New Delhi: Sanofi Pasteur said its affiliate Shantha Biotechnics has received approval from the World Health Organization for storage of its oral cholera vaccine Shanchol at high temperatures, thus increasing its availability.
After the approval by the WHO, Shanchol may be kept for a single period of time at the temperature of up to 40C for up to 14 days immediately prior to administration.
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 during transport, Sanofi Pasteur said in a statement.
Shantha Biotechnics’ Executive Director and COO Mahesh Bhalgat said: “This is a significant milestone in our efforts towards effective cholera prevention and control.”
WHO’s approval will help 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, he added.
The WHO approval for use of Shanchol in controlled temperature chain was granted after a review of its stability data, the statement said.
“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,” said Anuradha Gupta, Deputy CEO of Gavi, the Vaccine Alliance.
Cholera is caused by a bacterium, Vibrio cholerae, which produces a toxin that affects the intestines.
“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,” Sanofi India MD N Rajaram said.