SII started the Phases two and three of the clinical human trials of the nasal form of vaccine Monday on 330 participants at different locations around the country.
According to Dr Prasad Kulkarni, the director of clinical trials at the institute, SII got the green signal from the Drug Controller General of India (DCGI) on March 5 to carry out advanced safety tests on the swine flu vaccine.
Clinical trials
As per reports, 330 people in three groups--paediatric, adult and elderly (9-19 years, 20-48 years and 48 and above)--will be put under the trial.
A single dose of the swine flu vaccine which is developed with egg-based technology will be initially tested in four cities across India.
Pune-based company said that the cost of the vaccine for single dose will be around Rs 150-200. At the same time, it would be available globally at a cost between $9-15.
Other Indian pharmaceutical players for swine flu vaccine
After Ahmedabad-based pharma major Zydus Cadila, SII is the second company to have started Phase II/III trials.
Other Indian pharmaceutical players Bharat Biotech and Panacea Biotech are also working on the vaccination. Pandyflu is an indigenous swine flu vaccine, which is being developed by Panacea Biotec.
Recently, Biological E Limited, a major pharma and vaccine manufacturing Indian company, joined hands with American VaxInnate Corporation, a privately held biotechnology company, to license its recombinant H1N1 pandemic swine flu vaccine.
Swine flu toll in India
On March 8, the health officials announced that swine flu or influenza A (H1N1) took lives of three more people in Gujarat, taking the toll due to the swine flu pandemic in India so far to 1395, just five short of touching 1400.
State-wise death count:
378 Maharashtra
299 Gujarat
194 Rajasthan
148 Karnataka
95 Delhi
52 Andhra Pradesh
40 Punjab
38 Haryana
37 Kerala
26 Madhya Pradesh
19 Uttar Pradesh
13 Uttarakhand
11 Chhattisgarh
8 Chandigarh
8 Himachal Pradesh
7 Tamil Nadu
6 Puducherry
5 Goa
4 Jammu & Kashmir
3 Orissa
2 Assam
1 Mizoram
1 Dadra & Nagar Haveli
Thirty three new cases of the flu were reported by health officials, including 22 in Maharashtra, 1 each in Kerala and Haryana and 9 in Karnataka.
The officials said that with these numbers the total number of lab-confirmed cases of the virus reported in India so far has gone up to 29,837.
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