WHO Prequalifies Sanofi's Pediatric Pentavalent Vaccine Shan5
By Cyndi Root
Sanofi Pasteur announced in a press release that the World Health Organization (WHO) has prequalified its pediatric pentavalent vaccine Shan5. Developed and manufactured by Sanofi subsidiary, Shantha Biotechnics, the vaccine is the first jointly developed with the Indian company based in Hyderabad. WHO tentatively approved the vaccine based on a favorable review of the product and an on-site inspection of Shantha’s manufacturing site. A WHO stamp of approval allows United Nation agencies like UNICEF to purchase the vaccine for children in 50 emerging and low-income countries.
Olivier Charmeil, Sanofi Pasteur President and CEO 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.”
Shan5 Vaccine
Shan5 is a vaccine for children ages 6 months to five years old. It protects against five diseases: diphtheria, tetanus, pertussis, Hib, and hepatitis B. The vaccine is a liquid preparation, a pentavalent vaccine containing diphtheria and tetanus toxoids, whole cell pertussis, recombinant DNA derived hepatitis B surface antigen, and components of Hemophilus influenza type b (Hib).
WHO Actions
In 2010, WHO withdrew Shan5’s prequalification status because of complaints about white sediment sticking to glass vials. The particulates would not re-suspend even after shaking vigorously. WHO initiated site inspections, asked for expert reviews, and conducted independent testing. On April 26, 2010, WHO recalled the vaccine and recommended destruction of all lots of Shan5.
In its press release regarding the WHO approval, Shantha acknowledges the four-year ban on its vaccine. Shantha Chairman K.I. Varaprasad Reddy said that the lost sales in that time period amounted to 1,500 crore. He added that the WHO disqualification occurred even though there were no adverse reactions to the vaccine.
Acquired by Sanofi in 2009, the Shantha Shan5 ban took place just after the acquisition. Sanofi responded by investing about $180 million to address the issues that WHO identified in the ban. The investment was worth it to the two companies, as the world needs over 200 million doses according to Shantha, worth about $92 million yearly.