Rotavirus vaccine

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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
  • US: ℞-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
ChemSpider
  • none
KEGG
 ☒NcheckY (what is this?)  (verify)

The rotavirus vaccine is a

developing world and 37–96% of the risk of death among young children due to severe diarrhea.[1] Immunizing babies decreases rates of disease among older people and those who have not been immunized.[2]

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] The vaccines are made from weakened rotavirus.[1]

The vaccine first became available in the United States in 2006.[3] It is on the World Health Organization's List of Essential Medicines.[4][5] 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.[6]

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.

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.[9]

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][8]

Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections.[2] 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 six weeks 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

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 a

lyophilized pentavalent vaccine licensed for use in India in 2018. 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 manufactured by the Serum Institute of India.[25][26]

History

In 1998, a rotavirus vaccine (RotaShield, by

Merck.[30] Both are taken orally and contain disabled live virus.[3]

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.[31]

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.[citation needed
]

Temporary suspension in the US

On 22 March 2010, the detection of DNA from

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).[32] 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.[32] In May 2010 the suspension of the Rotarix vaccine was lifted.[33]

Research

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

The vaccine has been associated with lower rates of

type 1 diabetes.[36][37]

References

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    .
  2. ^
    S2CID 1893099
    .
  3. ^ a b "Rotavirus Vaccine Live Oral". The American Society of Health-System Pharmacists. Archived from the original on 22 December 2015. Retrieved 14 December 2015.
  4. hdl:10665/325771
    . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  5. hdl:10665/345533
    . WHO/MHP/HPS/EML/2021.02.
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    .
  7. hdl:10665/241489
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  8. ^
    PMID 27059361
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  9. PMID 34788488
    .
  10. ^ "Rotavirus Deaths & Rotavirus Vaccine Introduction Maps—ROTA Council". rotacouncil.org. Archived from the original on 12 July 2016. Retrieved 29 July 2016.
  11. S2CID 23996836
    .
  12. PMID 20107215
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  13. PMID 19491186
    .
  14. ^ "WHO | Estimated rotavirus deaths for children under 5 years of age: 2013, 215 000". WHO. Archived from the original on 2 April 2014. Retrieved 30 March 2021.
  15. PMID 25048849
    .
  16. ^
    S2CID 40193617
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  17. ^ "Approval Letter—Rotarix". U.S. Food and Drug Administration. 3 April 2008. Archived from the original on 29 November 2014.
  18. ISBN 978-1-4557-0090-5
    .
  19. ^ "RotaTeq Is Approved In Canada" (PDF) (Press release). Merck Frosst Canada. 23 August 2006. Archived from the original (PDF) on 2 October 2008. Retrieved 29 February 2008.
  20. S2CID 5347100
    .
  21. ^ "Merck Ends Delivery of Lifesaving Vaccines to Africa". The Presidential Daily Brief: Intriguing. OZY. Ozymandias.com. 2 November 2018. Archived from the original on 2 November 2018. Retrieved 2 November 2018.
  22. hdl:10665/242243
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  23. ^ "ROTAVAC—Bharat Biotech". Archived from the original on 7 June 2019. Retrieved 29 October 2019.
  24. ^ a b c Rota Council (2016). Rotavirus: Common, Severe, Devastating, Preventable (PDF). Archived (PDF) from the original on 8 September 2017.
  25. ^ "ROTASIIL". WHO—Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). 17 July 2020. Retrieved 30 March 2021.
  26. PMID 28434688
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  27. PMID 11207352
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  28. S2CID 23664999
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  29. PMID 15343145
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  30. PMID 17055370
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  31. PMID 24707510
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  32. ^ a b U.S. Food and Drug Administration. "Update on Recommendations for the Use of Rotavirus Vaccines". Food and Drug Administration. Archived from the original on 19 June 2012. Retrieved 13 July 2012.
  33. ^ "Rotarix Vaccine Suspension Lifted". FDA's MedWatch Safety Alerts. May 2010. Archived from the original on 24 August 2010.
  34. ^ Clinical trial number 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 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 at ClinicalTrials.gov
  35. ISSN 0261-3077. Archived
    from the original on 23 March 2017. Retrieved 24 March 2017.
  36. ^ "Rotavirus vaccination tied to lower rates of type 1 diabetes". Reuters. 22 January 2019. Retrieved 10 February 2019.
  37. ISSN 0362-4331
    . Retrieved 10 February 2019.

Further reading

External links

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