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New Delhi, March, 9 : Pune-based Serum India's
swine flu vaccine 'Fluvac' will be ready for commercial use by April-May,
subject to all regulatory clearances. The Pune-based company received
the drug regulators go-ahead on March 5 to carry out advanced safety
tests on the vaccine Phase II/III clinical trials crucial
for its introduction in the market.
On Monday, it started clinical trials of nasal form of vaccine
on 300 subjects at different locations around the country. After
Ahmedabad-based Zydus Cadila, Serum Institute becomes the second
company to have started Phase II/III trials, pushing it closer to
the finishing line.
"The single dose vaccine will be available in two forms nasal
spray and as an injectable. The inhalation vaccine uses a live virus,
which will be administered to three age groups. Further trials will
be carried out later to test safety of the injectable vaccine on
another set of people", Serum Institute of India's executive
director S Jadhav told TOI.
The age group on which these trials will be administered is 9-19
years, 20-48 years and 48 and above. A single dose of the vaccine
developed with egg-based technology will be initially tested in
four cities across the country. The vaccine developed by indigenous
players will most likely be administered as a single dose, and priced
around Rs 150-200, sources close to the development said. (H1N1
vaccine globally cost between $9-15)
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