Indigenous swine flu vaccine?s human trials begin

[Ronan Kelly]

Indigenous swine flu vaccine?s human trials begin


Siddhesh Inamdar

PUNE: After getting a clearance from the Drugs Controller-General of India (DCGI), the Pune-based Serum Institute of India (SSI) on Thursday started human clinical trials of the swine flu vaccine that it developed.

Additional Medical Director of the institute Prasad Kulkarni told The Hindu, ?Phase one of the human clinical trials of the vaccine will be conducted by a designated CRO [Clinical Research Organisation ] in Ahmedabad. We cannot disclose the name of the CRO. The trials will be conducted on 50 healthy adult volunteers. Phase one will check for the safety of the vaccine.?

Dr. Kulkarni added that the SSI expected the early data of the human trials to be available by February. ?Once we have confidence in the safety of the vaccine, phase two would start. It would be conducted in multiple centres unlike phase one that is to be conducted in Ahmedabad alone. The data of phase two should be available by March-end or early April.?

The vaccine would then go for commercial production.

In India, the swine flu vaccine is being developed by Panacea Biotech Limited (New Delhi) and Bharat Pharmaceuticals (Mumbai) and the SSI in Pune.

Following the submission of the final toxicity and tolerance report of the vaccine trial conducted on animals, the SSI was granted permission by the DCGI to go ahead with the human trials.

http://www.hindu.com/2010/01/08/stories/2010010855641000.htm

 

[Pathfinder]

Re: Indigenous swine flu vaccine?s human trials begin

Indigenous H1N1 vaccine by March: Katoch

TNN, 8 January 2010, 01:10am IST

CHANDIGARH: H1N1?s indigenous vaccines are expected to hit the Indian market by March this year at half the price of the imported ones. Dr VM Katoch, director-general, Indian Council of Medical Research (ICMR) and secretary to the Government of India, department of health research, made an announcement on Thursday while interacting with the media.

Dr Katoch was in Chandigarh to inaugurate the new academic session of PGI. Dr Katoch informed that there were four pharmaceutical companies, including Zydus Cadila and Panacea Biotec, which are in advanced stage of research. He said Zydus Cadila had already completed human trials, while Panacea was conducting animal trials.

`We are 15-days ahead of the schedule and will introduce the vaccine as early as possible,?? said Katoch adding that government of India is negotiating on vaccine prices keeping in view community need.

The prices of indigenous vaccines would be in range of Rs 50-100, in contrast with imported ones which cost Rs 300-400. The imported vaccine will be made available for public health workers by the January-end, said Dr Katoch. He informed that the government was trying to make regulatory clearance for research easier for pharma companies so that they do not have to run from pillar to post.There is also a thrust to transform research into products and make it available to public.

http://timesofindia.indiatimes.com/...ccine-by-March-Katoch/articleshow/5421716.cms