Shantha Biotech, a subsidiary of global pharmaceutical giant Sanofi Aventis, is initiating fresh clinical trials on its combination vaccine Shan5, to regain the World Health Organization’s (WHO’s) recognition over the product soon.
Shan5, a combination vaccine that protects against five diseases — Diphtheria, Pertussis, Tetanus, Haemophilus influenzae type B and Hepatitis B — was a major revenue earner for the company until WHO withdrew the pre-qualification it had given to Shan5 in July 2010. This decision was driven by the abnormal visual appearance of the product.
Although none of the information gathered by WHO and Unicef (United Nations Children's Fund) suggests a safety problem or adverse events following immunisation with the vaccine, the company has decided to go for clinical trials before it applies for a fresh pre-qualification, it is learnt.
Shantha hopes to clear the clinical trials and be ready to participate in the Unicef vaccine-procurement bid process for 2013-15 supplies, according to company officials.
“Shantha is committed to have Shan5 prequalified again by the WHO. We intend to participate in the UNICEF bidding process for Shan5 which opens in 2012 for the 2013-2015 period and are working on the submission to the Drug Controller General of India (DCGI). Accordingly, we will conduct the required clinical trials to meet with current WHO expectations for vaccine pre-qualification approvals” Shantha Biotech, Chief Executive Officer, Harish Iyer said.
The clinical trial is part of an action plan designed by Sanofi’s vaccine arm — Sanofi Pasteur — about two years ago to improve the robustness of the processes used by Shantha.
Sanofi had acquired majority stake in Shanta for Rs 3,783 crore two years ago.