As the international pharmaceutical companies announced that they are ready to roll out their H1N1 vaccines between December and February,
the city-based vaccine major Serum Institute of India (SII), which is among the three Indian pharma companies working on the vaccine, said that if everything goes as per plan, they will not wait for the March deadline and will launch the vaccine way ahead keeping pace with the international players.

Moreover, the SII has diverted Rs 1.6 million US dollars given by the World Health
Organisation (WHO) for developing the avian flu vaccine for development of swine flu vaccine, said Rajeev Dhere, senior director of SII.

"With support from the WHO as well as the Government of India, we will be going in for toxicity study in animals in October and then conduct clinical trials on humans at the beginning of December. We will not wait for the March deadline given by the Indian companies. Our attempt is to launch the vaccine way ahead keeping pace with the international players," said Dhere.

Moreover, the SII has veered the WHO's financial assistance granted to develop and manufacture avian flu vaccine for development of H1N1 vaccine. "The WHO has requested the SII to take up the work of H1N1 vaccine on priority and asked us to redirect the funds meant for developing avian flu vaccine to the development of H1N1 vaccine," Dhere said.

Elaborating on the scheduled plan of vaccine development, Dhere said "A month after the animal trials, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted to Drugs Controller General of India (DCGI) for carrying out human clinical trials
at the end of October," said Dhere. "After obtaining necessary permission from DCGI, the human clinical trials will begin in December," said Dhere.

"The vaccine has to go through the regular testing process but the DCGI has promised us that they will do their best to fasttrack the process following guidelines of the WHO and European Medicines Agency," said Dhere.

"If these human trials are successful, we have the technology to produce a vaccine that can be pressed into service for commercial production depending upon the scale of requirement after regulatory clearances," said Dhere.

The Serum Institute of India (SII) was part of a teleconference held with over 30 countries by the Director-General of the World Health Organisation (WHO), Dr Margaret Chan, to develop a preventive vaccine against H1N1 flu, hours after the disease was declared a global pandemic.