Table 1.
Overview of oral, live-attenuated rotavirus vaccines pre-qualified by the World Health Organization as of Jan 2020
| Vaccine | Manufacturer | Composition | Dosage | Formulation | Storagea | EPI schedule | WHO pre-qualificationa |
|---|---|---|---|---|---|---|---|
| RotaTeq | Merck & Co., Inc. | Pentavalent human-bovine mono-reassortants: human G1, G2, G3, G4, P[8] on bovine rotavirus (WC3) backbone | 2–2.8 x 106 IU/serotype | Liquid | 2–8 C, 24 mo | 6, 10, 14 weeks | Oct 2008 |
| Rotarix | GlaxoSmithKline Biologicals | Monovalent G1P[8] (strain RIX4414) human rotavirus | ≥106 CCID50 | Liquid | 2–8 C, 24 mo | 6, 10 weeks | Mar 2009 |
| Rotavacb | Bharat Biotech International Ltd. | Monovalent G9P[11] (strain 116E) natural human-bovine reassortant | ≥105 FFU | Liquid | −20 C, 60 mo After thaw: 2–8 C, 6 mo | 6, 10, 14 weeks | Jan 2018 |
| Rotasiilc | Serum Institute of India Pvt. Ltd. | Pentavalent human-bovine mono-reassortants (BRV-PV): human G1, G2, G3, G4, G9 on bovine rotavirus (UK) backbone | ≥105.6 FFU/serotype | Lyophilized | 2–8 C, 30 mo | 6, 10, 14 weeks | Sep 2018 |
| Rotasiil Thermo | Same | Same | Same | Lyophilized | 25 C, 30 mo | Same | Jan 2020 |
Abbreviations: CCID50, cell culture infective dose 50; EPI, Expanded Programme on Immunizations; IU, international units; FFU, focus-forming units; WHO, World Health Organization
a. Ref18
b. Rotavac 5D: storage at 2–8 C but not yet pre-qualified by WHO
c. Rotasiil: liquid formulation requiring storage at 2–8 C not yet pre-qualified by WHO