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1 |
What disease is to be controlled by the use of this
vaccine?
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General Information |
2 |
On what host species is the vaccine to be
used?
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General Information, C3 |
3 |
What is the host range of the parent organism from
which the vaccine was constructed?
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A7 |
4 |
If the vaccine is intended for animals, what are the
proposed target species/breeds for the vaccine? Specify age range,
risk factor groups, and geographic area, if applicable.
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General Information, C3 |
5 |
Provide data regarding level and duration of
immunity produced in the host species after vaccination with the
GMO.
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General Information, C10 |
6 |
Over what period can the vaccine organism be
detected in the vaccinated animals or their excretions? Provide
supporting data.
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General Information, C9 |
7 |
Can the vaccine organism spread from vaccinated to
non-vaccinated animals or to other species (including humans)? If
so, what is the mechanism and frequency? Provide data, if
available.
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C3, D2 |
8 |
Is there any evidence to indicate whether the
susceptibility of the host to the vaccine organism could be affected
by the current state of the host (e.g. immunosuppression or
superimposition of other disease) or by other treatments (e.g.
drugs)? If so, elaborate.
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C10 |
9 |
Does the genetic material of the vaccine organism
have the potential to become incorporated in whole or in part into
the genome of any cells of the vaccinated host?
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D2 |
10 |
If this is a viral vaccine, can the nucleic acid of
the virus in the vaccine be rescued, or be restored to wild type, by
recombination or complementation with intracellular
viruses?
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B3, B5, D2 |
11 |
In trials, is it proposed to dispose of waste which
contains vaccine organisms? If so. describe the
arrangements.
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D7 |
12 |
What is the fate of the vaccinated animals at the
conclusion of the trial (in the case of an experiment)?
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D7 |
13 |
Will the vaccinated animals carry vaccine organisms
at the end of the trial? If so:
i) will they be likely to
disseminate the vaccine organisms to their family contacts or to the
general population?
ii) what measures, if any, will be taken to
minimize this possibility?
iii) will the organisms be able to
cross the placenta?
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D2
D7
D2
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14 |
Is the use of this vaccine organism likely to
preclude its use for vaccination against other diseases
subsequently? Will its usefulness for other vaccinations be
affected?
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C8 |
15 |
Is the vaccine likely to have any deleterious
effects on pregnant humans or animals? If so, specify. For humans,
provide data from animal models.
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C2 |
