POM-V Prescription Required

BadgerBCG

Active ingredient: Mycobacterium bovis subsp. bovis

Form

Injection

Species

Badger

Manufacturer

Animal and Plant Health Agency

VMD MA No.

03326/5000

What it's used for

For the active immunisation of badgers to reduce lesions of tuberculosis caused by Mycobacterium bovis. For use in badgers from the age at which they emerg...

Full indications, dosage and side effects ↓

View official SPC (PDF)

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Clinical information

BadgerBCG — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.

For the active immunisation of badgers to reduce lesions of tuberculosis caused
by Mycobacterium bovis.
For use in badgers from the age at which they emerge from the sett.
Onset of immunity is 17 weeks. This is a Limited Marketing Authorisation.
Duration of immunity is unknown.
However, annual vaccination on a population basis is recommended in view of
the estimated 30% rate of turnover including new cubs and badger movement.

For use in badgers from the age at which they emerge from the sett: 1 ml
reconstituted vaccine containing 2-8 × 10
colony forming units.
Reconstitution:
Only Sauton diluent provided with BadgerBCG should be used for
reconstitution.
The rubber stopper must not be wiped with any antiseptic or detergent. If
alcohol is used to swab the rubber stopper of the vial, it must be allowed to
evaporate before the stopper is penetrated with the syringe needle. Syringes
and needles should be sterile before use.
The vaccine should be visually inspected both before and after reconstitution for
any foreign particulate matter prior to the administration. Using a syringe fitted
with a suitable needle, transfer 1ml of Sauton diluent to the vial. Carefully invert
the vial a few times to resuspend the lyophilised vaccine completely. DO NOT
SHAKE. Gently swirl the vial of resuspended vaccine before drawing up the
contents of the vial which constitute one dose. When drawn up into the syringe
the vaccine suspension should appear homogeneous, slightly opaque and
colourless.
Administration is by intramuscular injection.

None

Palpable small swellings (maximum 30 mm) at the injection site are common
observations. On rare occasions swelling at the injection site may persist for at
least 2 years, although in most cases they resolve within 8 months.

None

Revised: November 2025
MA split from NI Expiry following AN: 02025/2025

i. Special precautions for use in animals
None
ii. Special precautions to be taken by the person administering the veterinary
medicinal product to animals
BadgerBCG should not be handled by persons receiving systemic
corticosteroids or immunosuppressive treatment including radiotherapy,
those suffering from malignant conditions (e.g., lymphoma, leukaemia,
Hodgkin’s disease or other tumours of the reticulo-endothelial system),
those with primary or secondary immunodeficiencies, those with HIV-
infection. The reaction to self injection and infection with Bacille Calmette
Guérin (BCG) may be exaggerated in these persons, and a generalised
BCG-infection is possible.
In case of accidental self-injection, seek medical advice immediately and
show the package leaflet or the label to the physician.
To the physician:
BadgerBCG is a 1ml dose of the identical AJ Vaccines BCG product
which is licensed for human use at a dose of 0.1ml. Overdose above
0.1ml increases the risk of suppurative lymphadenitis and may lead to
excessive scar formation. Gross overdosage increases the risk of
undesirable BCG complications. Expert advice, including that of a chest
physician, should be sought regarding the appropriate treatment regimen
for the management or prophylaxis of systemic infections or persistent
local infections following self injection with BCG.
Antibiotic sensitivity of the BCG strain:
Minimum inhibitory concentrations (MIC) for selected anti-tuberculous
drugs for the BCG Danish strain 1331 (as determined by Bactec 460).
Drug Minimum Inhibitory Concentration (MIC) Isoniazid 0.4 mg/l Streptomycin 2.0 mg/l Rifampicin 2.0 mg/l Ethambutol 2.5 mg/l
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.

Revised: November 2025
MA split from NI Expiry following AN: 02025/2025

No information is available on the compatibility of this vaccine with any other.
Therefore the safety and efficacy of this product when used with any other
(either when used on the same day or at different times) has not been
demonstrated.

Store and transport refrigerated (2C – 8C).
Store and transport in the original package in order to protect from light.

Not applicable.

Revised: November 2025
MA split from NI Expiry following AN: 02025/2025
5. IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against Mycobacterium bovis.
ATCvet code: QI20XE01

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.