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      Vaccines for human use are preparations containing antigenic substances capable of inducing a specific and active immunity in man against an infecting agent or the toxin or the antigen elaborated by it or an allergen. They shall have been shown to have acceptable immunogenic activity in man with the intended vaccination schedule.

      Vaccines for human use may contain: organisms inactivated by chemical or physical means that maintain adequate immunogenic properties; living organisms that are naturally avirulent or that have been treated to attenuate their virulence whilst retaining adequate immunogenic properties; antigens extracted from the organisms or secreted by them or produced by genetic engineering. The antigens may be used in their native state or may be detoxified by chemical or physical means and may be aggregated, polymerized or conjugated to a carrier to increase their immunogenicity.

Allergen vaccines Allergen vaccines are preparations of allergens obtained by extraction of the active constituents from micro-organism, animal or vegetable substances with a suitable menstruum.

Bacterial vaccines Bacterial vaccines are prepared from cultures of suitable strains grown on suitable solid media or in suitable liquid media and contain live or inactivated bacteria or their immunogenic components. They are suspensions of various degrees of opacity in colourless or almost colourless liquids or they may be freeze-dried.

      Inactivated bacterial vaccines contain bacteria or their immunogenic components that have been inactivated in such a way that adequate immunogenicity is retained.

      Living bacterial vaccines are prepared from strains of attenuated virulence that are capable of stimulating immunity against the pathogenic strains of the same or antigenically related species of bacteria.

      The concentration of living or inactivated bacteria of each of the bacterial varieties or species present is measured in terms of International Units of opacity or, where appropriate, by direct cell count or, in the case of living bacteria, by viable count.

Bacterial toxoids Bacterial toxoids are prepared from toxins by diminishing their toxicity to a non-detectable level or by completely eliminating it, without destroying their immunogenicity, by methods that avoid the reversion of toxoid to toxin. The toxins are obtained from selected strains of specific micro-organisms grown in media free, as far as possible, from ingredients known to cause toxic, allergic or other undesirable reactions in man.

      Toxoids may be liquid or freeze-dried. They may be purified and adsorbed. Adsorbed toxoids are suspensions of white or grey particles dispersed in colourless or pale yellow liquids and may form a sediment at the bottom of the container. 

Viral vaccines Viral vaccines are prepared from viruses grown in animals, in embryonated eggs, in suitable cell cultures or in suitable tissues or by culture of genetically engineered cells. They are liquids that vary in opacity according to the type of preparation or may be freezedried. Liquid preparations and freeze-dried preparations after reconstitution may be coloured if a pH indicator such as phenol red has been used in the culture medium.

      Living viral vaccines are usually prepared from strains of the specific virus that are of attenuatedvirulence.

Combined vaccines Combined vaccines are mixtures of two or more vaccines.

      Vaccines, reconstituted where necessary, comply with the following requirements unless otherwise stated in the individual monographs.

Packaging and storage Unless otherwise stated in the monograph, vaccines shall be stored at a temperature between 2º and 8º, protected from light; avoid freezing.

Aluminium For adsorbed vaccines containing aluminium, not more than 1.25 mg of aluminium per single human dose, unless otherwise stated in the monograph when determined by the method described under the “Determination of Aluminium”, p. 178.

Calcium For adsorbed vaccines containing calcium, not more than 1.3 mg of calcium per single human dose, unless otherwise stated in the monograph, when determined by the method described under the “Determination of Calcium”, p. 178.

Phenol For vaccines containing phenol as a preservative, not more than 0.25 per cent w/v, unless otherwise stated in the monograph, when determined by the method described under the “Determination of Phenol”, p. 179.

Thiomersal¹ For vaccines containing thiomersal as a preservative, not less than 0.005 per cent w/v and not more than 0.02 per cent w/v, when determined by the method described under the “Determination of Thiomersal”, p. 179.

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¹Vaccines available in some countries may contain thiomersal. Riskbenefit should be considered when medical problem exists.

Formaldehyde For vaccines containing formaldehyde, not more than 0.02 per cent w/v of free formaldehyde, when determined by the method described under the “Determination of Formaldehyde”, p. 178.

Sterility Unless otherwise stated, all vaccines comply with the “Sterility Test” (Appendix 10.1), except that for living bacterial vaccines, growth of the organism from which the vaccine was prepared is permitted.

Abnormal toxicity Complies with the “Abnormal Toxicity Test” (Appendix 8.1).

Water For freeze-dried vaccines, not more than 3.0 per cent w/w (Karl Fischer Method, Appendix 4.12).

      The provisions of this monograph apply to the following vaccines:

Allergen Vaccines

House Dust Mite Allergen Vaccine 

Bacterial Vaccines 

Bacillus Calmette-Guérin Vaccine, Freeze-Dried

Percutaneous Bacillus Calmette-Guérin Vaccine

Cholera Vaccine

Diphtheria Vaccine, Adsorbed

Haemophilus Type b Conjugate Vaccine

Meningococcal Polysaccharide Vaccine

Pertussis Vaccine, Adsorbed

Pertussis Vaccine, Adsorbed (Acellular Component)

Pneumococcal Polysaccharide Vaccine

Pneumococcal Polysaccharide Conjugate Vaccine, Adsorbed

Tetanus Vaccine, Adsorbed

Typhoid Polysaccharide Vaccine

Typhoid Vaccine, Oral

Viral Vaccines

Hepatitis A Vaccine, Inactivated

Hepatitis B Vaccine, Recombinant

Influenza Vaccine, Inactivated (Whole Virion)

Influenza Vaccine, Inactivated (Split Virion)

Influenza Vaccine, Inactivated (Surface Antigen)

Influenza Vaccine, Inactivated (Surface Antigen, Virosome)

Japanese Encephalitis Vaccine, Inactivated

Measles Vaccine, Live

Mumps Vaccine, Live

Poliomyelitis Vaccine, Inactivated

Poliomyelitis Vaccine, Oral

Rabies Vaccine, Inactivated

Rubella Vaccine, Live

Varicella Vaccine, Live

Yellow Fever Vaccine

Combined Vaccines

Diphtheria and Tetanus Vaccine, Adsorbed

Diphtheria, Tetanus and Pertussis Vaccine, Adsorbed

Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine, Adsorbed

Measles, Mumps and Rubella Vaccine, Live

Tetanus and Diphtheria Vaccine for Adult Use, Adsorbed