Table 1:
Globally and nationally licensed live oral rotavirus vaccines
| Number of doses | Vaccine strains (genotypes) | Year of introduction | Availability | Efficacy in phase 3 vaccine trials | Comments | |
|---|---|---|---|---|---|---|
|
| ||||||
| RotaTeq (Merck, West Point, PA, USA) | Three doses | Pentavalent bovine-human reassortant strains: WC3 × WI79 (G1P[5]); WC3 × SC-2 (G2P[5]); WC3 × WI78 (G3P[5]); WC3 × BrB (G4P[5]); and WC3 × WI79 (G6P[8]) | 2006 | Worldwide | 51–64% in developing countries and 94-100% in developed countries | Available in more than 100 countries, and recommended by WHO for global use |
| Rotarix (GlaxoSmithKline, Rixensart, Belgium) | Two doses | Monovalent attenuated human strain: 89–12 (G1P[8]) | 2006 | Worldwide | 49–72% in developing countries and 72–97% in developed countries | Available in more than 100 countries, and recommended by WHO for global use |
| Lanzhou lamb rotavirus vaccine (Lanzhou Institute of Biological Products, Lanzhou, China) | Multiple doses | Monovalent ovine rotavirus strain: LLR-85 (G10P[12]) | 2000 | China | Not applicable | Vaccine licensed based on immunogenicity data from phase 2 trials; post-licensure studies show effectiveness of 35–77%; a trivalent reassortant vaccine candidate that uses the vaccine strain is currently in a phase 3 trial |
| Rotavin-M1 (PolyVac, Hanoi, Vietnam) | Two doses | Monovalent attenuated human strain: KH0118–2003 (G1P[8]) | 2012 | Vietnam | Not applicable | Vaccine licensed based on immunogenicity data from phase 2 trials |
| ROTAVAC (Bharat Biotech International, Hyderabad, India) | Three doses | Monovalent neonatal strain: 116E (G9P[11]) | 2014 | Low-income countries and some middle-income countries worldwide | 56% in India | Vaccine has been implemented in routine immunisation of nine Indian states, which constitute about 50% of the birth cohort; WHO prequalified for global use in 2018 |
| ROTASIIL (Serum Institute of India, Pune, India) | Three doses | Pentavalent bovine-human reassortant strains: UK × D (G1P[5]); UK × DS1 (G2P[5]); UK × P (G3P[5]); UK × ST3 (G4P[5]); and UK × AU32 (G9P[5]) | 2017 | India | 66% in Niger and 39% in India | Vaccine administered out of the cold chain in clinical trial; under consideration by WHO for global recommendation |