The SII, which recently submitted the phase I clinical trial safety reports to the Drugs Controller General of India (DCGI), began the vaccine development programme in mid-2009.
Pune-based vaccine manufacturer Serum Institute of India (SII) is looking at a mid-April date for the launch of their H1N1 nasal drop vaccine. The injectable variety of the vaccine will be available only in May.
The SII, which recently submitted the phase I clinical trial safety reports to the Drugs Controller General of India (DCGI), began the vaccine development programme in mid-2009.
“We have finished the first phase of safety trials for the nasal drops at Ahmedabad and have submitted the report to DCGI. We are now waiting for the go-ahead from them before we begin the second and third phases,” said Dr Rajiv Dhere, director, vaccine production unit at SII.
The company hopes to begin the next phase of trials in the next eight to 10 days. “We have found the vaccine safe to be taken to the next stage of trials,” said Dhere.
A total of nearly 600 individuals would be included in the different phases of trials. Althoguh the first phase of clinical trials for the nasal drops have been completed, the company is yet to complete the trials for the injectable vaccine, work on which had begun prior to the nasal drop variety.
“We began the first phase of trials for the injectable vaccine in the last week of January. We are now waiting for it to get over,” said Prasad Kulkarni, additional medical director at SII.
He said that the nasal drops will be launched in the second week of April and the injectable ones will be launched in May. The company is yet to work out on the pricing of the vaccine.
The second phase of trials will be conducted in three cities — Delhi, Ahmedabad and Pune. In the nasal drop category, the company will produce up to 10 million doses per month, whereas in case of the injectable vaccine, it will be about 1.2 million doses a month, depending on the demand. The company has invested nearly Rs14 crore for a dedicated facility at Hadapsar to manufacture the H1N1 vaccine.
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