Serum Institute of India (SII) is working at a furious pace on producing a H1N1 vaccine. SII is among the three labs selected by the WHO in India to develop the vaccine. So far, there has been no vaccine made of this kind anywhere worldwide and around 25-30 labs globally are working on developing this vaccine.

Serum Institute of India Ltd, the flagship company of the Poonawalla group is the world?s largest producer of Measles and DTP group of vaccines. The company?s range of products is used across 140 countries. It also makes bacterial vaccines, anti-cancer products, viral vaccines, recombinant and combination vaccines, and anti sera, plasma, and hormonal products.

?This is an emergency situation as the state government has invoked the Epidemic Act. Work is in progress on the master seed and the working seed and once these are characterised, the first pilot batch of vaccines should be ready in the next couple of weeks,? Suresh Jadhav, executive director, Serum Institute of India said.

A lot of significance is being attached to the production of the H1N1 vaccine in light of the first swine flu death recorded in Pune on Monday. Reeda Shaikh, a Class 9 student of St Anne?s High School in Pune, died at the hospital making her the country?s first swine flu fatality. Globally, the death toll in the swine flu pandemic passed the 1,000 mark since the outbreak was uncovered in April.

Maharashtra alone reported 159 cases until Tuesday of which Pune was worst hit with 109 cases including one death. Swine flu now reaches 168 countries and territories, the WHO said in its latest update on its website. Around 25-30 laboratories worldwide are working on the H1N1 vaccine. In India, WHO selected Serum Institute along with Bharat Biotech International Ltd in Hyderabad and Panacea Biotech Ltd in New Delhi, to develop the vaccine in April.

?We cannot compromise on the scientific process but the company is in talks with the Drugs Controller General of India (DCGI) and Indian Council of Medical Research (ICMR) to speed up the administrative process and overcome regulatory hurdles so that the mass production of vaccine can begin early,? Jadhav said. Alongside, the company is also working on making nasal drops for the H1N1 strain in anticipation of a possible large outbreak in the country.

?We received the strains from WHO three weeks ago. We are working on the master and working seed. Once this is ready and the first pilot batch is made, we will have to carry out animal toxicity studies before approaching DCGI for conducting the Phase 1 study,? Jadhav said. The first phase usually takes one or two months and this is followed by the second phase of study. DCGI has promised us that they will do their best to fast track the process following guidelines of WHO, US FDA and European Medicines Agency, he said.

Animal trials on ferrets would commence around September-October and these are likely to be conducted in a Holland-based lab, he said. Final testing would be done in the UK-based National Institute for Biological Standards and Control (NIBSC) and the lab corroborates the results of Serum Institute. The vaccine will then be ready for human testing and can be produced on a mass basis after this, he explained.

Serum Institute of India is bringing in technology from another country to make nasal drops. WHO enabled this tie-up, Jadhav said. The nasal drops could come in useful if there is a large outbreak and many would have to be immunised. Panacea Biotech also working on the H1N1 vaccine is learnt to be working on a common protein kind of vaccine that could

offer immunity to all kinds of influenza.