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Shantha Bio gets WHO nod for pentavalent vaccine
Shantha Bio Gets WHO Nod For Pentavalent Vaccine. City-based Shantha Biotechnics, now a part of Paris-based a Sanofi group, on Monday said Shan5, its paediatric pentavalent vaccine developed and manufactured in-house, received prequalification status from the World Health Organisation (WHO).
Eyes Rs 500 crore in revenues from the Shan5 vaccine in five years time
Shan is a fully-liquid, five-in- one vaccine that provides effective protection for children from 6 weeks of age against five diseases: diphtheria, tetanus, pertussis, Hib and hepatitis B. It has been developed and is produced by Shantha in Hyderabad
Hyderabad: City-based Shantha Biotechnics, now a part of Paris-based a Sanofi group, on Monday said Shan5, its paediatric pentavalent vaccine developed and manufactured in-house, received prequalification status from the World Health Organisation (WHO).
This approval qualifies Shan5 vaccine for purchase by United Nations agencies, mainly UNICEF and other multilateral agencies.
“Shan5 is a fully-liquid, five-in-one vaccine that provides effective protection for children from 6 weeks of age against five diseases: diphtheria, tetanus, pertussis, Hib and hepatitis B. It has been developed and is produced by Shantha in Hyderabad,” Harish Iyer, Managing Director and CEO, Shantha, told media here.
According to him, the company is expecting revenues of Rs 500 crore from the vaccine in five years time. “Over 200 million doses of such vaccine are required worldwide every year and we are hopeful of garnering significant chunk of the market. The Shan5 prequalification will give more children around the world access to the latest vaccine and help secure the supply of pentavalent combination vaccines in over 50 emerging and low-income countries," he explained.
The vaccine maker which was acquired by Sanofi in 2009 developed similar vaccine and sold 18 million doses between 2008 and 2010 after WHO pre-qualification. But the vaccine was subsequently withdrawn from the market due to some issues in the sedimentation of the vaccine. However, the company has better pentavalent vaccine in Shan5 which has received marketing authorization in India in March 2014.
“The development of Shan5 benefitted from Sanofi Pasteur’s more than 50 years of experience with combination vaccines, ensuring robust process and guaranteeing international quality standards,” said Iyer. Sanofi Pasteur is the vaccines division of Sanofi.
The Shantha Chief further said that Sanofi had invested over Rs 1,000 crore in Shantha and upgraded its facilities since the acquisition. “Now, Shantha’s manufacturing facilities in India will serve Indian needs and provide Sanofi access to additional vaccine markets globally,” he added.
Varaprasad Reddy, founder of Shantha Biotechnics and Non-Executive Chairman of the board expressed his delight over the Shan5 receiving WHO nod. “It is very happy and momentous day for all of us at Shantha. My waiting period of four years has ended and we very jubilant,” he said. We are committed and focused to our priority and passion which is to serve people through high quality and affordable vaccines, he added.
Besides Shan5, Shantha has three WHO-prequalified vaccines in its portfolio. They include Shanchol cholera vaccine, Shanvac-B for hepatitis B and ShanTT tetanus vaccine. Now, Sanofi Pasteur and Shantha are also developing a new vaccine against rotavirus, and also a pediatric combination vaccine based on Shan5 that will incorporate Inactivated Polio Vaccine (IPV) for securing polio eradication.
