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| Pune-based institute in race to develop vaccine |
| P B Jayakumar / Mumbai Aug 11, 2009, 01:01 IST |
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The Serum Institute of India (SIIL) may figure among the first of the global drug companies to develop a vaccine for swine flu. Scientists at the Pune-based company are gearing up for animal trials by next month in order to commercialise the vaccine before the end of next year.
SIIL successfully developed small quantities of the vaccine, required for animal trials, within three weeks of receiving the sample strains from the World Health Organization (WHO). The company is currently developing a seed bank and a standardisation process to proceed to the animal trial stage. If successful, the vaccine-specialised drug maker will invest over Rs 80 crore to set up manufacturing facilities for the vaccine, SIIL Executive Director Dr Suresh Jadhav told Business Standard.
“If the animal trials are successful, we hope the human clinical trial stage can begin by November. Then the vaccine can be given a fast-track status by the Drug Controller General of India (DCGI) to help the country develop and commercialise an India-made vaccine by as early as the end of next year,” he said.
He pointed out that the SIIL vaccine would be at least 100 per cent cheaper than other vaccines developed by multinational companies for the H1N1 influenza virus.
The World Health Organization (WHO) — in association with over 100 companies and research institutions globally — is trying to develop a vaccine for the pandemic flu virus, which has affected over 162,000 people in different parts of the world and is fast spreading in India, too. Multinational companies such as Novartis are working on launching the first vaccine within a few months. In India, biotech companies Panacea Biotech and Bharat Biotech are also trying to develop the vaccine.
Sources said various countries have developed specific regulatory procedures to expedite the approval of pandemic vaccines. In the USA, for example, less data are required when the manufacturer already has a licenced influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.
In the European Union, the European Medicines Agency uses a rolling review procedure, whereby manufacturers can sendt sets of data for regulatory review as they become available, without having to wait until all data can be put together in a single formal application.
SIIL is already working on developing a vaccine for the H5N1 (bird flu) strain of virus with WHO assi*stance and has developed a seasonal flu vaccine, which is now in the clinical trial stage.
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