Available Rotavirus Vaccine Products

There are now four globally available rotavirus vaccines. All four vaccines prequalified by WHO have shown similar efficacy rates in low-income settings.

Rotavirus Vaccines Prequalified by WHO

 

VACCINEROTARIX®ROTASIIL®RotaTeq®ROTAVAC®
MANUFACTURERGlaxoSmithKlineSerum Institute of IndiaMerck & Co., Inc.Bharat Biotech
FORMULATIONSingle, attenuated human rotavirus strain5 human-bovine (UK) reassortant rotaviruses5 human-bovine reassortant rotavirusesSingle, attenuated human rotavirus strain
STRAINS PRESENT IN VACCINEG1P[8]G1, G2, G3, G4, and G9G1, G2, G3, G4, and P[8]G9P[11]
PROTECTION AGAINST OTHER STRAINS?Yes, broad protection demonstratedYes, broad protection demonstratedYes, broad protection demonstratedYes, broad protection demonstrated
EFFICACY AGAINST SEVERE ROTAVIRUS DIARRHEA (HIGH-INCOME COUNTRIES)85-96% (1,2)No data98-100% (7,8)No data
EFFICACY AGAINST SEVERE ROTAVIRUS DIARRHEA (LOW- AND MIDDLE-INCOME COUNTRIES)49-77% (3)36% (in India) (4)
67% (in Niger) (5)
43-64% (9,10)56% (in India) (11,12)
DOSAGE VOLUME1 mL (liquid)
1.5mL (freeze-dried)
2.5 mL2.5 mL.5 mL
SCHEDULE2-dose

Given on same schedule as DPT1 and 2 vaccine doses
3-dose

Given on same schedule as DPT1,2, and 3 vaccine doses
3-dose

Given on same schedule as DPT1,2, and 3 vaccine doses
3-dose

Given on same schedule as DPT1,2, and 3 vaccine doses
PRESENTATION1. Liquid vaccine (oral applicator)

2. Liquid vaccine (squeeze tube)

3. Freeze-dried vaccine reconstituted
with buffer (oral applicator)
Freeze-dried vaccine
(lyophilized) in glass vial reconstituted with antacid diluent from separate vial (oral syringe)
Liquid vaccine suspended in a buffer (oral squeeze tube)Liquid in glass vial (separate droppers)
STORAGE AND SHELF-LIFERefrigerated (2-8°C): 36 months

Cannot freeze

Protected from light
(Vaccine) Refrigerated (2-8°C): 30 months (per WHO pre-qualification)

(Diluent) Ambient temperature or refrigerated (2-8°C): 60 months

Once reconstituted, can be refrigerated (2-8°C) for up to 6 hours
Refrigerated (2-8°C): 24 months

Cannot freeze

Protected from light
Refrigerated (2-8°C) at local level: 6 months

Frozen (-20°C) at central and district level: 5 years

Can be frozen-thawed up to 6 times without losing potency
SAFETY: CLINICAL STUDIES (intussusception risk)No increased risk detectedNo increased risk detectedNo increased risk detectedNo increased risk detected
SAFETY: POST-INTRODUCTION (intussusception risk)Low-level risk in some countries, not in othersLow-level risk in some countries, not in othersLow-level risk in some countries, not in othersLow-level risk in some countries, not in others

Updated as of April 2019

Global Recommendation

Since 2009, the World Health Organization has recommended that all countries introduce rotavirus vaccines into their national immunization programs.

“Rotavirus vaccines should be included in all national immunization programmes and considered a priority, particularly in countries with high rotavirus gastroenteritis-associated fatality rates, such as in south and south-eastern Asia and sub-Saharan Africa.”

WHO Position Paper on Rotavirus Vaccines

To obtain the maximum benefit from vaccination, all efforts should be more to provide timely rotavirus vaccination on the recommended schedule, particularly in low-income countries where rotavirus infection early in life is more likely.

Nationally Available Vaccines

 

VACCINECOMPANYSTATUSSTRAIN
Rotavin M1 (13)POLYVACLicensed in VietnamG1P[8]
Lanzhou Lamb rotavirus (lamb-human reassortant) LLR
LLR+ (14)
Lanzhou Biologicals / Xinkexian
Biological Technology (China)
Licensed in ChinaG10, P[12] + G1, G2, G3, G4

Updated as of April 2019 

Several rotavirus vaccines using novel approaches aimed at increasing their impact in low-income settings are in advanced stages of development, including a neonatal vaccine, and a non-replicating rotavirus vaccine administered by intramuscular injection.

For additional information about product specification, please see Gavi resources here.

For more information, check out the Current and Upcoming Rotavirus Vaccines brief.

References

1. Vesikari, T., et al., Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet, 2007. 370(9601): p. 1757-1763.

2. Ruiz-Palacios, G.M.P-S.IV.F.R.A.H.B.T.C.S.C. and Y. Cervantes, Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. New England Journal of Medicine, 2006. 354(1): p. 2725-2732.

3. Madhi, S.A., et al., Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med, 2010. 362(4): p. 289-298.

4. Kulkarni, P.S., et al., A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine, 2017. 35(45): p. 6228-6237.

5. Isanaka, S., et al., Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. New England Journal of Medicine, 2017. 376(12): p. 1121-1130.

6. Naik, S.P., et al., Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL(R)). Vaccine, 2017. 35(22): p. 2962-2969.

7. Vesikari, T., et al., Safety and efficacy of a pentavlent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med, 2006. 354(1): p. 23-33.

8. Block, S.L., et al., Efficacy. immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics, 2007. 119(1): p. 11-8.

9. Zama, K., et al., Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. The Lancet, 2010. 376(9741): p. 615-623

10. Armah, G.E., et al., Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. The Lancet, 2010. 376(9741): p. 606-614.

11. Bhandari, N., et al., Efficacy of monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. Lancet, 2014. 383(9935): p. 2136-2143.

12. Bhandari, N., et al., Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life. Vaccine, 2014. 32 (Supplement 1): p. A110-A116.

13. Dang, D.A., et al., A dose-escalation safety and immunogenecity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine, 2012. 30 Suppl 1: p. A114-21.

14. Fu, C., J. Tate, and B. Jiang, Effectiveness of Lanzhou lamb rotavirus vaccine against hospitalized gastroenteritis: Further analysis and update. Human Vaccines, 2010. 6(11): p. 953.

Sources
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The ROTA Council was created in collaboration with an advisory group of 24 child health leaders from around the world. We promote the use of rotavirus vaccines as part of a comprehensive approach to addressing diarrheal disease.

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