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
| VACCINE | RotaTeq® | ROTARIX® | ROTAVAC® | ROTAVAC5D | ROTASIIL® | ROTASIIL-Liquid | ROTASIIL Thermo |
|---|---|---|---|---|---|---|---|
| MANUFACTURER | Merck & Co., Inc. | GlaxoSmithKline | Bharat Biotech | Bharat Biotech | Serum Institute of India | Serum Institute of India | Serum Institute of India |
| YEAR WHO PRE-QUALIFIED | 2008 | 2009- plastic tube 2019- strip of 5 single tubes | 2018 | 2021 | 2018 | 2021 | 2020 |
| FORMULATION | 5 human-bovine reassortant rotaviruses | Single, attenuated human rotavirus strain | Single, attenuated human rotavirus strain | Single, attenuated human rotavirus strain | 5 human-bovine (UK) reassortant rotaviruses | 5 human-bovine (UK) reassortant rotaviruses | 5 human-bovine (UK) reassortant rotaviruses |
| STRAINS PRESENT IN VACCINE | G1, G2, G3, G4, and P[8] | G1P[8] | G9P[11] | G9P | G1, G2, G3, G4, and G9 | G1, G2, G3, G4, G9 | G1, G2, G3, G4, G9 |
| PROTECTION AGAINST OTHER STRAINS? | Yes, broad protection demonstrated | Yes, broad protection demonstrated | Yes, broad protection demonstrated | Yes, broad protection demonstrated | |||
| EFFICACY AGAINST SEVERE ROTAVIRUS DIARRHEA (HIGH-INCOME COUNTRIES) | 98-100% (7,8) | 85-96% (1,2) | No data | No data | No data | No data | No data |
| EFFICACY AGAINST SEVERE ROTAVIRUS DIARRHEA (LOW- AND MIDDLE-INCOME COUNTRIES) | 43-64% (9,10) | 49-77% (3) | 56% (in India) (11,12) | Immunogenicity was non-inferior to that of ROTAVAC (Zambia) | 36% (in India) (4) 67% (in Niger) (5) | Immunogenicity was non-inferior to that of the lyophilized ROTASIIL (India) | 36% (in India) (4) 67% (in Niger) (5) |
| DOSAGE VOLUME | 2 mL | 1.5 mL (liquid) 1.5mL (freeze-dried) | .5 mL | 5 mL | 2.5 mL | 2 mL | 2.5 mL |
| SCHEDULE | 3-dose Given on same schedule as DPT1,2, and 3 vaccine doses | 2-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 | 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 |
| PRESENTATION | Liquid vaccine suspended in a buffer (oral squeeze tube) | Liquid vaccine (oral squeeze tube) as: - single-dose squeezable plastic tube - strip of 5 single-dose plastic tubes | Liquid (frozen) vaccine in glass vial (separate oral droppers) | Liquid vaccine in glass vial (separate oral droppers) | Freeze-dried vaccine (lyophilized) in glass vial reconstituted with antacid diluent from separate vial (oral syringe) | Liquid vaccine as: -Strip of 5 single-dose squeezable plastic tubes -Liquid vaccine in 2-dose vials | Freeze-dried vaccine (lyophilized) in glass vial reconstituted with antacid diluent from separate vial (oral syringe) |
| STORAGE AND SHELF-LIFE | Refrigerated (2-8°C): 24 months Cannot freeze Protected from light | Refrigerated (2-8˚C): 24 months Cannot freeze | 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 | Refrigerated (2-8˚C): 24 months | (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 | -Stored at temperatures <25˚C: 30 months (per WHO prequalification) - (Diluent) Ambient temperature or refrigerated (2-8˚C): 60 months - Once reconstituted, can be refrigerated (2-8˚C) for up to 6 hours |
| SAFETY: CLINICAL STUDIES (intussusception risk) | No increased risk detected | No increased risk detected | No increased risk detected | No increased risk detected | |||
| SAFETY: POST-INTRODUCTION (intussusception risk) | Low-level risk in some countries, not in others | Low-level risk in some countries, not in others | Low-level risk in some countries, not in others | Low-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.”
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
| VACCINE | COMPANY | STATUS | STRAIN |
|---|---|---|---|
| Rotavin M1 (13) | POLYVAC | Licensed in Vietnam | G1P[8] |
| Lanzhou Lamb rotavirus (lamb-human reassortant) LLR LLR+ (14) | Lanzhou Biologicals / Xinkexian Biological Technology (China) | Licensed in China | G10, 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.