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{{Short description|Vaccine to prevent Hepatitis A}}
{{Short description|Vaccine to prevent hepatitis A}}
{{Use dmy dates|date=February 2021}}
{{Use dmy dates|date=November 2022}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Drugbox
{{Drugbox
| type=vaccine
| type=vaccine
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| Watchedfields = changed
| Watchedfields = changed
| verifiedrevid = 447912941
| verifiedrevid = 447912941
|image=Havrix junior mondose (hepatitis A).jpg
| image = Havrix junior mondose (hepatitis A).jpg
| alt =
|caption=Havrix junior monodose (hepatitis A) for children
| caption = Havrix junior monodose (hepatitis A) for children

<!-- Vaccine data -->
<!-- Vaccine data -->
| target = [[Hepatitis A]] virus
| target = [[Hepatitis A]] virus
| vaccine_type = Inactivated or attenuated
| vaccine_type = Inactivated or attenuated

<!-- Clinical data -->
<!-- Clinical data -->
| tradename = Biovac A, Havrix, Vaqta, others
| tradename = Havrix, others
| Drugs.com = {{drugs.com|monograph|hepatitis-a-virus-vaccine-inactivated}}
| Drugs.com = {{drugs.com|monograph|hepatitis-a-virus-vaccine-inactivated}}
| MedlinePlus = a695003
| MedlinePlus = a695003
| pregnancy_AU = B2
| pregnancy_AU = B2
| pregnancy_category =
| pregnancy_category =
| routes_of_administration = [[Intramuscular]]
| routes_of_administration = [[Intramuscular]]
| ATC_prefix = J07
| ATC_prefix = J07
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| legal_US = Rx-only
| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref>{{cite web | title=Havrix - referral | website=European Medicines Agency | date=27 June 2024 | url=https://www.ema.europa.eu/en/medicines/human/referrals/havrix | access-date=12 July 2024}}</ref>
| legal_status =
| legal_status = Rx-only


<!-- Identifiers -->
<!-- Identifiers -->
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<!-- Definition and medical uses -->
<!-- Definition and medical uses -->
'''Hepatitis A vaccine''' is a [[vaccine]] that prevents [[hepatitis A]].<ref name=WHO2012>{{cite journal | vauthors = ((World Health Organization)) | title = WHO position paper on hepatitis A vaccines – June 2012 | journal = Wkly Epidemiol Rec | year = 2012 | volume = 87 | issue = 28/29 | pages = 261–76 | pmid = 22905367 | hdl = 10665/241938 | lay-url=https://www.who.int/immunization/position_papers/PP_hep_A_july2012_summary.pdf?ua=1 }}</ref> It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life.<ref>{{Cite web|url=https://www.cdc.gov/hepatitis/hav/havfaq.htm#B5|title = Hepatitis a Q&As for Health Professionals &#124; CDC|date = 19 January 2022}}</ref> If given, two doses are recommended beginning after the age of one.<ref name=WHO2012/> It is given by [[intramuscular|injection into a muscle]].<ref name=WHO2012/> The first hepatitis A vaccine was approved in [[Europe]] in 1991, and the [[United States]] in 1995.<ref name=":0">{{cite book|last1=Patravale|first1=Vandana|url=https://books.google.com/books?id=VWdEAgAAQBAJ&pg=PA212|title=Nanoparticulate drug delivery perspectives on the transition from laboratory to market|last2=Dandekar|first2=Prajakta|last3=Jain|first3=Ratnesh|date=2012|publisher=Woodhead Pub.|isbn=9781908818195|edition=1. publ.|location=Oxford|page=212}}</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO21st">{{cite book|title=World Health Organization model list of essential medicines: 21st list 2019|vauthors=((World Health Organization))|publisher=World Health Organization|year=2019|location=Geneva|hdl=10665/325771|id=WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO|author-link=World Health Organization|hdl-access=free}}</ref>
'''Hepatitis A vaccine''' is a [[vaccine]] that prevents [[hepatitis A]].<ref name=WHO2012>{{cite journal | vauthors = ((World Health Organization)) | title = WHO position paper on hepatitis A vaccines – June 2012 | journal = Weekly Epidemiological Record | year = 2012 | volume = 87 | issue = 28/29 | pages = 261–76 | pmid = 22905367 | hdl = 10665/241938 | hdl-access=free | author-link=World Health Organization }}</ref><ref name=WHO2022>{{cite journal | vauthors = ((World Health Organization)) | title = WHO position paper on hepatitis A vaccines – October 2022 | journal = Weekly Epidemiological Record | year = 2022 | volume = 97 | issue = 40 | pages = 493–512 | hdl = 10665/363397 | hdl-access=free | author-link=World Health Organization }}</ref> It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life.<ref>{{Cite web|url=https://www.cdc.gov/hepatitis-a/hcp/clinical-overview/ |title = Clinical Overview of Hepatitis A |date = 19 January 2022}}</ref> If given, two doses are recommended beginning after the age of one.<ref name=WHO2012/> It is given by [[intramuscular|injection into a muscle]].<ref name=WHO2012/> The first hepatitis A vaccine was approved in the European Union in 1991, and the United States in 1995.<ref name=":0">{{cite book | vauthors = Patravale V, Dandekar P, Jain R |url=https://books.google.com/books?id=VWdEAgAAQBAJ&pg=PA212|title=Nanoparticulate drug delivery perspectives on the transition from laboratory to market|date=2012|publisher=Woodhead Pub.|isbn=9781908818195|edition=1. publ.|location=Oxford|page=212}}</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO23rd">{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }}</ref>


<!-- Recommendations -->
<!-- Recommendations -->
The [[World Health Organization]] (WHO) recommends universal vaccination in areas where the disease is moderately common.<ref name=WHO2012/> Where the disease is very common, widespread vaccination is not recommended as all people typically develop immunity through infection during childhood.<ref name=WHO2012/> The [[Centers for Disease Control and Prevention]] (CDC) recommends vaccinating:
The [[World Health Organization]] (WHO) recommends universal vaccination in areas where the disease is moderately common.<ref name=WHO2012/> Where the disease is very common, widespread vaccination is not recommended as all people typically develop immunity through infection during childhood.<ref name=WHO2012/> The US [[Centers for Disease Control and Prevention]] (CDC) recommends vaccinating:<ref>{{cite journal | vauthors = Nelson NP, Weng MK, Hofmeister MG, Moore KL, Doshani M, Kamili S, Koneru A, Haber P, Hagan L, Romero JR, Schillie S, Harris AM | title = Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020 | journal = MMWR. Recommendations and Reports | volume = 69 | issue = 5 | pages = 1–38 | date = July 2020 | pmid = 32614811 | pmc = 8631741 | doi=10.15585/mmwr.rr6905a1 | url = <!-- Official URL --> https://www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6905a1-H.pdf }}</ref>
* All children aged 12–23 months
* All children aged 12–23 months
* Unvaccinated children and adolescents aged 2–18 years
* Unvaccinated children and adolescents aged 2–18 years
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* People with [[HIV]]
* People with [[HIV]]
* People with [[chronic liver disease]]
* People with [[chronic liver disease]]
* Any person wishing to obtain immunity<ref name="CDC 2020"/>
* Any person wishing to obtain immunity<ref name="CDC 2021"/>


In addition, a person who has not previously received hepatitis A vaccine and who has direct contact with someone with hepatitis A should get hepatitis A vaccine within 2 weeks after exposure.<ref name="CDC 2020">{{Cite web|date=2020-07-28|title=Hepatitis A VIS|url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html|access-date=2020-10-08}} {{PD-notice}}</ref>
In addition, a person who has not previously received hepatitis A vaccine and who has direct contact with someone with hepatitis A should get hepatitis A vaccine within two weeks after exposure.<ref name="CDC 2021">{{Cite web |title=Hepatitis A Vaccine Information Statement |url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html |publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) |date=October 2021 |access-date=13 July 2022}} {{PD-notice}}</ref>


<!-- Safety and formulation-->
<!-- Safety and formulation-->
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<!-- Risks of Vaccine Reaction -->
<!-- Risks of Vaccine Reaction -->
Soreness or redness where the shot is given, fever, headache, tiredness, or loss of appetite can happen after hepatitis A vaccine. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.[https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html]
Soreness or redness where the shot is given, fever, headache, tiredness, or loss of appetite can happen after hepatitis A vaccine. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.<ref name="CDC 2021"/>


<!-- History, society and culture -->
<!-- History, society and culture -->


==Medical uses==
==Medical uses==
Within the U.S., the vaccine "Vaqta" developed by [[Maurice Hilleman]] and his team at [[Merck & Co.]] was licensed in 1995.<ref>{{Cite web|title=Hepatitis A: Vaccine Licensed {{!}} History of Vaccines|url=https://www.historyofvaccines.org/content/hepatitis-vaccine-licensed|access-date=2021-02-06|website=historyofvaccines.org|language=en}}</ref><ref>{{Cite journal|last=Tulchinsky|first=Theodore H.|date=2018|title=Maurice Hilleman: Creator of Vaccines That Changed the World|journal=Case Studies in Public Health|pages=443–470|doi=10.1016/B978-0-12-804571-8.00003-2|pmc=7150172|isbn=9780128045718}}</ref><ref>{{Cite web|title=Materials Documenting the Contribution of Dr. Maurice Hilleman to the Millennium Time Capsule Ceremony|url=https://americanhistory.si.edu/collections/search/object/nmah_1877060|access-date=2021-02-14|website=National Museum of American History|language=en}}</ref> The vaccine was phased in, around 1996, for children living in high-risk areas. In 1999, its usage was spread to areas with elevating levels of infection. In the U.S. {{asof|2007|lc=y}}, the vaccine is strongly recommended for all children 12 to 23 months of age in an attempt to eradicate the virus nationwide. Although the original [[Food and Drug Administration]] (FDA) license for Havrix by [[GlaxoSmithKline]] is dated in 1995,<ref name=Immunization_info>{{cite web | title = Hepatitis A Vaccine Information | work = Vaccine Information | publisher = ImmunizationInfo | url = http://www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=3 | access-date = 2008-06-19 | url-status = dead | archive-url = https://web.archive.org/web/20070630091756/http://www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=3 | archive-date = 30 June 2007}}</ref> it had been approved in Europe in 1991.<ref name=":0" /><ref>{{Cite web|title=Hepatitis A Vaccine - an overview {{!}} ScienceDirect Topics|url=https://www.sciencedirect.com/topics/medicine-and-dentistry/hepatitis-a-vaccine|access-date=2021-02-14|website=sciencedirect.com}}</ref>
Within the US, the vaccine Vaqta, developed by [[Maurice Hilleman]] and his team at [[Merck & Co.]] was licensed in 1995.<ref>{{Cite web|title=Hepatitis A: Vaccine Licensed {{!}} History of Vaccines|url=https://www.historyofvaccines.org/content/hepatitis-vaccine-licensed|access-date=6 February 2021|website=historyofvaccines.org|language=en}}{{Dead link|date=January 2023 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref>{{Cite journal| vauthors = Tulchinsky TH |date=2018|title=Maurice Hilleman: Creator of Vaccines That Changed the World|journal=Case Studies in Public Health|pages=443–470|doi=10.1016/B978-0-12-804571-8.00003-2|pmc=7150172|isbn=9780128045718}}</ref><ref>{{Cite web|title=Materials Documenting the Contribution of Dr. Maurice Hilleman to the Millennium Time Capsule Ceremony|url=https://americanhistory.si.edu/collections/search/object/nmah_1877060|access-date=14 February 2021|website=National Museum of American History|language=en}}</ref> The vaccine was phased in, around 1996, for children living in high-risk areas. In 1999, its usage was widened to areas with elevating levels of infection. In the US {{asof|2007|lc=y}}, the vaccine is strongly recommended for all children 12 to 23 months of age in an attempt to eradicate the virus nationwide. Although the original [[Food and Drug Administration]] (FDA) license for Havrix by [[GlaxoSmithKline]] is dated 1995,<ref name=Immunization_info>{{cite web | title = Hepatitis A Vaccine Information | work = Vaccine Information | publisher = ImmunizationInfo | url = http://www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=3 | access-date = 19 June 2008 | url-status = dead | archive-url = https://web.archive.org/web/20070630091756/http://www.immunizationinfo.org/vaccineInfo/vaccine_detail.cfv?id=3 | archive-date = 30 June 2007}}</ref> it had been approved in Europe in 1991.<ref name=":0" /><ref>{{Cite web|title=Hepatitis A Vaccine - an overview {{!}} ScienceDirect Topics|url=https://www.sciencedirect.com/topics/medicine-and-dentistry/hepatitis-a-vaccine|access-date=14 February 2021|website=sciencedirect.com}}</ref>


The U.S. [[Centers for Disease Control and Prevention]] (CDC), recommends vaccination of all children over one year of age, people whose sexual activity puts them at risk, people with chronic liver disease, people who are being treated with clotting factor concentrates, people working in close proximity to the virus, and people who are living in communities where an outbreak is present.<ref name=CDC_2006>{{cite web | title = Hepatitis A Vaccine: What you need to know | work = Vaccine Information Statement | publisher = [[Centers for Disease Control and Prevention]] (CDC) | url = https://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-a.pdf | date = 2006-03-21 | access-date = 2007-03-12 | url-status = live | archive-url = https://web.archive.org/web/20071120133442/http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-a.pdf | archive-date = 20 November 2007}}</ref> Hepatitis A is the most common vaccine-preventable virus acquired during travel,<ref name=CDC-Yellow-Book>{{cite web|title=Hepatitis, Viral, Type A |work=Travelers' Health: Yellow Book (CDC) |url=http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=hav.htm |access-date=2007-03-12 |url-status=dead |archive-url=https://web.archive.org/web/20070328034621/http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=hav.htm |archive-date=28 March 2007}}</ref> so people traveling to places where the virus is common like the Indian subcontinent, Africa, Central America, South America, Asia, and Eastern Europe should be vaccinated.<ref name=CDC_2006 /><ref name=NHS_2006>{{cite web|title=Hepatitis A: Introduction |publisher=NHS Direct |url=http://www.nhsdirect.nhs.uk/articles/article.aspx?articleId=667 |date=2006-10-10 |access-date=2007-03-12 |archive-url=https://web.archive.org/web/20070310143748/http://www.nhsdirect.nhs.uk/articles/article.aspx?articleId=667 |archive-date=10 March 2007 |url-status=dead}}</ref>
The US [[Centers for Disease Control and Prevention]] (CDC) recommends vaccination of all children over one year of age, people whose sexual activity puts them at risk, people with chronic liver disease, people who are being treated with clotting factor concentrates, people working in close proximity to the virus, and people who are living in communities where an outbreak is present.<ref name=CDC_2006>{{cite web | title = Hepatitis A Vaccine: What you need to know | work = Vaccine Information Statement | publisher = U.S. [[Centers for Disease Control and Prevention]] (CDC) | url = https://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-a.pdf | date = 21 March 2006 | access-date = 12 March 2007 | url-status = live | archive-url = https://web.archive.org/web/20071120133442/http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-a.pdf | archive-date = 20 November 2007}}</ref> Hepatitis A is the most common vaccine-preventable virus acquired during travel,<ref name=CDC-Yellow-Book>{{cite web|title=Hepatitis, Viral, Type A |work=Travelers' Health: Yellow Book (CDC) |url=http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=hav.htm |access-date=12 March 2007 |url-status=dead |archive-url=https://web.archive.org/web/20070328034621/http://www2.ncid.cdc.gov/travel/yb/utils/ybGet.asp?section=dis&obj=hav.htm |archive-date=28 March 2007}}</ref> so people traveling to places where the virus is common like the Indian subcontinent, Africa, Central America, South America, Asia, and Eastern Europe should be vaccinated.<ref name=CDC_2006 /><ref name=NHS_2006>{{cite web|title=Hepatitis A: Introduction |publisher=NHS Direct |url=http://www.nhsdirect.nhs.uk/articles/article.aspx?articleId=667 |date=10 October 2006 |access-date=12 March 2007 |archive-url=https://web.archive.org/web/20070310143748/http://www.nhsdirect.nhs.uk/articles/article.aspx?articleId=667 |archive-date=10 March 2007 |url-status=dead}}</ref>


The vaccine is given in the muscle of the upper arm, in two doses for the best protection. The initial dose of the vaccine should be followed up by a booster six to twelve months later.<ref name=CDC_2006 /> Protection against hepatitis A begins approximately two to four weeks after the initial vaccination.<ref name=CDC_2006 /><ref name=NHS_2006 /> Protection lasts at least 15 years and is estimated to last at least 25 years if the booster is administered.<ref name=Ott2012>{{cite journal |vauthors=Ott JJ, Irving G, Wiersma ST |title=Long-term protective effects of hepatitis A vaccines. A systematic review |journal=Vaccine |volume=31 |issue=1 |pages=3–11 |date=December 2012 |pmid=22609026 |doi=10.1016/j.vaccine.2012.04.104|doi-access=free }}</ref>
The vaccine is given in the muscle of the upper arm, in two doses for the best protection. The initial dose of the vaccine should be followed up by a booster six to twelve months later.<ref name=CDC_2006 /> Protection against hepatitis A begins approximately two to four weeks after the initial vaccination.<ref name=CDC_2006 /><ref name=NHS_2006 /> Protection lasts at least 15 years and is estimated to last at least 25 years if the booster is administered.<ref name=Ott2012>{{cite journal |vauthors=Ott JJ, Irving G, Wiersma ST |title=Long-term protective effects of hepatitis A vaccines. A systematic review |journal=Vaccine |volume=31 |issue=1 |pages=3–11 |date=December 2012 |pmid=22609026 |doi=10.1016/j.vaccine.2012.04.104|doi-access=free }}</ref>
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==Commercial vaccines==
==Commercial vaccines==
[[File:Havrix-rokote.jpg|thumb|Havrix vaccine]]
[[File:Havrix-rokote.jpg|thumb|Havrix vaccine]]

Several commercial hepatitis A vaccines are available. The definition of (U)nits varies among manufacturers depending on how hepatitis A antigen is measured in their products.
Several commercial hepatitis A vaccines are available. The definition of (U)nits varies among manufacturers depending on how hepatitis A antigen is measured in their products.
* Avaxim: made by [[Sanofi Pasteur]]. Inactivated hepatitis A virus produced in [[MRC-5]] cells. Each dose contains 160{{nbsp}}U of antigen adsorbed on [[aluminium hydroxide]] (0.3&nbsp;mg Al).<ref>[http://www.medicines.org.uk/emc/medicine/17385/PIL/AVAXIM/ Patient Information Leaflet] {{webarchive|url=https://web.archive.org/web/20110720014700/http://www.medicines.org.uk/emc/medicine/17385/PIL/AVAXIM/ |date=20 July 2011 }}, sanofi pasteur, July 2010. Archived on the electronic Medicines Compendium of the UK. Accessed 30 November 2010.</ref>
* Avaxim: made by [[Sanofi Pasteur]]. Inactivated hepatitis A virus produced in [[MRC-5]] cells. Each dose contains 160{{nbsp}}U of antigen adsorbed on [[aluminium hydroxide]] (0.3&nbsp;mg Al).<ref>[http://www.medicines.org.uk/emc/medicine/17385/PIL/AVAXIM/ Patient Information Leaflet] {{webarchive|url=https://web.archive.org/web/20110720014700/http://www.medicines.org.uk/emc/medicine/17385/PIL/AVAXIM/ |date=20 July 2011 }}, sanofi pasteur, July 2010. Archived on the electronic Medicines Compendium of the UK. Accessed 30 November 2010.</ref>
* Epaxal: made by [[Crucell]]. Also sold under the brand names HAVpur and VIROHEP-A. This vaccine consists of [[virosome]]s, artificial particles composed of synthetic [[lipids]] and [[influenza]] proteins in addition to the hepatitis A antigen. It does not contain [[aluminium]].<ref>[http://www.crucell.com/Products-Epaxal Epaxal] {{webarchive|url=https://web.archive.org/web/20110119133907/http://www.crucell.com/Products-Epaxal |date=19 January 2011 }}, Crucell website. Accessed 30 November 2010.</ref>
* Epaxal: made by [[Crucell]]. Also sold under the brand names HAVpur and VIROHEP-A. This vaccine consists of [[virosome]]s, artificial particles composed of synthetic [[lipids]] and [[influenza]] proteins in addition to the hepatitis A antigen. It does not contain [[aluminium]].<ref>[http://www.crucell.com/Products-Epaxal Epaxal] {{webarchive|url=https://web.archive.org/web/20110119133907/http://www.crucell.com/Products-Epaxal |date=19 January 2011 }}, Crucell website. Accessed 30 November 2010.</ref>
* Havrix: made by [[GlaxoSmithKline]]. Inactivated hepatitis A virus produced in MRC-5 cells. Each adult dose contains 1440 [[ELISA]] units of viral antigen adsorbed on aluminium hydroxide (0.5&nbsp;mg Al). The pediatric (child) doses contain half the amount of viral antigen and aluminium.<ref>[https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM224555.pdf Full Prescribing Information] {{webarchive|url=https://web.archive.org/web/20110818203700/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM224555.pdf |date=18 August 2011 }}, GlaxoSmithKline, July 2010. Archived on FDA website. Accessed 30 November 2010.</ref>
* Havrix: made by [[GlaxoSmithKline]]. Inactivated hepatitis A virus produced in MRC-5 cells. Each adult dose contains 1440 [[ELISA]] units of viral antigen adsorbed on aluminium hydroxide (0.5&nbsp;mg Al). The pediatric (child) doses contain half the amount of viral antigen and aluminium.<ref>[https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM224555.pdf Full Prescribing Information] {{webarchive|url=https://web.archive.org/web/20110818203700/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM224555.pdf |date=18 August 2011 }}, GlaxoSmithKline, July 2010. Archived on FDA website. Accessed 30 November 2010.</ref>
* Healive: made by [[Sinovac Biotech|Sinovac]]. Inactivated hepatitis A virus cultured in human [[diploid cell]], followed by harvest, purification, inactivation, and aluminium adsorption. Each adult dose contains 500{{nbsp}}U of viral antigen. The pediatric dose contains 250{{nbsp}}U of viral antigen.
* Vaqta: made by [[Merck & Co.|Merck]]. Inactivated hepatitis A virus produced in MRC-5 cells. An adult dose contains 50{{nbsp}}U of antigen adsorbed onto 0.45&nbsp;mg of aluminium (as aluminium hydroxyphosphate sulfate); a child dose contains half the amounts of antigen and aluminium.<ref>{{cite web|title=VAQTA (Hepatitis A Vaccine, Inactivated)|url=https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm110049.pdf|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=7 February 2014|page=11|url-status=live|archive-url=https://web.archive.org/web/20150221023153/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110049.pdf|archive-date=21 February 2015}}</ref>
* Vaqta: made by [[Merck & Co.|Merck]]. Inactivated hepatitis A virus produced in MRC-5 cells. An adult dose contains 50{{nbsp}}U of antigen adsorbed onto 0.45&nbsp;mg of aluminium (as aluminium hydroxyphosphate sulfate); a child dose contains half the amounts of antigen and aluminium.<ref>{{cite web|title=VAQTA (Hepatitis A Vaccine, Inactivated)|url=https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm110049.pdf|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=7 February 2014|page=11|url-status=live|archive-url=https://web.archive.org/web/20150221023153/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM110049.pdf|archive-date=21 February 2015}}</ref>
* Biovac-A: made by [[Pukang Biotec|Pukang]], sold under the brand name Biovac-A in India and under the brand names Mevac-A in Guatemala, Philippines, Bangladesh, Nepal, Uzbekistan and Chile etc. It is a [[freeze-dried]] live attenuated hepatitis A vaccine. Hepatitis A virus H2 strain is produced in human diploid cells. A pack of 0.5ml vial of Biovac-A and 0.5ml ampoule of SWFI (sterile water for injection), contains not be less than 6.5 Lg CCID50. Only a single dose is needed. It is recommended by the WHO. Long term persistence research data predicated that [[sero-conversion]] remained and antibody titre was not less than 128{{nbsp}}IU/ml, 15 years after vaccination.{{citation needed|date=January 2021}}


===Combination vaccines===
===Combination vaccines===
* [[Hepatitis A and B vaccine]] is a vaccine against hepatitis A and [[hepatitis B]].<ref>{{cite web | title=Twinrix | website=U.S. [[Food and Drug Administration]] (FDA) | date=3 October 2019 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/twinrix | access-date=18 October 2020}}</ref>
* [[Hepatitis A and B vaccine]] is a vaccine against hepatitis A and [[hepatitis B]].<ref>{{cite web | title=Twinrix | website=U.S. [[Food and Drug Administration]] (FDA) | date=3 October 2019 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/twinrix | access-date=18 October 2020}}</ref>
* [[Hepatitis A and typhoid vaccine]] is a vaccine against hepatitis A and [[typhoid]].<ref>{{cite web |url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2013-PI-01314-1&d=202010181016933|title=Australian Product Information – Vivaxim (Salmonella typhi Vi polysaccharide and hepatitis A virus antigen) Vaccine |access-date=18 October 2020 }}</ref><ref>{{cite web |url=https://www.nps.org.au/medicine-finder/vivaxim-solution-for-injection |title=Vivaxim Salmonella typhi vaccine; Hepatitis A vaccine |access-date=18 October 2020 }}</ref><ref>{{cite web | title=Vivaxim 1mL injection syringe composite pack | website=Therapeutic Goods Administration (TGA) | url=http://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=82745 | access-date=18 October 2020}}</ref><ref>{{cite web | title=Summary for ARTG Entry: 82745 Vivaxim 1mL injection syringe composite pack | website=Therapeutic Goods Administration (TGA) | url=http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=E218E86A08F82F6CCA2585FB003CB527&agid=(PrintDetailsPublic)&actionid=1 | access-date=18 October 2020 }}{{Dead link|date=February 2022 |bot=InternetArchiveBot |fix-attempted=yes }}</ref>
* [[Hepatitis A and typhoid vaccine]] is a vaccine against hepatitis A and [[typhoid]].<ref>{{cite web |url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2013-PI-01314-1&d=202010181016933|title=Australian Product Information – Vivaxim (Salmonella typhi Vi polysaccharide and hepatitis A virus antigen) Vaccine |access-date=18 October 2020 }}</ref><ref>{{cite web |url=https://www.nps.org.au/medicine-finder/vivaxim-solution-for-injection |title=Vivaxim Salmonella typhi vaccine; Hepatitis A vaccine |date=6 March 2020 |access-date=18 October 2020 }}</ref><ref>{{cite web | title=Vivaxim 1mL injection syringe composite pack | publisher=Therapeutic Goods Administration (TGA) | url=http://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=82745 | access-date=18 October 2020 | archive-date=19 October 2020 | archive-url=https://web.archive.org/web/20201019104651/http://tga-search.clients.funnelback.com/s/search.html?collection=tga-artg&profile=record&meta_i=82745 | url-status=dead }}</ref><ref>{{cite web | title=Summary for ARTG Entry: 82745 Vivaxim 1mL injection syringe composite pack | publisher=Therapeutic Goods Administration (TGA) | url=http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=E218E86A08F82F6CCA2585FB003CB527&agid=(PrintDetailsPublic)&actionid=1 | access-date=18 October 2020 }}{{Dead link|date=February 2022 |bot=InternetArchiveBot |fix-attempted=yes }}</ref>


==References==
==References==
Line 93: Line 97:


== Further reading ==
== Further reading ==
{{refbegin}}
* {{cite book | title=Immunisation against infectious disease | chapter=Chapter 17: Hepatitis A | chapter-url=https://www.gov.uk/government/publications/hepatitis-a-the-green-book-chapter-17 | publisher=Public Health England | editor-first=Mary | editor-last=Ramsay | name-list-style = vanc | url=https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book | year=2013 }}
* {{cite book | title=Immunisation against infectious disease | chapter=Chapter 17: Hepatitis A | chapter-url=https://www.gov.uk/government/publications/hepatitis-a-the-green-book-chapter-17 | publisher=Public Health England | veditors = Ramsay M | url=https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book | year=2013 }}
* {{cite book | publisher = U.S. [[Centers for Disease Control and Prevention]] (CDC) | title = Epidemiology and Prevention of Vaccine-Preventable Diseases | veditors = Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S | edition = 14th | location = Washington D.C. | year = 2021 | chapter = Chapter 9: Hepatitis A | chapter-url = https://www.cdc.gov/vaccines/pubs/pinkbook/hepa.html | url=https://www.cdc.gov/vaccines/pubs/pinkbook/index.html }}
{{refend}}


==External links==
==External links==
* {{cite web | title=Hepatitis A Vaccine Information Statement | website=[[Centers for Disease Control and Prevention]] (CDC) | date=8 April 2021 | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html }}
* {{cite web | title=Hepatitis A Vaccine Information Statement | date = 27 April 2023 | publisher = U.S. [[Centers for Disease Control and Prevention]] (CDC) | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html }}
* {{MeshName|Hepatitis A Vaccines}}
* {{MeshName|Hepatitis A Vaccines}}


{{Vaccines}}
{{Vaccines}}
{{Portal bar | Medicine | Viruses}}
{{Portal bar | Medicine | Viruses}}
{{Authority control}}


{{DEFAULTSORT:Hepatitis A Vaccine}}
{{DEFAULTSORT:Hepatitis A Vaccine}}
[[Category:Hepatitis A]]
[[Category:Hepatitis A]]
[[Category:Inactivated vaccines]]
[[Category:Drugs developed by GSK plc]]
[[Category:Hepatitis vaccines]]
[[Category:Hepatitis vaccines]]
[[Category:GlaxoSmithKline brands]]
[[Category:Inactivated vaccines]]
[[Category:Merck & Co. brands]]
[[Category:Drugs developed by Merck & Co.]]
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[[Category:World Health Organization essential medicines (vaccines)]]
[[Category:Wikipedia medicine articles ready to translate]]
[[Category:Wikipedia medicine articles ready to translate]]
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[[Category:World Health Organization essential medicines (vaccines)]]

Revision as of 02:59, 12 November 2024

Hepatitis A vaccine
Havrix junior monodose (hepatitis A) for children
Vaccine description
TargetHepatitis A virus
Vaccine typeInactivated or attenuated
Clinical data
Trade namesHavrix, others
AHFS/Drugs.comMonograph
MedlinePlusa695003
Pregnancy
category
  • AU: B2
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only[1]
  • In general: ℞ (Prescription only)
Identifiers
DrugBank
ChemSpider
  • none
UNII
 ☒NcheckY (what is this?)  (verify)

Hepatitis A vaccine is a vaccine that prevents hepatitis A.[2][3] It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life.[4] If given, two doses are recommended beginning after the age of one.[2] It is given by injection into a muscle.[2] The first hepatitis A vaccine was approved in the European Union in 1991, and the United States in 1995.[5] It is on the World Health Organization's List of Essential Medicines.[6]

The World Health Organization (WHO) recommends universal vaccination in areas where the disease is moderately common.[2] Where the disease is very common, widespread vaccination is not recommended as all people typically develop immunity through infection during childhood.[2] The US Centers for Disease Control and Prevention (CDC) recommends vaccinating:[7]

In addition, a person who has not previously received hepatitis A vaccine and who has direct contact with someone with hepatitis A should get hepatitis A vaccine within two weeks after exposure.[8]

Severe side effects are very rare.[2] Pain at the site of injection occurs in about 15% of children and half of adults.[2] Most hepatitis A vaccines contain inactivated virus while a few contain weakened virus.[2] The ones with weakened virus are not recommended during pregnancy or in those with poor immune function.[2] A few formulations combine hepatitis A with either hepatitis B or typhoid vaccine.[2]

Soreness or redness where the shot is given, fever, headache, tiredness, or loss of appetite can happen after hepatitis A vaccine. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injury, or death.[8]


Medical uses

Within the US, the vaccine Vaqta, developed by Maurice Hilleman and his team at Merck & Co. was licensed in 1995.[9][10][11] The vaccine was phased in, around 1996, for children living in high-risk areas. In 1999, its usage was widened to areas with elevating levels of infection. In the US as of 2007, the vaccine is strongly recommended for all children 12 to 23 months of age in an attempt to eradicate the virus nationwide. Although the original Food and Drug Administration (FDA) license for Havrix by GlaxoSmithKline is dated 1995,[12] it had been approved in Europe in 1991.[5][13]

The US Centers for Disease Control and Prevention (CDC) recommends vaccination of all children over one year of age, people whose sexual activity puts them at risk, people with chronic liver disease, people who are being treated with clotting factor concentrates, people working in close proximity to the virus, and people who are living in communities where an outbreak is present.[14] Hepatitis A is the most common vaccine-preventable virus acquired during travel,[15] so people traveling to places where the virus is common like the Indian subcontinent, Africa, Central America, South America, Asia, and Eastern Europe should be vaccinated.[14][16]

The vaccine is given in the muscle of the upper arm, in two doses for the best protection. The initial dose of the vaccine should be followed up by a booster six to twelve months later.[14] Protection against hepatitis A begins approximately two to four weeks after the initial vaccination.[14][16] Protection lasts at least 15 years and is estimated to last at least 25 years if the booster is administered.[17]

A Cochrane review found that both types of vaccines offer significant protection, for at least two years using the inactivated vaccine and at least five years with the attenuated vaccine. The review concluded that the inactivated vaccine is safe, but required more high quality evidence to assess the safety of the attenuated vaccine.[18][needs update]

Commercial vaccines

Havrix vaccine

Several commercial hepatitis A vaccines are available. The definition of (U)nits varies among manufacturers depending on how hepatitis A antigen is measured in their products.

  • Avaxim: made by Sanofi Pasteur. Inactivated hepatitis A virus produced in MRC-5 cells. Each dose contains 160 U of antigen adsorbed on aluminium hydroxide (0.3 mg Al).[19]
  • Epaxal: made by Crucell. Also sold under the brand names HAVpur and VIROHEP-A. This vaccine consists of virosomes, artificial particles composed of synthetic lipids and influenza proteins in addition to the hepatitis A antigen. It does not contain aluminium.[20]
  • Havrix: made by GlaxoSmithKline. Inactivated hepatitis A virus produced in MRC-5 cells. Each adult dose contains 1440 ELISA units of viral antigen adsorbed on aluminium hydroxide (0.5 mg Al). The pediatric (child) doses contain half the amount of viral antigen and aluminium.[21]
  • Vaqta: made by Merck. Inactivated hepatitis A virus produced in MRC-5 cells. An adult dose contains 50 U of antigen adsorbed onto 0.45 mg of aluminium (as aluminium hydroxyphosphate sulfate); a child dose contains half the amounts of antigen and aluminium.[22]

Combination vaccines

References

  1. ^ "Havrix - referral". European Medicines Agency. 27 June 2024. Retrieved 12 July 2024.
  2. ^ a b c d e f g h i j World Health Organization (2012). "WHO position paper on hepatitis A vaccines – June 2012". Weekly Epidemiological Record. 87 (28/29): 261–76. hdl:10665/241938. PMID 22905367.
  3. ^ World Health Organization (2022). "WHO position paper on hepatitis A vaccines – October 2022". Weekly Epidemiological Record. 97 (40): 493–512. hdl:10665/363397.
  4. ^ "Clinical Overview of Hepatitis A". 19 January 2022.
  5. ^ a b Patravale V, Dandekar P, Jain R (2012). Nanoparticulate drug delivery perspectives on the transition from laboratory to market (1. publ. ed.). Oxford: Woodhead Pub. p. 212. ISBN 9781908818195.
  6. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  7. ^ Nelson NP, Weng MK, Hofmeister MG, Moore KL, Doshani M, Kamili S, et al. (July 2020). "Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020" (PDF). MMWR. Recommendations and Reports. 69 (5): 1–38. doi:10.15585/mmwr.rr6905a1. PMC 8631741. PMID 32614811.
  8. ^ a b c "Hepatitis A Vaccine Information Statement". U.S. Centers for Disease Control and Prevention (CDC). October 2021. Retrieved 13 July 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ "Hepatitis A: Vaccine Licensed | History of Vaccines". historyofvaccines.org. Retrieved 6 February 2021.[permanent dead link‍]
  10. ^ Tulchinsky TH (2018). "Maurice Hilleman: Creator of Vaccines That Changed the World". Case Studies in Public Health: 443–470. doi:10.1016/B978-0-12-804571-8.00003-2. ISBN 9780128045718. PMC 7150172.
  11. ^ "Materials Documenting the Contribution of Dr. Maurice Hilleman to the Millennium Time Capsule Ceremony". National Museum of American History. Retrieved 14 February 2021.
  12. ^ "Hepatitis A Vaccine Information". Vaccine Information. ImmunizationInfo. Archived from the original on 30 June 2007. Retrieved 19 June 2008.
  13. ^ "Hepatitis A Vaccine - an overview | ScienceDirect Topics". sciencedirect.com. Retrieved 14 February 2021.
  14. ^ a b c d "Hepatitis A Vaccine: What you need to know" (PDF). Vaccine Information Statement. U.S. Centers for Disease Control and Prevention (CDC). 21 March 2006. Archived (PDF) from the original on 20 November 2007. Retrieved 12 March 2007.
  15. ^ "Hepatitis, Viral, Type A". Travelers' Health: Yellow Book (CDC). Archived from the original on 28 March 2007. Retrieved 12 March 2007.
  16. ^ a b "Hepatitis A: Introduction". NHS Direct. 10 October 2006. Archived from the original on 10 March 2007. Retrieved 12 March 2007.
  17. ^ Ott JJ, Irving G, Wiersma ST (December 2012). "Long-term protective effects of hepatitis A vaccines. A systematic review". Vaccine. 31 (1): 3–11. doi:10.1016/j.vaccine.2012.04.104. PMID 22609026.
  18. ^ Irving GJ, Holden J, Yang R, Pope D (2012). "Hepatitis A immunisation in persons not previously exposed to hepatitis A". Cochrane Database Syst Rev. 7 (7): CD009051. doi:10.1002/14651858.CD009051.pub2. PMC 6823267. PMID 22786522.
  19. ^ Patient Information Leaflet Archived 20 July 2011 at the Wayback Machine, sanofi pasteur, July 2010. Archived on the electronic Medicines Compendium of the UK. Accessed 30 November 2010.
  20. ^ Epaxal Archived 19 January 2011 at the Wayback Machine, Crucell website. Accessed 30 November 2010.
  21. ^ Full Prescribing Information Archived 18 August 2011 at the Wayback Machine, GlaxoSmithKline, July 2010. Archived on FDA website. Accessed 30 November 2010.
  22. ^ "VAQTA (Hepatitis A Vaccine, Inactivated)" (PDF). U.S. Food and Drug Administration (FDA). p. 11. Archived (PDF) from the original on 21 February 2015. Retrieved 7 February 2014.
  23. ^ "Twinrix". U.S. Food and Drug Administration (FDA). 3 October 2019. Retrieved 18 October 2020.
  24. ^ "Australian Product Information – Vivaxim (Salmonella typhi Vi polysaccharide and hepatitis A virus antigen) Vaccine". Retrieved 18 October 2020.
  25. ^ "Vivaxim Salmonella typhi vaccine; Hepatitis A vaccine". 6 March 2020. Retrieved 18 October 2020.
  26. ^ "Vivaxim 1mL injection syringe composite pack". Therapeutic Goods Administration (TGA). Archived from the original on 19 October 2020. Retrieved 18 October 2020.
  27. ^ "Summary for ARTG Entry: 82745 Vivaxim 1mL injection syringe composite pack". Therapeutic Goods Administration (TGA). Retrieved 18 October 2020.[permanent dead link‍]

Further reading

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