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VACCINES FOR HUMAN USE
DEFINITION
Vaccines for human use are preparations containing antigens
capable of inducing a specific and active immunity in man
against an infecting agent or the toxin or antigen elaborated
by it. Immune responses include the induction of the innate
and the adaptive (cellular, humoral) parts of the immune
system. Vaccines for human use shall have been shown to have
acceptable immunogenic activity and safety in man with the
intended vaccination schedule.
Vaccines for human use may contain: whole micro-organisms
(bacteria, viruses or parasites), inactivated by chemical
or physical means that maintain adequate immunogenic
properties; whole live micro-organisms that are naturally
avirulent or that have been treated to attenuate their virulence
whilst retaining adequate immunogenic properties; antigens
extracted from the micro-organisms or secreted by the
micro-organisms or produced by genetic engineering or
chemical synthesis. The antigens may be used in their native
state or may be detoxified or otherwise modified by chemical
or physical means and may be aggregated, polymerised or
conjugated to a carrier to increase their immunogenicity.
Vaccines may contain an adjuvant. Where the antigen is
adsorbed on a mineral adjuvant, the vaccine is referred to as
‘adsorbed’.
Bacterial vaccines containing whole cells are suspensions of
various degrees of opacity in colourless or almost colourless
liquids, or may be freeze-dried. They may be adsorbed. The
concentration of living or inactivated bacteria is expressed in
terms of International Units of opacity or, where appropriate,
is determined by direct cell count or, for live bacteria, by
viable count.
Bacterial vaccines containing bacterial components are
suspensions or freeze-dried products. They may be adsorbed.
The antigen content is determined by a suitable validated assay.
Bacterial toxoids are prepared from toxins by diminishing their
toxicity to an acceptable level or by completely eliminating
it by physical or chemical procedures whilst retaining
adequate immunogenic properties. The toxins are obtained
from selected strains of micro-organisms. The method of
production is such that the toxoid does not revert to toxin.
The toxoids are purified. Purification is performed before
and/or after detoxification. Toxoid vaccines may be adsorbed.
Viral vaccines are prepared from viruses grown in animals, in
fertilised 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 freeze-dried. They may be adsorbed. 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.
Synthetic antigen vaccines are generally clear or colourless
liquids. The concentration of the components is usually
expressed in terms of specific antigen content.
Combined vaccines are multicomponent preparations
formulated so that different antigens are administered
simultaneously. The different antigenic components are
intended to protect against different strains or types of
the same organism and/or against different organisms. A
combined vaccine may be supplied by the manufacturer either as a single liquid or freeze-dried preparation or as several
constituents with directions for admixture before use. Where
there is no monograph to cover a particular combination, the
vaccine complies with the monograph for each individual
component, with any necessary modifications approved by
the competent authority.
Adsorbed vaccines are suspensions and may form a sediment
at the bottom of the container .
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