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Serum - Protection from birth onwards

Wednesday, August 5, 2009

Serum Institute to speed up vaccine production

DNA. Pune

Serum Institute of India (SII) in Pune is looking forward to an early date for producing a H1N1 vaccine.

In April, the company had announced that it had got the World Health Organisation contract to develop and manufacture the vaccine. The company is in talks with both the Drugs Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) to bring down the administrative time lag.

"We cannot compromise on the scientific process but we are talking to both the DCGI and ICMR so that the delay regarding the administrative process can be reduced and the mass production of vaccine can begin at an earlier date," Dr Rajeev Dhere, the director of the vaccine production unit at SII, said.

It was in April this year that WHO selected SII, along with Bharat Biotech International Limited in Hyderabad and Panacea Biotech Ltd in New Delhi, to develop the H1N1 vaccine. The Pune institute had received the H1N1 virus strain from UK-based National Institute for Biological Standards and Control.

Officials at SII said the strain arrived about three weeks ago. "The vaccine has to go through the regular testing process but DCGI had promised us that they will do their best to fast track the process following guidelines of WHO and European Medicines Agency," Dr Suresh Jadhav, the executive director of SII, said.

The company has zeroed in on three laboratories outside India where animal trials on ferrets would commence around September-October. "In all probability, we are sending the samples for testing at a lab in Holland," Jadhav said.

SII is working on influenza A H1N1 strain to prepare an injectible vaccine for H1N1.