Even as the country is sitting on the edge with onset of life-threatening swine-flu pandemic, the Indian Council for Medical Research (ICMR) has taken the initiative to fast-track the indigenous production of the H1N1 vaccine in the country. In this regard, the ICMR is presently identifying the prospective investigators to undertake phase-I and/or phase-II trials of the vaccine which is being developed by three Indian biotech companies.
The indigenous development of the swine flu vaccine is being done on the directive of the World Health Organisation (WHO) after the disease was declared a global pandemic by the WHO.
Presently, the indigenous development of the swine flu vaccine is in full swing in the country. So far, the government has granted licences for the H1N1 vaccine to three companies, Serum Institute of India, Panacea Biotec and Bharat Biotech and the preventive vaccine against the H1N1 flu is expected to be ready for clinical trials in humans by December.
As India has also joined the international community's effort to make a vaccine for the H1N1 pandemic that has affected 135 countries in the world, it has to identify labs to conduct the human trials as early as possible. The government is not restricting its search for labs to government sector alone. It is an open call for all including the private sector to join the government effort to fast track the indigenous development of the swine flu vaccine in the country, a senior ICMR official said.
"In pursuance of the central government's resolve to have indigenous vaccine for currently circulating pandemic flu strain, the H1N1, the Council has received action plans for killed inactivated (grown in egg and or in cell culture), live attenuated (cold-adapted) and vaccine developed from virus like particles. Some of these vaccines are likely to be available for human trials by November/December 2009," the ICMR official said.
The ICMR has invited letters of intent from prospective investigators to undertake phase-I and/or phase-II (based on recommendations of Drugs Controller General of India). The letter of intent should include a brief description of interest, experience, expertise, infrastructure available for conducting phase-I/II multi-centre clinical trials (preferable for viral vaccines) to evaluate safety, immunogenicity and tolerability of candidate vaccine(s).