Paediatric pentavalent vaccine ‘Shan5’, developed and manufactured by Hyderabad-based Shantha Biotechnics, an affiliate of French pharmaceutical company Sanofi, has regained prequalification (PQ) status from the World Health Organisation (WHO).
This status qualifies the vaccine, which provides protection for children against diphtheria, tetanus, pertussis, Hib and hepatitis B, for purchase by United Nations agencies, governments and other organisations.
Shantha’s founder and non-executive chairman, KI Varaprasad Reddy, on Monday said the company had lost PQ status with WHO in 2010 “for a very trivial reason. Sedimentation had been the issue”. In three years prior to the withdrawal of PQ status, he said Shantha had supplied received orders to the tune of Rs 1,500 crore and supplied 18 million doses.
Nevertheless, he said, the loss of PQ status had made Shantha to come out with a better product. Sanofi, which acquired Shantha in 2009, had spent around Rs 1,000 crore on upgradation of the facility.
Shantha’s CEO, Harish Iyer, said Shan5 was the first vaccine developed by Shantha and Sanofi Pasteur, the vaccines division of Sanofi.
“We have also done the largest clinical trial” of the vaccine with 1,100 infants at 11 medical school study centres across India, he said, adding the company received marketing authorisation in the country in March, this year.