Ronan Kelly
Retired 2020
Indian vaccine for swine flu to be ready by March
HYDERABAD: The Indian vaccine against the pandemic strain of swine flu will be ready for use by March next with authorities planning to fast-track clinical trials in accordance with international protocols.
It has been proposed to combine the different phases of clinical trials from safety to immunogenicity in fast-track mode to make the vaccine available in March next as otherwise it would be ready only by the end of 2010, Vishwa Mohan Katoch, Director-General, Indian Council of Medical Research (ICMR) while speaking to The Hindu from New Delhi on Tuesday.
Three 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. The entire exercise of finalising the fast-track protocol would be completed in the next two or three weeks after the issue was examined by the committee for drugs and vaccines and another special committee on H1N1 influenza virus.
Dr.Katoch, however, said the decision on administering one or two doses would be taken after the completion of human trials. Novartis and Glaxo Smith Kline too had expressed interest in conducting short trials in India and the protocols for the same would be finalised soon. ?We are talking to them.?
Even as the doctors treating H1N1 influenza patients here observed that the virus had become more virulent, the ICMR chief maintained that he had no such report. If Tamiflu was administered in time, the recovery would be complete, he said pointing out that even a 72-year-old person recovered. There was need to create awareness of this among people and even the medical fraternity.
According to Krishna Ella, chairman and managing director Bharat Biotech, which, along with two other firms will produce the WHO strain of the vaccine, 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 fast-track mode, he said it was planned to produce initially five million to six million doses. The production would be scaled up depending on the requirement.
http://www.hindu.com/2009/09/16/stories/2009091652071200.htm
Ro's notes: India's current population: 1.2 billion.
HYDERABAD: The Indian vaccine against the pandemic strain of swine flu will be ready for use by March next with authorities planning to fast-track clinical trials in accordance with international protocols.
It has been proposed to combine the different phases of clinical trials from safety to immunogenicity in fast-track mode to make the vaccine available in March next as otherwise it would be ready only by the end of 2010, Vishwa Mohan Katoch, Director-General, Indian Council of Medical Research (ICMR) while speaking to The Hindu from New Delhi on Tuesday.
Three 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. The entire exercise of finalising the fast-track protocol would be completed in the next two or three weeks after the issue was examined by the committee for drugs and vaccines and another special committee on H1N1 influenza virus.
Dr.Katoch, however, said the decision on administering one or two doses would be taken after the completion of human trials. Novartis and Glaxo Smith Kline too had expressed interest in conducting short trials in India and the protocols for the same would be finalised soon. ?We are talking to them.?
Even as the doctors treating H1N1 influenza patients here observed that the virus had become more virulent, the ICMR chief maintained that he had no such report. If Tamiflu was administered in time, the recovery would be complete, he said pointing out that even a 72-year-old person recovered. There was need to create awareness of this among people and even the medical fraternity.
According to Krishna Ella, chairman and managing director Bharat Biotech, which, along with two other firms will produce the WHO strain of the vaccine, 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 fast-track mode, he said it was planned to produce initially five million to six million doses. The production would be scaled up depending on the requirement.
http://www.hindu.com/2009/09/16/stories/2009091652071200.htm
Ro's notes: India's current population: 1.2 billion.