Indian efforts to develop the H1N1 vaccine are well on the course and the three Indian companies involved in the task are set to begin the clinical trials by January and hoping to roll out the final products by May-June 2010, if all goes well.
Serum Institute of India Ltd, Pune, is trying to manufacture the vaccine by growing seed virus in the eggs which is a conventional and an established technology. This company already has experience of having used this technology for avian influenza and has moved ahead as per the report submitted by the company. They have already grown the vaccine strain and immunogenicity studies have been completed. Data is being analysed. They have informed that they will be ready for human trials in December, 2009 and vaccines should be ready by May 2010 for human use, according to the sources with the Department of Research.
Panacea Biotech had initially contemplated producing a cell based vaccine but now have moved to well-established egg based technology because of better success in the latter method. Immunogenicity studies in mice have been completed, and data is being analysed. The pre-clinical testing in animals will be completed by December and they are planning to begin the clinical trials in January 2010. It is expected to be over by the end of March and vaccine will be available by April, sources said.
Bharat Biotech, Hyderabad, is working to produce the cell-based vaccine and has informed that they will complete the animal tests by the end of December. Animal immunogenicity studies are going on. They plan to start the clinical trials in January, 2010 which may be completed by March, 2010. The company has informed that the vaccine should be available for commercial use in April, 2010.
Sources said the ICMR has been monitoring the efforts regarding the technical aspects of manufacture of H1N1 vaccines. The government has already started discussions with the foreign companies anticipating that they would be releasing the vaccines earlier than the Indian companies.
Cadila Pharmaceutical India Ltd has also proposed production of an H1N1 vaccine using the virus like particles (VLP) technology in technical collaboration with a US based company Novavax, in which Cadila has a majority share. The technology has been licensed to Cadila in India and it will set up a plant to manufacture the vaccine in India. It has been already assessed and approved by the Review Committee for genetically and Engineered Modified Organisms (RCGEM) of DBT. The merits of this technology are to be debated by a high-powered committee, sources said.
Biological E Ltd, Hyderabad, has proposed production of an H1N1 vaccine using toll like receptors (TLR) technology platform in technical collaboration with Vaccinate (a US based biotech company). The technology is being transferred to Biological E and the vaccine would be manufactured at Hyderabad. Approval of the RCGEM is being sought, sources said.