WHO prequalifies new cholera vaccine

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A new oral vaccine for cholera, Euvichol-S, has been prequalified by the World Health Organisation.

This was according to a press statement released by the WHO on Thursday, on its website.

 

The organisation said the prequalification occurred last Friday, April 12, 2024.

 

The goal of WHO vaccine prequalification is to ensure that vaccines used in immunisation programmes are safe and effective. In prequalifying vaccines, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe and effective.

WHO also ensures the continued safety and efficacy of prequalified vaccines through regular re-evaluation, site inspection, targeted testing, and investigation of any product complaints or adverse events following immunisation.

 

National regulatory agencies and national control laboratories play a vital role in WHO vaccine prequalification since they are responsible for regulatory oversight, testing, and release of WHO-prequalified vaccines.

 

The UN agency noted that the inactivated oral vaccine Euvichol-S has a similar efficacy to existing vaccines but a simplified formulation, allowing opportunities to rapidly increase production capacity.

The development of Euvichol-S is a collaboration between EuBiologics, the International Vaccine Institute, and the Bill and Melinda Gates Foundation.

 

“The new vaccine is the third product of the same family of vaccines we have for cholera in our WHO prequalification list,” said the Director of the WHO Department for Regulation and Prequalification, Dr Rogerio Gaspar. “The new prequalification is hoped to enable a rapid increase in production and supply which many communities battling with cholera outbreaks urgently need.”

 

In Nigeria, cholera is an endemic and seasonal disease, occurring annually mostly during the rainy season and more often in areas with poor sanitation.

There were 473,000 cholera cases reported to WHO in 2022 – double the number from 2021. A further increase of cases by 700,000 was estimated for 2023. Currently, 23 countries are reporting cholera outbreaks with the most severe impacts seen in Comoros, the Democratic Republic of the Congo, Ethiopia, Mozambique, Somalia, Zambia, and Zimbabwe.

 

“WHO prequalification 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.

Vaccines provide the fastest intervention to prevent, limit, and control cholera outbreaks but supplies have been at the lowest point amidst countries facing dire shortcomings in other areas of cholera prevention and management such as safe water, hygiene and sanitation,” the global health body noted.

Meanwhile, Gavi, the Vaccine Alliance, and the United Nations Children’s Fund welcome the news of the new vaccine.

A joint statement by the organisations noted that the prequalification of the new product will help EuBiologics, the manufacturer, produce more volumes of vaccine, faster, and at a lower cost – a key step to expanding supply amidst the ongoing acute global upsurge of cholera outbreaks.

 

“Today’s approval will help increase the overall supply of OCV available in 2024, with approximately 50 million doses now forecasted to be available to the global stockpile this year, compared to 38 million in 2023.

Euvichol-S is an important product innovation: a simplified formulation of Euvichol-Plus that reduces the number of vaccine components – delivering a vaccine that studies have shown remains equally effective against key cholera serogroups while lowering production cost and complexity – thus allowing for larger volumes to be produced faster,” the statement read in part.

 

Most recently, Gavi, UNICEF, and partners announced the largest-ever global deployment of cholera diagnostic tests to support surveillance and response.

 

WHO said more than 1.2 million diagnostic tests will be distributed to 14 high-risk countries over the coming months.

Prequalification of Euvichol-S represents a lifeline for vulnerable communities around the world,” said the Managing Director of Vaccine Markets & Health Security at Gavi, Dr Derrick Sim. “Every vaccine dose delivered through Gavi programmes today represents years of planning and investment to shape the market so supply matches countries’ needs.

 

“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.”

The statement added that EuBiologics is currently the only supplier of OCV to the global stockpile, although other manufacturers are expected to have products available in the coming years.

 

“Gavi, the Vaccine Alliance works to shape the OCV market, and funds the global stockpile of OCV doses, along with transport and vaccination activities in lower-income countries.

 

“UNICEF leads on procurement and delivery of doses to countries. Use of the stockpile for emergency response is overseen by the International Coordinating Group for Vaccine Provision, led by WHO,” it added.

The Director of UNICEF Supply Division, Leila Pakkala said, “Despite cholera being preventable and easily treatable, children continue to suffer from this potentially fatal disease. 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.

 

“The approval means that UNICEF can increase the procurement and delivery of cholera vaccines by more than 25 per cent, pushing back harder on deadly cholera outbreaks.”

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