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Live attenuated TB vaccine Pregnancy: Vaccination not recommended during pregnancy or lactation, although no harmful effects to foetus or breastfed child have been associated. In areas with high risk of TB infection, may be given during pregnancy or lactation if benefit outweighs risk.

BCG vaccine

Brand names: BCG vaccine

BCG is a live attenuated vaccine derived from Mycobacterium bovis, given to provide protection against tuberculosis, particularly severe forms in children.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.1 mL of the reconstituted vaccine (adults and children aged 12 months and over)
Route: Intradermal (strictly)
Frequency: Single dose
Product: BCG Vaccine AJV. Inject strictly intradermally in the arm, over the distal insertion of the deltoid muscle onto the humerus (approx. one third down the upper arm). Infants under 12 months of age: 0.05 mL of the reconstituted vaccine, strictly intradermal. Consult national recommendations regarding the need for tuberculin testing prior to administration. Use a 1 mL syringe subgraduated into hundredths of mL with a short bevel needle (25G/0.50 mm or 26G/0.45 mm); jet injectors or multiple puncture devices should not be used. Must under no circumstances be administered intravascularly. See SPC section 6.6 for reconstitution.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Acute severe febrile illness or generalised infected skin conditions (postpone vaccination)
  • Patients on systemic corticosteroids or other immunosuppressive treatment including radiotherapy (also infants exposed in utero or via breastfeeding, e.g. maternal TNF-alpha antagonists)
  • Malignant conditions (e.g. lymphoma, leukaemia, Hodgkin's disease, other reticulo-endothelial tumours)
  • Primary or secondary immunodeficiencies; HIV-infection, including infants born to HIV-positive mothers
  • Patients receiving anti-tuberculosis drugs

Side effects

  • Expected: induration at injection site, local lesion that may ulcerate and heal over months leaving a small flat scar; erythema and tenderness; regional lymph node enlargement to ~1 cm
  • Enlargement of regional lymph node >1 cm (uncommon)
  • Headache (uncommon)
  • Injection site abscess, suppurative lymphadenitis, osteomyelitis, osteitis (rare)
  • Fever, injection site ulceration, injection site discharge; anaphylactic/allergic reaction (rare)

Interactions

  • May be given concurrently with inactivated or live vaccines (including MMR), but other vaccines should not be given into the same arm
  • If not given at the same time, allow an interval of not less than four weeks between two live vaccines
  • Advisable not to give further vaccination in the BCG arm for 3 months (risk of regional lymphadenitis)

Clinical monograph

How it works

It stimulates a cell-mediated immune response against mycobacterial antigens, conferring protection most notably against tuberculous meningitis and miliary tuberculosis in infants.

Prescribing in practice

  • As a live vaccine it is contraindicated in individuals who are significantly immunocompromised, including infants with suspected or confirmed HIV or severe combined immunodeficiency.
  • It is given intradermally by appropriately trained staff, as incorrect deeper administration increases the risk of local complications such as abscess.
  • In the UK it is offered to infants and others at increased risk of tuberculosis rather than universally, in line with the national immunisation programme.

Monitoring

Review the injection site for expected local healing and for any persistent abscess or regional lymphadenopathy.

Counselling the patient

  • A small raised blister forms at the injection site and heals over several weeks, sometimes leaving a small scar.
  • Keep the site clean and dry and avoid covering it with airtight dressings.
  • Seek advice if the site develops a discharging sore or the nearby glands become swollen.

Evidence & guidelines

BCG is recommended for infants and individuals at increased tuberculosis risk under the UK immunisation programme.

Reference: UKHSA Green Book ch 32; NICE NG33; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.