Appendix 29. BCG vaccine

Update: January 2022

Composition, forms and route of administration

• Live attenuated bacterial vaccine
• Powder for injection, to be dissolved with the entire vial of the specific solvent supplied by the manufacturer, in multidose vial, for intradermal injection

Dosage and vaccination schedule

Refer to national recommendations. In countries with a high incidence of TB (> 40 cases per 100,000), WHO recommends [1] Citation 1. World Health Organization. BCG vaccines: WHO position paper – February 2018/Vaccins BCG: Note de synthèse de l’OMS – Février 2018. Weekly epidemiological record/Relevé épidémiologique hebdomadaire, 23 FEBRUARY 2018, 93^th YEAR/23 FÉVRIER 2018, 93^e ANNÉE, No 8, 2018, 93, 73–96.
https://apps.who.int/iris/bitstream/handle/10665/260306/WER9308.pdf;jsessionid=872A2E82241BA438A3C9953650A92DF0?sequence=1 :

• Child under 12 months: 0.05 ml single dose as soon as possible after birth
• Child 12 months and over a Citation a. BCG vaccine provides high protection for neonates, but only moderate for school age TST negative children. and adult: 0.1 ml single dose

Technique and site of administration

• Clean the injection site with clean water. Do not use antiseptics as risk of inactivation of vaccine). Allow to dry.
• Administer intradermally. If the injection is correctly performed, an "orange-skin" papule measuring 5-8 mm in diameter should appear at the injection site.
• The vaccine is administered in the deltoid region of the arm, about one-third down the upper arm over the insertion of the deltoid muscle.
• The vaccine should be injected in the same place for each child so that the BCG scar is easier to locate.

Contra-indications

• Do not administer to patients with congenital or acquired immunodeficiency (e.g. HIV infection or serologic status unknown, but symptoms consistent with HIV infection, immunosuppressive therapy, malignant haemopathy).
• Postpone vaccination until recovery in the event of acute extensive dermatosis, acute complicated malnutrition or severe acute febrile illness (minor infections are not contra-indications).

Adverse effects

• Local reaction 2-4 weeks after injection: papule that ends up as an ulcer and usually heals spontaneously (dry dressing only) after 2 to 5 months, leaving a permanent
• Complications requiring no specific treatment and which almost always evolve favourably:
  • persistent ulcer with serous discharge for over 4 months after injection;
  • non-suppurated adenitis, most often axillary, sometimes cervical;
  • abscess at the injection site due to infection (red, hot and painful abscess) or inadvertent intradermal injection (cold and painless abscess).
• Uncommon complications:
  • suppurative lymphadenitis, mostly in neonates, usually due to inadvertent intradermal injection. The lymph node, which can have a diameter of over 3 cm, evolves toward chronic softening and fistulisation;
  • osteomyelitis (in exceptional cases);
  • disseminated BCG disease b Citation b. If disseminated BCG disease is diagnosed, a 6-month TB treatment should be administered. , usually in immunocompromised children under 2 years, with a high mortality rate [2] Citation 2. Hesseling AC, Rabie H, Marais BJ, Manders M, Lips M, Schaaf HS, et al. Bacille Calmette-Guérin vaccine-induced disease in HIV-infected and HIV-uninfected children. Clin Infect Dis. 2006;42:548–58. 
    https://doi.org/10.1086/499953 . 

Precautions

• If administered simultaneously with other vaccines, use different syringes and injection sites. Do not mix with other vaccines in the same syringe.
• Pregnancy: CONTRA-INDICATED
• Breastfeeding: no contra-indication

Storage

• Reconstituted vaccine: between 2 °C and 8 °C for 6 hours max.
• Powder: between 2 °C and 8 °C.
• Solvent: a cold chain is not required for 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.