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March 09, 2010

Swine Flu Vaccine Ready For Commercial Use by April-May

NEW DELHI: Pune-based Serum India's swine flu vaccine 'Fluvac' will be ready for commercial use by April-May, subject to all regulatory clearances.

Fluvac,a swine flu vaccineThe 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 've started Phase II/III trials, pushing it closer to the finishing line.

"The single dose vaccine will be available in two forms —nasal spray & 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", said Serum Institute of India's executive director S.Jadhav .

The age group on which these trials will be administered is 9-19 yrs, 20-48 yrs. & 48 & 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, & priced around Rs.150-200, sources close to the development said.(H1N1 vaccine globally cost between $9-15)
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