Available Rotavirus Vaccine Products

A 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.

VACCINERotarix™RotaTeq
MANUFACTURERGlaxoSmithKlineMerck & Co., Ind.
FORMULATIONMonovalent attenuated human rotavirus strainPentavalent, human-bovine reassortant vaccine
STRAINS PRESENT IN VACCINEG1P[8]G1, G2, G3, G4, and P[8]
PROTECTION AGAINST OTHER STRAINS?Yes, broad protection demonstratedYes, broad protection demonstrated
EFFICACY AGAINST SEVERE ROTAVIRUS DIARRHEA IN CHILDREN <1 YR (HIGH-INCOME COUNTRIES)95.8-100%85-96%
EFFICACY AGAINST SEVERE ROTAVIRUS DIARRHEA IN CHILDREN <1YR (LOW- AND MIDDLE-INCOME COUNTRIES)49-85%51-64%
DOSAGEAt least 106 of live attenuated human G1P[8] particles per doseA minimum titer of approximately 2.0 to 2.8 x 106 infectious units per reassortant and not greater than 116 x 106 infectious units per aggregate dose
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
PRESENTATION1. Liquid vaccine in oral, single-dose applicator
2. Liquid vaccine in squeezable, polyethylene single-dose tube
3. Lyophilized vaccine, reconstituted with CaCO3 buffer, oral applicator
Liquid vaccine in oral squeezable tube
SHELF-LIFEYesNo
STORAGE REQUIREMENTS2-8°C, not frozen and protected from light2-8°C, not frozen and protected from light
SAFETY: CLINICAL STUDIES (intussusception risk)No 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 others

ROTA Council Recommendations

  • To optimize the rollout of vaccines and maximize the number of eligible infants immunized, WHO, UNICEF, Gavi and other partners should continue to support countries that plan to introduce the vaccine.
  • Special emphasis should be placed on assessments of cold chain and other system requirements, plans for timing of vaccine introduction based on available supply and plans to ensure sustainable financing and support of rotavirus vaccination.
  • If the rotavirus vaccine of choice is not available due to supply constraints, countries should strongly consider introducing any prequalified rotavirus vaccine that is available in the short-term, and working with Gavi on longer-term options for the vaccine of choice.

 

Nationally Available Vaccines

VACCINECOMPANYSTATUSSTRAIN
ROTAVAC [2]Bharat Biotech InternationalLicensed in India; WHO Prequalification expected 2017G9P[11]
Rotavin M1 [3]POLYVACLicensed in VietnamVietnamese
Lamb rotavirus (lamb-human reassortant) LLR
LLR+ [4]
Lanzhou Biologicals / Xinkexian
Biological Technology (China)
Licensed in ChinaG10, P[12] + G1, G2, G3, G4

Still more products are currently in development by both developed and developing country manufacturers.

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

ROTA Council Recommendations

  • To optimize the rollout of vaccines and maximize the number of eligible infants immunized, WHO, UNICEF, Gavi and other partners should continue to support countries that plan to introduce the vaccine.
  • Special emphasis should be placed on assessments of cold chain and other system requirements, plans for timing of vaccine introduction based on available supply and plans to ensure sustainable financing and support of rotavirus vaccination.
  • If the rotavirus vaccine of choice is not available due to supply constraints, countries should strongly consider introducing any prequalified rotavirus vaccine that is available in the short-term, and working with Gavi on longer-term options for the vaccine of choice.