Formulary
Bacillus Calmette-Gurin vaccine: Indications, Dosing, Side Effects and Interactions
Calmette-Gurin vaccine BCG (Bacillus Calmette-Gurin) vaccine is a live attenuated vaccine derived from Mycobacterium bovis .
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Bacillus Calmette-Gurin vaccine: Indications, Dosing, Side Effects and Interactions
Calmette-Gurin vaccine BCG (Bacillus Calmette-Gurin) vaccine is a live attenuated vaccine derived from Mycobacterium bovis .
Drug action
Calmette-Gurin vaccine BCG (Bacillus Calmette-Gurin) vaccine is a live attenuated vaccine derived from Mycobacterium bovis .
Indications and dose
**Immunisation against tuberculosis for Bacillus Calmette-Gurin vaccine**
- **Neonate** (By intradermal injection): 0.05 mL, to be injected at insertion of deltoid muscle onto humerus (keloid formation more likely with sites higher on arm); tip of shoulder should be avoided.
- **Child 1-11 months** (By intradermal injection): 0.05 mL, to be injected at insertion of deltoid muscle onto humerus (keloid formation more likely with sites higher on arm); tip of shoulder should be avoided.
- **Child 1-17 years** (By intradermal injection): 0.1 mL, to be injected at insertion of deltoid muscle onto humerus (keloid formation more likely with sites higher on arm); tip of shoulder should be avoided.
Cautions
For all vaccines, general Acute illness; minor illnesses Cautions, further information Illness UKHSA advises vaccination may be postponed if the individual is suffering from an acute illness; however, it is not necessary to postpone immunisation in patients with minor illnesses without fever or systemic upset. Predisposition to neurological problems UKHSA advises: when there is a personal or family history of febrile convulsions, there is an increased risk of these occurring during fever from any cause including immunisation, but this is not a contra-indication to immunisation. In children who have had a seizure associated with fever without neurological deterioration, immunisation is recommended ; advice on the management of fever should be given before immunisation. When a child has had a convulsion not associated with fever, and the neurological condition is not deteriorating, immunisation is recommended ; children with stable neurological disorders (e.g. spina bifida, congenital brain abnormality, and peri-natal hypoxic-ischaemic encephalopathy) should be immunised according to the recommended schedule; when there is a still evolving neurological problem , including poorly controlled epilepsy, immunisation should be deferred and the child referred to a specialist. Immunisation is recommended if a cause for the neurological disorder is identified. If a cause is not identified, immunisation should be deferred until the condition is stable. Impaired immune response and drugs affecting immune response Immune response to vaccines may be reduced in immunosuppressed patients, UKHSA advises consider seeking specialist advice. Cautions For all vaccines, live Cautions, further information Impaired immune response and drugs affecting immune response There is a risk of generalised infection with live vaccines. UKHSA advises seek specialist advice for immunosuppressed patients, including those who are: taking high doses of corticosteroids (dose equivalents of prednisolone: adults , at least 40 mg daily for more than 1 week or at least 20 mg daily for more than 14 days; children , 2 mg/kg (or more than 40 mg) daily for more than 1 week or 1 mg/ kg (or more than 20 mg) daily for more than 14 days); taking immunosuppressive drugs; receiving treatment for malignant or non-malignant conditions with chemotherapy or generalised radiotherapy. UKHSA advises live vaccines should be postponed until at least 3 months after stopping high-dose systemic corticosteroids, or non-biological oral immune modulating drugs; and at least 6 months after stopping other immunosuppressive drugs, or generalised radiotherapy; and at least 12 months after discontinuing immunosuppressive biological therapy. Cautions For Bacillus Calmette-Gurin vaccine Cautions, further information When BCG is given to infants, there is no need to delay routine primary immunisations. No further vaccination should be given in the arm used for BCG vaccination for at least 3 months because of the risk of regional lymphadenitis.
Contraindications
For all vaccines, live Contra-indications, further information Impaired immune response UKHSA advises severely immunosuppressed patients should not be given live vaccines (including those with severe primary immunodeficiency). Contra-indications For Bacillus Calmette-Gurin vaccine Children less than 2 years of age in household contact with known or suspected case of active tuberculosis (in children); generalised septic skin conditions; history of active or latent tuberculosis; severe combined immunodeficiency disorder Contra-indications, further information Manufacturer advises using a lesion-free site to administer BCG vaccine to patients with eczema.
Side effects
For all vaccines, general Common or very common Abdominal pain; appetite decreased; arthralgia; diarrhoea; dizziness; fatigue; fever; headache; lymphadenopathy; malaise; myalgia; nausea; skin reactions; vomiting Uncommon Hypersensitivity Side-effects For all vaccines, live Common or very common Abdominal pain; arthralgia; diarrhoea; fever; headache; myalgia; nausea; skin reactions; vomiting Uncommon Dizziness Side-effects For Bacillus Calmette-Gurin vaccine Uncommon Lymphadenitis suppurative Rare or very rare Osteitis; osteomyelitis Frequency not known Seizure; syncope
Pregnancy
For all vaccines, live UKHSA advises live vaccines should not be administered routinely to pregnant women because of the theoretical risk of fetal infection, but where there is a significant risk of exposure to disease the need for vaccination may outweigh any possible risk to the fetus. Termination of pregnancy following inadvertent immunisation is not recommended.
Breast feeding
For all vaccines, live Although there is a theoretical risk of live vaccine being present in breast milk, vaccination is not contra-indicated for women who are breast-feeding when there is significant risk of exposure to disease.
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Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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