BCG vaccine

VERBATIM (UK SPC §4.2 Posology): 'Adults and children aged 12 months and over: A dose of 0.1 ml of the reconstituted vaccine is injected strictly by the intradermal route. Infants under 12 months of age: A dose of 0.05 ml of the reconstituted vaccine is injected strictly by the intradermal route. National recommendations should be consulted regarding the need for tuberculin testing prior to administration of BCG Vaccine AJV.' The dose is a VOLUME of vaccine reconstituted according to §6.6; §6.6 was not retrieved in this bundle and no potency per dose or per millilitre appears in any fetched section, so the strength behind the volume is not quantified here — reconstitute strictly per the product's own SPC. MAXDOSE LEFT EMPTY: no maximum dose is stated anywhere in the fetched SPC. §4.8 does warn that 'An excessive response to the BCG Vaccine AJV may result in a discharging ulcer. This may be attributable to inadvertent subcutaneous injection or to excessive dosage', but no ceiling figure is given. TECHNIQUE (§4.2 Method of Administration, verbatim): 'The injection site should be clean and dry. If antiseptics (such as alcohol) are applied to swab the skin, they should be allowed to evaporate completely before the injection is made. BCG Vaccine AJV should be administered by personnel trained in the intradermal technique... The skin is stretched between thumb and forefinger. The needle should be almost parallel with the skin surface and slowly inserted (bevel upwards), approximately 2 mm into the superficial layers of the dermis. The needle should be visible through the epidermis during insertion. The injection is given slowly. A raised, blanched bleb is a sign of correct injection. The injection site is best left uncovered to facilitate healing.' EQUIPMENT (§4.2): 'BCG Vaccine AJV should be administered with a syringe of 1 ml subgraduated into hundredths of ml (1/100 ml) fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm). Jet injectors or multiple puncture devices should not be used to administer the vaccine.' DEPTH (§4.4): 'Administering the vaccine too deep increases the risk of discharging ulcer, lymphadenitis and abscess formation.' TUBERCULIN-POSITIVE PERSONS (§4.4): 'Tuberculin positive persons (consult national recommendations for the definition of a positive tuberculin reaction) do not require the vaccine. Administration of the vaccine to such persons may result in a severe local reaction.' OTHER VACCINES (§4.5): intradermal BCG may be given concurrently with inactivated or live vaccines including MMR, but other vaccines given at the same time 'should not be given into the same arm'. 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'. 'It is advisable not to give further vaccination in the arm used for BCG vaccination for 3 months because of the risk of regional lymphadenitis.' EXCIPIENTS (§4.4): 'BCG Vaccine AJV contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose and is essentially free of potassium and sodium.'

The paediatric dose is an age-banded VOLUME of reconstituted vaccine, not a weight-based dose, so dosePerKg is null; concentration is null because no potency per millilitre appears in any fetched section. VERBATIM (UK SPC §4.2): 'Adults and children aged 12 months and over: A dose of 0.1 ml of the reconstituted vaccine is injected strictly by the intradermal route. Infants under 12 months of age: A dose of 0.05 ml of the reconstituted vaccine is injected strictly by the intradermal route.' PREMATURE INFANTS (§4.4, verbatim): 'The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born <= 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.' INFANT-SPECIFIC CONTRAINDICATIONS (§4.3): the vaccine must not be given to infants exposed to immunosuppressive treatment in utero or via breastfeeding 'for as long as a postnatal influence of the immune status of the infant remains possible (e.g. maternal treatment with TNF-alpha antagonists)', nor to infants born to HIV-positive mothers. IRIS (§4.4): immune reconstitution inflammatory syndrome has been reported after starting antiretroviral therapy in HIV-infected children, or other severe immune-deficiency treatment, in children with prior BCG vaccination. Follow current UK national immunisation policy for eligibility and pre-vaccination tuberculin testing, and verify against a children's formulary.