Indian swine flu vaccine- take time

The clinical trials of vaccines against the pandemic strain of swine flu have started in Australia, China, Germany, the U.K. and the U.S., according to the World Health Organisation (WHO). Some of these vaccines could complete the process for regulatory approval and be ready for public use by next month.
India has hitherto not been producing flu vaccines. But now three leading manufacturers - Serum Institute of India in Pune, Bharat Biotech in Hyderabad and Panacea Biotec in Delhi - are seeking to make the swine flu vaccine within the country. But it looks like the indigenous vaccine will not be ready for several months more, and even subsequently it may be available only in limited quantities.
The Serum Institute of India was one of six manufacturers in developing countries chosen by the WHO for a programme to expand global pandemic vaccine production beyond a few wealthy countries that possess such capacity.
The company has received the seed strain and started making the swine flu vaccine, its executive director Suresh Jadhav told The Hindu. He also spoke about the long procedure that had to be completed to get the vaccine to the public. This included putting in place a production process that gave the best possible yield, scaling up of the process, quality-testing, pre-clinical tests for toxicity in animals and clinical trials in humans. Then regulatory approval had to be secured before the vaccine could be made commercially available. Phase-I clinical trials was likely to start in the first quarter of 2010.
The company currently had the capacity to produce only limited quantities of the vaccine, Dr. Jadhav said. Large-scale production would require the establishment of a new facility with appropriate levels of bio-safety. The Serum Institute would be able to make such an investment only if there was an assured demand for flu vaccines, he said.
Moreover, under the WHO scheme, the Serum Institute is committed to providing at least 10 per cent of its swine flu vaccine production for use in other countries, according to a report that has appeared in the latest issue of the Indian edition of the magazine Technology Review.
Bharat Biotech too has received the seed strain and begun the process of making a pandemic vaccine, said Krishna Ella, its chairman and managing director. Instead of the conventional eggbased method, the company intended to make the vaccine by growing the virus in cell culture. A vaccine that could be used for clinical trials was expected to be ready in fourfive months, Dr. Ella told this correspondent.
Bharat Biotech would be able to make only limited quantities of the vaccine. However, Dr. Ella said the Bangalore veterinary vaccine unit of Biovet, another company promoted by him, could be used. The veterinary vaccine production could be shut down if required, and the unit switched to large-scale production of the swine flu vaccine.
But "we need more encouragement from the government," he said. "If I produce the vaccine, who is going to buy?" There had to be either a purchase commitment from the government to buy the vaccine or grants to support the company in its efforts. International vaccine manufacturers were given such purchase commitments by governments, he said.
A spokesperson for Panacea Biotec said the company was not at present making any statement on its pandemic vaccine.