Description
BCG Vaccine (Bacillus Calmette-Guérin) is a freeze-dried live bacterial vaccine prepared from an attenuated strain of Mycobacterium bovis. When reconstituted as directed with the accompanying phosphate buffered saline diluent, the vaccine contains between 8 x 106 and 32 x 106 colony forming units per mL of product and monosodium glutamate 1.5% w/v. Active ingredients: Bacillus Calmette and Guérin 1.5 mg
Excipients: monosodium glutamate 1.5% w/v
Diluent: sodium chloride 0.85%
sodium phosphate – dibasic 0.25%
sodium phosphate – monobasic 0.06%
polysorbate 80 0.025%
water for injection q.s. 1.5 mL
This vaccine does not contain added preservative.
This vaccine fulfils WHO requirements for Dried BCG Vaccine.
Pharmacology
Clinical studies have demonstrated that BCG vaccine induces a cell-mediated immune response (tuberculin positive skin reaction) in at least 90% of adult recipients. The development of this response takes several weeks. Clinical trials have not shown a consistent relationship between the size of tuberculin reactions and the protection provided by BCG vaccines.
Two retrospective case control studies in Aboriginal Canadian Indians have shown that Sanofi Pasteur Limited’s BCG Vaccine provides approximately 60% protective efficacy.
Indications
BCG Vaccine is indicated for active immunisation against tuberculosis.
BCG VACCINE Data Sheet
Contraindications
Allergy to any component of BCG Vaccine including monosodium glutamate and polysorbate 80 or an anaphylactic or other allergic reaction to a previous dose of BCG vaccine are contraindications to vaccination. Individuals who have previously had tuberculosis or who have a positive tuberculin reaction of over 5 mm.
Individuals with significant fever. Immunisation with BCG Vaccine should be deferred during the course of a moderate or severe febrile illness or acute infection to avoid superimposing potential adverse effects of the vaccine on the underlying illness.
Individuals with generalised skin disease such as eczema, furunculosis, atopic dermatitis or other exudative or inflammatory dermatologic conditions.
Keloid and lupoid reactions may occur at the site of injection. This should be considered in deciding whether to vaccinate individuals predisposed to such reactions. BCG vaccine should not be administered to individuals with known natural or acquired immunodeficiency conditions or those receiving immunosuppressant therapy because of the risk of disseminated BCG infection in those individuals. BCG Vaccine should not be administered to individuals with a high risk of HIV infection where HIV antibody status is unknown.
Precautions
The stopper of the vial for this product contains dry natural latex rubber. Natural latex rubber has been associated with allergic reactions.
BCG Vaccine contains viable attenuated mycobacteria and should be handled as potentially infectious. All equipment and material used during reconstitution and subsequent immunisation should be handled and disposed of as biohazardous material.
BCG vaccination is a preventative measure, and has no value in the treatment of tuberculosis. BCG immunisation will not prevent the development of active tuberculosis in individuals who are already infected with Mycobacterium tuberculosis.
As with most vaccines, vaccination will not protect 100% of susceptible individuals.
This presentation of BCG Vaccine is not a treatment for carcinoma in-situ of the urinary bladder.
If a tuberculin skin test has been carried out, those who develop positive reactions should not be immunised (see Contraindications).
Do not combine BCG Vaccine in the same syringe as other vaccines.
Effects on fertility
It is not known whether BCG Vaccine can affect reproduction capacity
Use in Pregnancy (Category B2)
There is no convincing evidence of the risk to the foetus from immunisation of pregnant woman using bacterial vaccines. Although no harmful effects of BCG Vaccine on the foetus have been observed, vaccination of women during pregnancy is not recommended unless there is an excessive risk of unavoidable exposure to infective tuberculosis.
Use in lactation
It is not known whether BCG Vaccine is excreted in human milk. Because live vaccines may be excreted in human milk, caution should be exercised when BCG Vaccine is administered to a nursing woman.
Use in the elderly
Clinical experience with BCG Vaccine in the elderly is limited.
Genotoxicity
No genotoxicity studies have been conducted with BCG Vaccine.
Carcinogenicity
No carcinogenicity studies have been conducted with BCG Vaccine.
Effect on laboratory tests
Inteference of BCG Vaccine with laboratory tests has not been studied.
Interactions with other medicines
BCG Vaccine must not be combined with other vaccines in the same syringe; however, it may be administered at the same time as other vaccines provided they are injected SEPARATELY and at different sites. A 4 week interval between administration of BCG vaccine and other live vaccines is recommended.
Adverse effects
Response to BCG vaccination
General disorders and administration site conditions
Following intradermal vaccination a red, small indurated papule (measuring 5 – 15mm in diameter) appears within 1 to 3 weeks. The papule tends to soften and breakdown, resulting in a small ulcer in the majority of subjects. The ulcers heal over a number of weeks, usually leaving a superficial scar.
Some enlargement of the regional lymph nodes may accompany the lesion at the vaccination site. This was observed in 25% of subjects in a study in newborn infants.
Spontaneous regression usually occurs within a few months. If abscesses of the lymph nodes develop, they should be punctured (aspirated) only if they are soft and
fluctuating. Antituberculous chemoprophylaxis should be considered. Surgical incision or excision of the lymph nodes is not recommended.
In studies of BCG Vaccine ulceration of > 5 mm at the site of intradermal vaccination is the most common adverse reaction observed (35 – 69% of subjects).
In some cases, a cold abscess may appear at the site of injection. Spontaneous resorption usually occurs.
Inadvertent subcutaneous injection may result in abscess formation and may lead to ugly retracted scars.
Gross local or generalised infections should be treated with antituberculous chemotherapy.
Disseminated Mycobacterium bovis, var BCG, infection occurred in four Aboriginal Canadian infants who had been immunised with BCG Vaccine in the neonatal period.
All cases were in infants with immunodeficiencies (including severe combined immunodeficiency, HIV/AIDS, defect in interferon gamma) which had not been detected before immunisation.
Disseminated BCG infection has been reported rarely after BCG vaccination, principally in immunocompromised individuals. In some cases deaths have been associated with disseminated BCG infection.
Anaphylactoid reactions have been reported rarely following administration of BCG Vaccine. Keloid formation and cutaneous reactions such as erythema nodosum have also been reported after BCG vaccination.
Regional (e.g. axillary) lymphadenopathy follows BCG vaccination (various strains from various manufacturers) with a frequency ranging from 1 – 10%. Suppurative lymphadenitis is much less common than lymphadenopathy, occurring in 0.03 – 0.5% of BCG vaccine recipients. Multiple lymphadenitis, hepatomegaly, splenomegaly and
other nonfatal disseminated lesions have occurred at rates of 0.31 to 0.39 per 1 million vaccinations.
One case of osteomyelitis associated with BCG Vaccine was reported in 1998.
Osteitis has been observed mostly in Scandinavian countries, possibly related to the strain used. The risk for developing osteitis after BCG vaccination varies by country.
Source: Sanofi-Aventis Data Sheet, 18th May 2012 – http://www.medsafe.govt.nz/profs/Datasheet/b/bcginj.pdf
