Protection Gaps Against Cholera in the US: Lack of New Vaccine Supply and National Stockpile

Protection Gaps Against Cholera in the US

Protection Gaps Against Cholera in the US

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Dr. Peter Hotez, a vaccine expert, labels the American government’s decision to forgo maintaining a national stockpile of cholera vaccines as “shortsighted.” Picture provided by Dr. Peter Hotez Wednesday, October 13 (UPI) — Some of the finest infectious disease specialists in the country are worried that Americans could become extremely vulnerable to a public health issue that can spread and kill swiftly due to shortages of the U.S. cholera vaccine.

“The monkeypox caught us off guard. Dr. Peter Hotez, co-director of Texas Children’s Hospital Center for Vaccine Development, told UPI in a phone interview that this is a wake-up call and that we cannot let cholera catch us off guard once more. There is now only one cholera vaccine that has received FDA approval. Children who go to cholera hotspots should also receive this travel vaccine, according to the U.S. government.

However, it has been out of stock for about two years and is listed as a drug shortage in the United States. Furthermore, there is no federal vaccine stockpile that might be used as a fallback in case a large-scale cholera outbreak occurs in this country as a result of a calamity. According to Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, the 21st-century factors that contribute to cholera outbreaks in other parts of the world, most recently in Haiti, include rising poverty, urbanization, political instability, and conflict, as well as climate change that causes natural disasters.

According to Hotez, who cited his book Preventing the Next Pandemic from 2021, “We’ll see increased cases of cholera, monkeypox, and coronavirus-like infections” internationally.

“Epidemics are pretty explosive when they happen, and a lot of people can die very fast,” he continued. A company cannot start up in six months. Nobody is taking an aerial view of the issue, which is the issue of the lack of proper stockpiling of the cholera vaccine in the United States.

increases when a calamity occurs

In places lacking access to clean water, good hygiene, and proper sanitation, cholera, a severe diarrheal disease brought on by the bacterium Vibirocholerae, may become more prevalent after man-made or natural disasters. According to the Centers for Disease Control and Prevention, 1.3 million to 4 million people worldwide contract cholera each year, and 21,000 to 143,000 people pass away as a result.

Cholera was widespread in the 1800s but is now quite uncommon in the United States, according to the CDC, due of the advancements made in sewage and water treatment.

Yet, according to Hotez, the United States is not immune to an issue that persistently plagues so many other nations. He pointed out, for instance, that a cholera breakout following a hurricane could be risky for the Texas Gulf Coast, where he currently resides. So, Hotez continued, “I believe it is stupid on the part of the U.S. government to not provide stockpiling [of cholera vaccine]. … The United States has to increase its stockpiles from where they are at the moment.

According to the CDC, overseas travel is the primary cause of almost all cholera cases that are recorded in the United States. However, the number of cholera cases in the United States rose when outbreaks happened in nations close to the country, such as Haiti in 2010. Infections have also been brought on by imported, tainted seafood. The International Coordinating Group of the World Health Organization and allies set up an emergency stockpile of oral cholera vaccine in 2013.

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Amna Smailbegovic, a spokeswoman for the WHO, told UPI that more than 123 million doses have been sent to 23 nations, ranging from Bangladesh to Zimbabwe, since the stockpile was established. The amount of cholera vaccine delivered from the worldwide stockpile increased to 27 million doses in 2021 from 200,000 doses in 2013, according to WHO, as a result of an increase in manufacturing.

“Vaccines from the global stockpile may be requested by any nation. However, the likelihood of a cholera outbreak in high-income nations is quite low, so we do not anticipate this to be the case, the WHO stated in an email.

Not examined in the US.

Nevertheless, Shanchol and Euvichol-Plus, the two-dose cholera vaccines currently accessible for mass vaccination campaigns through the WHO’s global stockpile, were neither developed nor produced in the United States, which experts claim the FDA favors.

In a statement sent by email to UPI on Wednesday, CDC spokesperson Candice Hoffmann emphasized the “strong and reliable drinking water systems, proper sanitation, hygiene, and sewage infrastructures” in the country.

According to Hoffman, “CDC would work closely with FDA to pursue emergency use authorization for Shanchol and Euvichol-Plus cholera vaccines utilizing data from its utilization overseas” if a cholera outbreak did happen. The FDA stated that it carefully assesses available safety, effectiveness, and manufacturing quality information to authorize emergency use, a procedure that may slow down a quick response to a public health emergency.

For instance, it took three weeks for Pfizer Inc. to get authorization for the emergency use of its COVID-19 vaccine towards the end of 2020. According to WHO, 23.5 million doses of the cholera vaccine have already been shipped from the global stockpile this year. Another 8 million doses, needed for the second dosage of the two-dose protocol, are still awaiting shipping.

There is no vaccination on hand.

In contrast, spokesperson Dawn Young told UPI in an email that there isn’t even a single dosage of cholera vaccine in the U.S. Strategic National Stockpile in case of epidemics. At the height of COVID-19, this stockpile provided ventilators, personal protective equipment, and two varieties of monkeypox vaccine.

The FDA’s national medicine shortage list has included Vaxchora, the only cholera vaccine that has received FDA approval, for well over a year. Additionally, there had been no cholera vaccine available for decades for at-risk U.S. tourists until Vaxchora got FDA approval in 2016 for use in individuals aged 18 through 64.

The last batch of the one-dose oral cholera vaccine for U.S. travelers to other countries, according to Maryland-based Emergent BioSolutions, which makes Vaxchora, was shipped in December 2020.

We deliberately chose to stop producing Vaxchora because of the pandemic’s unprecedented effects and stoppage in international travel. In an email, Jonathan Wong, general manager and global vice president of Emergent Travel Health, stated that the company “[but] continued to assiduously monitor travel health trends in preparation for manufacturing ramp-up.”

Vaxchora production was begun, according to Emergent, but more supplies won’t be accessible until the beginning of 2023, the company told UPI. The vaccine is manufactured at Emergent’s facility in Bern, Switzerland, and each dosage costs roughly $300.

A congressional investigation into the production of COVID-19 vaccinations has focused on Emergent, which has announced plans to produce enough cholera vaccine to “meet full year (2023) predicted demand.” The need to keep cholera vaccines on hand in the United States has been around for more than ten years.

Humanitarian supply

A national cholera vaccine stockpile should be established as a “humanitarian and diplomatic resource,” according to a 2010 New England Journal of Medicine study co-authored by Hotez, Dr. Matthew Waldor, and Dr. John D. Clemens.

Though a few years later, the WHO’s global stockpile started, that never happened. In a telephone interview with UPI, Waldor, a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said that while cholera is still a problem in many parts of the world, there have only been “just the occasional imported cases” domestically over the past 20 years that haven’t resulted in outbreaks.

Apart from charity and healthcare professionals, he described the risk to most U.S. overseas travelers as “extremely minimal,” adding that the lack of cholera vaccination for travelers is “not a calamity” because cholera is “generally treated” with fluids and medication. Waldor acknowledged he might be “overly pessimistic” about the U.S. cholera vaccine gap, but added that “it’s OK [for U.S.-based overseas tourists] to be really safe and get it [cholera vaccine]. I don’t think there’s a huge risk for cholera in the United States, but out of a surplus of caution, it could be prudent to have some in the stockpile, he added.

Waldor emphasized the significance of cholera vaccines in general and mentioned that his team intends to start a phase 1 clinical trial of its own vaccine candidate in Boston, most likely in November.

If his vaccine is found to be safe and effective, he said he expects it will be added to the global stockpile and disseminated and produced in the nations that most urgently require it.

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