WHO approves cholera vaccine for use at temperatures high as 40 degree Celsius for up to 14 days

Sanofi Pasteur announced that its affiliate Shantha Biotechnics has received approval from the World Health Organisation (WHO) for Shanchol, its oral cholera vaccine. The vaccine may be kept for single period of time of up to 14 days at temperature of up to 40°C immediately prior to administration, provided the vaccine has not reached its expiry date and vaccine vial monitor has not reached discard point. The approval is of great significance to regions where the vaccine is used, including India, as it eliminates the challenges of maintaining the vaccine cold chain (between +2°C and +8°C to maintain vaccine potency) during transport.

Commenting on this development, Dr Mahesh Bhalgat, Executive Director and Chief Operating Officer, Shantha Biotechnics, said, "This is a significant milestone in our efforts towards effective cholera prevention and control. 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."

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, Shantha Biotechnics’ 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.

"Cholera is an easily preventable disease that has no place in the 21st Century," said Anuradha Gupta, Deputy CEO of Gavi, the Vaccine Alliance. "This important development will make it easier to deliver vaccines to the remote areas where it is desperately needed, saving lives and contributing to the global effort to finally consign this disease to the history books."

Responding to the WHO’s approval, N Rajaram, Managing Director, Sanofi India, said, "The storage label change takes us a few steps closer to our vision of a world where no lives are lost to preventable infectious diseases, as it has the potential to significantly change cholera control efforts for the better, not only in India but also in other parts of the world where the vaccine is needed the most. It is indeed a great news as it will help increase vaccine access and decrease the cost of conducting vaccination campaigns worldwide."

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