Sanofi ($SNY) subsidiary Shantha Biotech plans to relaunch the company's pentavalent Shan5 vaccine in 2013. The vaccine was removed from the World Health Organization's prequalification list for 2012 after white sediment was discovered in some vials. No adverse effects were linked to the manufacturing snafu. Since then the Indian division has been working to implement corrective measures at its manufacturing facility, noted Sanofi CEO Chris Viehbacher.
A Central Drugs Standard Control Organization official told India's Business Standard that the facility was originally slated for inspection in early 2012, but that Sanofi wanted to conduct more vaccine stability studies. "The company undertook extended studies on the vaccine, though Shan5 is absolutely ready for relaunch, only because the Sanofi management was very particular about its global reputation. Since we began the process of trials from the start as if it's a new vaccine, it may be out in the market only in 2013," the official told the Business Standard.
The loss of WHO prequalification also cost Sanofi a three-year, $340 million contract for the vaccine, which protects against diphtheria, pertussis, tetanus, influenza B and hepatitis B. Shantha's manufacturing problem predated Sanofi's buyout of the vaccine company, notes FiercePharmaManufacturing.
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