Live oral vaccines for infant rotavirus gastroenteritis prevention
This page catalogs 4 rotavirus vaccine products spanning US-licensed oral vaccines, a WHO-prequalified product developed in India, and the withdrawn first-generation product. Rotavirus vaccines are administered orally rather than by injection, and the history of this category includes the 1999 withdrawal of RotaShield due to intussusception risk — a landmark event in vaccine safety surveillance.
Last updated: April 2026.
| Trade Name | Generic Designation | Manufacturer | Vaccine Type | Regulatory Status & Year | Key Notes |
|---|---|---|---|---|---|
| RotaShield | Rotavirus vaccine, live oral (rhesus-based) | Wyeth-Lederle | Live reassortant | FDA Licensed, 1998; Withdrawn 1999 | Withdrawn due to intussusception risk |
| Rotarix | Rotavirus vaccine, live oral (monovalent) | GSK | Live-attenuated (human) | FDA Licensed, 2008 | 2-dose oral series |
| RotaTeq | Rotavirus vaccine, live oral (pentavalent) | Merck | Live reassortant (bovine-human) | FDA Licensed, 2006 | 3-dose oral series |
| Rotavac | Rotavirus vaccine (116E strain) | Bharat Biotech | Live-attenuated | WHO Prequalified, 2018 | India-developed; affordable global option |
Regulatory data sourced from FDA CBER Vaccines Licensed for Use in the United States (March 2026) and WHO Prequalified Vaccines list. Catalog scope informed by Khan, Shaz, The Ultimate Vaccine Timeline.