Friday, August 7, 2009

Human trials of H1N1 vaccine by Dec: Serum

PUNE: The preventive vaccine against the H1N1 flu will be ready for clinical trials in humans by December, senior director of city-based Serum
Institute of India Limited (SIIL) Rajeev Dhere told on Thursday. "The development of the vaccine is in full swing. We obtained the H1N1 virus strain from UK-based National Institute for Biological Standards and Control (NIBSC) a month ago. If everything goes as per the scheduled plan and strategy, the vaccine will be out for human clinical trials in December," said Dhere. Elaborating on the scheduled plan of vaccine development, Dhere said, "First, a trial batch comprising a few thousand doses will be out and animal trials will be done by the third week of August to assess the immunogenicity of the vaccine," said Dhere. The company has zeroed in on two laboratories in India in Bangalore and Pune where animal trials will be carried out, Dhere added. "A month after the animal trials, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted by the end of October to the Drugs Controller General of India (DCGI) for carrying out human clinical trials," said Dhere. "After obtaining the necessary permission from the DCGI, human clinical trials will begin in December," said Dhere. "The vaccine has to go through a regular testing process, but the DCGI had promised us they will do their best to fast-track the process following guidelines of the World Health Organisation (WHO) and European Medicines Agency," Dhere said. "If these human trials are successful, we have the technology to produce a vaccine which can be pressed into service for commercial production depending upon the scale of requirement after regulatory clearances," he added. The SIIL was part of a teleconference spread over 30 countries with the director-general of the WHO, Dr Margaret Chan, to develop a preventive vaccine against H1N1 flu hours after the disease was declared globally pandemic.
1) SII obtains virus strain from UK-based NIBSC in July
2) Animal trials or pre-clinical trials will begin in August
3) A report of the toxicity and immunogenicity of the vaccine will be submitted to the DCGI in October
4) Safety trials in humans or clinical trials will begin by December

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