Shantha’s Pentavalent Pediatric Vaccine Prequalified by World Health Organization

Sanofi Pasteur, the vaccines division of Sanofi has announced that its pediatric pentavalent vaccine Shan5, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, has received prequalification status from the World Health Organization (WHO).

This status qualifies Shan5 vaccine for purchase by United Nations agencies, mainly UNICEF. Shan5 prequalification will give more children around the world access to the latest high-quality, fully-liquid, 5-in-1 vaccine and help secure the supply of pentavalent combination vaccines in more than 50 emerging and low-income countries. 

“Shan5 is the first product that puts together the best of Shantha and Sanofi Pasteur’s assets and talents,” said Olivier Charmeil, Sanofi Pasteur President and CEO. “Today, a significant number of babies born every year do not have access to modern vaccination programmes. By delivering large supplies of high-quality and affordable vaccines to emerging and low-income countries, Shantha will be contributing to filing this gap for the benefits of babies and their parents.”  

Shan5 is produced at Shantha’s state-of-the-art manufacturing facility in Hyderabad, and received Marketing Authorization in India in March 2014. 

“The development of Shan5 benefitted from Sanofi Pasteur’s more than 50 years of experience with whole-cell pertussis and combination vaccines — ensuring robust processes and guaranteeing international quality standards” said Harish Iyer, Shantha CEO at a media briefing in Hyderabad. “Shantha’s manufacturing platform in India will serve Indian needs and provide Sanofi Pasteur access to additional vaccine markets globally.”  

Dr Varaprasad Reddy, Founder of Shantha Biotechnics and Non-Executive Chairman of the board shared: “It is a very happy and momentous day for all of us at Shantha. My waiting period of 4 years has ended and we are very jubilant. I want to immensely thank all the scientists of Sanofi Pasteur and Shantha Biotechnics for their collective and cooperative work together, for achieving this goal of establishing Shan5. We move forward, committed and focused to our priority and passion which is to serve people through high quality, affordable vaccines.”