The Indian vaccine against the pandemic strain of swine flu would be commercially available by March next with the authorities planning to fast-track the clinical trials in humans in accordance with international protocols.
Vishwa Mohan Katoch, Director-General, Indian Council of Medical Research (ICMR) told The Hindu from New Delhi on Tuesday that it was proposed to combine the first and second phases for safety and immuno-genicity.
He said the three Indian companies, Bharat Biotech, Panacea Biotec and Serum Institute of India, which were taken "on board" to produce the vaccine would be completing animal trials by December. Following this the first and second phases in human trials would be combined in a fast-track mode to make the vaccine available by March next as otherwise it would be ready only by the end of next year if a normal schedule were to be followed.
He said the entire exercise of finalising the fast-track protocol would be completed in next two to three weeks after the issue is examined by the committee for drugs and vaccines and another special committee on A(H1N1) Influenza virus.
Dr. Katoch, however, said the question whether to administer one or two doses would be decided after the completion of human trials.
He said Novartis and Glaxo Smith Kline too have expressed interest to conduct short trials in India and the protocols for the same would be finalised soon. "We are talking to them".
Replying to a question, he denied that the virus had become more virulent and said the patients, whose flu-like symptoms persist even after 48 hours, were responding to Tamiflu and there was a case in which even a 72-year-old person had recovered. There was a need to create awareness about this among people and even medical fraternity.
Meanwhile, Krishna Ella, Chariman and Managing Director Bharat Biotech, which will produce the WHO strain of the vaccine along with the other two firms, said his company would be ready with the vaccine for animal trials by this month end. Urging ICMR to allow the first and second phases of human trials to be conducted in a fast track mode, he said it was planned to produce five to six million doses in the next three to four months. The production would be scaled up depending on the requirement.