The race for the indigenous H1N1 vaccine is hotting up, as 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. ?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,? S Jadhav, executive, director, Serum Institute of India (SII), said. The country?s swine flu death toll touched 1,401 on Wednesday.
Serum Institute has already begun clinical trials of the nasal form of the vaccine on 330 subjects in Pune, Mumbai and Ahmedabad. SII is bringing in technology from another country to make nasal drops. WHO has approved this tie-up, Jadhav said. The nasal drops could beecome useful if there is a large outbreak, he explained. 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.
Other vaccine makers, including Bharat Biotech, have completed phase 1 clinical trials of its cell culture-based H1N1 vaccine candidate
HN-VAC and is awaiting approval for the DCGI to go in for phase III clinical trials, Krishna Ella, CMD, Bharat Biotech, said. ?This was one of the largest phase 1 clinical trials of its kind in India wherein 160 subjects were evaluated for safety and immunogenicity. The report has been submitted to the DCGI and we are currently awaiting the approval from the regulator to go for Phase III clinical trials,? he said. The commercial roll out would depend on regulatory permission, ethical committee approval for conducting trials, how fast we can recruit the people for trials and then approval from the CRI (Central Research Institute, Kasauli), he said.
Zydus Cadila is currently in the middle of phase II and phase III trials and Panacea Biotech?s Pandyflu is also likely to be available in April. Panacea expects the process of licensing with government of India to be over by July 2010. Officials from Zydus Cadilla said they would disclose details on the branding for the vaccine closer to the launch period. Zydus will be manufacturing the vaccine at its facility at Moraiya, Gujarat. Initially, the company plans to produce 5-6 lakh doses per month which will be doubled to 10 lakh doses per month in the next 6 months.
While officials from the Serum Institute kept mum on production numbers, they said the vaccine would be affordable with price points ranging between Rs 150 to Rs 200 per dose. Globally, the vaccine costs around $9?$ 15 per dose.