2. INTRODUCTION
• BacillusCalmette–Guérin (BCG) vaccine is a vaccineprimarily used against tuberculosis
(TB).
• Is a live attenuated bacterial vaccinederived from M.bovis
• BCG vaccination reduces the risk of tuberculosisin people who are not infected withTB.
• The vaccine does not always prevent disease.
• It is more effective in children< 6yrs old, providing 50 to 80 % protection against meningeal
and miliaryTB.
• Protection againstTB will only start 6-8 weeks after the vaccination has been given and
lasts for about 10 years.
• Revaccinationis not recommended.
3. Medical uses
1. The main use of BCG is for vaccination against tuberculosis
2. BCG is used in the treatment of superficial forms of bladder cance
3. BCG has protective effects against some non-tuberculosis mycobacteria
like
a. Leprosy: BCG has a protective effect against leprosy in the range of 20 to
80%.
b. Buruli ulcer: BCG may protect against or delay the onset of Buruli ulcer.
4. DOSAGE ANDADMINISTRATION
• The vaccine is given just under the skin (intradermally),usually in the left upper arm.
• No other vaccine should be given in the same limb as the BCG for three months afterwards,
because of the risk of lymphadenitis (an enlarged lymph node that becomes infected).
• Given in first week in newbornsas Iraqi schedule
• Doses 0.05ml for children<1 year
0.1ml for children>1 year
• Some BCG vaccinesare freeze dried and become fine powder.A glass ampoule has to be
opened slowly to prevent the airflow from blowingout the powder.Then the powder has to
be diluted with saline water before injecting
5. Ingredients :
1. sodium, potassium and magnesium salts
2. glycerol, a common non-toxic stabiliser
3. citric acid
Brand names :
1. TheraCys® BCG
2. TICE® BCG
Storage :
1. The intact vials of BCGVACCINE should be stored refrigerated at 2–8°C (36–46°F).
2. This agent contains live bacteria and should be protected from direct sunlight
6. Side Effects
Very common side effect (affecting 9 out of 10 people):
• Hardness at the injection site, followed by a raised blister.
Uncommon side effects (affecting up to 1 in 100 people at each dose):
• Headache and fever
• An ulcer which develops from the blister at the injection site, two to six weeks after injection.
• This may be painful and take several weeks or months to heal fully.
• Swelling of lymph nodes in the armpit larger than 1 cm across an enlarged lymph node that becomes
infected (lymphadenitis)
Rare side effects (affecting up to 1 in 1000 people at each dose):
• More severe skin reactions. These usually heal within a few weeks.
• Bone inflammation (osteitis or osteomyelitis)
• An abscess at the injection site
7. CONTRAINDICATIONS
1.Whose immunologicresponses are impaired because of HIV infections,
congenital immunodeficiency such as chronic granulomatous disease or
interferon gamma receptor deficiency, leukemia, lymphoma,or generalized
malignancy
2.Whose immunologicresponses have been suppressed by steroids,
alkylating agents, antimetabolites, or radiation.
3. Allergy to any component of BCGVACCINE or an anaphylactic or allergic
reaction to a previous dose of BCGVACCINE are contraindications for
vaccination.
4.Pregnancy
