2.1.3  BCG vaccine storage, dosage and immunization schedule

BCG vaccine is a freeze-dried powder, supplied in small glass bottles called ampoules. Vaccines that come as powders must be mixed with a liquid called a diluent. This process is known as reconstitution, which means thoroughly mixing the powder with the diluent to activate the vaccine before it can be administered. Before use, you must reconstitute BCG vaccine powder with the appropriate diluent supplied for this purpose, using a mixing syringe to mix the diluent with the powder in the ampoule. You will learn how to do this in Study Session 4.

BCG storage

BCG vaccine can be also affected and damaged by heat and light, so it should be stored between +2°C and +8°C. The vaccine powder may be frozen for long-term storage, but the diluent and the reconstituted vaccine must never be frozen. Since BCG vaccine is easily destroyed by sunlight, the vials containing the vaccine powder are mostly made from black or brown glass. Some other vaccines which are supplied as powders can stay in good condition for a long time in a refrigerator and are not spoiled as long as they remain dry. But BCG vaccine can be spoiled and lose its strength in a very short time. Also, since other harmful bacteria can grow in the reconstituted BCG vaccine, it should be used within six hours of mixing the powder with the diluent. If there is any leftover reconstituted BCG vaccine, it should be thrown away in the correct medical waste container at the end of the immunization session.

BCG dosage and schedule

The recommended injection dose for newborns and infants under one year is 0.05 ml, containing 0.05 mg of BCG vaccine powder which has been reconstituted with 0.05 ml of the specific diluent supplied with the vaccine. For children aged over one year, the dose is twice this amount — 0.1 ml containing 0.1 mg of BCG vaccine powder.

How to give an intradermal injection and other vaccination routes are described in detail in Study Session 4 of this Module.

BCG vaccine is given at birth or as soon as possible thereafter. The vaccine is given intradermally (into the top layer of the skin) in the right upper arm in Ethiopia. This is so the injection site can be inspected later.

Table 2.1 summarises the characteristics of the BCG vaccine. The only reason for not giving the BCG vaccine is if the newborn has symptoms of HIV-disease, which may include a high-grade fever. You will learn more about routes of administration and cold storage of all the common vaccines, including BCG, in Study Sessions 4 and 6 of this Module.

Table 2.1  Summary of BCG vaccine characteristics.

CategoryDescription
Type of vaccineLive-attenuated antibacterial vaccine
Number of dosesOne
ScheduleAt birth, or as soon as possible after birth. If not given at birth, it is better to give within the first three months, when the infant is at greatest risk of developing the most severe forms of TB, such as TB meningitis. Immunization is generally ineffective at older ages.
Booster (additional dose)None
Contraindications Babies or infants showing symptoms of HIV infection
Adverse events

Study Session 7 discusses AEFIs, adverse events following immunization, more generally.

Mild normal reaction (swelling, small sore). Rarely, severe reaction, e.g. local abscess, or swelling of glands (lymph nodes)
Special precautionsCorrect intradermal administration is essential. A special syringe and needle is used for the administration of BCG vaccine (described in Study Session 4)
Dosage

BCG vaccine is given in the right arm in Ethiopia, but in the left arm in some other countries.

Infants aged under one year, give 0.05 mg of BCG vaccine powder reconstituted in 0.05 ml of diluent; over one year, give 0.01 mg in 0.1 ml of diluent
Injection siteOuter upper right arm or shoulder. Routes of administration are described in Study Session 4
Injection typeIntradermal (into the top layer of skin). Types of injection are described in Study Session 4
StorageStore between +2°C and +8°C. BCG vaccine powder may be frozen for long-term storage, but the diluent and reconstituted vaccine must never be frozen. Discard any reconstituted vaccine after no more than six hours. Vaccine storage is described in Study Session 6

2.1.2  Effectiveness of BCG vaccine

2.1.4  Adverse events following BCG immunization and how to treat them