Sanofi vaccines division Sanofi Pasteur announced that its pediatric pentavalent vaccine Shan5 has been awarded prequalification status by the World Health Organization (WHO). The 5-in-1 vaccine for children was developed and manufactured by Sanofi Pasteur affiliate Shantha Biotechnics in Hyderabad, India.
The status qualifies Shan5 for purchase by United Nations agencies and primarily UNICEF. This will help broaden access to the latest fully liquid, high quality pentavalent combination vaccines in more than 50 developing and low income countries. The prequalification status is based on positive opinion and recommendation of WHO auditors following a manufacturing site inspection, as well as study of a comprehensive data set.
Olivier Charmeil, Sanofi Pasteur President and CEO, said Shan5 is the first product from Shantha and Sanofi Pasteur’s collaboration. He said, “Today, a significant number of babies born every year do not have access to modern vaccination programs. 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.”
The vaccine provides protection for children from six weeks of age against five diseases. These are diphtheria, tetanus, pertussis, Hib, and hepatitis B. Shan5 joins the list of Sanofi Pasteur’s vaccines which have also received prequalification status from WHO: Shanchol vaccine for cholera, Shanvac-B vaccine for hepatitis B, and ShanTT vaccine for tetanus.
Harish Iyer, Shantha CEO, said the development of Shan5 leveraged Sanofi Pasteur’s expertise built on more than 50 years of experience with whole-cell pertussis and combination vaccines. Shantha is a pioneering biotechnology company acquired by Sanofi Pasteur in 2009. Sanofi Pasteur and Shantha are also working to develop a new vaccine against rotavirus as well as a pediatric combination based on Shan5 that will include inactivated polio vaccine.
The pentavalent Shan5 vaccine received marketing authorization in India in March this year.
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