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Cholera Vaccine Shortage Reaches Worst Point Yet, With Experts Fearing Deadly Outbreaks

An unprecedented shortage of cholera vaccine has public health experts fearing that a recent surge of outbreaks across developing countries will only worsen, a situation they argue is as regrettable as it was avoidable.

At least 16 countries in Asia, Africa, and the Caribbean are dealing with cholera outbreaks. According to the latest report from the European Centre for Disease Prevention and Control, between Dec. 23 and Jan. 23, nearly 50,500 people contracted cholera and nearly 500 died. Those numbers will almost certainly rise amid the worst vaccine shortage since an oral vaccine was introduced in the 1990s.

Experts describe the dearth of doses as an unforced error that reflects a lack of interest in a disease that is only deadly for the poorest of the poor. Out of three vaccines qualified for use by the World Health Organization, only one is still being made, and its supplies barely cover a fraction of the global need. Cases continue to grow as climate change worsens weather patterns that are linked with flooding and outbreaks. And without sufficient vaccine supplies, medical personnel on the ground are left with containment strategies that are hardly sufficient during a humanitarian crisis.

"Cholera is a neglected disease. And it is neglected for neglected populations that are poor and do not make a good market," said Abdou Salam Gueye, the regional emergency director of the WHO African Region.

The global stockpile of cholera vaccine, which was established in 2013, is managed by the International Coordinating Group (ICG) on Vaccine Provision with the aim of supporting countries in need. That stockpile is supposed to have 5 million available doses ready to be delivered within a week. At the moment, it's running dry, as only one of the vaccine makers, EuBiologics, is producing doses of its vaccine, Euvichol-Plus. As of 2022, Shantha Biotechnics, an Indian subsidiary of French pharmaceutical company Sanofi, stopped producing its cholera vaccine, Shanchol, which at the time constituted 15% of the global stockpile.

Euvichol-Plus has been approved for people 1 and older and is supposed to be administered in two doses given at least two weeks apart. Yet last year, the ICG changed the administration protocol to one dose rather than two to stretch limited supplies further, even though that compromises the vaccine's effectiveness.

"What we started to do is the second dose within six months. And then we needed to stop the second doses altogether," said Daniela Garone, international medical coordinator at Médecins Sans Frontières and a member of the ICG. "But we don't know how much protection we receive — it is more than a year, but we don't know how long."

A regular protocol would offer protection that starts 10 days after vaccination and is 90% effective against severe diarrhea and dehydration for the first three months, with protection lasting for up to three years. Vaccines are especially important in areas where outbreaks happen in rapid succession and where surges in cases can continue for a year or longer.

Thirty countries experienced cholera outbreaks in 2023, and 14 requested a total of 76 million doses from the ICG, which only had 38 million doses of Euvichol-Plus. This means that current production barely covered half the need for a one-dose protocol, and only a fourth of what would be needed for a two-dose protocol. And EuBiologics is already running at capacity in making its vaccine.

And ideally, said Garone, there would be extra vaccine to set up preventative programs to forestall outbreaks. That would require an estimated minimum 40 million additional doses for 2024.

At the moment, said Garone, 2.4 million doses are being made a week, and all the doses that will be produced in the coming months have already been allocated. Countries that have been approved by the ICG to receive vaccine doses now "will not receive it until the second or third week of March because the vaccine is not produced yet," she said.

The reason behind this shortage is straightforward: At $1.50 a dose, cholera vaccines are unappealing to pharmaceutical companies, and demand is limited to poor countries or emergency situations such as wars or natural disasters. "The only way to maintain a healthy market is to have more than one manufacturer," said Garona. "You need global investment because it's not an attractive market."

With no immediate solution in sight, health workers on the ground have stopped relying much on vaccines as a primary intervention. "Responding in many countries in Africa, we try to intervene without putting cholera vaccine in the center of our strategy," said WHO's Gueye.

Instead, he said, the first goal is to reduce mortality to under 1%. This helps build trust with the affected population, which can otherwise be hesitant to seek care, both because of high mortality rates in health care centers and because of the specific symptoms of cholera, which can quickly impede people's ability to control vomiting and bowel movements. "Cholera [is] a disease that affects the dignity of people," said Gueye.

Only once they've built trust with local communities do health workers take secondary steps to improve water and sanitation, Gueye said, although resources can be scarce.

"If it is very difficult to do the water and sanitation [intervention] and sometimes impossible to do the good clinical care, the vaccine remains the only possibility," he said. "And unfortunately we don't have those vaccines."

In his experience, the one time African countries were able to access extra funding from the WHO to respond to cholera was in 2022, which helped bring an outbreak in Western Africa (Nigeria, Cameroon, and Niger) under control in record time. But recent requests for funding as cases rise have been unsuccessful. "We were able with less than $10 million to really do a good intervention," he said. "But now we have nothing."

Future outbreaks are only likely to intensify because of the effects of climate change, Gueye warns. In particular, in eastern and southern African nations such as Mozambique, Malawi, and Madagascar, flooding that can lead to cholera outbreaks used to be cyclical, but those cycles are now running into one another and prolonging outbreaks.

It's a situation he said underscores how global crises affect the poorest nations. "In my opinion cholera is not a public health problem. It's a development problem with public health consequences. If you support a country to have human development that is appropriate, the problem will disappear by itself," he said.

This has become harder because, in many cases, economic growth in the Global South has fostered more economic inequality, with the poor sinking deeper into poverty even as countries become richer overall. The good news is that a little funding would go a long way, such as increased support for climate change remediation. For instance, cholera prevention and treatment programs should qualify to receive at least a small portion of the $13 billion United Nations Green Climate Fund, he said.

"You don't need rocket science to know that cholera is a consequence of climate change," Gueye said. "We asked last year for around $31 million; we got less than 4 million. And that $13 billion that is available for climate change — why is it not oriented toward the cholera funding gap?"

How The Additives In Your Vaccines Rev Up Your Immune System

French veterinarian Gaston Ramon was researching diphtheria vaccines in the 1920s when he noticed something unusual. Adding breadcrumbs, tapioca, and other seemingly random ingredients made the vaccines work better.

Ramon used the word adjuvants to describe these additives, based on the Latin word adjuver, which means "to help." Today, there are more than half a dozen of them in use for various vaccines, and scientists continue to refine their understanding of how these helpers work to take the reins of the immune system and optimize inflammation. The research, experts say, might be the key to a new generation of vaccines that fight off more diseases for longer periods of time.

Vaccines already work by stimulating the inflammatory processes necessary to fight off infections, says Bali Pulendran, an immunologist at Stanford University in Palo Alto, California. Adjuvants take the process a step further, helping our bodies produce enough of the right type of inflammation but not too much of it. "You need just that Goldilocks zone—not too hot, not too cold, but just the right kind of inflammation of the right level and in the right place," Pulendran says. "That's where adjuvants can do their magic."

Controlled burn

The basic idea of a vaccine is to mimic the disease you want to protect against so that the immune system will respond in a specific way, says Larry Corey, an expert in virology, immunology, and vaccine development at the Fred Hutchinson Cancer Center in Seattle. Many vaccines do this with a killed version of a germ, a weakened version of a germ, or a toxic product of the germ that is packaged into a shot. Once injected, usually in the arm, the shot starts to trigger the immune system as soon as the offending agent, known as an antigen, enters the body. For an antigen that is new to the body, it takes two weeks to mobilize a measurable response.

The immediate reaction to a foreign antigen is called the innate immune response, and it involves specialized cells, such as dendritic cells and monocytes, which emit cytokines, prostaglandins, and other proteins that induce inflammation, Corey says. Symptoms of that immediate inflammation can include pain and swelling that may make your arm red and sore. In some cases, people also feel sick for a day or two.

In the meantime, immune cells carry the vaccine antigen to nearby lymph nodes, setting off a more lasting, "adaptive" immune response, during which yet more specialized cells, such as T cells and B cells, produce antibodies and develop a memory for the antigen. After they have been programmed, memory cells retreat to the bone marrow and lymph nodes, where they lay in wait until a similar invader appears again. The adaptive response is what leads to protection that can last for months to decades, Corey says.

Both the innate and adaptive immune responses rely on inflammatory processes, and vaccines are designed to try and induce just the right amount of it. "Vaccination is a form of inflammation," says Corey. "You're trying to elicit an immune response against the foreign antigen in a controlled way so you don't get sick."

Help needed

Some vaccines do a good job of inducing immunity simply by showing the immune system part of the pathogen being targeted; the meningococcal vaccine targeting meningitis is one example. But some diseases are particularly hard to develop vaccines for. HIV, for example, employs multiple strategies to avoid recognition by immune cells and downplay their response. Influenza and SARS-CoV-2 evolve variants that can evade immune recognition. The malaria parasite has a complicated life history with still poorly understood impacts on the immune system.

To develop vaccines for these and other elusive pathogens, scientists are tapping into the intricacies of the immune system—many of them still not completely understood. For the ever-evolving SARS-CoV-2 and influenza viruses, for example, some researchers are working on universal vaccines that would recognize the parts of antigens that remain stable even as other parts mutate to produce new strains.

Adjuvants are a major part of the effort to harness inflammation with vaccines, based on work dating back to Ramon's era. The Frenchman's discovery began with what was a routine procedure at the time. For decades, scientists had been injecting a toxin made by the diphtheria bacteria into horses to elicit an immune reaction. They would then extract the horse's blood, which was now filled with antibodies, and use the serum to treat people who were sick with diphtheria.

Ramon noticed that when horses developed infections around the site of the vaccine injection, they produced a more powerful anti-diphtheria serum. Soon he was adding breadcrumbs and other items to shots to try and spur the same inflammatory reaction and aid immunity.

Posts Mislead About COVID-19 Vaccine Safety With Out-of-Context Clip Of FDA Official

SciCheck Digest Given the extra scrutiny and large number of doses, reports of possible side effects to a vaccine safety monitoring system increased with the COVID-19 vaccines. The high number of reports does not mean the vaccines are unsafe, contrary to suggestions made by posts sharing a clip of a Food and Drug Administration official acknowledging the surge. How do we know vaccines are safe? No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects. In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants. One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA. As its website explains, VAERS "is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look." Anyone can submit a report to VAERS for any health problem that occurs after an immunization. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. The information is still valuable because it's a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists. Another monitoring system is the CDC's Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. To identify adverse events related to vaccination in near real time. In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks. The CDC and FDA vaccine safety monitoring systems, which were expanded for the COVID-19 vaccines and also include a new smartphone-based reporting tool called v-safe, have subsequently identified only a few, very rare adverse events. For more, see "How safe are the vaccines?" Link to this Full Story The COVID-19 vaccines are remarkably safe and only rarely cause serious side effects. Despite the good safety record, many people opposed to vaccination continue to point to the government's Vaccine Adverse Event Reporting System, or VAERS, to incorrectly suggest the COVID-19 shots are unsafe. As we've explained before, VAERS is one of several vaccine safety monitoring systems the Food and Drug Administration and the Centers for Disease Control and Prevention use to identify safety problems with vaccines. VAERS collects reports of health problems that occur after — but not necessarily because of — vaccination, with the goal of being able to quickly detect a safety signal, which can then be further investigated. The reports can be submitted by anyone and are not verified. The number of reports is known to increase with new vaccines, and the COVID-19 vaccines in particular had augmented reporting requirements. Yet, the sheer number of unvetted reports to VAERS for the COVID-19 vaccines is once again being spun as something concerning by vaccine opponents. Posts on social media are sharing a clip of Dr. Peter Marks, the head of the FDA division that oversees vaccines, testifying before Congress on Feb. 15. In the clip, Rep. Brad Wenstrup of Ohio, who is a podiatric physician, notes that as of mid-February, total reports to VAERS for the COVID-19 vaccines were "significantly higher than all other vaccines combined since 1990." He then asks Marks if the government was "prepared for such an avalanche of reports to VAERS." Reusing Wenstrup's "avalanche" language, Marks responds, "We tried to be prepared for that, but the avalanche of reports was tremendous." He briefly refers to the staffing challenges the government experienced in trying to find enough people to review the VAERS reports, when the clip being shared on social media ends. Later in his testimony, Marks said the staffing challenge was related to the review of the reports, since that is part of the evaluation of whether an adverse event might actually be caused by a vaccine. He also explained that the deluge of reports was partly due to the incredibly rapid rollout of millions of doses in a short period of time, and that reporting to VAERS after COVID-19 vaccination was highly encouraged. "We were encouraging safety reporting because we felt we needed to know any potential adverse events so we could try to investigate and find out if there was something we were missing," said Marks, who also noted in his opening remarks that "vaccines save the lives of millions of children and adults every year," and that Americans "can rest assured that vaccines that are authorized or approved are safe and effective." But the clip doesn't include those comments, and the posts don't explain that. Instead, the posts, which incorrectly refer to Marks as the FDA director, quote the "avalanche" statement or misleadingly imply the official had made some kind of compromising revelation about vaccine safety. "FDA director admits to historic number of adverse event reports about COVID vaccines," reads one popular post. It is suggestively captioned, "We warned everyone. Never forget that." Although the posts do not explicitly say the number of reports means the vaccines are unsafe, the implication is clear. Numerous responses to the posts show people misinterpreting the "avalanche" of reports as indicative of a safety problem. "Absolutely unacceptable," one comment reads. "Why are they still pushing it the thing!!!!! They should be arrested immediately." "Dr. Marks was making clear that VAERS reports were not necessarily caused by the vaccine," Cherie Duvall-Jones, a spokesperson for the FDA, told us in an email. "Additional analyses are required to determine causality, and the mere fact that an adverse event is reported does not indicate it was caused by the COVID-19 vaccine or that it was related." Sheer Number of VAERS Reports Not Concerning As we've explained before, there are several reasons why reporting to VAERS following COVID-19 vaccination has been so high compared with other vaccines. This includes the large number of doses — as of last May, more than 676 million doses in the U.S. — over a relatively short period of time, including a rollout that was initially prioritized to older and higher-risk individuals, who would be more likely to have health problems anyway. Health care providers are also required by law to report far more adverse events following vaccination with a COVID-19 vaccine than with other vaccines. It's well established that reporting to VAERS surges for any new vaccine — a phenomenon known as the Weber effect — and this has almost certainly been supercharged in the case of the COVID-19 vaccines, given the intense interest in these vaccines. One clue that this increased reporting to VAERS is not concerning is that reporting is high across the board, regardless of the plausibility of an event being vaccine-caused. "Every event, even those clearly unrelated to vaccines including for example animal bites, broken arms, and sunburn, is reported about an order of magnitude more for these vaccines in the pandemic than any time before," Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvania's Perelman School of Medicine, explained on X, the platform formerly known as Twitter, in response to a post sharing the Marks clip. High reporting in and of itself, then, is not a real safety signal. This is why VAERS data is analyzed and reviewed in particular ways, and used in conjunction with other safety monitoring systems, including those that are active rather than passive, as VAERS is, to identify true side effects. "Active surveillance involves proactively obtaining and rapidly analyzing information occurring in millions of individuals recorded in large healthcare data systems to verify safety signals identified through passive surveillance or to detect additional safety signals that may not have been reported as adverse events to passive surveillance systems," Duvall-Jones explained. Indeed, VAERS was useful in helping to identifying myocarditis and pericarditis as the main serious side effects of the mRNA COVID-19 vaccines. These rare conditions, which refer to inflammation of the heart and its surrounding tissue, are most common in adolescent and young adult males after a second dose. Editor's note: SciCheck's articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.Org's editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. Sources "VAERS." HHS. Accessed 23 Feb 2024. McDonald, Jessica. "What VAERS Can and Can't Do, and How Anti-Vaccination Groups Habitually Misuse Its Data." FactCheck.Org. 6 Jun 2023. McDonald, Jessica. "Increase in COVID-19 VAERS Reports Due To Reporting Requirements, Intense Scrutiny of Widely Given Vaccines." FactCheck.Org. 22 Dec 2021. "Assessing America's Vaccine Safety Systems, Part 1." Select Subcommittee on the Coronavirus Pandemic. U.S. House of Representatives. 15 Feb 2024. Duvall-Jones, Cherie. FDA press officer. Email sent to FactCheck.Org. 23 Feb 2024. "COVID Data Tracker." CDC. Last updated 10 May 2023 "Frequently Asked Questions (FAQs)." VAERS. HHS. Accessed 23 Feb 2024. Morris, Jeffrey S. (@jsm2334). "Yes the avalanche of reports was amazing as we can see in the publicly available data from the website …" X. 16 Feb 2024. "Selected Adverse Events Reported after COVID-19 Vaccination." CDC. Accessed 23 Feb 2024. "Clinical Considerations: Myocarditis and Pericarditis after Receipt of COVID-19 Vaccines Among Adolescents and Young Adults." CDC. Accessed 23 Feb 2024.

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