About the Vaccine
Vaccine Composition and Dosage
The two rotavirus vaccines that are currently licensed for use in infants in the United States have a similar composition.
- RotaTeq® (RV5)
- Licensed in 2006
- Administered in three doses at 2 months, 4 months, and 6 months of age
- Package insert for RotaTeq®[13 pages] provides dosage forms and strengths as well as administration guidance.
- Rotarix® (RV1)
- Licensed in 2008
- Administered in two doses at 2 months and 4 months of age
- Package insert for Rotarix® [23 pages] provides dosage forms and strengths, as well as administration guidance.
Both vaccines are given orally by putting drops in the infant’s mouth. The vaccine should not be injected.
Vaccine Effectiveness and Duration of Protection
- In large clinical trials, RotaTeq® demonstrated 98% protection against severe rotavirus gastroenteritis (fever, vomiting, diarrhea, and changes in behavior), and 74% protection against gastroenteritis of any severity (inflammation of the stomach and intestine) caused by rotavirus through the first rotavirus season (December through June) after vaccination.
- Infants who were vaccinated with RotaTeq® were also 94% less likely to visit an emergency room and 96% less likely to be hospitalized through the first two years after vaccination.
For more information on RotaTeq, visit the manufacturer’s site or the U.S. Food and Drug Administration (FDA) information page.
- Two clinical trials found Rotarix® to have 85 to 96% protection against severe rotavirus gastroenteritis through two rotavirus seasons (December through June).
- One study found Rotarix® to be 96% effective in reducing hospitalizations through two rotavirus seasons.
For more information on Rotarix®, visit the manufacturer’s site or the U.S. Food and Drug Administration (FDA) information page.