Shantha gets WHO nod for pentavalent vaccine

Hyderabad: After four years of WHO ban, Shantha Biotechnics, a Hyderabad-based arm of French vaccine maker Sanofi Pasteur, would resume its supply of pediatric pentavalent vaccine Shan5 to World Health Organisation (WHO) programme across the world.

Speaking to reporters on Monday, Harish Iyer, chief executive officer of Shantha Biotechnics, said that a WHO pre-qualification would allow the company to supply its vaccine, which could worth Rs 500 crore in terms of annual sales.

The pentavalent vaccine protects children against five diseases namely diphtheria, tetanus, pertussis, Hib, and hepatitis B.

According to Shantha’s non-executive chairman K.I. Varaprasad Reddy, Sanofi has invested close to 125 million euros or nearly Rs 1,000 crore in the company to address the issues highlighted by the WHO.

The global demand for pentavalent vaccine is pegged at 200 million doses a year, which is funded by governments and several multinational agencies. With disclosing Shantha’s manufacturing capacity, Mr Iyer expects to meet a significant amount of the global demand.

Mr Iyer said that the vaccine underwent rigours testing over 1,100 infants across the country. Following this, he said Shantha got approval from Drug Controller General of India (DCGI) in March and WHO in April.

Shantha had sold 18 million doses of its earlier version of the vaccine between 2008 and 2010. However, it was later withdrawn due to some issues in the sedimentation of the vaccine.

“Though there were no adverse reactions of the earlier vaccine, WHO had disqualified us. This led to a loss of sales of Rs 1,500 crore over three years,” Mr Reddy said.