Appendix 22. BCG vaccine

Composition and presentation

– Live attenuated bacterial vaccine
– Powder for injection (lyophilised vaccine) in multidose vial, to be dissolved with the entire vial of the specific solvent supplied by the manufacturer

Dosage and vaccination schedule

– Refer to national immunization recommendations.
– Children under 12 months1 : 0.05 ml as a single dose as soon after birth as possible
– Adults: 0.1 ml as a single dose

Technique and site of administration

– Clean the injection site with clean water, do not use antiseptics (risk of inactivation of live vaccine), allow to dry.
– Administer intradermally. If the injection is correctly done, it should provoke an "orange skin" papula, 5-8 mm in diameter.
– The vaccine is usually administered in the deltoid region of the arm, about one third down the upper arm over the insertion of the deltoid muscle. Follow national recommendations. The vaccine is injected in the same place for all children to make it easy to find the BCG scar subsequently.

Contra-indications

– Do not administer to patients with congenital or acquired immunodeficiency (HIV positive patients, patients with unknown HIV status but symptoms consistent with HIV, patients under immunosuppressive therapy or malignant haemopathy, etc.).
– Vaccination should be postponed in the event of acute extensive dermatosis, acute complicated malnutrition (BCG will be given at discharge from the nutritional centre once the child has recovered), severe acute febrile illness (minor infections are not contra-indications).

Adverse effects

– Complications requiring no specific treatment, with an evolution almost always favourable:
• normal local reaction 2 to 4 weeks after injection: papule which changes to an ulcer that usually heals spontaneously (dry dressing only) after 2 to 3 months, leaving a permanent scar;
• persistent ulcer, characterised by serous discharge persisting for over 4 months after injection;
• non-suppurated adenitis, most often axillary, sometimes cervical; cheloid scars;
• abscess at the injection site, due to common germs (red, hot and painful abscess) or poor manipulation during injection or a vaccine with too high a dose (cold and painless abscess).

– Atypical complications:
• Suppurative lymphadenitis, mostly observed in newborns, usually due to the administration of too high a dose of vaccine. The lymph node, with a diameter at times over 3 cm, evolves toward softening and fistulisation with chronic suppuration.
• Osteomyelitis in exceptional cases.
• Disseminated BCG disease, most commonly in immunocompromised infants (110 to 417 cases/100,000 doses in HIV-infected infants22,23). Mortality in this group could be as high as 75%24. If disseminated BCG disease is diagnosed, a full course of 6 months of anti-TB treatment should be administered. This is often indistinguishable from disseminated TB.

Precautions

– If administered simultaneously with EPI vaccines, use different syringes and injection sites.
Pregnancy: CONTRA-INDICATED
Breast-feeding: no contra-indication

Storage


Reconstituted vaccine: between 2°C and 8°C for 6 hours maximum, protected from light.
Powder: between 2°C and 8°C, protected from light. Freezing is possible but unnecessary.
Solvent: a cold chain is not required for storage. However, at least 24 hours before reconstitution of the vaccine, the solvent must be refrigerated between 2°C and 8°C so that the solvent and lyophilised powder are at the same temperature: a temperature difference during reconstitution may reduce vaccine efficacy. Do not freeze.



Footnotes
Ref Notes
1

Expert opinion indicates that vaccination of children older than 12 months of age is usually of limited benefit (although it is not harmful or contraindicated).