Shantha Biotechnics, an affiliate of Sanofi Pasteur, has received approval from the World Health Organisation (WHO) for Shanchol, its oral cholera vaccine. The approval is for use at temperatures as high as 40°C for up to 14 days, immediately prior to administration, among others.
The approval is of significance to regions where the vaccine is used, including India, as it eliminates the challenges of maintaining the vaccine cold chain (between plus 2°C and plus 8°C to maintain vaccine potency) during transport..
“The WHO’s approval will help us make Shanchol available to populations living in remote, hard-to-reach areas of India and other parts of the world, especially ones with erratic electricity supply,” Mahesh Bhalgat, Executive Director and Chief Operating Officer, Shantha Biotechnics said in a release issued here on Monday. The WHO approval for use of Shanchol in controlled temperature chain (CTC) was granted after a review of its stability data.
Used for prevention and control of cholera in outbreak, endemic settings during humanitarian crises, Shanchol cholera vaccine is the second mass campaign vaccine and first cholera vaccine worldwide to receive such a stamp of approval for storage and distribution outside the traditional cold chain, the release said.
Since WHO pre-qualification in 2011, 12 million doses of Shanchol vaccine have been shipped to 25 countries across the world, including Democratic Republic of the Congo, Haiti, Mozambique and South Sudan.
