About the Vaccine
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®pdf icon[13 pages]external iconprovides 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®pdf icon[23 pages]external iconprovides 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.
- 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.
- Also, infants who were vaccinated with RotaTeq®were 94% less likely to visit an emergency room and 96% less likely to be hospitalized through the first 2 years after vaccination.
For more information on RotaTeq, visit the manufacturer’s site or the U.S. Food and Drug Administration (FDA) information pageexternal icon.
- 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 siteexternal icon or the U.S. Food and Drug Administration (FDA) information pageexternal icon.