Shantha Biotech, an arm of the global pharma major Sanofi Aventis, is hopeful of launching its flagship pentavalent vaccine, Shan 5, by the end of 2013. The vaccine, which the company expected big returns from, was suspended by the World Health Organisation in July 2010 over quality issues at its manufacturing process.

“We are trying to recover the losses that were incurred earlier and are in constant touch with the WHO. There have been quality control interventions at various levels and we will come back with Shan 5 vaccine by the end of next year. Indeed, globally we hope to produce over one billion doses of antigens in the next three years, be it combination or standalone,” said Harish Iyer, chief executive officer of Shatha Biotech.

Shan5 is the company’s pentavalent vaccine for five diseases including Diphtheria, Tetanus, Haemophilus Influenza B, Hepatitis B and Pertussis in children The hexavalent vaccine Shan 6 aims to curb Diphteris in addition to the five diseases. “Shan5 will continue to be a pentavalent vaccine and we are looking at pathways to bring hexavalent and rotavirus vaccine along with the possibility of bringing measles vaccines in India,” he said.

The current production capacity of pentavalent vaccine stands at 500 million units per year. It is undergoing Phase I clinical trials at present. “We are not able to utilise the complete manufacturing capacity due to the suspension. This was something hard to predict then and we have done the root cause analysis, which shows that the quality issue was because of one component pertussis. The company is, however, upgrading the unutilised equipment which will be used later for Shan5 and Shan6,” he explained.

Meanwhile, the rotavirus vaccine of Shantha, which may come out by 2015, has completed one set of clinical trials and is moving to the next stage.

Talking about how the vaccine industry is increasingly becoming a level playing field, Iyer said: “Fundamentally, it is a very complex business and making a vaccine is different from making an aspirin. What the WHO is expecting today of manufacturers, they may not have expected four years ago.”

French pharma Sanofi, which had acquired Shantha around three years ago, had earlier announced that it would invest around $ 300 million in the coming few years to augment the manufacturing capacity of Shantha.