Serum Institute of India to launch swine flu vaccine before March 2010

The Serum Institute of India (SII), based in Pune, India, has announced that, it will launch, if everything goes according to plan, the vaccine against the H1N1 flu (swine flu ) much ahead of the March 2010 deadline.

The SII is one of the three Indian pharmaceutical companies working on developing the H1N1 flu vaccine – the other two firms being Panacea Biotech Limited, New Delhi, and Bharat Pharmaceuticals, Mumbai.

The announcement by the Serum Institute of India comes at a time when global pharmaceutical firms have announced that they are set to launch their vaccines vaccine against the H1N1 flu between December 2009 and February 2010,

According to Rajeev Dhere, senior director of the Serum Institute of India, the SII has diverted the US $1.6 million, given to it by the World Health Organisation (WHO) for developing a vaccine against the avian flu, to develop a vaccine against the swine flu.

The World Health Organisation, Dhere added, has requested the Serum Institute of India to take up the work of a vaccine against the H1N1 flu on priority.

With support from the WHO and the Government of India, the SII will conduct toxicity study in animals in October 2009, and then conduct clinical trials on humans in the beginning of December 2009, Rajeev Dhere said. The institute is attempting to launch the vaccine “way ahead of the deadline, keeping pace with the international players,” Dhere said.

A month after the trials on animals, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted to the Drugs Controller-General of India (DCGI) for carrying out human clinical trials by the end of October 2009. After getting the permission from DCGI, the SII will start the human clinical trials in December 2009.

Though the vaccine has to undergo the regular testing process, the DCGI has promised the SII that it will speed up the process according to the guidelines of the World Health Organization and the European Medicines Agency.

If these human trials are successful, Rajeev Dhere said, the Serum Institute has the technology to produce a vaccine that can be put to commercial production depending on the scale of requirement after necessary regulatory clearances.

The Serum Institute of India had participated in a teleconference held with over 30 countries by Dr Margaret Chan, Director-General of the World Health Organization, aimed at developing a preventive vaccine against the H1N1 flu, just a few hours after the disease was declared a worldwide pandemic.

It may be noted that the SII had successfully developed small quantities of the H1N1 flu vaccine, needed for animal trials, within just 3 weeks of receiving the sample strains from the World Health Organization.

The WHO, in association with over 100 companies as well as research institutions worldwide, is attempting to develop a preventive vaccine against the pandemic.

The H1N1 flu virus has affected people in several parts of the world and is spreading quickly in India.