appear at the injection site.
– Duration of protection is not known, and decreases over time.
– Storage
• Powder: between 2 °C and 8 °C. Freezing is possible but unnecessary
• Diluent: a cold chain is not required for storage. However, at least 12 hours before reconstitution of the vaccine, the diluent must be refrigerated between 2 °C and 8 °C so that the diluent and lyophilised powder are at the same temperature: a temperature difference during reconstitution may reduce vaccine efficacy. Do not freeze.
• Reconstituted vaccine: between 2 °C and 8 °C for 6 hours maximum.