Exclusive: halt to production of Shanchol vaccine alarms WHO amid ‘unprecedented’ global outbreaks
The manufacturer of one of only two cholera vaccines for use in humanitarian emergencies is to halt production at the end of this year, just as the world faces an “unprecedented” series of deadly outbreaks, the Guardian has learned.
Shantha Biotechnics, a wholly owned Indian subsidiary of the French pharmaceutical company Sanofi, will stop production of its Shanchol vaccine within months and cease supply by the end of 2023, causing alarm among health officials.
Philippe Barboza, the World Health Organization’s team lead for cholera, said Shantha’s move to halt production had come despite repeated appeals from the WHO’s director general, Dr Tedros Adhanom Ghebreyesus.
“To say the least, it’s a very disappointing strategy,” Barboza said.
Shanchol is one of only two oral cholera vaccines suitable for use in a global emergency stockpile used to supply countries battling outbreaks as well as for preventive vaccination campaigns. This year it made up about 15% of the stockpile’s doses.
Although easily treatable, cholera is estimated by the WHO to kill up to 143,000 people annually in the world’s poorest countries, where access to clean water and basic sanitation remains patchy. Countries including Haiti, Syria, Lebanon, Nigeria, Malawi and Ethiopia are fighting outbreaks now.
A spokesperson for Sanofi said the decision to stop producing the vaccine had been taken in October 2020 and that, as “a responsible partner”, it had “informed global health organisations and cholera stakeholders three years before supply discontinuation”.
The spokesperson said: “We took this decision in a context where we were already producing very small volumes versus the total demand for cholera vaccines and in the knowledge that other cholera vaccine manufacturers (current and new entrants) had already announced an increased supply capacity in the years to come.
“The production of Shanchol will stop at the end of this year. Supply will be discontinued next year. Additionally, in the interests of the global cholera programme we entered into an agreement with our public health partners to complete a transfer of knowledge related to the manufacture of Shanchol.”
Last week Tedros warned that the climate crisis had “turbocharged” the spread of cholera, with extreme weather events such as floods, cyclones and droughts further reducing people’s access to clean water.
Of particular concern, he said, was the average fatality rate from the disease, which this year, according to the WHO’s data, was almost three times the rate of the past five years.
“With an increasing number of outbreaks, supply [of vaccine] cannot keep up with demand,” Tedros warned. “We urge the world’s leading vaccine manufacturers to talk to us about how we can increase production.”
For a disease driven both by an excess and a scarcity of water, climate change had this year exacerbated all the usual causes of cholera, Barboza added. “What is, I would say, unprecedented is the concurrence and succession of massive outbreaks in different parts of the world,” he said.
The increased fatality rate was also “extremely concerning”, he added, particularly as cholera was relatively simple to treat with oral or intravenous hydration and antibiotics.
“In 2022, people should not die of cholera,” Barboza said. “You don’t need a respirator or anything very complicated, but people are dying just because they don’t have access to healthcare. And this is not acceptable.”
While two doses of the oral cholera vaccine only give immunity for around three years in adults, they have come to be seen by health officials as an important tool. Although the long-term solution to cholera remains ensuring access to clean water and good sanitation, “the vaccine is the gamechanger because it allows countries to buy time to implement the rest,” Barboza said.
He is urging other manufacturers to step forward to help boost supply. EuBiologics, the South Korean makers of the other oral cholera vaccine, Euvichol, were “doing their best” to increase capacity, he said, adding: “But, as you can understand, relying only on one manufacturer is extremely dangerous.”
In Malawi, the disease has killed 110 people and infected nearly 4,000 since March when the first case was reported, according to Khumbize Chiponda, Malawi’s health minister.
In Syria, where cholera was detected in late August, it has torn through the country, with more than 13,000 suspected cases reported, including 60 deaths. Probably as a result of that outbreak, neighbouring Lebanon has also recorded its first cases since 1993.
Earlier this month, authorities in Haiti reported the first new cases in three years: by 8 October there were more than 220 suspected cases in the Port-au-Prince area, including 16 deaths. Barboza said that if swift and concerted action were not taken, a repeat of the 2010 disaster, when nearly 10,000 people died, would be on the cards.
A spokesperson for Gavi, the Vaccine Alliance, which funds the international stockpile, said the organisation was committed to supporting countries’ efforts to control cholera. “The global stockpile of cholera vaccine, which Gavi has supported since 2014, is designed to be responsive to countries’ immediate needs in controlling outbreaks,” they added.
“The stockpile maintains a level of 5m doses, and for most of this year the available volume has exceeded this target. This is the case currently and should doses be called upon for current outbreaks, stocks can be replenished rapidly, with manufacturers responding to increased demand by maximising production when necessary.”