22.
Guiding principal 22: The study protocol should include written guarantees
that the manufacturer will provide sufficient amounts of vaccine, free of
charge, for the duration of the study. If the proposed study is on safety and/or
immunogenicity, in addition to plans for efficacy studies there should be a
written assurance that the manufacturer will provide sufficient amounts of the
vaccine, free of charge, for all the studies proposed. If the candidate product
is shown to be efficient, should must be an assurance of its free provision to
all study participants, for as long as required to ensure its immunizing activity;
23.
Guiding principal 23: There should be a written guarantee that, if the
vaccine candidate product under study proves to be efficient and adequate
for large-scale public use, including strain-specific, if indicated, the
manufacturer will provide this vaccine to Zimbabwe at special prices within an
appropriate period;
24.
Guiding principal 24: There should be previous agreement that if the
volunteers suffer any complication or injury secondary to the vaccine product
the sponsor will be responsible for their treatment and rehabilitation.
Volunteers must have guaranteed access to the best proven preventive and
therapeutic care. There must be agreements with hospitals or health care
institutions for the provision of the required medical and rehabilitation
services;
25.
Guiding principal 25: A monitoring system for long-term side effects in the
volunteers must be set up and volunteers must be followed for at least 5
years after the end of the trial;
26.
Guiding principal 26: 14. All HIV/AIDS vaccine studies must be assessed
and monitored by the National HIV Vaccine Committee;
28
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