The H1N1 vaccine will soon be available in India from the coming week, as the Indian Government has imported about 1.5 million dosages of the vaccines from Sanofi Pasteur. The doses have been approved in safety tests conducted on 100 adults at Bharatiya Vidyapith, Pune and Kalavati Saran Hospital, Delhi.

Meanwhile, Phase II and III human clinical trials of the H1N1 virus nasal spray vaccine by the Serum Institute of India begins at two sites in Pune today, including three other centres. The virus has claimed over 201 lies in Pune, itself.

Talking to Newsline Sunday, Dr. Prasad Kulkarni, the institute’s Director of Clinical trials said the Drug Controller General of India’s (DCGI) approval had been received for the next trial phase. Three age groups of about 330 participants i. e. paediatric, adult and elderly have been enrolled to take part in the tial, which will begin initially at four centres and two others, later on.

The Serum Institute of India will begin phase II and III human clinical trials of the nasal spray vaccine against the H1N1 virus at two sites in Pune and three other centres on Monday. The virus has claimed 201 lives in Pune itself.

Dr Prasad Kulkarni, director of clinical trials at the institute, told Newsline on Sunday that they had received the required approval from the Drug Controller General of India (DCGI). A total of 330 people in three age groups — paediatric, adult and elderly — will be enrolled for the trial. “Initially, the trial will begin at four centres; We will include two more later.”

Kolkata, Ahmedabad, Bangalore, Indore, Pune and Chennai have been identified as the trial sites, with a private hospital and a medical college taking part in the trial in Pune.

An institute official explaining the procedure of how the vaccine is used, informs the vaccine in the form of an inhalation mix will be administered in each nostril in 2.5 ml doses. The virus though live is in a weakened state and produces immunity without causing the disease. Given intra-nasally it mimics the natural route of the infection. Growing in the nasopharynx, it will produce local immunity followed by systemic immunity.

The laboratories of the Serum Institute and National Institute of Virology will test the results of the intra-nasal spray vaccine after it has been administered.

Officials are hopeful of submitting the trial data to the DCGI by the second or third week of April and the vaccines should be available commercially between 15th and 30th April.

Meanwhile, Indian Pharma companies like Zydus Cadila, Bharat Biotech International, Panacea Biotec and Serum Institute, are developing the vaccine indigenously, costing between Rs. 150 to Rs. 200, when available.