BCG

DESCRIPTION
It is a live freeze-dried vaccine made from an attenuated strain of Mycobacterium bovis.It is used for the prevention of tuberculosis.

COMPOSITION
Paediatric Dose 0.05 ml

ADMINISTRATION
For children under one year 0.05 ml, and for others 0.1 ml of reconstituted vaccine is given intradermally. Special syringes allow administration of the exact dose. The skin should not be cleaned with antiseptic.. The lyophilizate must be reconstituted by adding the entire content of the supplied container of diluent to the vaccine vial. The vaccine pellet should be completely dissolved in the diluent. Following reconstitution, the vaccine should be inspected visually for any foreign particulate matter prior to administration. If observed, the vaccine must be discarded.

A sterile syringe and a sterile needle should be used for the reconstitution and for each injection. Because of sensitivity to ultraviolet light, the vaccine must be protected from sunlight. If not used immediately after reconstitution, the vaccine should be kept on ice to maintain its temperature between +2°C and +8 °C. Any opened vials remaining at the end of an immunization session (within six [6] hours of reconstitution should be discarded. The vaccine vial monitor for this type of vaccine is attached to the vial cap and should be discarded when the vaccine is being reconstituted.

The diluent supplied is specially designed for use with this vaccine. Only this diluent may be used to reconstitute the vaccine. Do not use diluents from other types of vaccine or from other manufacturers. Water for injection may NOT be used for this purpose. Using an incorrect diluent may result in damage to the vaccine and/or serious reactions to those receiving the vaccine. Diluent must not be frozen but must be cooled between +2°C and +8°C before reconstitution..

IMMUNIZATION SCHEDULE

BCG should be given routinely to all infants at birth. There is no proven benefit of repeated BCG vaccination against TB. For maximum protection, this vaccine should be given as soon after birth as possible. It can be given at the same time as DTP, measles, polio (OPV and IPV), hepatitis B, Haemophilus influenzae type b, and yellow fever vaccines and vitamin A supplementation.

SIDE EFFECTS

A local reaction is normal after BCG. A small tender red swelling appears at the site of the injection, which gradually changes to a small vesicle and then an ulcer in 2 - 4 weeks. The reaction usually subsides within two to five months and in practically all children leaves a superficial scar 2-10 mm in diameter. Rarely, the nodule may persist and ulcerate. Occasionally, enlargement of axillary lymph nodes may appear in 2 - 4 months following immunization. Very rarely, enlarged lymph nodes can suppurate. Inadvertent subcutaneous injection may produce abscess formation and may lead to scarring. Keloid and lupoid reactions may also occur at the site of injection

CONTRAINDICATIONS
Immune deficiency
The vaccine is contraindicated in individuals with cell-mediated immune deficiency. Individuals known to be infected with human immunodeficiency virus (HIV), either non-symptomatic or symptomatic, should NOT receive BCG vaccine.

STORAGE
BCG vaccine should be stored and transported between +2°C and +8°C. It is even more stable if stored in temperatures as low as -20°C. The diluent should not be frozen. The vaccine should be protected from the light. Vaccine vials and diluents should be transported together.

PRESENTATION
The vaccine comes in boxes of .. . . (specify) ampoules/vials each containing .... (specify) doses.

Fig. The Vaccine Vial Monitor

Vaccine Vial Monitors (VVMs) are part of the label. The colour dot which appears on the label of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.

The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded.