Nilanjana Ghosh Choudhury. Pune
City-based Serum Institute of India (SII) has been told to concentrate on the development of the H1N1 vaccine and put the development of H5N1 (avian flu) vaccine on the back burner by the World Health Organisation (WHO) and the Drugs Controller General of India (DCGI). "Both organisations have asked us to stop the development of the H5N1 vaccine for the time being and instead concentrate completely on the development of the new injectable H1N1 vaccine," said executive director Dr Suresh Jadhav.
"The vaccine sample is ready and we are going to begin animal trials by next month in Holland, after which the first phase of clinical trials would begin by November," Jadhav said, adding that the commercial production is likely to begin by March-April 2010.
Company officials claimed that if the plans fall in place, it would be the first time that a vaccine was developed within six months of receiving the virus strain.
The Pune institute received the H1N1 virus strain fom the UK-based National Institute for Biological Standards and Control (NIBSC) about three weeks ago.
Serum Institute along with the Hyderabad-based Bharat Biotech International Limited and Delhi-based Panacea Biotech Ltd were selected this April by WHO to develop the H1N1 vaccine.
"The vaccine for avian flu is also ready and it was about to go for clinical trials very soon, but now the clinical trials will take place after the H1N1 vaccine is developed," Jadhav said.
" We have been working for two-and-a-half years on developing the H5N1 vaccine. We developed the vaccine for the common flu, based on which we had got the contract for developing the avian flu vaccine in 2006," he said.
DNA had earlier reported that the SII had requested the DCGI and the Indian Council of Medical Research (ICMR) to reduce the administrative time lag involved in clearance of vaccines."DCGI had promised all cooperation to fast track the process," Jadhav said.
The vaccine is being manufactured as per the guidelines from WHO and the European Medicines Agency.