Cholera vaccine explained

Verifiedfields:changed
Watchedfields:changed
Verifiedrevid:446094983
Type:vaccine
Target:Vibrio cholerae
Vaccine Type:inactivated
Tradename:Dukoral, Vaxchora, others
Dailymedid:Cholera
Pregnancy Au:B2
Pregnancy Category:[1]
Routes Of Administration:By mouth
Atc Prefix:J07
Atc Suffix:AE01
Legal Au:S4
Legal Au Comment:[2]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[3]
Legal Uk:POM
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Us Comment:[5] [6]
Legal Eu:Rx-only
Legal Eu Comment:[7] [8] [9]
Drugbank:DB11643
Drugbank2:DB14443
Chemspiderid:none
Unii:V9G528E9E0
Kegg:D03530

A cholera vaccine is a vaccine that is effective at reducing the risk of contracting cholera. The recommended cholera vaccines are administered orally to elicit local immune response in the gut where the intestinal cells produce antibodies against the cholera microbe. This immune response was poorly achieved with the injectable vaccines that were used until the 1970s. The first effective oral cholera vaccine was Dukoral, developed in Sweden in the 1980s. For the first six months after vaccination it provides about 85% protection, which decreases to approximately 60% during the first two years.[10] [11] When enough of the population is immunized, it may protect those who have not been immunized thereby increasing the total protective impact to more than 90 % (known as herd immunity).

The World Health Organization (WHO) recommends the use of three oral cholera vaccines – Dukoral, Shanchol, and Euvichol-Plus – in combination with other measures among those at high risk for cholera. Two vaccine doses with a 1–6 week interval are typically recommended. The duration of protection is at least two years in adults and six months in children aged 1–5 years. A live, attenuated single dose oral vaccine is available for those traveling to an area where cholera is common but is not WHO approved for public health use.[12] [13]

The available types of oral cholera vaccine are generally considered safe for the majority of the population. These vaccines were shown to be safe in pregnancy and in those with poor immune function. The main side effects which could be experienced includes mild abdominal pain or diarrhea may occur.

The first cholera vaccines were developed in the late 19th century. They were the first widely used vaccine that was made in a laboratory but were largely abandoned in the 1970s due to their then documented reactogenicity and poor efficacy.[14]

Oral cholera vaccines were first introduced in the 1990s. It is on the World Health Organization's List of Essential Medicines.[15] [16]

These vaccines are licensed for use in more than 60 countries. In countries where the disease is common, the vaccine appears to be cost effective.[17]

Medical use

In the late 20th 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.[18] The Dukoral vaccine, which combines formalin- and heat-killed whole cells of Vibrio cholerae O1 and a recombinant cholera toxin B subunit, was licensed in 1991 and has been used widely, mainly for travellers.[17] The Shanchol bivalent vaccine, which combines the O1 and O139 serogroups, was originally developed in Vietnam under the name mORCVAX in 1997 and given in 20 million doses in Vietnam's public health programme during the following decade through targeted mass vaccination of school-aged children in cholera endemic regions.[17]

The World Health Organization (WHO) recommends both preventive and reactive use of the vaccine, making the following key statements:[19]

The observed vaccine specific protection with two doses of the oral vaccine was 58–76%.[20] Herd immunity can multiply the effectiveness of vaccination. Dukoral has been licensed for children two years of age and older, Shanchol and Euvichol-Plus for children one year of age and older. The administration of the vaccine to adults confers additional indirect protection (herd immunity) also to children.

, the WHO established a revolving stockpile, initially of only 2 million oral cholera vaccine doses.[21] With donations from mainly the GAVI Alliance the stockpile has progressively expanded to now more than 40 million doses per year.[22] [23] It consists mainly of the Euvichol-Plus oral cholera vaccine being produced in South Korea. In total more than 150 million doses from the stockpile have been given in mass campaigns against both epidemic and endemic cholera in more than 25 cholera afflicted countries. A set goal of WHO's Global Task Force for Cholera Control (GTFCC) is, by using oral cholera vaccine and other available tools, by 2030 to have reduced cholera deaths by more than 90% and stopped transmission globally.  

Oral

The oral vaccines are generally of two forms: inactivated and attenuated.[24]

The first developed effective oral cholera vaccine, Dukoral, is a monovalent inactivated vaccine containing killed whole cells of V. cholerae O1 plus additional recombinant cholera toxin B subunit. 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.[25]

The two later inactivated oral cholera vaccines recommended by WHO, Shanchol and Euvichol-Plus, have an identical composition, containing killed whole cells of V. cholerae O1 (the same components as in Dukoral) plus formalin-killed V. cholerae O139 bacteria.

A live, attenuated oral vaccine (CVD 103-HgR or Vaxchora), derived from a serogroup O1 classical Inaba strain, was approved for use in travellers by the US FDA in 2016.[12] [13]

In 2024, the Euvichol-S vaccine, an optimized version of Euvichol-Plus, received WHO prequalification. This streamlined formulation is designed to maintain effectiveness while reducing production costs, significantly boosting the global oral cholera vaccine supply to 50 million doses, up from 38 million. This increase addresses the growing demand amid rising cholera outbreaks since 2021.[26]

Injectable

Although rarely in use, the injected cholera vaccines can be effective for people living where cholera is common. While being ineffective in young children, in such areas they can offer some degree of protection in adults and older children for up to six months.[10]

Side effects

Both the inactivated and attenuated oral vaccines available are generally safe.[17] Some of the common side effects include mild abdominal pain or diarrhea.[17] They are safe in pregnancy and in those with poor immune function.[17]

History of development

The first cholera vaccines were developed in the late 19th century. There were several pioneers in the development of the vaccine:

Oral cholera vaccines were first introduced in the 1990s.[17]

Society and culture

Legal status

In 2016, the US Food and Drug Administration (FDA) approved Vaxchora,[36] [13] a single-dose oral vaccine to prevent cholera for travelers., Vaxchora is the only FDA-approved vaccine for the prevention of cholera.[37]

Economics

The cost to immunize against cholera is between and $4.00 per vaccination.[38]

The Vaxchora vaccine can cost more than $250.[39]

Further reading

External links

Notes and References

  1. Web site: Vaxchora APMDS . Therapeutic Goods Administration (TGA) . 18 September 2023 . 7 March 2024.
  2. Web site: Summary for ARTG Entry:94483 Dukoral oral inactivated cholera vaccine liquid vial and buffer granules sachet . Therapeutic Goods Administration (TGA) . 30 July 2020.
  3. Web site: Dukoral Product information . Health Canada . 25 April 2012 . 30 July 2020.
  4. Web site: Dukoral suspension and effervescent granules for oral suspension, Cholera vaccine (inactivated, oral) – Summary of Product Characteristics (SmPC) . (emc) . 7 December 2015 . 30 July 2020.
  5. Web site: Vaxchora – cholera vaccine, live, oral kit . DailyMed . 24 October 2018 . 30 July 2020.
  6. Web site: Vaxchora – cholera vaccine, live, oral kit . DailyMed . 30 July 2020.
  7. Web site: Eukoral EPAR . European Medicines Agency (EMA) . 17 September 2018 . 30 July 2020.
  8. Web site: Vaxchora EPAR . European Medicines Agency (EMA) . 30 January 2020 . 30 July 2020.
  9. Web site: Vaxchora Product information . Union Register of medicinal products . 3 March 2023.
  10. Graves PM, Deeks JJ, Demicheli V, Jefferson T . Vaccines for preventing cholera: killed whole cell or other subunit vaccines (injected) . The Cochrane Database of Systematic Reviews . 8 . CD000974 . August 2010 . 2019 . 20687062 . 6532721 . 10.1002/14651858.CD000974.pub2.
  11. Sinclair D, Abba K, Zaman K, Qadri F, Graves PM . Oral vaccines for preventing cholera . The Cochrane Database of Systematic Reviews . 3 . CD008603 . March 2011 . 2011 . 21412922 . 6532691 . 10.1002/14651858.CD008603.pub2.
  12. Web site: Vaxchora (Cholera vaccine, Live, Oral) . . 15 March 2017 . live . https://web.archive.org/web/20170301015628/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM506235.pdf . 1 March 2017.
  13. Web site: Vaxchora approval letter . U.S. Food and Drug Administration. 10 June 2016 . 30 July 2020 . https://wayback.archive-it.org/7993/20170722071339/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM506321.pdf . 22 July 2017.
  14. Book: Stanberry LR . Vaccines for biodefense and emerging and neglected diseases . 2009 . Academic . Amsterdam . 978-0-08-091902-7 . 870 . 1st . live . https://web.archive.org/web/20170908135337/https://books.google.com/books?id=6Nu058ZNa1MC&pg=PA870 . 8 September 2017.
  15. Book: World Health Organization model list of essential medicines: 21st list 2019 . 2019 . 10665/325771 . World Health Organization . Geneva . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO . free . Organization WH .
  16. Book: World Health Organization model list of essential medicines: 22nd list (2021) . 2021 . 10665/345533 . World Health Organization . Geneva . WHO/MHP/HPS/EML/2021.02 . free . Organization WH .
  17. Cholera vaccines: WHO position paper – August 2017 . Weekly Epidemiological Record . 92 . 34 . 477–498 . August 2017 . 28845659 . 10665/258764 . free .
  18. Harris JB, LaRocque RC, Qadri F, Ryan ET, Calderwood SB . Cholera . Lancet . 379 . 9835 . 2466–76 . June 2012 . 22748592 . 3761070 . 10.1016/s0140-6736(12)60436-x.
  19. Book: Oral cholera vaccines in mass immunization campaigns: guidance for planning and use . 2010 . World Health Organization . 978-92-4-150043-2 . live . https://web.archive.org/web/20140903045312/http://whqlibdoc.who.int/publications/2010/9789241500432_eng.pdf . 3 September 2014.
  20. Bi Q, Ferreras E, Pezzoli L, Legros D, Ivers LC, Date K, Qadri F, Digilio L, Sack DA, Ali M, Lessler J, Luquero FJ, Azman AS . Protection against cholera from killed whole-cell oral cholera vaccines: a systematic review and meta-analysis . Lancet Infect Dis . 17 . 10 . 1080–8 . October 2017 . 28729167 . 5639147 . 10.1016/S1473-3099(17)30359-6 .
  21. Web site: Oral cholera vaccine stockpile . World Health Organization . 18 December 2013 . https://web.archive.org/web/20131212105249/http://www.who.int/cholera/vaccines/ocv_stockpile_2013/en/index.html . 12 December 2013.
  22. Web site: 8 January 2016 . WHO Doubles Global Supply of Cholera Vaccine . live . https://web.archive.org/web/20160108212639/https://www.nbcnews.com/health/health-news/world-health-organization-doubles-cholera-vaccine-supply-n492796 . 8 January 2016 . 9 January 2016 . NBC News.
  23. Web site: GAVI Board Approves Support to Expand Oral Cholera Vaccine Stockpile . https://web.archive.org/web/20131216184528/http://www.taskforce.org/press-room/press-releases/gavi-board-approves-support-expand-oral-cholera-vaccine-stockpile . 16 December 2013 . 18 December 2013 . The Task Force on Global Health.
  24. Web site: Cholera . 2024-05-03 . World Health Organization (WHO).
  25. Web site: Dukoral Canadian Product Monograph Part III: Consumer Information . https://web.archive.org/web/20160822025807/https://www.dukoralcanada.com/sites/default/files/consumer_info_en.pdf . 22 August 2016 . 8 May 2013 . Dukoral.
  26. Gavi and UNICEF welcome approval of new oral cholera vaccine . 2024-04-19 . UNICEF .
  27. Barranco C . 28 September 2020 . The first live attenuated vaccines . Nature Research .
  28. Dorsey TA, Harshfield GS . May 1959 . Studies on Control of Fowl Cholera . Agricultural Experiment Station Technical Bulletins (1939–2011).
  29. Bornside GH . 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 . 6759570 . 10.1093/jhmas/XXXVII.4.399 .
  30. Lopez AL, Gonzales ML, Aldaba JG, Nair GB . September 2014 . Killed oral cholera vaccines: history, development and implementation challenges . Therapeutic Advances in Vaccines and Immunotherapy . 2 . 5 . 123–148 . 4144262 . 10.1177/2051013614537819. 25177492 .
  31. Book: Un illustre inconnu. Une biographie du docteur Waldemar Mordekhaï Haffkine. . An illustrious stranger. A biography of Doctor Waldemar Mordechaï Haffkine . French . Hanhart J . Lichma . 2017 . 978-2-912553-84-3 . Paris.
  32. Bornside GH . Jaime Ferran and preventive inoculation against cholera . Bulletin of the History of Medicine . 55 . 4 . 516–532 . 1981 . 7039738 . 44441415 .
  33. Hawgood BJ . 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 . 17356724 . 10.1258/j.jmb.2007.05-59 . 42075270 .
  34. News: 11 December 2020 . Waldemar Haffkine: The vaccine pioneer the world forgot . BBC News . 20 January 2021.
  35. Book: Artenstein AW . Vaccines: A Biography . 2009 . Springer Science & Business Media . New York City . 978-0-08-091902-7 . 89–92 . 1 . live . https://web.archive.org/web/20170908135337/https://books.google.com/books?id=ewdL8ilILZAC . 8 September 2017.
  36. Web site: Vaxchora . U.S. Food and Drug Administration (FDA) . 1 September 2019 . 28 December 2019.
  37. FDA approves vaccine to prevent cholera for travelers . 10 June 2016 . U.S. Food and Drug Administration (FDA) . live . https://web.archive.org/web/20161218163210/https://www.fda.gov/news-events/press-announcements/fda-approves-vaccine-prevent-cholera-travelers . 18 December 2016.
  38. Martin S, Lopez AL, Bellos A, Deen J, Ali M, Alberti K, Anh DD, Costa A, Grais RF, Legros D, Luquero FJ, Ghai MB, Perea W, Sack DA . Post-licensure deployment of oral cholera vaccines: a systematic review . Bulletin of the World Health Organization . 92 . 12 . 881–93 . December 2014 . 25552772 . 4264394 . 10.2471/blt.14.139949.
  39. Web site: New Cholera Vaccine for Adult Travelers . Medscape . 17 April 2017 . 20 August 2017 . live . https://web.archive.org/web/20170908135337/http://www.medscape.com/viewarticle/878238 . 8 September 2017.

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