Indian swine flu vaccine makers are preparing to enter the final phase of trials before making these vaccines commercially available in the market. Pune’s Serum Institute’s Fluvac will soon be ready for commercial use, according to a report in The Financial Express.
“The company is likely to receive regulatory clearances by the second or third week of April. We have sought permission from the Drugs Controller-General of India (DCGI) for the phase-III trials of the inactivate version of the vaccine,” said S Jadav, executive directyor, Serum Institute of India, Pune. The country’s swine flu death toll now stands at 1,401.
The Institute had already begun clinical trials of the nasal form of the vaccine on 330 subjects in Pune, Mumbai and Ahmedabad. SII was bringing in technology from another country to make nasal drops. The WHO had approved this tie-up, said Jadav. The nasal drops could become useful if there was a large outbreak, he explained. After Ahmedabad-based Zydus Cadila, Serum Institute becomes the second company to have started phase 2 and 3 trials, pushing it closer to the finishing line.
Other vaccine makers, including Bharat Biotech, have completed phase I clinical trials of its cell-culture-based H1N1 vaccine candidate HN-VAC and is awaiting approval from the DGCI to go in for phase 3 clinical trials, according to Krishna Ella, CMD, Bharat Biotech.
Zydus Cadila is currently in the middle of phase 2 and 3 trials and Panacea Biotech’s Pandyflu is also likely to be available in April.
While officials from Serum Institute are mum on production numbers, they said the vaccine would be affordable with price points ranging from Rs 150 to Rs 250 per dose. Globally, the vaccine costs around $9-15 per dose