Sanofi Pasteur, the vaccines division of Sanofi, announced that its paediatric pentavalent vaccine Shan5, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India, has received prequalification status from the World Health Organization (WHO). This status is based on a review of a comprehensive set of data related to the process and the product characteristics, as well as on a positive recommendation of WHO's auditors following a site inspection of Shantha's manufacturing facilities. It 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 over 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 chief executive officer, "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 filling this gap for the benefits of babies and their parents."
Shan5 is produced at Shantha's state-of-the-art manufacturing facility in Hyderabad, India, and received marketing authorisation 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 chief executive officer, Shantha's manufacturing platform in India will serve Indian needs and provide Sanofi Pasteur access to additional vaccine markets globally."