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BCG vaccine

BCG Vaccine AJV, powder and solvent for suspension for injection.

Manufacturer
AJ Vaccines A/S
Label last updated
08 Aug 2024
Source
Official SmPC ↗

Live attenuated BCG, the tuberculosis vaccine, given by intradermal injection at birth or within 28 days for babies in higher-risk groups.

51 findings, each with the section of the label it comes from.

Ingredients and materials

  • Mycobacterium bovis BCG, Danish strain 1331, live attenuated: 2-8 x 10^5 cfu per 0.1 ml dose for adults and children over 12 monthss.2
  • Infants under 12 months receive 0.05 ml containing 1-4 x 10^5 cfus.2
  • Supplied as a multidose vial of powder plus a separate solvent, reconstituted before uses.2, 6.5
  • Powder excipient: sodium glutamates.6.1
  • Solvent excipients: magnesium sulphate heptahydrate, dipotassium phosphate, citric acid monohydrate, L-asparagine monohydrate, ferric ammonium citrate, glycerol 85 per cent, water for injectionss.6.1
  • The BCG Danish strain 1331 is resistant to pyrazinamide; the recorded minimum inhibitory concentration for isoniazid is 0.4 mg/l, and there is 'no consensus' on whether the strain should be classed as susceptible, intermediate or resistant at that levels.4.8, 5.1
  • Declared essentially free of potassium and sodium (less than 1 mmol each per dose)s.4.4

Manufacture, storage and handling

  • Shelf life 2 yearss.6.3
  • Must be used immediately after reconstitution; viability has been demonstrated for 4 hourss.6.3, 6.6
  • Store at 2C to 8C, do not freeze, store in the original package to protect from lights.6.4
  • Only the solvent supplied with this product may be used to reconstitute its.6.6
  • The rubber stopper must not be wiped with any antiseptic or detergent; alcohol must be allowed to evaporate before the needle enterss.6.6
  • Do not shake the vial when resuspending; gently swirl before each subsequent doses.6.6
  • Strictly intradermal, in the arm over the deltoid insertion, using a short-bevel needle and a 1 ml syringe graduated in hundredths; administered only by personnel trained in the intradermal techniques.4.2
  • Jet injectors and multiple puncture devices must not be useds.4.2
  • Must under no circumstances be administered intravascularlys.4.4
  • Must not be mixed with other medicinal productss.6.2

Safety findings

  • The expected reaction to successful vaccination is induration followed by a local lesion that may ulcerate weeks later and heal over months, leaving a small flat scars.4.8
  • Injecting too deep increases the risk of a discharging ulcer, lymphadenitis and abscess formations.4.4
  • An excessive response may produce a discharging ulcer, which may be attributable to inadvertent subcutaneous injection or to excessive dosages.4.8
  • Contraindicated in people on systemic corticosteroids or other immunosuppressive treatment including radiotherapy, and in infants exposed to immunosuppressive treatment in the womb or via breastfeeding for as long as a postnatal influence remains possibles.4.3
  • Contraindicated in malignant conditions such as lymphoma, leukaemia or Hodgkin's disease, and in primary or secondary immune deficienciess.4.3
  • Contraindicated in HIV infection, including infants born to HIV-positive motherss.4.3
  • Contraindicated in people receiving anti-tuberculosis drugss.4.3
  • Vaccination should be postponed in acute severe febrile illness or generalised infected skin conditions; eczema is not a contraindication but the vaccine site must be lesion-frees.4.3
  • In immunosuppressed patients the effect of vaccination may be exaggerated and a generalised BCG infection is possibles.4.3
  • Where immune status is in question, vaccination should be postponed until it has been evaluateds.4.3
  • Tuberculin-positive people do not need the vaccine and giving it may cause a severe local reactions.4.4
  • The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered in very premature infants born at or before 28 weeks, particularly those with previous respiratory immaturity; vaccination should not be withheld or delayed because the benefit is highs.4.4
  • Cases of immune reconstitution inflammatory syndrome (IRIS) have been reported after antiretroviral therapy began in HIV-infected children, or after treatment for other severe immune deficiencies, in children previously vaccinated with BCG; adenitis, suppurative adenitis, purulent discharge, skin ulceration, skin abscesses and fever have been reported weeks to months after immune therapy starteds.4.4
  • Although anaphylaxis is rare, facilities for its management should always be available, and patients should be observed for up to 15 to 20 minutes after immunisations.4.4
  • The vaccine must not be given in the same arm as other vaccines, and further vaccination in the BCG arm should be avoided for 3 months because of the risk of regional lymphadenitiss.4.5
  • Adverse reactions listed as uncommon: enlargement of a regional lymph node over 1 cm, suppurative lymphadenitis, osteomyelitis, injection site abscess, fever, injection site ulceration and discharges.4.8
  • Listed as rare: headache, osteitis, anaphylactic reaction, allergic reactions.4.8
  • Apnoea in very premature infants is a listed adverse reactions.4.8
  • Post-marketing surveillance has reported syncope, seizures and convulsionss.4.8
  • Pregnancy: no harmful effects to the foetus have been associated with the vaccine, but vaccination is not recommended during pregnancys.4.6
  • Breastfeeding: no harmful effects to the breastfed child have been associated, but vaccination of the mother is not recommended during lactations.4.6
  • In areas of high tuberculosis risk the vaccine may be given during pregnancy or lactation if the benefit outweighs the risks.4.6
  • Fertility: no clinical or non-clinical data are available on effects on male or female fertilitys.4.6
  • Overdose increases the risk of suppurative lymphadenitis, may lead to excessive scar formation, and gross overdosage increases the risk of undesirable BCG complicationss.4.9

Evidence and claims

  • Vaccination elicits a cell-mediated immune response that confers 'a variable degree of protection' against M. tuberculosis infections.5.1
  • The duration of immunity after BCG vaccination is not known, but there are some indications of waning immunity after 10 yearss.5.1
  • Vaccinated people normally become tuberculin positive after 6 weeks; the relationship between the post-vaccination tuberculin skin test reaction and the degree of protection 'remains unclear's.5.1
  • Minimum inhibitory concentrations are recorded for isoniazid, streptomycin, rifampicin and ethambutol; the strain is resistant to pyrazinamides.5.1
  • Preclinical safety data: 'No relevant data available's.5.3

Document and licensing

  • Marketing authorisation holder: AJ Vaccines A/S, Copenhagen, Denmarks.7
  • First authorised 9 September 2002, latest renewal 26 October 2007s.9
  • Date of revision of the text: 19 October 2023s.10
  • The text names no manufacturer other than the holder, and states no batch release sites.7
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

After reconstitution, 1 dose (0.1 ml) for adults and children aged 12 months and over contains:
 Mycobacterium bovis BCG (Bacillus Calmette-Guérin), Danish strain 1331, live attenuated, 2-8 x 10^5 cfu.
 After reconstitution, 1 dose (0.05 ml) for infants under 12 months of age contains:
 Mycobacterium bovis BCG (Bacillus Calmette-Guérin), Danish strain 1331, live attenuated, 1-4 x 10^5 cfu.
 This is a multidose container. See section 6.5 for the number of doses per vial.
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • attenuated - Weakened on purpose so the organism cannot cause the disease in a healthy person.

Other ingredients (excipients)

Section 6.1 source ↗

  • Powder:Sodium glutamateA salt of the amino acid glutamate (MSG is the monosodium form). Here it acts as a stabiliser.
  • Solvent:Magnesium sulphate heptahydrateDipotassium phosphate Citric acid monohydrateL-asparagine monohydrateFerric ammonium citrateGlycerol 85%Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
Audit trail: every flagged sentence in the document (12)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. Jet injectors or multiple puncture devices should not be used to administer the vaccine.

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • should not be used - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be used

4.3 Contraindications

  1. Furthermore BCG Vaccine AJV should not be given to persons suffering from malignant conditions (e.g. lymphoma, leukaemia, Hodgkin's disease or other tumours of the reticulo-endothelial system), those with primary or secondary immune-deficiencies, those with HIV-infection, including infants born to HIV-positive mothers.

    Section 4.3 Contraindications source ↗

    In plain English

    • should not be given - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be given

  2. BCG Vaccine AJV should not be given to patients who are receiving anti-tuberculosis drugs.

    Section 4.3 Contraindications source ↗

    In plain English

    • should not be given - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be given

4.5 Interaction with other medicinal products and other forms of interaction

  1. Intradermal BCG vaccination may be given concurrently with inactivated or live vaccines, including combined measles, mumps and rubella vaccines.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • inactivated - Killed. The organism cannot replicate at all.

    Genetic engineering, vectors and GMOs matched: live

  2. Other vaccines to be given at the same time as BCG Vaccine AJV should not be given into the same arm.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • should not be given - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be given

  3. If not given at the same time an interval of not less than four weeks should normally be allowed to lapse between the administrations of any two live vaccines.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Genetic engineering, vectors and GMOs matched: live

4.6 Fertility, pregnancy and lactation

  1. Although no harmful effects to the foetus have been associated with BCG Vaccine AJV, vaccination is not recommended during pregnancy.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • not recommended - The manufacturer advises against it. This is weaker than 'contraindicated', which means it must not be given.

    Not recommended, contraindicated or restricted matched: not recommended

  2. Although no harmful effects to the breastfed child have been associated with BCG Vaccine AJV, vaccination of the mother is not recommended during lactation.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • not recommended - The manufacturer advises against it. This is weaker than 'contraindicated', which means it must not be given.

    Not recommended, contraindicated or restricted matched: not recommended

4.8 Undesirable effects

  1. Antibiotic sensitivity of the BCG strain:

    Section 4.8 Undesirable effects source ↗

    Trace residues and process chemicals matched: antibiotic

5.1 Pharmacodynamic properties

  1. Tuberculosis, live attenuated (ATC code):J 07 AN 01.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  2. Vaccination with BCG Vaccine AJV elicits a cell-mediated immune response that confers a variable degree of protection to infection with M. tuberculosis.

    Section 5.1 Pharmacodynamic properties source ↗

    Efficacy, effectiveness and endpoints matched: immune response

  3. The duration of immunity after BCG vaccination is not known, but there are some indications of a waning immunity after 10 years.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studied matched: not known

Read the whole document at the source ↗