rotavirus vaccine

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.{{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}}{{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 }} A 2021 Cochrane systematic review concluded that Rotavac, Rotateq, and Rotarix vaccines are safe and are effective at preventing diarrhea that is related to a rotavirus infection.{{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 }}

Rotavirus vaccines are licensed in more than 100 countries, and more than 80 countries have introduced routine rotavirus vaccination.{{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}} The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.{{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 }} 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.{{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 }} 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.{{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 = }} 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.{{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}}

Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections. 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%.{{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 }}

The World Health Organization recommends the first dose of vaccine be given right after six weeks of age.

File:Rotarix.jpg

Rotarix is a monovalent, human, live attenuated rotavirus vaccine containing one rotavirus strain of G1P[8] specificity.

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.{{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 }} It was approved in the European Union in 2006, and by the US FDA in April 2008.{{cite web | title=Rotarix | website=U.S. Food and Drug Administration (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 }}{{cite web | title=Rotarix | publisher=U.S. Food and Drug Administration (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 }} It is taken by mouth.{{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 }}{{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}}

Rotateq is a live, oral pentavalent vaccine that contains five rotavirus strains produced by reassortment.{{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 Food and Drug Administration (FDA) approved Rotateq for use in the United States.{{cite web | title=Rotateq | website=U.S. Food and Drug Administration (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 }}{{cite web | title=Rotateq | publisher=U.S. Food and Drug Administration (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 }} In August 2006, Health Canada approved Rotateq for use in Canada.{{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}} 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,{{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 }} an effort which was slated to come to an end in 2020.{{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=|date=2 November 2018 |work=OZY | publisher = Ozymandias.com |access-date=2 November 2018 |department=The Presidential Daily Brief: Intriguing }}

Rotavac was licensed for use in India in 2014 and is manufactured by Bharat Biotech International Limited. It is a live attenuated, monovalent vaccine containing a G9P[11] human strain isolated from an Indian child.{{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 }} 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.{{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}}

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[8] human rotavirus strain.{{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}}

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[12] lamb rotavirus strain.

Rotasiil is a lyophilized 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 Serum Institute of India.{{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}}{{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 }}

In 1998, a rotavirus vaccine (RotaShield, by Wyeth) 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{{nbsp}}A, and researchers had detected no statistically significant serious adverse effects. However post-licensure studies conducted in the United States by Trudy Murphy 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.{{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 }}{{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 }} 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,{{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) }} 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 GlaxoSmithKline and Rotateq by Merck.{{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 }} Both are taken orally and contain disabled live virus.

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.{{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 }}

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.{{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 }}

More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of Gavi, the Vaccine Alliance.

In March 2010, the detection of DNA from porcine circovirus 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).{{cite web|author=U.S. Food and Drug Administration|title=Update on Recommendations for the Use of Rotavirus Vaccines|website=Food and Drug Administration|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}} 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. In May 2010 the suspension of the Rotarix vaccine was lifted.{{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 }}

Doctors Without Borders (MSF) developed a heat-stable version named BRV-PV. Phase 3 of the clinical trials was completed in Niger on 31 December 2020.{{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}}{{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}}

The vaccine has been associated with lower rates of type 1 diabetes.{{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}}{{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=The New York Times|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}}

{{Reflist}}

{{refbegin}}

• {{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 }}
• {{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 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 }}

{{refend}}

• {{cite web | title=Rotavirus Vaccine Information Statement | website=U.S. Centers for Disease Control and Prevention (CDC) | date=27 April 2023 | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/rotavirus.html }}
• {{MeshName|Rotavirus Vaccines}}

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