Serum Institute of India (SII), exporter of vaccines and immuno-biologicals to 138 countries, is hopeful to produce a swine flu vaccine by March-April 2010, its top official said.

“The H1N1 vaccine is ready for human trials, which will begin in the third week of December. We are hoping to start manufacturing the drug in March-April 2010,” Rajiv Dhere, senior director of the vaccine production unit, SII, told FC.

He said the company had kept the new manufacturing plant with an investment of Rs 14 crore ready to commercially produce the injectible and nasal drop variant of the vaccines.

The company, which is recognised by the WHO, is developing both intra-nasal (nasal spray) and intra-muscular (injection) vaccine. Studies carried out on two animals have confirmed the tolerance and safety level of the new intra-nasal H1N1 influenza vaccine.

Prabhakar Y Naik, director and CEO of Pune-based institute Intox, which carried out the toxicity study of SII’s vaccine, confirmed the successful trial of intra-nasal vaccine. “Our trials spread over three months on rats and mice did not show any adverse effects of the intra-nasal vaccine,” he said.

The histopathology report also did not show any adverse reactions in the microscopic examination of animal tissues, he added.

Naik said the trials of the intra-muscular vaccine were also successful and the detailed report would be give to SII within a week.

“The indigenously developed technology with which we have produced the vaccine has proved successful,” Dhere said. The samples for human trials would be now be sent to National Control Authority, Kasauli in Himachal Pradesh for “quality control testing and certification”. After that the company would approach Drug Controller General of India.