WHO pre-qualifies simplified version of oral cholera vaccine

The World Health Organisation (WHO) has pre-qualified Euvichol-S, a new oral vaccine for cholera.

WHO pre-qualification of medicines assesses the quality, safety and efficacy of medicinal products.

If the product is found to meet the specified requirements, and the associated manufacturing sites and contract research organisations are compliant with WHO standards, the product is added to the WHO list of pre-qualified medicinal products.

The vaccine received pre-qualification on April 12 and can now be made available to countries around the world.

Announcing the development in a statement, WHO said Euvichol-S has a similar efficacy to existing vaccines but a simplified formulation, allowing opportunities to rapidly increase production capacity.

The WHO pre-qualification list already includes Euvichol and Euvichol-Plus inactivated oral cholera vaccines produced by EuBiologicals Co., Ltd, Republic of South Korea, which also produces the new vaccine Euvichol-S.

Reacting to the development, Derrick Sim, managing director of vaccine markets & health security at Gavi, said the pre-qualification of Euvichol-S represents a lifeline for vulnerable communities around the world.

“Every vaccine dose delivered through Gavi programmes today represents years of planning and investment to shape the market so supply matches countries’ needs,” he said.

“The approval of this new product could not have come at a more important time given the acute upsurge of cholera outbreaks we are seeing worldwide.

“We commend EuBiologics for their role in ensuring countries around the world have access to cholera vaccine as part of their response toolkit.”

Leila Pakkala, United Nations Children’s Fund (UNICEF) director of supply division, said the approval means that UNICEF can increase the procurement and delivery of cholera vaccines by more than 25 percent and push back harder on deadly cholera outbreaks.

“Despite cholera being preventable and easily treatable, children continue to suffer from this potentially fatal disease,” she said.

“UNICEF has already secured access to all the available doses of the just-approved vaccine and will deliver these to the countries at the highest possible speed.”