In a major step towards enabling companies to manufacture low cost drugs for less developed countries, the Seoul based International Vaccine Institute (IVI) is going to provide inactivated oral cholera vaccine technology. It is believed that the proposed vaccine will be less costly compared to other vaccines available in the market.
Accroding to Dr Rodney Carbis, head, vaccine development, International Vaccine Institute, Seoul National University, the results of phase II clinical trials of cholera vaccine conducted in India and Vietnam have shown that the more assessment of antigen resulted in a more immunogenic product and has been a successful operation. The phase II clinical trails is also funded by the Gates Foundation.
The institute would provide the technology to the Hyderabad based Shanta Biotechnics Limited for cholera vaccine. It will also provide Vi typhoid vaccine to Bharat Biotech for developing typhoid vaccine. A second generation Vi conjugate typhoid vaccine is also developed at IVI and the preliminary results have shown that the conjugate vaccine is considerably more immunogenic that the VI capsular polysaccharide vaccine.
He said, that probably within next 2-3 years the vaccine will be out in the market as phase III trails of cholera vaccine has already begun in India. The Gates Foundation is also providing the funding. The estimated figure as such is not available.
Before the transfer of technology several quality control examinations would be developed to assess antigen content and contamination. Minor improvements to the manufacturing process would also be implemented so that the vaccine will compile with the WHO requirements. We will also try to lobby the WHO to include the vaccine in its pre qualification list in near future, he said.
The vaccine will be produced to address the large scales requirement in countries where the public health requirement is more. It will be licensed in India and Indonesia. The clinical trials are being conducted in association the National Institute of Cholera and Enteric Diseases in Kolkata, he added.
He further said, that one of the critical functions of IVI is to make vaccine technologies available to manufacturer in developing countries. The large numbers of multinational pharmaceutical companies do not have the capacity to meet the world demand for the vaccine particularly against diseases that primarily occur in less developed countries. Not only this, because of the business model it is difficult for these companies to provide vaccines at affordable cost which can be used in public health system in less developed countries. This tie-up is aimed to ensure the supply of affordable vaccine for protection against infectious diseases.
It has been found that cholera is a major cause for death due to rapid dehydration. Unfortunately the rate of diseases is high in less developed countries, which do not have enough vaccines as well as public healthcare spending.