Rotavirus Vaccination: Information for Health Care Providers

What to know

CDC recommends that infants get rotavirus vaccine to protect against rotavirus disease.

Overview

Two rotavirus vaccines are currently licensed for use in infants in the United States.

  • RotaTeq® (RV5) has been approved for use since 2006, and is given in three doses at 2 months, 4 months, and 6 months of age.
  • Rotarix® (RV1) has been approved for use since 2008, and is given in two doses at 2 months and 4 months of age.

The first dose of either vaccine should be given before a child is 15 weeks of age. Children should receive all doses of rotavirus vaccine before they turn 8 months old.

Both vaccines are given by putting drops in the child's mouth.

Rotavirus vaccine recommendations

There are two rotavirus vaccines approved for use in infants in the United States; both are safe and effective. Infants should get 2 or 3 doses of rotavirus vaccine, depending on the brand of vaccine used.

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®[13 pages] provides dosage forms and strengths as well as administration guidance.
  • Rotarix® (RV1)

Both vaccines are given orally by putting drops in the infant's mouth. The vaccine should not be injected.

RotaTeq® (RV5)

  • 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.

Rotarix® (RV1)

  • 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.

Rotavirus vaccine storage and handling

Rotavirus vaccine must be kept at refrigerator temperatures. Below are links to two documents that outline temperature and storage best practices for refrigerated vaccines.

The Vaccine Storage and Handling Toolkit is a comprehensive resource for healthcare providers on recommendations and best practices for:

  • Managing vaccine inventory and transport
  • Storing and preparing vaccine
  • Monitoring vaccine temperature
  • Using and maintaining storage unit temperature monitoring equipment
  • Preparing for emergency storage, handling, and transport situations
  • Developing standard operating procedures for routine and emergency vaccine management and training staff

Also see Vaccine Storage and Handling Recommendations and Guidelines.

Administering the rotavirus vaccine

Both rotavirus vaccines are administered orally, by putting drops in the infant's mouth. Each requires multiple doses:

  • RotaTeq® (RV5) is given in three doses at 2 months, 4 months, and 6 months of age.
  • Rotarix® (RV1) is given in two doses at 2 months and 4 months of age.

View Standing Orders for Administering Rotavirus Vaccines to Infants from the Immunization Action Coalition.

More administration information can be found at Ask the Experts on Immunize.org.

Rotavirus vaccine can be administered at the same doctor visit as DTaP vaccine, Hib vaccine, polio vaccine, hepatitis B vaccine, and pneumococcal conjugate vaccine. Available evidence suggests that rotavirus vaccine does not interfere with the immune response to these vaccines. The infant's immune response to influenza vaccine administered at the same time as rotavirus vaccine has not been studied. However, the Advisory Committee on Immunization Practices (ACIP) has recommended that an inactivated vaccine (e.g., inactivated influenza vaccine) may be administered either simultaneously or at any time before or after a different inactivated vaccine or live vaccine (e.g., rotavirus vaccine).

Infants for whom the first dose of rotavirus vaccine was inadvertently administered at age 15 weeks or older should receive the remaining doses of the series at the routinely recommended intervals. Timing of the first dose should not affect the safety and efficacy of the remaining doses. Rotavirus vaccine should not be given after age 8 months 0 days, even if the series is incomplete.