Rotavirus vaccine

Rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children.[1] The vaccines prevent 1534% of severe diarrhea in the developing world and 3796% of severe diarrhea in the developed world.[2] The vaccines decrease the risk of death among young children due to diarrhea.[1] Immunizing babies decreases rates of disease among older people and those who have not been immunized.[3]

Rotavirus vaccine
Vaccine description
TargetRotavirus
Vaccine typeAttenuated
Clinical data
Trade namesRotarix, RotaTeq, others
AHFS/Drugs.comMonograph
MedlinePlusa607024
License data
Routes of
administration
by mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
  • 889856-77-3
ChemSpider
  • none
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The World Health Organization (WHO) recommends that rotavirus vaccine be included in national routine vaccinations programs, especially in areas where the disease is common.[1] This should be done along with promoting breastfeeding, handwashing, clean water, and good sanitation.[1] It is given by mouth and requires two or three doses.[1] It should be given starting around six weeks of age.[1]

The vaccines are safe.[1] This includes their use in people with HIV/AIDS.[1] While an earlier version of the vaccine was linked to intussusception, the current versions are not.[4] Older recommendations were to avoid rotavirus vaccination in babies who have had intussusception.[1] The vaccines are made from weakened rotavirus.[1]

The vaccine first became available in the United States in 2006.[5] It is on the World Health Organization's List of Essential Medicines.[6] As of 2013, there are two types of vaccine available globally, Rotarix and RotaTeq. Others are used in some countries.[1]

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.[7]

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.[8][9] A 2019 Cochrane review concluded that RV1, RV5, and Rotavac vaccines are safe and are effective at preventing diarrhea.[2]

Rotavirus vaccines are licensed in more than 100 countries, and more than 80 countries have introduced routine rotavirus vaccination.[10] The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.[11] 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.[12] 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.[13] 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.[14][9]

Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections.[3] 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%.[15]

Schedule

The World Health Organization recommends the first dose of vaccine be given right after 6 weeks of age.[1] Two or three doses more than a month apart should be given, depending on the vaccine administered.[1] 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.[1]

Types

Rotarix

Rotarix vaccine for oral administration

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.[16] It was approved in Europe in 2006 and by the U.S. FDA in April 2008. It is administered by mouth.[17][18]

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.[19] 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,[20] an effort which was slated to come to an end in 2020.[21]

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.[22] 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.[23]

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.[24]

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.[24]

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, which is manufactured by Serum Institute of India Pvt. Ltd., was licensed for use in India in 2018.[25][26]

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.[27] 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[16] and RotaTeq by Merck.[28] 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.[29]

Society and culture

More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of Gavi, the Vaccine Alliance.[24] 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.

Temporary suspension in the US

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).[30] 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.[30] In May 2010 the suspension of the Rotarix vaccine was lifted.[31]

Research

Additional rotavirus vaccines are under development.[32] 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.[33]

Doctors Without Borders (MSF) developed a heat-stable version named BRV-PV. Phase 3 of the clinical trials were completed in Niger on December 31, 2020.[34][35]

The vaccine has been associated with lower rates of type 1 diabetes.[36][37]

References

  1. World Health Organization (2013). "Rotavirus vaccines: WHO position paper—January 2013". Weekly Epidemiological Record. 88 (5): 49–64. hdl:10665/242024. PMID 23424730. Lay summary (PDF).
  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.
  3. 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.
  4. 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.
  5. "Rotavirus Vaccine Live Oral". The American Society of Health-System Pharmacists. Archived from the original on 2015-12-22. Retrieved Dec 14, 2015.
  6. 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.
  7. 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.
  8. World Health Organization (December 2009). "Rotavirus vaccines: an update". Weekly Epidemiological Record. 84 (51–52): 533–37. hdl:10665/241489.
  9. 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.
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  13. 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.
  14. "WHO | Estimated rotavirus deaths for children under 5 years of age: 2013, 215 000". WHO. Retrieved 2021-03-30.
  15. 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.
  16. 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. S2CID 40193617.
  17. April 3, 2008 Approval Letter—Rotarix Archived November 29, 2014, at the Wayback Machine, FDA, April 3, 2008
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  19. "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.
  20. McCarthy M (2003). "Project seeks to "fast track" rotavirus vaccine". Lancet. 361 (9357): 582. doi:10.1016/S0140-6736(03)12549-4. PMID 12598149. S2CID 5347100.
  21. "Merck Ends Delivery of Lifesaving Vaccines to Africa". The Presidential Daily Brief: Intriguing. OZY. 2 November 2018. Retrieved 2 November 2018.
  22. World Health Organization (2014). "Global Advisory Committee on Vaccine Safety, 11-12 June 2014". Weekly Epidemiological Record. 89 (29): 321–36. hdl:10665/242243.
  23. "ROTAVAC—Bharat Biotech". Archived from the original on 2019-06-07. Retrieved 2019-10-29.
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  25. "ROTASIIL". WHO—Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). 2020-07-17. Retrieved 2021-03-30.
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  27. Hall, Harriet (2018). "Diving into the VAERS Dumpster: Fake News about Vaccine Injuries". Skeptical Inquirer. 42 (6): 28–31.
  28. 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.
  29. 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.
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  31. FDA's MedWatch Safety Alerts: May 2010 Rotarix Vaccine Suspension Lifted Archived 2010-08-24 at the Wayback Machine
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  33. Kang G, et al. Rotavirus vaccines. Indian J of Med Microbiol 2006;24:4:252-7.
  34. Epicentre (2021-02-09). "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". Medecins Sans Frontieres, Netherlands, Serum Institute of India Pvt. Ltd., FORSANI (Forum Santé Niger), Ministère de la Santé Publique, Niger, Children's Hospital Medical Center, Cincinnati. Cite journal requires |journal= (help)
  35. 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.
  36. "Rotavirus vaccination tied to lower rates of type 1 diabetes". Reuters. 2019-01-22. Retrieved 2019-02-10.
  37. Bakalar, Nicholas (2019-01-30). "Rotavirus Vaccine May Protect Against Type 1 Diabetes". The New York Times. ISSN 0362-4331. Retrieved 2019-02-10.

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