Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: AJ Vaccines A/S, 5 Artillerivej, DK-2300 Copenhagen S, Denmark
BCG Vaccine AJV should not be administered to individuals known to be hypersensitive to the active substance or to any excipients listed in section 6.1.
Vaccination should be postponed in persons suffering from acute severe febrile illness or with generalised infected skin conditions. Eczema is not a contraindication, but the vaccine site should be lesion free.
BCG Vaccine AJV should not be administered to persons in treatment with systemic corticosteroids or other immunosuppressive treatment including radiotherapy. This also includes 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-α antagonists).
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.
In persons whose immune status is in question, the BCG vaccination should be postponed until the immune status has been evaluated.
The effect of BCG vaccination may be exaggerated in immunosuppressed patients, and a generalised BCG-infection is possible.
BCG Vaccine AJV should not be given to patients who are receiving anti-tuberculosis drugs.
Although anaphylaxis is rare, facilities for its management should always be available during vaccination. Whenever possible, patients should be observed for an allergic reaction for up to 15-20 minutes after receiving immunization.
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.
Administering the vaccine too deep increases the risk of discharging ulcer, lymphadenitis and abscess formation. See section 4.2 for method of administration.
BCG Vaccine AJV should under no circumstances be administered intravascularly.
Regarding undesirable effects caused by BCG-infection and the susceptibility of the strain to anti-tuberculous drugs refer to section 4.8.
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.
Cases of Immune reconstitution inflammatory syndrome (IRIS) have been reported after the onset of antiretroviral therapy in HIV-infected children or after initiating treatment for other severe immune deficiencies in children who had prior BCG vaccination. Adenitis, suppurative adenitis, purulent discharge, skin ulceration, skin abscesses, fever, have been reported in association with IRIS, appearing within weeks to months after initiation of immune therapy. Clinicians should be aware of this syndrome when treating patients with primary or secondary immunodeficiency who had prior BCG vaccination.
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.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Intradermal BCG vaccination may be given concurrently with inactivated or live vaccines, including combined measles, mumps and rubella vaccines.
Other vaccines to be given at the same time as BCG Vaccine AJV 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.
Although no harmful effects to the foetus have been associated with BCG Vaccine AJV, vaccination is not recommended during pregnancy.
Although no harmful effects to the breastfed child have been associated with BCG Vaccine AJV, vaccination of the mother is not recommended during lactation.
However, in areas with high risk of tuberculosis infection, BCG Vaccine AJV may be given during pregnancy or lactation if the benefit of vaccination outweighs the risk.
No clinical or non-clinical data are available on the possible effects of BCG Vaccine AJV on male or female fertility.
BCG Vaccine AJV has no or negligible influence on the ability to drive and use machines.
The expected reaction to successful vaccination with BCG Vaccine AJV includes induration at the injection site followed by a local lesion that may ulcerate some weeks later and heal over some months leaving a small, flat scar.
A local site reaction may include erythema and tenderness.
It also may include enlargement of a regional lymph node to <1 cm.
Undesirable effects of the vaccine include the following:
| Uncommon (≥1/1000 to <1/100) | Rare (≥1/10000 to <1/1000) | |
|---|---|---|
| Blood and lymphatic system disorder | Enlargement of regional lymph node >1 cm | |
| Nervous system disorder | Headache | |
| Musculoskeletal and connective tissue disorders | Osteitis | |
| Infections and infestations | Suppurative lymphadenitis | Osteomyelitis, Injection site abscess |
| General disorders and administration site conditions | Fever, Injection site ulceration, Injection site discharge | |
| Immune system disorders | Anaphylactic reaction, Allergic reaction |
Apnoea in very premature infants (born ≤28 weeks of gestation) (see section 4.4).
During post-marketing safety surveillance syncope among patients receiving injections have been reported. Also seizures and convulsions have been reported.
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. The ulcer should be encouraged to dry and abrasion (by tight clothes, for example) avoided.
Expert advice should be sought regarding the appropriate treatment regimen for the management of systemic infections or persistent local infections following vaccination with BCG Vaccine AJV.
Section 5.1 includes a table with minimum inhibitory concentrations (MIC) for selected anti-tuberculous drugs towards the BCG Danish strain 1331 [as determined by Bactec 460].
The MIC for isoniazid is 0.4 mg/l. There is no consensus as to whether Mycobacterium bovis should be classified as susceptible, intermediately susceptible or resistant to isoniazid when the MIC is 0.4 mg/l. However, based on criteria set for Mycobacterium tuberculosis, the strain could be considered to be of intermediate susceptibility.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
BCG Vaccine AJV should not be mixed with other medicinal products except those mentioned in section 6.6.
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