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New cholera vaccine-makers gearing up as global stocks run out

The global stockpile of cholera vaccine has dried up, with doses being given to patients as fast as they are produced, but the good news is three new vaccine-makers – including one in SA – are establishing production lines and joining efforts to replenish stocks.

And a fourth company, the only currently making the vaccine, is working flat out to expand its production.

Yet despite this, the total global supply of the vaccine that will become available this year will be, at best, a quarter of what is needed, reports The New York Times.
At the end of February, countries had already reported 79 300 cases and 1 100 deaths from cholera this year. Since there is no uniform system for counting cases, this is probably a gross underestimate.

In October 2022, the organisation that manages the global emergency cholera vaccine stockpile made an unprecedented recommendation that people receive only one dose of the vaccine instead of two, in efforts to stretch the supply. A single dose provides between six months and two years of immunity, while the full regimen of two doses delivered a month apart gives adults roughly four years of protection.

Last year, countries sent requests for 76m doses for single-dose “reactive campaigns” – efforts to vaccinate people in places with active outbreaks.

There were only 38m doses in the stockpile, so only half of the requests were filled, and those were with just a single dose. No vaccines were left for preventive campaigns that would ideally be carried out in places like Gaza, where conditions for large outbreaks exist, or in places where cholera is endemic.

The race to make more cholera vaccine illustrates all of the reasons it’s so hard to respond to epidemics, even with the participation of committed pharmaceutical companies undeterred by the slim profit margins in an immunisation that’s mostly for poor people.

Current outbreaks are being driven by the spread of conflict and climate disasters that force people into crowded living situations without adequate sanitation systems.

In recent months, there have been outbreaks in 17 countries, including Afghanistan, Zambia and Syria.

Yet demand has only grown since then.

The South Korean company EuBiologics is currently the sole company worldwide making the vaccine. The company had been aware for some time that there would be pressure on supplies because the only other firm that made it, an Indian subsidiary of Sanofi, had announced in 2018 that it would end production of the vaccine, which it did in 2023.

To cover the gap in vaccine production, Rachel Park, director of international business at EuBiologics, said the company decided to try to simplify its vaccine formula, streamlining steps and ingredients so it could make more doses faster.

The company was then making more of the bulk drug product than it could put into tubes quickly, so it contracted a second Korean firm to assist.

EuBiologics also invested in construction of a second manufacturing site that would double the amount of vaccine the company could make. It has taken the lengthy and expensive steps of having both the simplified vaccine and its new facility approved by the WHO in a process called pre-qualification, meaning that countries will not have to administer their own regulatory assessments.

When the new plant starts producing, the company will be able to make up to 46m doses a year.

“EuBiologics is the unsung hero of the story,” said Dr Julia Lynch, director of the cholera vaccine programme for the International Vaccine Institute, a UN-backed organisation based in Seoul. “They are doing everything they can to increase volumes as fast as possible.”

Together, these steps should increase production to a total of about 46m doses this year, and to about 90m doses in 2025 and onward, she said. But that will still probably be significantly less than what the world requires.

“Doses are being allotted before they are even produced,” said Dr Daniela Garone, international medical co-ordinator for Doctors Without Borders, who is on the committee that decides which countries will receive doses, and how many. “We weren’t expecting it to be better this year, but we didn’t think it would be this much worse.”

There is some more hope on the horizon: three more drug companies have cholera vaccines in their pipeline. The International Vaccine Institute has licensed its vaccine to Biological E, a large Indian firm, and is sharing the formula and equipment for making it.

If all goes well, that vaccine could come to market by the end of 2026 because Biological E already makes many products prequalified by the WHO.

In South Africa, Biovac will soon start clinical trials on what eventually could be the first vaccine ever produced from start to finish in sub-Saharan Africa. Biovac hopes to conclude the trials by 2027, thereafter, it will probably take at least a year to obtain WHO prequalification, said Dr Morena Makhoana, Biovac’s chief executive.

Bharat Biotech, another big Indian company with large production capacity, is working on its own oral cholera vaccine which it could bring to market by the end of 2025.

To spur companies to invest in producing cholera vaccines, Gavi, the international organisation that supplies immunisations to low- and middle-income countries, has indicated the possibility of advance market commitments, and the promise of future orders that would encourage drugmakers to invest in producing the cholera vaccine.

Gavi pays EuBiologics $1.53 per dose for the vaccine.

Bharat and Biological E both plan to produce about 15m doses per year initially, Lynch said, “modest quantities” by the standards of these huge Indian companies that could make more if the market continues to grow.

The potential demand is difficult to predict, she said. “That’s really the question: is what the world is going through right now a kind of phenomena of a few years triggered by something? Or is this a new normal? A new kind of set point?”

 

The New York Times article – Global Stockpile of Cholera Vaccine Is Gone as Outbreaks Spread (Restricted access)

 

See more from MedicalBrief archives:

 

Cholera vaccine shortage a global crisis

 

Desperate countries face world shortage of 50m cholera vaccines

 

Zimbabwe declares state of emergency over cholera outbreak

 

SA confirms cholera cases amid global resurgence

 

 

 

 

 

 

 

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