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{{Short description|Vaccine used to protect against rotavirus infections}} |
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{{Main|Rotavirus}} |
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{{Use dmy dates|date=May 2024}} |
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{{Drugbox |
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{{cs1 config |name-list-style=vanc |display-authors=6}} |
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| verifiedrevid = 388152869 |
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{{Infobox drug |
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| Verifiedfields = changed |
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<!--Vacine data--> |
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| verifiedrevid = 448003467 |
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| type = vaccine |
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| type = vaccine |
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| target = rotavirus |
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| image = |
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| width = |
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| alt = |
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| caption = |
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<!-- Vaccine data --> |
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| target = ] |
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| vaccine_type = attenuated |
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| vaccine_type = attenuated |
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<!--Clinical data--> |
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<!-- Clinical data --> |
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| tradename = |
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| pronounce = |
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| tradename = Rotarix, Rotateq, others |
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| Drugs.com = {{drugs.com|monograph|rotavirus-vaccine-live-oral}} |
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| MedlinePlus = a607024 |
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| MedlinePlus = a607024 |
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| DailyMedID = Rotavirus |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> |
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| pregnancy_AU_comment = |
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| pregnancy_US = <!-- A / B / C / D / X --> |
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| pregnancy_category = |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled--> |
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| routes_of_administration = ] |
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| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C --> |
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| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> |
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| routes_of_administration = oral |
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<!--Identifiers--> |
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| ATC_prefix = J07 |
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| ATC_prefix = J07 |
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| ATC_suffix = BH02 |
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| ATC_suffix = BH01 |
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| ATC_supplemental = {{ATC|J07|BH02}} |
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<!--Chemical data--> |
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<!-- Legal status --> |
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| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> |
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| legal_AU_comment = |
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| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> |
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| legal_BR_comment = |
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| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> |
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| legal_CA_comment = |
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| legal_DE = <!-- Anlage I, II, III or Unscheduled --> |
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| legal_DE_comment = |
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| legal_NZ = <!-- Class A, B, C --> |
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| legal_NZ_comment = |
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| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> |
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| legal_UK_comment = |
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| legal_US = Rx-only |
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| legal_US_comment = <ref>{{cite web | title=Rotarix- rotavirus vaccine, live, oral kit; Rotarix- rotavirus vaccine, live, oral solution | website=DailyMed | date=24 January 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f3182470-1965-4e20-dbaf-e3506f893ea5 | access-date=27 May 2024 | archive-date=1 December 2023 | archive-url=https://web.archive.org/web/20231201110332/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f3182470-1965-4e20-dbaf-e3506f893ea5 | url-status=live }}</ref><ref>{{cite web | title=Rotateq- rotavirus vaccine, live, oral, pentavalent solution | website=DailyMed | date=7 March 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaf3b24e-85fd-43ee-b657-2ee4df312ec3 | access-date=27 May 2024 | archive-date=12 September 2023 | archive-url=https://web.archive.org/web/20230912231502/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aaf3b24e-85fd-43ee-b657-2ee4df312ec3 | url-status=live }}</ref> |
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| legal_EU = Rx-only |
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| legal_EU_comment = <ref>{{cite web | title=Rotarix EPAR | website=] (EMA) | date=21 February 2006 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/rotarix | access-date=27 May 2024 | archive-date=1 December 2023 | archive-url=https://web.archive.org/web/20231201180604/https://www.ema.europa.eu/en/medicines/human/EPAR/rotarix | url-status=live }}</ref><ref>{{cite web | website=] (EMA) | title=Rotateq | date=27 June 2006 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/rotateq | access-date=27 May 2024 | archive-date=2 May 2024 | archive-url=https://web.archive.org/web/20240502160202/https://www.ema.europa.eu/en/medicines/human/EPAR/rotateq | url-status=live }}</ref><ref>{{cite web | website=] (EMA) | title=Rotashield EPAR | date=7 June 2001 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/rotashield | access-date=27 May 2024 | archive-date=1 October 2022 | archive-url=https://web.archive.org/web/20221001220538/https://www.ema.europa.eu/en/medicines/human/EPAR/rotashield | url-status=live }}</ref> |
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> |
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| legal_UN_comment = |
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| legal_status = Rx-only |
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<!-- Identifiers --> |
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| CAS_number = 889856-77-3 |
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| CAS_supplemental = |
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| PubChem = |
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| IUPHAR_ligand = |
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| DrugBank = |
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| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}} |
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| ChemSpiderID = none |
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| UNII = |
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| KEGG = D10193 |
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| KEGG2 = D10211 |
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| ChEBI = |
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| ChEMBL = |
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| NIAID_ChemDB = |
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}} |
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}} |
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A '''rotavirus vaccine''' protects children from ]es, which are the leading cause of severe ] among infants and young children.<ref name="Dennehy2000">{{cite journal |author=Dennehy PH |title=Transmission of rotavirus and other enteric pathogens in the home |journal=Pediatr. Infect. Dis. J. |volume=19 |issue=10 Suppl |pages=S103–5 |year=2000 |pmid=11052397 |doi=10.1097/00006454-200010001-00003}}</ref> Each year more than 500,000 children die from diarrhoeal disease caused by rotavirus,<ref> </ref> and another two million are hospitalised.<ref name="Simpson2007">{{cite journal |
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|author=Simpson E, Wittet S, Bonilla J, Gamazina K, Cooley L, Winkler JL |
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|title=Use of formative research in developing a knowledge translation approach to rotavirus vaccine introduction in developing countries |
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|journal=BMC Public Health |
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|volume=7 |
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|pages=281 |
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|year=2007 |
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|pmid=17919334 |
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|doi=10.1186/1471-2458-7-281 |
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|url=http://www.biomedcentral.com/1471-2458/7/281 |
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|pmc=2173895 |
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}}</ref> Nearly every child in the world will suffer an episode of diarrhea caused by rotavirus before age five.<ref name="Valazquez1996">{{cite journal |
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|author=Velázquez FR, Matson DO, Calva JJ, Guerrero L, Morrow AL, Carter-Campbell S, Glass RI, Estes MK, Pickering LK, Ruiz-Palacios GM |
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|title=Rotavirus infections in infants as protection against subsequent infections |
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|journal=N. Engl. J. Med. |
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|volume=335 |
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|issue=14 |
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|pages=1022–8 |
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|year=1996 |
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|pmid=8793926 |
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|url=http://content.nejm.org/cgi/content/full/335/14/1022 |
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|doi=10.1056/NEJM199610033351404 |
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}}</ref> |
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Although the severity of rotavirus infections differs between children living in developed and developing countries, the rates of infection is similar in both settings. <ref name="pmid18202442">{{cite journal | author = Dennehy PH | title = Rotavirus vaccines: an overview | journal = Clinical Microbiology Reviews | volume = 21 | issue = 1 | pages = 198–208 | year = 2008 | month = January | pmid = 18202442 | pmc = 2223838 | doi = 10.1128/CMR.00029-07 | url = | issn = }}</ref> Clean water supplies and good hygiene have little effect on the transmission of infection, and further improvements are unlikely to prevent disease. <ref name="pmid18202442"/> Safe and effective vaccines are needed, especially in poorer countries where most deaths from the disease occur. <ref name="pmid19817620">{{cite journal | author = Parashar UD, Burton A, Lanata C, Boschi-Pinto C, Shibuya K, Steele D, Birmingham M, Glass RI | title = Global mortality associated with rotavirus disease among children in 2004 | journal = The Journal of Infectious Diseases | volume = 200 Suppl 1 | issue = | pages = S9–S15 | year = 2009 | month = November | pmid = 19817620 | doi = 10.1086/605025 | url = | issn = }}</ref> |
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On June 5, 2009, the ] (WHO) recommended that rotavirus vaccine be included in all national immunization programs. Clinical trials “in high-mortality, low-socioeconomic settings of South Africa and Malawi,” WHO stated, “found that the vaccine significantly reduced severe diarrhoea episodes due to rotavirus.” This announcement pertains to GlaxoSmithKline’s oral RotarixTM vaccine. Results of clinical trials with Merck’s oral RotaTeq vaccine in poorer communities in Bangladesh, Vietnam, Ghana, Mali, and Kenya were executed in fall of 2009.<ref>, World Health Organization, Media centre, News, " . . . rotavirus diarrhoea and pneumonia, the two biggest vaccine-preventable diseases . . . ," June 5, 2009.</ref><ref>, Reuters, editing by Stephanie Nebehay, June 5, 2009.</ref> |
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The '''rotavirus vaccine''' is a ] used to protect against ] infections, which are the leading cause of severe ] among young children.<ref name=WHO2013/> The vaccines prevent 15–34% of severe diarrhea in the ] and 37–96% of the risk of death among young children due to severe diarrhea.<ref name=WHO2013/> Immunizing babies decreases rates of disease among older people and those who have not been immunized.<ref name=Patel11>{{cite journal | vauthors = Patel MM, Steele D, Gentsch JR, Wecker J, Glass RI, Parashar UD | title = Real-world impact of rotavirus vaccination | journal = The Pediatric Infectious Disease Journal | volume = 30 | issue = 1 Suppl | pages = S1–S5 | date = January 2011 | pmid = 21183833 | doi = 10.1097/INF.0b013e3181fefa1f | s2cid = 1893099 | doi-access = free }}</ref> |
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The ''Rotavirus Vaccine Program'' aims to reduce child morbidity and mortality from diarrhoeal disease by accelerating the availability of rotavirus vaccines in developing countries. The Rotavirus Vaccine Program is a collaboration between ], WHO, and the U.S. ], and is funded by the ].<ref></ref> |
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The ] (WHO) recommends that rotavirus vaccine be included in national ] programs, especially in areas where the disease is common.<ref name=WHO2013/> This should be done along with promoting ], handwashing, clean water, and good sanitation.<ref name=WHO2013/> It is given ] and requires two or three doses.<ref name=WHO2013/> The vaccines are safe.<ref name=WHO2013/> This includes their use in people with ].<ref name=WHO2013/> The vaccines are made from ].<ref name=WHO2013/> |
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The vaccine first became available in the United States in 2006.<ref name=AHFS2015>{{cite web|title=Rotavirus Vaccine Live Oral|url=https://www.drugs.com/monograph/rotavirus-vaccine-live-oral.html|publisher=The American Society of Health-System Pharmacists|access-date=14 December 2015|url-status=live|archive-url=https://web.archive.org/web/20151222170220/http://www.drugs.com/monograph/rotavirus-vaccine-live-oral.html|archive-date=22 December 2015 }}</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> The vaccine is available in many countries.<ref name=WHO2013>{{cite journal | vauthors = | title = Rotavirus vaccines. WHO position paper – January 2013 | journal = Relevé Épidémiologique Hebdomadaire | volume = 88 | issue = 5 | pages = 49–64 | date = February 2013 | pmid = 23424730 | author-link = World Health Organization | hdl = 10665/242024 }}</ref> |
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==Medical uses== |
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=== Effectiveness === |
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Safety and efficacy trials in Africa and Asia found that the vaccines dramatically reduced severe disease among infants in developing countries, where a majority of rotavirus-related deaths occur.<ref>{{cite journal |vauthors=((World Health Organization)) |title=Rotavirus vaccines: an update |journal=Weekly Epidemiological Record |date=December 2009 |volume=84 |issue=51–52 |pages=533–37 |hdl=10665/241489 | author-link = World Health Organization}}</ref><ref name=":1">{{cite journal | vauthors = Parashar UD, Johnson H, Steele AD, Tate JE | title = Health Impact of Rotavirus Vaccination in Developing Countries: Progress and Way Forward | journal = Clinical Infectious Diseases | volume = 62 | issue = Suppl 2 | pages = S91–S95 | date = May 2016 | pmid = 27059361 | doi = 10.1093/cid/civ1015 | veditors = Parashar UD, Tate JE | doi-access = free | pmc = 11343039 }}</ref> A 2021 ] systematic review concluded that Rotavac, Rotateq, and Rotarix vaccines are safe and are effective at preventing diarrhea that is related to a rotavirus infection.<ref>{{cite journal | vauthors = Bergman H, Henschke N, Hungerford D, Pitan F, Ndwandwe D, Cunliffe N, Soares-Weiser K | title = Vaccines for preventing rotavirus diarrhoea: vaccines in use | journal = The Cochrane Database of Systematic Reviews | volume = 2021 | issue = 11 | pages = CD008521 | date = November 2021 | pmid = 34788488 | pmc = 8597890 | doi = 10.1002/14651858.CD008521.pub6 | collaboration = Cochrane Infectious Diseases Group }}</ref> |
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Rotavirus vaccines are licensed in more than 100 countries, and more than 80 countries have introduced routine rotavirus vaccination.<ref>{{Cite web|url=http://rotacouncil.org/toolkit/rotavirus-burden-vaccine-introduction-map/|title=Rotavirus Deaths & Rotavirus Vaccine Introduction Maps—ROTA Council|website=rotacouncil.org|access-date=29 July 2016|url-status=dead|archive-url=https://web.archive.org/web/20160712033209/http://rotacouncil.org/toolkit/rotavirus-burden-vaccine-introduction-map/|archive-date=12 July 2016}}</ref> The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.<ref name="pmid21734466">{{cite journal | vauthors = Giaquinto C, Dominiak-Felden G, Van Damme P, Myint TT, Maldonado YA, Spoulou V, Mast TC, Staat MA | title = Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries | journal = Human Vaccines | volume = 7 | issue = 7 | pages = 734–748 | date = July 2011 | pmid = 21734466 | doi = 10.4161/hv.7.7.15511 | s2cid = 23996836 | doi-access = free }}</ref> In Mexico, which in 2006 was among the first countries in the world to introduce rotavirus vaccine, the diarrheal disease death rates from rotavirus dropped by more than 65% among children age two and under during the 2009 rotavirus season.<ref>{{cite journal | vauthors = Richardson V, Hernandez-Pichardo J, Quintanar-Solares M, Esparza-Aguilar M, Johnson B, Gomez-Altamirano CM, Parashar U, Patel M | title = Effect of rotavirus vaccination on death from childhood diarrhea in Mexico | journal = The New England Journal of Medicine | volume = 362 | issue = 4 | pages = 299–305 | date = January 2010 | pmid = 20107215 | doi = 10.1056/NEJMoa0905211 | doi-access = free }}</ref> In Nicaragua, which in 2006 became the first developing country to introduce the rotavirus vaccine, investigators recorded a substantial impact, with rotavirus vaccine preventing 60% of cases against severe rotavirus and cutting emergency room visits in half.<ref>{{cite journal | vauthors = Patel M, Pedreira C, De Oliveira LH, Tate J, Orozco M, Mercado J, Gonzalez A, Malespin O, Amador JJ, Umaña J, Balmaseda A, Perez MC, Gentsch J, Kerin T, Hull J, Mijatovic S, Andrus J, Parashar U | title = Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua | journal = JAMA | volume = 301 | issue = 21 | pages = 2243–2251 | date = June 2009 | pmid = 19491186 | doi = 10.1001/jama.2009.756 | doi-access = }}</ref> In the United States, vaccination has reduced rotavirus-related hospitalizations by as much as 86% since 2006. In April 2016, the World Health Organization released statistics for the period of 2000–2013, which showed developing countries that have introduced rotavirus vaccines experienced significant decreases in deaths and hospitalizations from rotavirus diarrhea after introduction.<ref>{{Cite web|title=WHO {{!}} Estimated rotavirus deaths for children under 5 years of age: 2013, 215 000|url=http://www.who.int/immunization/monitoring_surveillance/burden/estimates/rotavirus/en/|archive-url=https://web.archive.org/web/20140402225525/http://www.who.int/immunization/monitoring_surveillance/burden/estimates/rotavirus/en/|url-status=dead|archive-date=2 April 2014|access-date=30 March 2021|website=WHO}}</ref><ref name=":1" /> |
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Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections.<ref name="Patel11" /> A 2014 review of available clinical trial data from countries routinely using rotavirus vaccines in their national immunization programs found that rotavirus vaccines have reduced rotavirus hospitalizations by 49–92% and all-cause diarrhea hospitalizations by 17–55%.<ref>{{cite journal | vauthors = Tate JE, Parashar UD | title = Rotavirus vaccines in routine use | journal = Clinical Infectious Diseases | volume = 59 | issue = 9 | pages = 1291–1301 | date = November 2014 | pmid = 25048849 | doi = 10.1093/cid/ciu564 | doi-access = free }}</ref> |
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===Schedule=== |
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The World Health Organization recommends the first dose of vaccine be given right after six weeks of age.<ref name="WHO2013" /> |
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==Types== |
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=== Rotarix === |
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] |
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Rotarix is a ], human, live attenuated rotavirus vaccine containing one rotavirus strain of G1P specificity. |
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Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.<ref name="pmid17280473">{{cite journal | vauthors = O'Ryan M | title = Rotarix (RIX4414): an oral human rotavirus vaccine | journal = Expert Review of Vaccines | volume = 6 | issue = 1 | pages = 11–19 | date = February 2007 | pmid = 17280473 | doi = 10.1586/14760584.6.1.11 | s2cid = 40193617 }}</ref> It was approved in the European Union in 2006, and by the US FDA in April 2008.<ref>{{cite web | title=Rotarix | website=U.S. ] (FDA) | date=4 November 2022 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/rotarix | access-date=27 May 2024 | archive-date=14 February 2024 | archive-url=https://web.archive.org/web/20240214171156/https://www.fda.gov/vaccines-blood-biologics/vaccines/rotarix | url-status=live }}</ref><ref>{{cite web | title=Rotarix | publisher=U.S. ] (FDA) | date=13 April 2009 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm | archive-url=https://wayback.archive-it.org/7993/20170722073215/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm | access-date=27 May 2024 | archive-date=22 July 2017 }}</ref> It is taken ].<ref>{{cite web | url = https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm | date = 3 April 2008 | title = Approval Letter—Rotarix | archive-url = https://web.archive.org/web/20141129032224/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm | archive-date=29 November 2014| work = U.S. Food and Drug Administration }}</ref><ref name="Clark2013">{{cite book| vauthors = Clark HF, Offit PA, Parashar UD |author-link2=Paul A. Offit | veditors = Plotkin SA, Orenstein WA, Offit PA |title=Vaccines|chapter-url=https://books.google.com/books?id=hoigDQ6vdDQC&pg=PA669|year=2013|publisher=Elsevier Saunders|isbn=978-1-4557-0090-5|pages=669–687|chapter=30. Rotavirus Vaccines}}</ref> |
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=== Rotateq === |
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Rotateq is a live, oral ] that contains five rotavirus strains produced by ].{{medcn|date=May 2024}} The rotavirus{{nbsp}}A parent strains of the reassortants were isolated from human and bovine hosts.{{medcn|date=May 2024}} Four reassortant rotaviruses express one of the outer capsid, VP7, proteins (serotypes G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein VP4 (type P7) from the bovine rotavirus parent strain.{{medcn|date=May 2024}} The fifth reassortant virus expresses the attachment protein VP4, (type P1A), from the human rotavirus parent strain and the outer capsid protein VP7 (serotype G6) from the bovine rotavirus parent strain.{{medcn|date=May 2024}} In February 2006, the US ] (FDA) approved Rotateq for use in the United States.<ref>{{cite web | title=Rotateq | website=U.S. ] (FDA) | date=14 August 2020 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/rotateq | access-date=27 May 2024 | archive-date=17 May 2024 | archive-url=https://web.archive.org/web/20240517102946/https://www.fda.gov/vaccines-blood-biologics/vaccines/rotateq | url-status=live }}</ref><ref>{{cite web | title=Rotateq | publisher=U.S. ] (FDA) | date=25 February 2009 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094063.htm | archive-url=https://wayback.archive-it.org/7993/20170722071743/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094063.htm | access-date=27 May 2024 | archive-date=22 July 2017 }}</ref> In August 2006, ] approved Rotateq for use in Canada.<ref>{{cite press release|url=http://www.merckfrosst.ca/assets/en/pdf/press/product_info/rotateq/press_releases/Release_NATIONAL_CNW.pdf|title=Rotateq Is Approved In Canada|publisher=Merck Frosst Canada|date=23 August 2006|access-date=29 February 2008|url-status=dead|archive-url=https://web.archive.org/web/20081002175444/http://www.merckfrosst.ca/assets/en/pdf/press/product_info/rotateq/press_releases/Release_NATIONAL_CNW.pdf|archive-date=2 October 2008}}</ref> Merck worked with a range of partners including governmental and non-governmental organisations to develop and implement mechanisms for providing access to this vaccine in the developing world,<ref name="pmid12598149">{{cite journal | vauthors = McCarthy M | title = Project seeks to "fast track" rotavirus vaccine | url = https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)12549-4/fulltext | journal = Lancet | volume = 361 | issue = 9357 | pages = 582 | date = February 2003 | pmid = 12598149 | doi = 10.1016/S0140-6736(03)12549-4 | url-access = registration | s2cid = 5347100 | access-date = 2 November 2018 | archive-date = 29 August 2021 | archive-url = https://web.archive.org/web/20210829165429/https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2803%2912549-4/fulltext | url-status = live }}</ref> an effort which was slated to come to an end in 2020.<ref>{{Cite news|url=https://www.ozy.com/presidential-daily-brief/pdb-90376/supply-shortage-90393 | archive-url = https://web.archive.org/web/20181102151230/https://www.ozy.com/presidential-daily-brief/pdb-90376/supply-shortage-90393 | archive-date = 2 November 2018 |title=Merck Ends Delivery of Lifesaving Vaccines to Africa|last=<!--no byline-->|date=2 November 2018 |work=OZY | publisher = Ozymandias.com |access-date=2 November 2018 |department=The Presidential Daily Brief: Intriguing }}</ref> |
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=== Rotavac === |
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Rotavac was licensed for use in India in 2014 and is manufactured by ]. It is a live attenuated, monovalent vaccine containing a G9P human strain isolated from an Indian child.<ref>{{Cite journal|vauthors=((World Health Organization))| author-link = World Health Organization|year=2014|title=Global Advisory Committee on Vaccine Safety, 11-12 June 2014|journal=Weekly Epidemiological Record|issue=29|volume=89|pages=321–36|hdl=10665/242243 }}</ref> It is given by mouth in a three-dose series, four weeks apart, beginning at six weeks of age up until eight months of age.<ref>{{Cite web|url=https://www.bharatbiotech.com/rotavac.html|title=ROTAVAC—Bharat Biotech|access-date=29 October 2019|url-status=dead|archive-url=https://web.archive.org/web/20190607144113/https://www.bharatbiotech.com/rotavac.html|archive-date=7 June 2019}}</ref> |
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=== Rotavin-M1 === |
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Rotavin-M1 was licensed for use in Vietnam in 2007 and is manufactured by the Center for Research and Production of Vaccines. The vaccine contains a G1P human rotavirus strain.<ref name=Rota2016>{{Cite book|url=http://rotacouncil.org/wp-content/uploads/2016/03/White-paper-FINAL-v2.pdf|title=Rotavirus: Common, Severe, Devastating, Preventable|author=Rota Council|year=2016|url-status=live|archive-url=https://web.archive.org/web/20170908183637/http://rotacouncil.org/wp-content/uploads/2016/03/White-paper-FINAL-v2.pdf|archive-date=8 September 2017}}</ref> |
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=== Lanzhou lamb === |
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The Lanzhou lamb rotavirus vaccine was licensed for use in China in 2000 and is manufactured by the Lanzhou Institute of Biological Products. It contains a G10P lamb rotavirus strain.<ref name=Rota2016 /> |
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===Rotasiil=== |
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Rotasiil is a ] pentavalent vaccine licensed for use in India in 2018. It contains human bovine reassortant strains of rotavirus serotypes G1, G2, G3, G4, and G9. This is the world's first thermostable vaccine which can be stored without refrigeration at or below 25 °C. Rotasiil is manufactured by the ].<ref>{{Cite web|date=17 July 2020|title=ROTASIIL|url=https://extranet.who.int/pqweb/content/rotasiil|access-date=30 March 2021|website=WHO—Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)|language=en|archive-date=27 July 2022|archive-url=https://web.archive.org/web/20220727215313/https://extranet.who.int/pqweb/content/rotasiil|url-status=live}}</ref><ref name="pmid28434688">{{cite journal | vauthors = Naik SP, Zade JK, Sabale RN, Pisal SS, Menon R, Bankar SG, Gairola S, Dhere RM | title = Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL®) | journal = Vaccine | volume = 35 | issue = 22 | pages = 2962–2969 | date = May 2017 | pmid = 28434688 | doi = 10.1016/j.vaccine.2017.04.025 }}</ref> |
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== History == |
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== History == |
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In 1998, a rotavirus vaccine (RotaShield, by ]) was licensed for use in the United States. Clinical trials in the United States, ], and ] had found it to be 80 to 100% effective at preventing severe diarrhea caused by rotavirus{{nbsp}}A, and researchers had detected no statistically significant serious adverse effects. However post-licensure studies conducted in the United States by ] and her colleagues at the Centers For Disease Control and Prevention (CDC) and Kramarz et al., found that Infants who received the vaccine were 30 times more likely to develop a severe form of bowel obstruction, called intussusception, during 3 to 7 days after the first dose than unvaccinated infants.<ref>{{cite journal | vauthors = Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, Zanardi LR, Setia S, Fair E, LeBaron CW, Wharton M, Livengood JR | title = Intussusception among infants given an oral rotavirus vaccine | journal = The New England Journal of Medicine | volume = 344 | issue = 8 | pages = 564–572 | date = February 2001 | pmid = 11207352 | doi = 10.1056/NEJM200102223440804 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Kramarz P, France EK, Destefano F, Black SB, Shinefield H, Ward JI, Chang EJ, Chen RT, Shatin D, Hill J, Lieu T, Ogren JM | title = Population-based study of rotavirus vaccination and intussusception | journal = The Pediatric Infectious Disease Journal | volume = 20 | issue = 4 | pages = 410–416 | date = April 2001 | pmid = 11332666 | doi = 10.1097/00006454-200104000-00008 | s2cid = 23664999 }}</ref> The excess risk was estimated between one case in 5,000 to 10,000 vaccinees. Based on these data, the Advisory Committee on Immunization Practices (ACIP) withdrew its recommendation to use the vaccine,<ref>{{cite journal | title = Suspension of rotavirus vaccine after reports of intussusception--United States, 1999 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 53 | issue = 34 | pages = 786–789 | date = September 2004 | pmid = 15343145 | author1 = Centers for Disease Control and Prevention (CDC) }}</ref> and the manufacturer of the vaccine withdrew it from the market in 1999. There then followed eight years of delay until rival manufacturers were able to introduce new vaccines that were shown to be more safe and effective in children: Rotarix by ]<ref name="pmid17280473"/> and Rotateq by ].<ref name="pmid17055370">{{cite journal | vauthors = Matson DO | title = The pentavalent rotavirus vaccine, Rotateq | journal = Seminars in Pediatric Infectious Diseases | volume = 17 | issue = 4 | pages = 195–199 | date = October 2006 | pmid = 17055370 | doi = 10.1053/j.spid.2006.08.005 }}</ref> Both are taken orally and contain disabled live virus.<ref name="AHFS2015" /> |
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In 1998 a rotavirus vaccine (RotaShield, by ]) was licensed for use in the United States. Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe diarrhea caused by rotavirus A, and researchers had detected no statistically significant serious adverse effects. The manufacturer of the vaccine, however, withdrew it from the market in 1999, after it was discovered that the vaccine may have contributed to an increased risk for ], or bowel obstruction, in one of every 12,000 vaccinated infants. The experience provoked debate about the relative risks and benefits of a rotavirus vaccine.<ref name="pmid16099078">{{cite journal |author=Bines J |title=Intussusception and rotavirus vaccines |journal=Vaccine |volume=24 |issue=18 |pages=3772–6 |year=2006 |pmid=16099078 |doi=10.1016/j.vaccine.2005.07.031}}</ref> |
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The World Health Organization recommends that rotavirus vaccine be included in all national immunization schedules because the risk of intussusception following rotavirus vaccination remains very low compared with the benefits of preventing the impact of severe and deadly diarrhoea.<ref>{{cite journal | vauthors = | title = Global Advisory Committee on Vaccine Safety, 11–12 December 2013 | journal = Relevé Épidémiologique Hebdomadaire | volume = 89 | issue = 7 | pages = 53–60 | date = February 2014 | pmid = 24707510 | author-link = World Health Organization | hdl = 10665/242177 }}</ref> |
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In 2006, two vaccines against Rotavirus A infection were shown to be safe and effective in children: Rotarix by ]<ref name="pmid17280473">{{cite journal |author=O'Ryan M |title=Rotarix (RIX4414): an oral human rotavirus vaccine |journal=Expert review of vaccines |volume=6 |issue=1 |pages=11–9 |year=2007 |pmid=17280473 |doi=10.1586/14760584.6.1.11}}</ref> and RotaTeq by ].<ref name="pmid17055370">{{cite journal |author=Matson DO |title=The pentavalent rotavirus vaccine, RotaTeq |journal=Seminars in paediatric infectious diseases |volume=17 |issue=4 |pages=195–9 |year=2006 |pmid=17055370 |doi=10.1053/j.spid.2006.08.005}}</ref> Both are taken orally and contain disabled live virus. |
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== Rotarix == |
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==Society and culture== |
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=== Economics === |
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Rotarix is a human, live attenuated rotavirus vaccine containing a rotavirus strain of G1P specificity. |
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A 2009 review estimated that vaccination against rotavirus would prevent about 45% of deaths due to rotavirus gastroenteritis, or about 228,000 deaths annually worldwide. At US$5 per dose, the estimated cost per life saved was $3,015, $9,951, and $11,296 in low-, lower-middle-, and upper-middle-income countries, respectively.<ref>{{cite journal | vauthors = Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD | title = Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries | journal = The Journal of Infectious Diseases | volume = 200 | issue = Suppl 1 | pages = S16–S27 | date = November 2009 | pmid = 19817595 | doi = 10.1086/605026 | doi-access = free }}</ref> |
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ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.<ref name="pmid17280473">{{cite journal |
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|author=O'Ryan M |
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|title=Rotarix (RIX4414): an oral human rotavirus vaccine |
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|journal=Expert Rev Vaccines |
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|volume=6 |
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|issue=1 |
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|pages=11–9 |
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|year=2007 |
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|pmid=17280473 |
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|doi=10.1586/14760584.6.1.11 |
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}}</ref> The licensure of Rotarix is in process in the European Union.<ref name="pmid16397428">{{cite journal |
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|author=Vesikari T, Giaquinto C, Huppertz HI |
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|title=Clinical trials of rotavirus vaccines in Europe |
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|journal=Pediatr. Infect. Dis. J. |
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|volume=25 |
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|issue=1 Suppl |
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|pages=S42–7 |
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|year=2006 |
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|pmid=16397428 |
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|doi=10.1097/01.inf.0000197565.45345.4e |
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}}</ref> |
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In March 2010 FDA officials urged pediatricians to temporarily stop using GlaxoSmithKline's Rotarix because they found it contaminated with fragments of genetic material — broken pieces of DNA — from what's called ]-1. Even though it is believed to be benign, vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean — Merck's RotaTeq — the FDA decided to err on the side of caution. In May 2010 the suspension of the vaccine was lifted. <ref>FDA's MedWatch Safety Alerts: May 2010 </ref> |
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More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of ].<ref name=Rota2016 /> |
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== RotaTeq == |
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], the inventors of RotaTeq.]] |
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=== Temporary suspension in the US === |
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RotaTeq is a live, oral pentavalent vaccine that contains five rotaviruses produced by ]. The rotavirus A parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid, VP7, proteins (serotypes G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein VP4 (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein VP4, (type P1A), from the human rotavirus parent strain and the outer capsid protein VP7 (serotype G6) from the bovine rotavirus parent strain. In February 2006, the ] approved RotaTeq for use in the United States. In August 2006, ] approved RotaTeq for use in Canada.<ref>{{cite press release|url= http://www.merckfrosst.ca/assets/en/pdf/press/product_info/rotateq/press_releases/Release_NATIONAL_CNW.pdf|title=RotaTeq Is Approved In Canada|publisher=Merck Frosst Canada|date=2006-08-23|accessdate=2008-02-29}}</ref> Merck is working with a range of partners including the Rotavirus Vaccine Program, PATH, (Program for Appropriate Technology in Health) and other governmental and non-governmental organisations to develop and implement mechanisms for providing access to this vaccine in the developing world.<ref name="pmid12598149">{{cite journal |author=McCarthy M |title=Project seeks to "fast track" rotavirus vaccine |journal=Lancet |volume=361 |issue=9357 |pages=582 |year=2003 |pmid=12598149 |doi=10.1016/S0140-6736(03)12549-4}}</ref> |
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In March 2010, the detection of DNA from ] types 1 and 2 within Rotateq and Rotarix prompted the FDA to suspend the use of rotavirus vaccines while conducting an investigation the finding of DNA from porcine circovirus-1 (PCV1) in the vaccine in collaboration with the 12 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).<ref name=ucm212140>{{cite web|author=U.S. Food and Drug Administration|title=Update on Recommendations for the Use of Rotavirus Vaccines|website=]|url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm212140.htm|access-date=13 July 2012|url-status=live|archive-url=https://web.archive.org/web/20120619125145/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm212140.htm|archive-date=19 June 2012}}</ref> On 6 May 2010, the FDA announced its decision to revoke the suspension, stating that porcine circovirus types 1 and 2 pose no safety risks in humans and concluded that health risks involved did not offset the benefits of the vaccination.<ref name=ucm212140/> In May 2010 the suspension of the Rotarix vaccine was lifted.<ref>{{cite web | work = FDA's MedWatch Safety Alerts | date = May 2010 | url = https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213978.htm#Rotarix%20Vaccine%20Suspension%20Lifted | title = Rotarix Vaccine Suspension Lifted | archive-url = https://web.archive.org/web/20100824030729/https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213978.htm | archive-date=24 August 2010 }}</ref> |
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== Effectiveness == |
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==Research== |
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] (MSF) developed a heat-stable version named BRV-PV. Phase 3 of the clinical trials was completed in Niger on 31 December 2020.<ref>{{ClinicalTrialsGov|NCT02145000\Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis Among Infants in Niger}}</ref><ref>{{Cite news |url= https://www.theguardian.com/global-development/2017/mar/22/rotavirus-vaccine-could-save-lives-of-almost-500000-children-a-year |title=Rotavirus vaccine could save lives of almost 500,000 children a year| vauthors = Hodal K |date=22 March 2017|work=The Guardian|access-date=24 March 2017|issn=0261-3077 |url-status=live |archive-url= https://web.archive.org/web/20170323204037/https://www.theguardian.com/global-development/2017/mar/22/rotavirus-vaccine-could-save-lives-of-almost-500000-children-a-year |archive-date=23 March 2017}}</ref> |
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A 2009 review estimated that vaccination against rotavirus would prevent about 45% of deaths due to rotavirus gastroenteritis, or about 228,000 deaths annually worldwide. At $5 per dose the estimated cost per life saved was $3,015, $9,951 and $11,296 in low-, lower-middle-, and upper-middle-income countries, respectively.<ref>{{cite journal |author=Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD |title=Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries |journal=J Infect Dis |volume=200 |issue=Suppl 1 |pages=S16–27 |year=2009 |pmid=19817595 |doi=10.1086/605026 }}</ref> |
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The vaccine has been associated with lower rates of ].<ref>{{Cite news|url=https://www.reuters.com/article/us-health-diabetes-rotavirus-idUSKCN1PG2L8|title=Rotavirus vaccination tied to lower rates of type 1 diabetes|date=22 January 2019|work=Reuters|access-date=10 February 2019|archive-date=10 February 2019|archive-url=https://web.archive.org/web/20190210073715/https://www.reuters.com/article/us-health-diabetes-rotavirus-idUSKCN1PG2L8|url-status=live}}</ref><ref>{{Cite news|url=https://www.nytimes.com/2019/01/30/well/live/rotavirus-vaccine-may-protect-against-type-1-diabetes.html|title=Rotavirus Vaccine May Protect Against Type 1 Diabetes|vauthors=Bakalar N|date=30 January 2019|work=]|access-date=10 February 2019|issn=0362-4331|archive-date=12 February 2019|archive-url=https://web.archive.org/web/20190212012020/https://www.nytimes.com/2019/01/30/well/live/rotavirus-vaccine-may-protect-against-type-1-diabetes.html|url-status=live}}</ref> |
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== References == |
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== References == |
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{{Reflist}} |
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{{reflist|colwidth=30em}} |
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== Further reading == |
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==External links== |
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{{refbegin}} |
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* |
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*: ''Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP).'' |
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* {{cite journal | vauthors = Cortese MM, Parashar UD | title = Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP) | journal = MMWR. Recommendations and Reports | volume = 58 | issue = RR-2 | pages = 1–25 | date = February 2009 | pmid = 19194371 | url = https://www.cdc.gov/mmwr/pdf/rr/rr5802.pdf | access-date = 6 January 2020 | archive-date = 17 October 2020 | archive-url = https://web.archive.org/web/20201017215846/https://www.cdc.gov/mmwr/pdf/rr/rr5802.pdf | url-status = live }} |
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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 19: Rotavirus | chapter-url = https://www.cdc.gov/vaccines/pubs/pinkbook/rota.html | url = https://www.cdc.gov/vaccines/pubs/pinkbook/index.html | access-date = 17 February 2023 | archive-date = 30 December 2016 | archive-url = https://web.archive.org/web/20161230001534/https://www.cdc.gov/vaccines/pubs/pinkbook/index.html | url-status = live }} |
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* from the US Centers for Disease Control and Prevention (as of December 1, 2007, available in English, Spanish, Somali, and Thai) |
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{{refend}} |
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== External links == |
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* {{cite web | title=Rotavirus Vaccine Information Statement | website=U.S. ] (CDC) | date=27 April 2023 | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/rotavirus.html }} |
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* {{MeshName|Rotavirus Vaccines}} |
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{{Portal bar | Medicine | Viruses}} |
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{{DEFAULTSORT:Rotavirus Vaccine}} |
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