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.
The SSI was part of an international teleconference held by the Director-General of the World Health Organisation Margaret Chan to discuss developing a preventive swine flu vaccine hours after the disease was declared a global pandemic.