Cholera vaccine

Short description: Vaccine to prevent cholera

Cholera vaccineError creating thumbnail: Unable to save thumbnail to destination

Vaccine description
Target disease| Vibrio cholerae
Type| Killed/Inactivated
Clinical data
Trade names| Dukoral, Vaxchora, others
AHFS/Drugs.com| Micromedex Detailed Consumer Information
Pregnancy
category|

* AU: B2

* [1]

ATC code|

* J07AE01 (WHO) J07AE02 (WHO) J07AE51 (WHO)

Legal status
Legal status|

* AU: S4 (Prescription only) [1][2]
* CA: ℞-only / Schedule D[3]
* UK: POM (Prescription only) [4]
* US: ℞-only [5][6]
* EU: Rx-only [7][8][9]

Identifiers
DrugBank|

* DB11643 Y
* DB14443 Y

ChemSpider|

* none

UNII|

* V9G528E9E0

KEGG|

* D03530

NY (what is this?) (verify)

A cholera vaccine is a vaccine that is effective at preventing cholera.[10] For the first six months after vaccination it provides about 85 percent protection, which decreases to 50 percent or 62 percent during the first year.[10][11][12] After two years the level of protection decreases to less than 50 percent.[10] When enough of the population is immunized, it may protect those who have not been immunized (known as herd immunity).[10]

The World Health Organization (WHO) recommends the use of cholera vaccines in combination with other measures among those at high risk.[10] With the oral vaccine, two or three doses are typically recommended.[10] The duration of protection is two years in adults and six months in children aged 2–5 years.[10] A single dose vaccine is available for those traveling to an area where cholera is common.[13][14][15] In 2010, in some countries an injectable cholera vaccine was available.[10][11]

The available types of oral vaccine are generally safe.[10] Mild abdominal pain or diarrhea may occur.[10] They are safe in pregnancy and in those with poor immune function.[10] They are licensed for use in more than 60 countries.[10] In countries where the disease is common, the vaccine appears to be cost effective.[10]

The first cholera vaccines were developed in the late 1900s.[16] They were the first widely used vaccine that was made in a laboratory.[16] Oral cholera vaccines were first introduced in the 1990s.[10] It is on the World Health Organization's List of Essential Medicines.[17][18]

## Contents

* 1 Medical use
* 1.1 Oral
* 1.2 Injectable
* 2 Side effects
* 3 History of development
* 4 Society and culture
* 4.1 Legal status
* 4.2 Economics
* 5 References
* 6 Further reading
* 7 External links

## Medical use

In the late twentieth century, oral cholera vaccines started to be used on a massive scale, with millions of vaccinations taking place, as a tool to control cholera outbreaks in addition to the traditional interventions of improving safe water supplies, sanitation, handwashing, and other means of improving hygiene.[19] The Dukoral monovalent vaccine from Sweden, which combines formalin, heat-killed whole cells of Vibrio cholerae O1, and a recombinant cholera toxin B subunit, was licensed in 1991, mainly for travellers. Out of a million doses sold during the following decade, 63 negative side effects were reported.[10] The Shanchol bivalent vaccine (also manufactured under the name mORCVAX), which combines the O1 and O139 serogroups, was originally licensed in Vietnam in 1997 and given in 20 million doses to children in Vietnam during the following decade.[10] As of 2010[update], Vietnam continued to incorporate oral cholera vaccination in its public health programme, administering the vaccination through targeted mass vaccination of school-aged children in cholera endemic regions.[10]

The cholera vaccine is widely used by backpackers and persons visiting locations where there is a high risk of cholera infection. However, since it does not provide 100 percent immunity from the disease, food hygiene precautions are also recommended when visiting an area where there is a high risk of becoming infected with cholera. Although the protection observed has been described as "moderate", herd immunity can multiply the effectiveness of vaccination. Dukoral has been licensed for children two years of age and older, Shanchol for children one year of age and older. The administration of the vaccine to adults confers additional indirect protection (herd immunity) to children.

The World Health Organization (WHO) recommends both preventive and reactive use of the vaccine, making the following key statements:[20]

> WHO recommends that current available cholera vaccines be used as complements to traditional control and preventive measures in areas where the disease is endemic and should be considered in areas at risk for outbreaks. Vaccination should not disrupt the provision of other high priority health interventions to control or prevent cholera outbreaks.... Reactive vaccination might be considered in view of limiting the extent of large prolonged outbreaks, provided the local infrastructure allows it, and an in-depth analysis of past cholera data and identification of a defined target area have been performed.

The WHO as of late 2013 established a revolving stockpile of two million OCV doses.[21] The supply is increasing to six million as a South Korean companies has gone into production (2016), the old production not being able to handle WHO demand in Haiti and Sudan for 2015, nor prior years. GAVI Alliance donated $115 million to help pay for expansions.[22][23]

### Oral

Dukoral: vial of inactivated vaccine with packet of sodium bicarbonate buffer.

The oral vaccines are generally of two forms: inactivated and attenuated.[citation needed]

Inactivated oral vaccines provide protection in 52 percent of cases the first year following vaccination and in 62 percent of cases the second year.[12] Two variants of the inactivated oral vaccine currently are in use: WC-rBS and BivWC. WC-rBS (marketed as "Dukoral") is a monovalent inactivated vaccine containing killed whole cells of V. cholerae O1 plus additional recombinant cholera toxin B subunit. BivWC (marketed as "Shanchol" and "mORCVAX") is a bivalent inactivated vaccine containing killed whole cells of V. cholerae O1 and V. cholerae O139. mORCVAX is only available in Vietnam.[citation needed]

Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and Classical biotypes are included in the vaccine. Dukoral is taken orally with bicarbonate buffer, which protects the antigens from the gastric acid. The vaccine acts by inducing antibodies against both the bacterial components and CTB. The antibacterial intestinal antibodies prevent the bacteria from attaching to the intestinal wall, thereby impeding colonisation of V. cholerae O1. The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface, thereby preventing the toxin-mediated diarrhoeal symptoms.[24]

A live, attenuated oral vaccine (CVD 103-HgR or Vaxchora), derived from a serogroup O1 classical Inaba strain, was approved by the US FDA in 2016.[13][25][14]

### Injectable

Although rarely in use, the injected cholera vaccines are effective for people living where cholera is common. They offer some degree of protection for up to two years after a single shot, and for three to four years with annual booster. They reduce the risk of death from cholera by 50 percent in the first year after vaccination.[11]

## Side effects

Both of the available types of oral vaccine are generally safe.[10] Mild abdominal pain or diarrhea may occur.[10] They are safe in pregnancy and in those with poor immune function.[10] They are licensed for use in more than 60 countries.[10] In countries where the disease is common, the vaccine appears to be cost effective.[10]

## History of development

File:ASC Leiden - Coutinho Collection - G 01 - Ziguinchor, Senegal - Cholera vaccinations by Guinean nurse - 1973.tif The first cholera vaccines were developed in the late 19th century. There were several pioneers in the development of the vaccine:

* The first known attempt at a cholera vaccine was made by Louis Pasteur and it was aimed at preventing cholera in chickens.[26] This was the first widely used vaccine that was made in a laboratory.[16] Later use showed this early cholera vaccine to be ineffective.[27]
* In 1884, Spanish physician Jaume Ferran i Clua developed a live vaccine he had isolated from cholera patients in Marseilles, and used it that on over 30,000 individuals in Valencia during that year's epidemic. However, his vaccine and inoculation was rather controversial and was rejected by his peers and several investigation commissions,[28] but it ended up demonstrating its effectiveness and being recognized for it.[29]
* In 1892, Waldemar Haffkine developed an effective vaccine with less severe side effects, later testing it on more than 40,000 people in the Calcutta area from 1893 to 1896.[30] His vaccine was accepted by the medical community, and is credited as the first effective human cholera vaccine.[28][31][32][33]
* Finally, in 1896, Wilhelm Kolle introduced a heat-killed vaccine that was significantly easier to prepare than Haffkine's, using it on a large scale in Japan in 1902.[34]

Oral cholera vaccines were first introduced in the 1990s.[10]

## Society and culture

### Legal status

In 2016, the U.S. Food and Drug Administration (FDA) approved Vaxchora,[15][14][25] a single-dose oral vaccine to prevent cholera for travelers. As of June 2016[update], Vaxchora was the only FDA-approved vaccine for the prevention of cholera.[25]

### Economics

The cost to immunize against cholera is between US$0.10 and US$4.00 per vaccination.[35]

The Vaxchora vaccine can cost more than US$250.[36]

## References

1. ↑ 1.0 1.1 https://www.tga.gov.au/resources/auspmd/vaxchora
2. ↑ "Summary for ARTG Entry:94483 Dukoral oral inactivated cholera vaccine liquid vial and buffer granules sachet". https://www.tga.gov.au/resources/artg/94483.
3. ↑ "Dukoral Product information". 25 April 2012. https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=71450.
4. ↑ "Dukoral suspension and effervescent granules for oral suspension, Cholera vaccine (inactivated, oral) - Summary of Product Characteristics (SmPC)". 7 December 2015. https://www.medicines.org.uk/emc/product/5087/smpc.
5. ↑ "Vaxchora- cholera vaccine, live, oral kit". 24 October 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01dae2ac-8332-4e23-b971-67dc36c3ee16.
6. ↑ "Vaxchora- cholera vaccine, live, oral kit". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7baa7ebb-cb08-4799-80d4-66c16966d223.
7. ↑ "Eukoral EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/dukoral.
8. ↑ "Vaxchora EPAR". 30 January 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/vaxchora.
9. ↑ "Vaxchora Product information". https://ec.europa.eu/health/documents/community-register/html/h1423.htm.
10. ↑ 10.00 10.01 10.02 10.03 10.04 10.05 10.06 10.07 10.08 10.09 10.10 10.11 10.12 10.13 10.14 10.15 10.16 10.17 10.18 10.19 10.20 10.21 10.22 "Cholera vaccines: WHO position paper – August 2017". Weekly Epidemiological Record 92 (34): 477–498. August 2017. PMID 28845659.
11. ↑ 11.0 11.1 11.2 "Vaccines for preventing cholera: killed whole cell or other subunit vaccines (injected)". The Cochrane Database of Systematic Reviews 2019 (8): CD000974. August 2010. doi:10.1002/14651858.CD000974.pub2. PMID 20687062.
12. ↑ 12.0 12.1 "Oral vaccines for preventing cholera". The Cochrane Database of Systematic Reviews 2011 (3): CD008603. March 2011. doi:10.1002/14651858.CD008603.pub2. PMID 21412922.
13. ↑ 13.0 13.1 "Vaxchora (Cholera vaccine, Live, Oral)". U.S. Food and Drug Administration. https://www.fda.gov/media/98688/download.
14. ↑ 14.0 14.1 14.2 "Vaxchora approval letter". U.S. Food and Drug Administration. 10 June 2016. https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM506321.pdf. This article incorporates text from a publication now in the public domain:
15. ↑ 15.0 15.1 "Vaxchora". 1 September 2019. https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxchora.
16. ↑ 16.0 16.1 16.2 Vaccines for biodefense and emerging and neglected diseases (1st ed.). Amsterdam: Academic. 2009. p. 870. ISBN 978-0-08-091902-7. https://books.google.com/books?id=6Nu058ZNa1MC&pg=PA870.
17. ↑ World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. 2019. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
18. ↑ World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. 2021. WHO/MHP/HPS/EML/2021.02.
19. ↑ "Cholera". Lancet 379 (9835): 2466–2476. June 2012. doi:10.1016/s0140-6736(12)60436-x. PMID 22748592.
20. ↑ Oral cholera vaccines in mass immunization campaigns: guidance for planning and use. World Health Organization. 2010. ISBN 978-92-4-150043-2. http://apps.who.int/iris/bitstream/handle/10665/44448/9789241500432_eng.pdf.
21. ↑ "Oral cholera vaccine stockpile". World Health Organization. https://www.who.int/cholera/vaccines/ocv_stockpile_2013/en/index.html.
22. ↑ "WHO Doubles Global Supply of Cholera Vaccine". 8 January 2016. https://www.nbcnews.com/health/health-news/world-health-organization-doubles-cholera-vaccine-supply-n492796.
23. ↑ "GAVI Board Approves Support to Expand Oral Cholera Vaccine Stockpile". The Task Force on Global Health. http://www.taskforce.org/press-room/press-releases/gavi-board-approves-support-expand-oral-cholera-vaccine-stockpile.
24. ↑ "Dukoral Canadian Product Monograph Part III: Consumer Information". http://www.dukoralcanada.com/sites/default/files/consumer_info_en.pdf.
25. ↑ 25.0 25.1 25.2 "FDA approves vaccine to prevent cholera for travelers" (Press release). U.S. Food and Drug Administration (FDA). 10 June 2016. Archived from the original on 18 December 2016. This article incorporates text from a publication now in the public domain:
26. ↑ "The first live attenuated vaccines" (in en). Nature Research. 28 September 2020. https://www.nature.com/articles/d42859-020-00008-5.
27. ↑ "Studies on Control of Fowl Cholera". Agricultural Experiment Station Technical Bulletins (1939-2011). May 1959. https://openprairie.sdstate.edu/agexperimentsta_tb/34.
28. ↑ 28.0 28.1 "Waldemar Haffkine's cholera vaccines and the Ferran-Haffkine priority dispute". Journal of the History of Medicine and Allied Sciences 37 (4): 399–422. December 1982. doi:10.1093/jhmas/XXXVII.4.399. PMID 6759570.
29. ↑ "Killed oral cholera vaccines: history, development and implementation challenges". Therapeutic Advances in Vaccines and Immunotherapy 2 (5): 123–148. September 2014. doi:10.1177/2051013614537819. PMID 25177492.
30. ↑ (in French) Un illustre inconnu. Une biographie du docteur Waldemar Mordekhaï Haffkine.. Paris: Lichma. 2017. ISBN 978-2-912553-84-3.
31. ↑ "Jaime Ferran and preventive inoculation against cholera". Bulletin of the History of Medicine 55 (4): 516–532. 1981. PMID 7039738.
32. ↑ "Waldemar Mordecai Haffkine, CIE (1860-1930): prophylactic vaccination against cholera and bubonic plague in British India". Journal of Medical Biography 15 (1): 9–19. February 2007. doi:10.1258/j.jmb.2007.05-59. PMID 17356724.
33. ↑ "Waldemar Haffkine: The vaccine pioneer the world forgot" (in en-GB). BBC News. 11 December 2020. https://www.bbc.com/news/world-asia-india-55050012.
34. ↑ Vaccines: A Biography (1 ed.). New York City: Springer Science & Business Media. 2009. pp. 89–92. ISBN 978-0-08-091902-7. https://books.google.com/books?id=ewdL8ilILZAC.
35. ↑ "Post-licensure deployment of oral cholera vaccines: a systematic review". Bulletin of the World Health Organization 92 (12): 881–93. December 2014. doi:10.2471/blt.14.139949. PMID 25552772.
36. ↑ "New Cholera Vaccine for Adult Travelers". Medscape. 17 April 2017. http://www.medscape.com/viewarticle/878238. "This vaccine can cost more than $250, and travelers may have to pay out of pocket if their insurance does not cover travel vaccines"

## Further reading

* The immunological basis for immunization series: module 14: cholera. World Health Organization (WHO). 2010. ISBN 978-92-4-159974-0.
* "Chapter 14: Cholera". Immunisation against infectious disease. Public Health England. 2013. https://www.gov.uk/government/publications/cholera-the-green-book-chapter-14.
* "Cholera". CDC Yellow Book 2020: Health Information for International Travel. New York: Oxford University Press. 2017. https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/cholera.
* ﻿Cholera and enterotoxigenic escherichia coli (ETEC) travellers' diarrhea vaccine: Canadian Immunization Guide﻿ (Report). https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-3-cholera-enterotoxigenic-escherichia-coli-travellers-diarrhea-vaccine.html.

## External links

* "Cholera Vaccine Information Statement". October 2019. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/cholera.html.
* Cholera Vaccines at the US National Library of Medicine Medical Subject Headings (MeSH)

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Artificial induction of immunity / Immunization: Vaccines, Vaccination, Infection, Biology:Inoculat, Inoculation (J07)

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