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{{Short description|Vaccine to prevent hepatitis A}} |
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{{Globalize/USA|date=June 2011}} |
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{{Use dmy dates|date=November 2022}} |
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{{Drugbox |
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| type=vaccine |
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| image = Havrix junior mondose (hepatitis A).jpg |
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| alt = |
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| caption = Havrix junior monodose (hepatitis A) for children |
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<!--Vacine data--> |
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<!-- Vaccine data --> |
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| target = ] virus |
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| type = vaccine |
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| vaccine_type = Inactivated or attenuated |
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| target = ] |
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| vaccine_type = Killed |
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<!--Clinical data--> |
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| tradename = |
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| tradename = Havrix, others |
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| Drugs.com = {{drugs.com|CDI|hepatitis_a_vaccine}} |
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| Drugs.com = {{drugs.com|monograph|hepatitis-a-virus-vaccine-inactivated}} |
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| pregnancy_category = safety undetermined, risk likely low |
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| legal_US = Rx-only |
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| legal_status = Rx-only (US) |
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| legal_EU = Rx-only |
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| 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> |
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| routes_of_administration = IM |
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| legal_status = Rx-only |
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| DrugBank = DB10989 |
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| UNII = G54MT8V18G |
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<!--Chemical data--> |
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'''Hepatitis A vaccine''' is a vaccine against the ] virus. The first successful vaccine against it was invented by ] at ].<ref>{{cite book |author=Offit PA |title=Vaccinated: One Man's Quest to Defeat the World's Deadliest Diseases |location=Washington, DC |publisher=Smithsonian |isbn=0-06-122796-X |year=2007 |page=107 }}</ref> The vaccine protects against the virus in more than 95% of cases and provides protection from the virus for at least ten years<ref>Van Damme P, Banatvala J, Fay O, Iwarson S, McMahon B, Van Herck K, Shouval D, Bonanni P, Connor B, Cooksley G, Leroux-Roels G, Von Sonnenburg F; International Consensus Group on Hepatitis A Virus Immunity, 2003. Hepatitis A booster vaccination: is there a need? Lancet. 2003 Sep 27;362(9389):1065-71.</ref>. The vaccine contains inactivated Hepatitis A virus which stimulates active immunity against a future infection.<ref name=Avaxim>{{cite web | title = Avaxim | work = NetDoctor.co.uk | url = http://www.netdoctor.co.uk/medicines/100003051.html | accessdate = 2007-03-12}}</ref> |
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<!-- Definition and medical uses --> |
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The vaccine was first phased in around 1996 for children living in high-risk areas. In 1999, it was spread to areas with elevating levels of infection. Today, in the U.S., the vaccine is strongly recommended for all children 12 to 23 months of age in an attempt to eradicate the virus nationwide. The original 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 | accessdate = 2008-06-19}}</ref> it has been in use in Europe since 1993. |
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'''Hepatitis A vaccine''' is a ] that prevents ].<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 ].<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 ].<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> |
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<!-- Recommendations --> |
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According to the ] the following people should be vaccinated: 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 within 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 = CDC | url = http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-hep-a.pdf | date = 2006-03-21 | accessdate = 2007-03-12}}</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 | accessdate = 2007-03-12}}</ref> so people travelling to places where the virus is common like the Indian Subcontinent, Africa, Central America, South America, the far East, and Eastern Europe should also 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 | accessdate = 2007-03-12 |archiveurl = http://web.archive.org/web/20070310143748/http://www.nhsdirect.nhs.uk/articles/article.aspx?articleId=667 <!-- Bot retrieved archive --> |archivedate = 2007-03-10}}</ref> |
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The ] (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 ] (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> |
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* All children aged 12–23 months |
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* Unvaccinated children and adolescents aged 2–18 years |
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* International travelers |
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* ] |
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* People who use injection or non-injection drugs |
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* People who have an occupational risk for infection |
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* People who anticipate close contact with an ] |
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* People experiencing ] |
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* People with ] |
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* People with ] |
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* Any person wishing to obtain immunity<ref name="CDC 2021"/> |
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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. ] (CDC) |date=October 2021 |access-date=13 July 2022}} {{PD-notice}}</ref> |
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The vaccine should be given in the muscle of the upper arm and be given 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=Avaxim /><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 is proven to last at least 10 years and is estimated to last 21 to 27 years if the full course is administered.<ref>{{cite journal |author=Hammitt LL, Bulkow L, Hennessy TW, ''et al'' |title=Persistence of antibody to Hepatitis A virus 10 years after vaccination among children and adults |journal=J. Infect. Dis. |volume=198 |issue=12 |pages=1776–82 |year=2008 |month=December |pmid=18976095 |doi=10.1086/593335 |url=}}</ref> |
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<!-- Safety and formulation--> |
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Severe side effects are very rare.<ref name="WHO2012" /> Pain at the site of injection occurs in about 15% of children and half of adults.<ref name="WHO2012" /> Most hepatitis A vaccines contain inactivated virus while a few contain weakened virus.<ref name="WHO2012" /> The ones with weakened virus are not recommended during ] or in those with ].<ref name="WHO2012" /> A few formulations combine hepatitis A with either ] or ].<ref name="WHO2012" /> |
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<!-- Risks of Vaccine Reaction --> |
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Soreness or redness where the shot is given, fever, headache, tiredness, or loss of appetite can happen after receiving the 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"/> |
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<!-- History, society and culture --> |
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==Medical uses== |
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Within the US, the vaccine Vaqta, developed by ] and his team at ] was licensed in 1995.<ref>{{Cite web|title=Hepatitis A: Vaccine Licensed {{!}} History of Vaccines|url=https://www.historyofvaccines.org/content/hepatitis-vaccine-licensed|archive-url=https://web.archive.org/web/20220121173413/https://www.historyofvaccines.org/content/hepatitis-vaccine-licensed|url-status=dead|archive-date=21 January 2022|access-date=6 February 2021|website=historyofvaccines.org|language=en}}</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 elevated 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 ] (FDA) license for Havrix by ] 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> |
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The US ] (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 near 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. ] (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> |
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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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A ] 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.<ref>{{cite journal |vauthors=Irving GJ, Holden J, Yang R, Pope D |title=Hepatitis A immunisation in persons not previously exposed to hepatitis A |journal=Cochrane Database Syst Rev |volume=7 |issue= 7|pages=CD009051 |year=2012 |pmid=22786522 |doi=10.1002/14651858.CD009051.pub2|pmc=6823267 }}</ref>{{Update inline|reason=Updated version https://www.ncbi.nlm.nih.gov/pubmed/31846062|date = February 2020}} |
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==Commercial vaccines== |
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==Commercial vaccines== |
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This may not be a comprehensive list of all commercial Hepatitis A vaccines available. Please note that the definition of "U" (units) may vary between manufacturers depending on what test they use to measure Hepatitis A antigen in their products. |
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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. |
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*Avaxim: made by ]. Inactivated Hepatitis A virus produced in ] cells. Each dose contains 160 U of antigen adsorbed on ] (0.3 mg Al). <ref>, sanofi pasteur, July 2010. Archived on the electronic Medicines Compendium of the UK. Accessed 30 November 2010.</ref> |
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* Avaxim: made by ]. Inactivated hepatitis A virus produced in ] cells. Each dose contains 160{{nbsp}}U of antigen adsorbed on ] (0.3 mg Al).<ref> {{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> |
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*Epaxal: made by ]. Also sold under the brand names HAVpur® and VIROHEP-A. This vaccine consists of ], artificial particles composed of synthetic ] and ] proteins in addition to the Hepatitis A antigen. It does not contain ]. <ref>, Crucell website. Accessed 30 November 2010. </ref> |
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*Havrix: made by ]. Inactivated Hepatitis A virus produced in ] cells. Each adult dose contains 1440 ] units of viral antigen adsorbed on ] (0.5 mg Al). The pediatric (child) doses contain half the amount of viral antigen and aluminium. <ref>, GlaxoSmithKline, July 2010. Archived on FDA website. Accessed 30 November 2010. </ref> |
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* Epaxal: made by ]. Also sold under the brand names HAVpur and VIROHEP-A. This vaccine consists of ]s, artificial particles composed of synthetic ] and ] proteins in addition to the hepatitis A antigen. It does not contain ].<ref> {{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> |
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*Vaqta: made by ]. Inactivated Hepatitis A virus produced in ] 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. |
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* Havrix: made by ]. Inactivated hepatitis A virus produced in MRC-5 cells. Each adult dose contains 1440 ] 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.<ref> {{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> |
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* Vaqta: made by ]. Inactivated hepatitis A virus produced in MRC-5 cells. An adult dose contains 50{{nbsp}}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.<ref>{{cite web|title=VAQTA (Hepatitis A Vaccine, Inactivated)|url=https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm110049.pdf|publisher=U.S. ] (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> |
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===Combination vaccines=== |
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* ] is a vaccine against hepatitis A and ].<ref>{{cite web | title=Twinrix | website=U.S. ] (FDA) | date=3 October 2019 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/twinrix | access-date=18 October 2020}}</ref> |
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* ] is a vaccine against hepatitis A and ].<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> |
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==References== |
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==References== |
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{{Reflist}} |
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== Further reading == |
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{{refbegin}} |
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* {{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 }} |
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* {{cite book | publisher = U.S. ] (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 }} |
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{{refend}} |
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==See also== |
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==External links== |
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* {{cite web | title=Hepatitis A Vaccine Information Statement | date = 27 April 2023 | publisher = U.S. ] (CDC) | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-a.html }} |
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* {{MeshName|Hepatitis A Vaccines}} |
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{{Vaccines}} |
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{{Portal bar | Medicine | Viruses}} |
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{{Use dmy dates|date=June 2011}} |
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{{Authority control}} |
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{{DEFAULTSORT:Hepatitis A Vaccine}} |
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