Shan5, a paediatric pentavalent vaccine by Shantha Biotechnics Pvt Ltd, an arm of Sanofi Pasteur, has received prequalification status from the WHO.

This is a five-in-one vaccine to provide protection to children from diphtheria, tetanus, pertussis, Hib and hepatitis B.

While announcing the status, Harish Iyer, Managing Director and CEO of Shantha said on Monday that Shan5 is the first vaccine jointly developed by Shantha and its parent Sanofi.

WHO’s prequalification status allows to company to bid for its supply orders, besides making it eligible for some funding from the UN’s recognised agencies.

An earlier version developed by the Hyderabad-based company was recognised by WHO and the company sold 18 million doses between 2008 and 2010. But WHO withdrew it due to some issues in the sedimentation of the vaccine.

“This was a set back which gave us strength. With the acquisition of 98 per cent of Shantha’s stake by Sanofi in 2009, we collaborated to bring out the product again,’’ said founder and non-executive chairman of Shantha Varaprasada Reddy.

Redeveloped During the last four years, the product was redeveloped and was approved by the Drug Controller General of India in March this year.

According to Iyer, Sanofi had invested ₹1,000 crore in expanding the production and human resource base in the company since its acquisition. “Shan5 is now being produced in our manufacturing facility here. We will be participating in the global tenders to supply it to the WHO and other associated agencies,’’ he said. The price of the vaccine and expected volumes of sales were not disclosed.

The global demand for the vaccine is 200 million doses.

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