Rotavirus vaccine

Rotavirus vaccine
Dose of oral vaccine against rotavirus
Vaccine description
Target diseaseRotaviral enteritis
TypeAttenuated virus
Names
Trade namesRotarix, RotaTeq, others
Clinical data
Pregnancy
category
  • US: C (Risk not ruled out)[1]
    Routes of
    use    		By mouth
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa607024
    Legal
    License data

    Rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children.[2] The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of severe diarrhea in the developed world.[3] The vaccines decrease the risk of death among young children due to diarrhea.[2] Immunizing babies decreases rates of disease among older people and those who have not been immunized.[4]

    The World Health Organization (WHO) recommends that rotavirus vaccine be included in national routine vaccinations programs, especially in areas where the disease is common.[2] This should be done along with promoting breastfeeding, handwashing, clean water, and good sanitation.[2] It is given by mouth as a liquid and requires two or three doses.[2] It should be given starting around six weeks of age.[2]

    The vaccines are safe.[2] This includes their use in people with HIV/AIDS.[2] While an earlier version of the vaccine was linked to intussusception, the current versions are not.[5] Older recommendations were to avoid rotavirus vaccination in babies who have had intussusception.[2] The vaccines are made from weakened rotavirus.[2]

    The vaccine first became available in the United States in 2006.[6] It is on the World Health Organization's List of Essential Medicines.[7] In low income countries it was available at US$2 to $4 per dose as of 2016 ($0.30 to $0.60 after subsidy).[8] In the United Kingdom one dose costs around £35.[9] In the United States it is around US$200.[8][10] As of 2013 there are two types of vaccine available globally, Rotarix and RotaTeq.[2] Others are used in some countries.[2]

    Medical uses

    Effectiveness

    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.[11]

    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.[12][13] A 2019 Cochrane review concluded that RV1, RV5, and Rotavac vaccines are safe and are effective at preventing diarrhea.[3]

    Rotavirus vaccines are licensed in more than 100 countries, and more than 80 countries have introduced routine rotavirus vaccination.[14] The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.[15] 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.[16] 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.[17] In the United States, vaccination has reduced rotavirus-related hospitalizations by as much as 86% since 2006. Recent studies in developing countries that have introduced rotavirus vaccines have supported these findings, showing significant decreases in deaths and hospitalizations from rotavirus diarrhea after introduction.[13]

    Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections.[4] 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%.[18]

    Schedule

    The World Health Organization recommends the first dose of vaccine be given right after 6 weeks of age.[2] Two or three doses more than a month apart should be given, depending on the vaccine administered.[2] Because the majority of cases occur between six months and two years of age, the vaccine is not recommended for use in children over two years of age.[2]

    Dosage

    The defined daily dose is not established.[19]

    Types

    Rotarix

    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.[20] It was approved by the U.S. FDA in April 2008.[21]

    RotaTeq

    H. Fred Clark and Paul Offit, the inventors of RotaTeq.

    RotaTeq is a live, oral pentavalent vaccine that contains five rotavirus strains produced by reassortment. 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 U.S. Food and Drug Administration approved RotaTeq for use in the United States. In August 2006, Health Canada approved RotaTeq for use in Canada.[22] 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,[23] an effort which was slated to come to an end in 2020.[24]

    Rotavac

    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.[25] 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.[26]

    Rotavin-M1

    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.[8]

    Lanzhou lamb

    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.[8]

    Rotasiil

    Rotasiil is lyophilized pentavalent vaccine. It contain human bovine reassortant strains of rotavirus serotypes G1, G2, G3, G4 and G9. This is world's first thermostable vaccine which can be stored without refrigeration at or below 25 °C. Rotasiil is recently launched in India.[27]

    History

    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 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 intussusception, or bowel obstruction, in one of every 12,000 vaccinated infants.[28] 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[20] and RotaTeq by Merck.[29] 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 diarrhea.[30]

    In 2011, Merck agreed to sell its vaccine to Gavi at $3.50 per dose, for distribution to West African countries, compared to about $70 in the United States. GlaxoSmithKline sells its vaccine for $2.25 per dose. In 2018, Merck announced it would no longer be able to meet its commitments for West Africa, while opening sales to China at about $40 per dose under a 2012 contract. This may leave some countries unable to obtain the previously expected supply, while other providers get approvals and ramp up production.[31]

    Society and culture

    More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of Gavi, the Vaccine Alliance.[8] In order to make rotavirus vaccines available, accessible, and affordable in all countries—particularly low- and middle-income countries in Africa and Asia where the majority of rotavirus deaths occur—international non-governmental organization PATH, the WHO, the U.S. Centers for Disease Control and Prevention (CDC), and Gavi have partnered with research institutions and governments to generate and disseminate evidence, lower prices, and accelerate introduction. These and other organizations continue to work to improve coverage and public health impact of rotavirus vaccination today.

    Cost

    Area Vaccine US$ (per course)
    Australia Rotarix/RotaTeq Not in public domain
    France Rotarix US$60[32]
    Gavi Rotarix/RotaTeq US$2.13–3.56/dose
    Gavi-eligible countries Rotarix/RotaTeq US$0.30–0.60 (Subsidized co-pay price)
    India Rotavac/Rotarix/RotaTeq US$1 (Rotavac) /$31(Rotarix)[33] /$41(RotaTeq)
    Japan Rotarix/RotaTeq[34] JPY¥10000 (Rotarix, desired delivery price, per dose[35])

    JPY¥5800(RotaTeq, per dose)[36]

    PAHO Rotarix/RotaTeq US$13–15.45
    United Kingdom Rotarix US$45 (estimated)
    United States Rotarix/RotaTeq US$184–192 (CDC)

    US$213–226 (private market)

    The cost of rotavirus vaccination varies depending on country, from a low of approximately US$0.50 in GAVI-eligible countries up to a high of US$185–$226 in the United States. Wholesale cost for GAVI has fallen by 67 percent between 2006 and 2011 to US$2.13–3.56 per dose, as part of an offer made by a pharmaceutical company to the GAVI Alliance.[8] However, the vaccine is still more expensive than most other childhood vaccines included in the WHO's Expanded Programme on Immunization.[37]

    The cost in developed countries is much higher. In France, for example, the vaccine is available to the public for EUR 60.38 (Jan 2016) fully at the user's charge.[38] The table shows current prices of rotavirus vaccines in various countries and regions:[8]

    The development of new vaccines intended to be offered at lower cost than the current globally approved vaccines is ongoing. Rotavac, manufactured by India-based Bharat Biotech and currently licensed only in India, plans to make the vaccine available for US$1 per dose for public markets.[39] Vaccines from Serum Institute of India, Pvt., Ltd. and Sanofi affiliate Shantha Biotechnics are currently in Phase III clinical trials.[40][41]

    Temporary suspension

    On March 22, 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).[42] On May 6, 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.[42] In May 2010 the suspension of the Rotarix vaccine was lifted.[43]

    Research

    Additional rotavirus vaccines are under development.[44] These include: a human neonatal P[6]G3 strain, RV3, developed by Ruth Bishop and colleagues in Australia; a human bovine reassortant vaccine developed by Albert Kapikian and presently undergoing development and trials in different countries; and a non-replicating rotavirus vaccine (NRRV) candidate made of the P2-VP8 fusion protein, which is currently undergoing development and trials in South Africa. Rotavirus antigens for parenteral delivery, such as the P2-VP8 candidate, can be expressed as virus-like particles prepared in baculovirus, expressed antigens, DNA vaccines, and killed virus. These novel approaches are being pursued using animal models and, in the case of the NRRV P2-VP8 candidate, clinical trials.[45]

    Doctors Without Borders (MSF) developed a heat-stable version named BRV-PV. It is currently being studied.[46]

    The vaccine has been associated with lower rates of type 1 diabetes.[47][48]

    References

    1. ↑ "Rotavirus Vaccine Live Oral". The American Society of Health-System Pharmacists. Archived from the original on 2015-12-22. Retrieved Dec 14, 2015.
    2. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 World Health Organization (2013). "Rotavirus vaccines : WHO position paper — January 2013". Weekly Epidemiological Record. 88 (5): 49–64. hdl:10665/242024. PMID 23424730.
    3. 1 2 Soares-Weiser, Karla; Bergman, Hanna; Henschke, Nicholas; Pitan, Femi; Cunliffe, Nigel (2019). "Vaccines for preventing rotavirus diarrhoea: vaccines in use". The Cochrane Database of Systematic Reviews. 3: CD008521. doi:10.1002/14651858.CD008521.pub4. ISSN 1469-493X. PMC 6434239. PMID 30912133.
    4. 1 2 Patel MM, Steele D, Gentsch JR, Wecker J, Glass RI, Parashar UD (January 2011). "Real-world impact of rotavirus vaccination". Pediatr. Infect. Dis. J. 30 (1 Suppl): S1–5. doi:10.1097/INF.0b013e3181fefa1f. PMID 21183833.
    5. ↑ Lu, Hai-Ling; Ding, Ying; Goyal, Hemant; Xu, Hua-Guo (4 October 2019). "Association Between Rotavirus Vaccination and Risk of Intussusception Among Neonates and Infants". JAMA Network Open. 2 (10): e1912458. doi:10.1001/jamanetworkopen.2019.12458. PMC 6784808. PMID 31584679.
    6. ↑ Saleh, Amr; Qamar, Shahraz; Tekin, Aysun; Singh, Romil; Kashyap, Rahul (July 2021). "Vaccine Development Throughout History". Cureus. 13 (7): e16635. doi:10.7759/cureus.16635. ISSN 2168-8184. PMID 34462676. Archived from the original on 2022-05-21. Retrieved 2022-05-21.
    7. ↑ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
    8. 1 2 3 4 5 6 7 Rota Council (2016). Rotavirus: Common, Severe, Devastating, Preventable (PDF). Archived (PDF) from the original on 2017-09-08.
    9. ↑ "14. Vaccines". British National Formulary (BNF) (82 ed.). London: BMJ Group and the Pharmaceutical Press. September 2021 – March 2022. pp. 1392–1393. ISBN 978-0-85711-413-6.{{cite book}}: CS1 maint: date format (link)
    10. ↑ Hamilton, Richart (2015). Tarascon Pocket Pharmacopoeia (2015 Deluxe Lab-Coat ed.). Jones & Bartlett Learning. p. 317. ISBN 9781284057560.
    11. ↑ Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD (2009). "Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries". J Infect Dis. 200 (Suppl 1): S16–27. doi:10.1086/605026. PMID 19817595.
    12. ↑ World Health Organization (December 2009). "Rotavirus vaccines: an update". Weekly Epidemiological Record. 84 (51–52): 533–37. hdl:10665/241489.
    13. 1 2 Parashar, U. D.; Johnson, H.; Steele, A. D.; Tate, J. E. (2016). Parashar, UD; Tate, JE (eds.). "Health Benefits of Rotavirus Vaccination in Developing Countries". Clinical Infectious Diseases. 62 (Suppl 2): S91–S228. doi:10.1093/cid/civ1015. PMID 27059361. Archived from the original on 2020-04-27.
    14. ↑ "Rotavirus Deaths & Rotavirus Vaccine Introduction Maps – ROTA Council". rotacouncil.org. Archived from the original on 2016-07-12. Retrieved 2016-07-29.
    15. ↑ Giaquinto C, Dominiak-Felden G, Van Damme P, Myint TT, Maldonado YA, Spoulou V, Mast TC, Staat MA (July 2011). "Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries". Human Vaccines. 7 (7): 734–48. doi:10.4161/hv.7.7.15511. PMID 21734466. Archived from the original on 2020-05-04. Retrieved 2012-05-10.
    16. ↑ Richardson V, Hernandez-Pichardo J, Quintanar-Solares M, et al. (January 2010). "Effect of rotavirus vaccination on death from childhood diarrhea in Mexico". N. Engl. J. Med. 362 (4): 299–305. doi:10.1056/NEJMoa0905211. PMID 20107215.
    17. ↑ Patel M, Pedreira C, De Oliveira LH, et al. (June 2009). "Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua". JAMA. 301 (21): 2243–51. doi:10.1001/jama.2009.756. PMID 19491186.
    18. ↑ Tate, Jacqueline E.; Parashar, Umesh D. (2014). "Rotavirus Vaccines in Routine Use". Clinical Infectious Diseases. 59 (9): 1291–1301. doi:10.1093/cid/ciu564. PMID 25048849.
    19. ↑ "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 1 July 2021. Retrieved 22 September 2020.
    20. 1 2 O'Ryan M (2007). "Rotarix (RIX4414): an oral human rotavirus vaccine". Expert Rev Vaccines. 6 (1): 11–9. doi:10.1586/14760584.6.1.11. PMID 17280473.
    21. ↑ April 3, 2008 Approval Letter - Rotarix Rotarix at the Wayback Machine (archived November 29, 2014), FDA, April 3, 2008
    22. ↑ "RotaTeq Is Approved In Canada" (PDF) (Press release). Merck Frosst Canada. 2006-08-23. Archived from the original (PDF) on 2008-10-02. Retrieved 2008-02-29.
    23. ↑ McCarthy M (2003). "Project seeks to "fast track" rotavirus vaccine". Lancet. 361 (9357): 582. doi:10.1016/S0140-6736(03)12549-4. PMID 12598149. Archived from the original on 2021-08-29. Retrieved 2018-11-02.
    24. ↑ "Merck Ends Delivery of Lifesaving Vaccines to Africa". The Presidential Daily Brief: Intriguing. OZY. 2 November 2018. Archived from the original on 2 November 2018. Retrieved 2 November 2018.
    25. ↑ World Health Organization (2014). "Global Advisory Committee on Vaccine Safety, 11-12 June 2014". Weekly Epidemiological Record. 89 (29): 321–36. hdl:10665/242243.
    26. ↑ "ROTAVAC - Bharat Biotech". Archived from the original on 2019-06-07. Retrieved 2019-10-29.
    27. ↑ Naik SP, Zade JK, Sabale RN, Pisal SS, Menon R, Bankar SG, Gairola S, Dhere RM (May 2017). "Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL®)". Vaccine. 35 (22): 2962–2969. doi:10.1016/j.vaccine.2017.04.025. PMID 28434688.
    28. ↑ Hall, Harriet (2018). "Diving into the VAERS Dumpster: Fake News about Vaccine Injuries". Skeptical Inquirer. 42 (6): 28–31.
    29. ↑ Matson DO (2006). "The pentavalent rotavirus vaccine, RotaTeq". Seminars in Pediatric Infectious Diseases. 17 (4): 195–9. doi:10.1053/j.spid.2006.08.005. PMID 17055370.
    30. ↑ World Health Organization (2014). "Global Advisory Committee on Vaccine Safety, 11-12 December 2013". Weekly Epidemiological Record. 89 (7): 53–60. hdl:10665/242177. PMID 24707510.
    31. ↑ "Merck Pulls Out Of Agreement To Supply Life-Saving Vaccine To Millions Of Kids". Archived from the original on 2018-11-03. Retrieved 2018-11-04.
    32. ↑ "Rotarix : Baisse du prix de vente conseillé - 06/03/2015 - Actu - le Moniteur des pharmacies.fr". Archived from the original on 2016-02-16. Retrieved 2016-02-13.
    33. ↑ "India-made, low-cost rotavirus vaccine likely by 2014". Archived from the original on 2016-09-16. Retrieved 2016-09-06.
    34. ↑ National Institute of Infectious Diseases ロタウイルス感染性胃腸炎とは at the Wayback Machine (archived 2017-02-03)
    35. ↑ "GSKと第一三共 国内初の乳幼児ロタウイルス胃腸炎予防ワクチンを新発売 | 国内ニュース | ニュース | ミクスOnline". Archived from the original on 2021-08-29. Retrieved 2017-02-22.
    36. ↑ "Archived copy" (PDF). Archived (PDF) from the original on 2017-02-22. Retrieved 2017-02-22.{{cite web}}: CS1 maint: archived copy as title (link)
    37. ↑ Madsen, Lizell B; Marte Ustrup; Thea K Fischer; C Bygbjerg; Flemming Konradsen (18 January 2012). "Reduced price on rotavirus vaccines: enough to facilitate access where most needed?". Bulletin of the World Health Organization. 90 (7): 554–556. doi:10.2471/BLT.11.094656. PMC 3397702. PMID 22807602.
    38. ↑ "Rotarix: baisse du prix de vente conseille". Archived from the original on 2016-02-16.
    39. ↑ "ROTAVAC clinical trial results | DEFEATDD.ORG - Resources to defeat diarrheal disease". www.defeatdd.org. Archived from the original on 2016-08-19. Retrieved 2016-07-29.
    40. ↑ Taylor, Phil (14 October 2014). "Sanofi unit takes low-cost rotavirus vaccine into phase III". Pharmaceutical Market Europe (PME). Archived from the original on 2014-10-21. Retrieved 17 October 2014.
    41. ↑ Zade, Jagdish K.; Kulkarni, Prasad S.; Desai, Sajjad A.; et al. (2014). "Bovine rotavirus pentavalent vaccine development in India". Vaccine. 32 (11): A124–A128. doi:10.1016/j.vaccine.2014.03.003. PMID 25091665.
    42. 1 2 U.S. Food and Drug Administration. "Update on Recommendations for the Use of Rotavirus Vaccines". Archived from the original on 19 June 2012. Retrieved 13 July 2012.
    43. ↑ FDA's MedWatch Safety Alerts: May 2010 Rotarix Vaccine Suspension Lifted FDA's MedWatch Safety Alerts: May 2010 at the Wayback Machine (archived 2010-08-24)
    44. ↑ Ward RL, Clark HF, Offit PA (September 2010). "Influence of potential protective mechanisms on the development of live rotavirus vaccines". The Journal of Infectious Diseases. 202 (Suppl): S72–9. doi:10.1086/653549. PMID 20684721.
    45. ↑ Kang G, et al. Rotavirus vaccines. Indian J of Med Microbiol 2006;24:4:252-7.
    46. ↑ Hodal, Kate (2017-03-22). "Rotavirus vaccine could save lives of almost 500,000 children a year". The Guardian. ISSN 0261-3077. Archived from the original on 2017-03-23. Retrieved 2017-03-24.
    47. ↑ "Rotavirus vaccination tied to lower rates of type 1 diabetes". Reuters. 2019-01-22. Archived from the original on 2019-02-10. Retrieved 2019-02-10.
    48. ↑ Bakalar, Nicholas (2019-01-30). "Rotavirus Vaccine May Protect Against Type 1 Diabetes". The New York Times. ISSN 0362-4331. Archived from the original on 2019-02-12. Retrieved 2019-02-10.

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