Tuberculosis is a contagious bacterial disease caused by the bacillus Mycobacterium tuberculosis. With 8 million new cases each year, tuberculosis is the second leading cause of death from infectious diseases throughout the world, after acquired immune deficiency syndrome (AIDS).

SYMPTOMS

• Following infection, usually through the airborne route, the bacteria grow within the pulmonary alveoli and macrophages. When bacterial multiplication can no longer be contained by the immune system (in 5 to 10% of patients), the active disease develops.

• The most common form of active tuberculosis is the pulmonary form. Symptoms include chronic cough, moderate fever, night time sweats, fatigue, decreased appetite and weight loss.

• Miliary (diffuse impairment of lungs, spleen, liver, and bone marrow) and meningeal tuberculosis are the most severe forms of the disease.

• Treatment relies on the administration of anti-tuberculosis drugs for many months.

DOSAGE AND ADMINISTRATION

BCG Vaccine vial of 10 doses (0.05 ml) for infants under one year old, to be reconstituted with 0.5 ml of sodium chloride injection.
BCG Vaccine vial of 20 doses (0.05 ml) for infants under one year old, to be reconstituted with 1 ml of sodium chloride injection.

Carefully invert the vial a few times to resuspend freeze-dried BCG. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourless. Reconstitute only with diluent provided by manufactures. Using an incorrect diluent may result in damage to the vaccine and / or serious reactions to those receiving the vaccine. Use immediately after reconstitution. If the vaccine is not used immediately then it should be stored in the dark at 2° to 8° C for no longer 6 hours (1 immunisation session).
Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution) must be discarded.
The vaccine is intended to be injected strictly via the intradermal route, avoiding the subcutaneous route.
The vaccination dose is 0.05 ml for children under one year of age including the new born, of the reconstituted vaccine given intradermally. The skin should not be cleaned with antiseptic. The vaccine should be preferably given with a tuberculin syringe or 25G/26G sterile needle and syringe.
Skin testing with tuberculin is not generally carried out before giving BCG, but when performed, those who are found to be positive reactors need not to be immunized.
The skin is stretched between thumb and forefinger and sterile needle (25 G or 26 G) inserted bevel upwards for about 2mm into superficial layers of the dermis (almost parallel with the surface). Raised blanched bleb showing tips of hair follicle is a sign of correct injection. The site of injection is at insertion of the deltoid muscle into the humerus. Sites higher on the arm are likely to lead to keloid formation.

SCHEDULE

BCG Vaccine should be given routinely to all infants at risk of early exposure to tuberculosis. This vaccine should be given soon after the child is born. BCG administered early in life provides high level of protection particularly against sever forms of childhood tuberculosis and tubercular meningitis. The vaccine can be given simultaneously with DTP, DT, TT, Measles, Polio and Hepatitis B vaccines, but at a separate site.

ADVERSE EVENTS

Adverse events occur in 1-10% of individuals who receive BCG and vary depending upon dosage, method of administration and age of vaccine. Lymphadenitis can also occur. Lymphangitis can occur if the vaccine is administered too close to the shoulder and is characterized by streaking from site of injection towards the regional lymph nodes. Lymphadenopathy of regional lymph nodes, which resolves spontaneously, occurs occasionally in young children. Osteomyelitis has been reported to occur rarely (one case per million vaccines) and most frequently in neonates. Disseminated BCG infection, which can be fatal, occurs rarely in 1-10 cases per 10 million vaccines and is more common in immunodeficient children.
A local reaction is normal. Following BCG vaccination, 2 to 3 weeks later a papule develops at the site of vaccination and increases slowly in size of a diameter of 4-8 mm in 5 weeks. It then subsides or breaks into a shallow ulcer covered with a crust. Healing occurs spontaneously in 6-12 weeks leaving a permanent, tiny round scar 2-10 mm in diameter. In rare cases an abscess may appear at the point of injection, or satellite adenitis, leading in exceptional cases to suppuration. Exceptional cases of lupus vulgaris at the point of injection have been reported. Inadvertent subcutaneous injection produces abscess formation and may lead to ugly scars. A risk generalised reaction to BCG exists in immunodepressed individuals vaccinated with BCG or living in contact with a vaccinated individual.

CONTRAINDICATIONS AND PRECAUTIONS

BCG vaccine is contraindicated in hypogamma- globulinemia, congenital immunodeficiency, sarcoidosis, leukaemia, generalized malignancy, HIV infections or any other disorder in which natural immune response is altered, as also those on immunosuppressive therapy, corticosteroids, radiotherapy. In chronic eczema or other dermatological disease, the vaccine can be given in a healthy area of skin.
Keloid and lupoid reactions may also occur at the site of injection and such children should not be revaccinated.
SPECIAL CASE OF CHILDREN BORN TO HIV SEROPOSITIVE MOTHERS.
The obligatory passage of maternal antibodies of the lgG type through the placenta makes it impossible to interpret the serology of the child until the age of about 9-10 months (persistence of the maternal antibodies has been detected up to 14 months). It is therefore necessary to wait until the child has been found to be seronegative, as determined by immuno-transfer (Western Blot) with the support, if necessary, of techniques for detecting the viral genome, before confirming that the child is not infected. If the child is not infected BCG vaccine is contraindicated irrespective of the child’s condition, given the potential risk of development of ’’BCG-itis’’ in the vaccinated child. The advice of a specialized medical team is required.
Neither absence of BCG scar formation nor negative PPD reaction is indicative of poor BCG uptake. There is no need to repeat BCG inoculation in babies who do not develop BCG scar as advocated in the guidelines of IAP.

STORAGE
BCG Vaccine (Freeze-dried) should be stored in dark between 2°C and 8°C. It is even more stable if stored in temperatures as low as -20°C. Protect from light. The diluent should not be frozen, but should be kept cool.
PRESENTATION
Live, attenuated BCG Vaccine (Bacillus Calmette Guerin strain)
Each 0.1 ml contains between: 1×105 and 33×105 C.F.U.
Reconstitute with Sodium Chloride Injection
Dose: 0.05 ml, Intradermally for infants under one year old

10 dose vial plus diluent (0.5 ml)
2 0 dose vial plus diluent (1 ml)