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)
Source: TimesofIndia
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