Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics, located in Hyderabad, has delivered the first 400,000 doses of its paediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur in the state of Madhya Pradesh.
Shan5 is a fully-liquid five-in-one, convenient, safe and high-quality vaccine that provides effective protection for children from 6 weeks of age against five diseases: diphtheria, tetanus, pertussis, Hib and hepatitis B (DTP - HepB - Hib). Shan5 vaccine has been developed and is produced at Shantha's state-of-the-art manufacturing facility in Hyderabad, and received marketing authorization in India in March 2014.
In April 2014, Shan5 was prequalified by 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.
In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37 million doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, depending on country needs.
The Shan5 vaccine will be used in the routine immunization programs of a number of Gavi-supported countries, enabling up to ten million children to receive protection from five pediatric diseases. "This supply illustrates how Shantha and Sanofi Pasteur meet public health needs", said president and CEO Olivier Charmeil, Sanofi Pasteur. "We are proud to contribute to making high-quality vaccines accessible to more children in developing countries."
"We are pleased to have obtained this first tender award since Shan5 was registered and WHO-prequalified in April 2014", said Dr Harish Iyer, CEO, Shantha. "As one of the strategic manufacturing platforms for Sanofi Pasteur, Shantha is delivering on its commitment to serve Indian health needs and provide access in under-served vaccine markets."
Shantha, which was acquired by Sanofi Pasteur Holding in 2009, is a biotechnology pioneer from the emerging countries, founded by Dr K I Varaprasad Reddy in 1993 in Hyderabad, India. Shantha is a fully integrated biotechnology company involved in R&D, manufacturing and marketing. Shantha's products complement Sanofi Pasteur's portfolio. Besides Shan5, three of its vaccines are WHO-prequalified: Shanchol cholera vaccine, Shanvac-B hepatitis B vaccine and ShanTT tetanus vaccine.
Sanofi Pasteur and Shantha are also developing a new vaccine against rotavirus and a pediatric combination vaccine based on Shan5, which will incorporate Sanofi Pasteur's Inactivated Polio Vaccine (IPV) in order to secure polio eradication.