BCG VACCINE Powder and solvent for suspension for injection Ref.[27960] Active ingredients: BCG vaccine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: AJ Vaccines A/S, 5 Artillerivej, DK-2300 Copenhagen S, Denmark

5.1. Pharmacodynamic properties

Pharmacotherapeutic group (ATC code): J07AN01

MIC values for selected anti-tuberculous agents against the BCG Danish strain 1331 using the Bactec 460 method are as follows:

DrugMinimum Inhibitory Concentration (MIC)
Isoniazid0.4 mg/l
Streptomycin2.0 mg/l
Rifampicin2.0 mg/l
Ethambutol2.5 mg/l

BCG Danish strain 1331 is resistant to pyrazinamide.

Vaccination with BCG Vaccine AJV elicits a cell-mediated immune response that confers a variable degree of protection to infection with M. tuberculosis. The duration of immunity after BCG vaccination is not known, but there are some indications of a waning immunity after 10 years.

Vaccinated persons normally become tuberculin positive after 6 weeks. A positive tuberculin skin test indicates a response of the immune system to prior BCG vaccination or to a mycobacterial infection. However the relationship between the post vaccination tuberculin skin test reaction and the degree of protection afforded by BCG remains unclear.

5.2. Pharmacokinetic properties

Not relevant for vaccines.

5.3. Preclinical safety data

No relevant data available.

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