Cholera vaccine

Cholera vaccine
Cholera vacine (Dukoral)
Vaccine description
Target diseaseCholera
TypeInactivated
Names
Trade namesDukoral, Vaxchora, Shanchol, Euvichol-Plus[1]
Clinical data
Main usesPrevent cholera[2]
Side effectsAbdominal pain, diarrhea[2]
Pregnancy
category
  • US: C (Risk not ruled out)
    External links
    AHFS/Drugs.comMicromedex Detailed Consumer Information
    US NLMCholera vaccine
    Legal
    Legal status

    Cholera vaccines are vaccines used to prevent cholera.[2][10] For the first six months after vaccination they provide about 85 percent protection, which decreases to 50 percent or 62 percent during the first year.[2][11] After two years the level of protection decreases to less than 50 percent.[2] When enough of the population is immunized, it may protect those who have not been immunized (known as herd immunity).[2]

    The World Health Organization (WHO) recommends the use of cholera vaccines in combination with other measures among those at high risk.[2] With the oral vaccine, two or three doses are typically recommended.[2] The duration of protection is two years in adults and six months in children aged 2–5 years.[2] A single dose vaccine is available for those traveling to an area where cholera is common.[12][13][14] In 2010, in some countries an injectable cholera vaccine was available.[2][15]

    The available types of oral vaccine are generally safe.[2] Mild abdominal pain or diarrhea may occur.[2] They are safe in pregnancy and in those with poor immune function.[2] They are licensed for use in more than 60 countries.[2] In countries where the disease is common, the vaccine appears to be cost effective.[2]

    The first vaccines used against cholera were developed in the late 1800s.[16] They were the first widely used vaccine that was made in a laboratory.[16] Oral vaccines were first introduced in the 1990s.[2] It is on the World Health Organization's List of Essential Medicines.[17] In Europe it is licensed for in children over the age of two years.[18] The cost to immunize against cholera is between 0.10 and 4.00 USD.[19] In the UK, two doses costs the NHS around £26.[20] The brand Vaxchora is the only cholera vaccine licensed for use in the US as of 2021.[1]

    Medical use

    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:[21]

    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.

    By mouth

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

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

    Inactivated oral vaccines provide protection in 52 percent of cases the first year following vaccination and in 62 percent of cases the second year.[11] 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.

    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.[22]

    A live, attenuated oral vaccine, Vaxchora was licensed for use in the US in 2016.[1] It is taken by mouth, avoiding eating and drinking for one hour before and after taking it.[1] It comes in 2 packets and is stored away from light and moisture, and in the cold but not frozen.[1] Other brands include Vaccin, Shanchol, and Euvichol-Plus.[1]

    It is generally given as 2 doses of 1.5 ml at least two weeks apart.[23]

    By injection

    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.[15]

    Dosage

    The defined daily dose is not established.[24]

    Side effects

    Both of the available types of oral vaccine are generally safe.[2] Mild abdominal pain or diarrhea may occur.[2] They are safe in pregnancy and in those with poor immune function.[2] They are licensed for use in more than 60 countries.[2] In countries where the disease is common, the vaccine appears to be cost effective.[2]

    History

    Cholera vaccinations by a Guinean nurse using a jet injector in Ziguinchor, Senegal, 1973

    The first vaccines used against cholera were developed in the late 19th century. They were the first widely used vaccine that was made in a laboratory.[16] There were several pioneers in the development of the vaccine. In 1884, Catalan 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. Waldemar Haffkine then developed a vaccine with less severe side effects, testing it on more than 40,000 people in the Calcutta area from 1893 to 1896.[25] 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.[26]

    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.[27] 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.[2] The Shanchol/mORCVAX bivalent vaccine, 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.[2] As of 2010, 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.[2]

    Oral cholera vaccines were first introduced in the 1990s.[2]

    Society and culture

    The cost to immunize against cholera is between US$0.10 and US$4.00 per vaccination.[19]

    The WHO as of late 2013 established a revolving stockpile of two million OCV doses.[28] 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.[29][30]

    In 2016, the U.S. Food and Drug Administration (FDA) approved Vaxchora,[14][13][31] a single-dose oral vaccine to prevent cholera for travelers. As of June 2016, Vaxchora was the only FDA-approved vaccine for the prevention of cholera.[31] The Vaxchora vaccine can cost more than US$250.[32]

    References

    1. 1 2 3 4 5 6 Bonville, Cynthia; Domachowske, Joseph (2021). "8. Cholera". In Domachowske, Joseph; Suryadevara, Manika (eds.). Vaccines: A Clinical Overview and Practical Guide. Switzerland: Springer. pp. 111–119. ISBN 978-3-030-58416-0. Archived from the original on 2022-02-23. Retrieved 2022-02-23.
    2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 World Health Organization (August 2017). "Cholera vaccines: WHO position paper – August 2017". Weekly Epidemiological Record. 92 (34): 477–498. hdl:10665/258764. PMID 28845659. Lay summary (PDF). {{cite journal}}: Cite uses deprecated parameter |lay-url= (help)
    3. ↑ "Summary for ARTG Entry:94483 Dukoral oral inactivated cholera vaccine liquid vial and buffer granules sachet". Therapeutic Goods Administration (TGA). Retrieved 30 July 2020.{{cite web}}: CS1 maint: url-status (link)
    4. ↑ "Dukoral Product information". Health Canada. Archived from the original on 8 February 2021. Retrieved 30 July 2020.
    5. ↑ "Dukoral suspension and effervescent granules for oral suspension, Cholera vaccine (inactivated, oral) - Summary of Product Characteristics (SmPC)". (emc). 7 December 2015. Archived from the original on 23 September 2020. Retrieved 30 July 2020.
    6. ↑ "Vaxchora- cholera vaccine, live, oral kit". DailyMed. 24 October 2018. Archived from the original on 9 February 2021. Retrieved 30 July 2020.
    7. ↑ "Vaxchora- cholera vaccine, live, oral kit". DailyMed. Archived from the original on 5 February 2021. Retrieved 30 July 2020.
    8. ↑ "Eukoral EPAR". European Medicines Agency (EMA). Archived from the original on 13 June 2020. Retrieved 30 July 2020.
    9. ↑ "Vaxchora EPAR". European Medicines Agency (EMA). 30 January 2020. Archived from the original on 8 January 2021. Retrieved 30 July 2020.
    10. ↑ Weil, Ana A.; Ryan, Edward T. (2022). "66. Cholera". In Jong, Elaine C.; Stevens, Dennis L. (eds.). Netter's Infectious Diseases (2nd ed.). Philadelphia: Elsevier. pp. 388–389. ISBN 978-0-323-71159-3. Archived from the original on 2022-02-24. Retrieved 2022-02-24.
    11. 1 2 Sinclair D, Abba K, Zaman K, Qadri F, Graves PM (2011). "Oral vaccines for preventing cholera". Cochrane Database Syst Rev (3): CD008603. doi:10.1002/14651858.CD008603.pub2. PMC 6532691. PMID 21412922.
    12. ↑ "Vaxchora (Cholera vaccine, Live, Oral)" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 1 March 2017. Retrieved 15 March 2017.
    13. 1 2 "Vaxchora approval letter" (PDF). U.S. Food and Drug Administration (FDA). 10 June 2016. Archived from the original (PDF) on 2017-07-22. Retrieved 2020-07-30. Public Domain This article incorporates text from this source, which is in the public domain.
    14. 1 2 "Vaxchora". U.S. Food and Drug Administration (FDA). 1 September 2019. Archived from the original on 17 December 2019. Retrieved 28 December 2019.
    15. 1 2 Graves PM, Deeks JJ, Demicheli V, Jefferson T (2010). "Vaccines for preventing cholera: killed whole cell or other subunit vaccines (injected)". Cochrane Database Syst Rev (8): CD000974. doi:10.1002/14651858.CD000974.pub2. PMC 6532721. PMID 20687062.
    16. 1 2 3 Stanberry, Lawrence R. (2009). Vaccines for biodefense and emerging and neglected diseases (1 ed.). Amsterdam: Academic. p. 870. ISBN 9780080919027. Archived from the original on 2017-09-08.
    17. ↑ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
    18. ↑ Prevatt, Natalie; Behrens, Ron H. (2021). "23. Paediatric vaccines for travel outside Europe". In Vesikari, Timo; Damme, Pierre Van (eds.). Pediatric Vaccines and Vaccinations: A European Textbook (Second ed.). Switzerland: Springer. p. 272. ISBN 978-3-030-77172-0. Archived from the original on 2022-01-11. Retrieved 2022-01-08.
    19. 1 2 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 (1 December 2014). "Post-licensure deployment of oral cholera vaccines: a systematic review". Bulletin of the World Health Organization. 92 (12): 881–93. doi:10.2471/blt.14.139949. PMC 4264394. PMID 25552772.
    20. ↑ "14. Vaccines". British National Formulary (BNF) (82 ed.). London: BMJ Group and the Pharmaceutical Press. September 2021 – March 2022. pp. 1366–1384. ISBN 978-0-85711-413-6.{{cite book}}: CS1 maint: date format (link)
    21. ↑ Oral cholera vaccines in mass immunization campaigns: guidance for planning and use (PDF). World Health Organization. 2010. ISBN 9789241500432. Archived (PDF) from the original on 2014-09-03.
    22. ↑ "Dukoral Canadian Product Monograph Part III: Consumer Information" (PDF). Dukoral. Archived from the original (PDF) on 24 April 2014. Retrieved 8 May 2013.
    23. ↑ "ORAL CHOLERA VACCINE O1 and O139 - Essential drugs". medicalguidelines.msf.org. Archived from the original on 28 August 2021. Retrieved 5 September 2020.
    24. ↑ "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 20 September 2020. Retrieved 22 September 2020.
    25. ↑ Hanhart, Joel (2017). Un illustre inconnu. Une biographie du docteur Waldemar Mordekhaï Haffkine. Paris: Lichma. ISBN 978-2-912553-84-3.
    26. ↑ Artenstein, Andrew W. (2009). Vaccines: A Biography (1 ed.). New York City: Springer Science & Business Media. pp. 89–92. ISBN 9780080919027. Archived from the original on 2017-09-08.
    27. ↑ Harris, JB; LaRocque, RC; Qadri, F; Ryan, ET; Calderwood, SB (30 Jun 2012). "Cholera". Lancet. 379 (9835): 2466–76. doi:10.1016/s0140-6736(12)60436-x. PMC 3761070. PMID 22748592.
    28. ↑ "Oral cholera vaccine stockpile". World Health Organization. Archived from the original on 12 December 2013. Retrieved 18 December 2013.
    29. ↑ "WHO Doubles Global Supply of Cholera Vaccine". Archived from the original on 2016-01-08. Retrieved 2016-01-09.
    30. ↑ "GAVI Board Approves Support to Expand Oral Cholera Vaccine Stockpile". The Task Force on Global Health. Archived from the original on 16 December 2013. Retrieved 18 December 2013.
    31. 1 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. Public Domain This article incorporates text from this source, which is in the public domain.
    32. ↑ "New Cholera Vaccine for Adult Travelers". Medscape. 17 April 2017. Archived from the original on 8 September 2017. Retrieved 20 August 2017. This vaccine can cost more than $250, and travelers may have to pay out of pocket if their insurance does not cover travel vaccines

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