Updated: May 17, 2010

Table of Contents

    Understanding the Disease

    Rotaviruses are intestinal viruses that infect virtually all children by three years of age. It is the most common cause of diarrhea in children, including hospital-acquired diarrhea; childcare center outbreaks are common. The illness often also includes fever and vomiting, lasts a week or longer, and can cause persistent infection in immunocompromised people. Most rotavirus infections are mild, but about 1 in 50 cases develop severe dehydration. Each year in the United States, rotavirus infections resulted in 22.5 hospitalizations and 301 emergency room visits per 10,000 children less than 3 years of age. That is, 1 in 150 children were hospitalized because of rotavirus infection and another 1 in 11 visited an emergency room or visited an outpatient clinic for rotavirus infection. In developing countries, rotavirus leads to an estimated 480,000 to 640,000 deaths each year.

    Available Vaccines

    Product: RotaTeq
    Manufacturer: Merck
    Year Licensed: 2006

    Product: RotaRix
    Manufacturer: GlaxoSmithKline
    Year Licensed: 2008, suspended March 22, 2010

    History of the Vaccine

    The rotavirus vaccines currently available in the US are both attenuated (weakened) live virus vaccines: Rotateq is a pentavalent human-bovine reassortant rotavirus vaccine licensed in 2006 and RotaRix is a monovalent attenuated human rotavirus licensed in 2008. Both vaccines are given by mouth.

    A previously released rotavirus vaccine, RotaShield, was withdrawn from the market in 1999. RotaShield, was a tetravalent, reassortant rhesus-human rotavirus vaccine licensed by the Food and Drug Administration (FDA) in August 1998. However, in July 1999, after approximately 1 million children had been immunized with that vaccine, the CDC suspended its recommendation because they detected an increase in the number of children who developed a serious bowel disease called “intussusception.” Investigators calculated that the risk of intussusception attributable to the vaccine was about 1 per 10,000 infants vaccinated which was about three times higher than for unvaccinated children. That vaccine was voluntarily withdrawn from the market by the manufacturer in October 1999. Those who received the RotaShield vaccine in 1998 and 1999 do not have a continuing risk of developing intussusception.

    Both Rotateq and RotaRix were tested in many thousands of children before licensure. No association with intussusception was found for either vaccine. Because the two licensed vaccines are different, the vaccine series should be completed using the same brand of vaccine, although if the previous dose type is unknown, the next vaccine dose should not be delayed.

    On March 22, 2010 the FDA recommended that the use of the Rotarix vaccine be suspended in the United States because of some DNA from a porcine (pig) virus detected in the vaccine. Subsequently, some DNA from this and another porcine virus were also detected in Rotateq. On May 14, 2010 the FDA updated their recommendations for the use of rotavirus vaccines based on a review of the literature and the input from experts. The FDA has determined that it is “appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of Rotateq” because both vaccines have excellent safety records and the benefits of the vaccines are substantial.

    Who Should and Should Not Receive the Vaccine

    Who should receive the rotavirus vaccine?

    • All full term infants should begin the series between the ages of 6-14 weeks of age. Breast fed infants can receive rotavirus vaccine.
    • There is limited information on the immunization of infants born at less than 37 weeks gestation but consideration should be given for immunization of these children because they may be at increased risk for hospitalization from gastroenteritis in the first year of life.

    Who should not receive the rotavirus vaccine?

    • The vaccine series should not be initiated after 15 weeks of age.
    • These vaccines should not be administered after 7 months of age because of insufficient data on vaccine safety in children who are 8 months of age and older.
    • A child who has had a life-threatening allergic reaction to a previous dose or a component of the vaccine should not get another dose.
    • A child who has had life-threatening allergic reaction to latex rubber should not receive the RotaRix vaccine which is packaged in a latex applicator.
    • There is no safety information for administration of rotavirus vaccine to infants who are immunocompromised. However, both children and adults who are immunocompromised because of congenital immunodeficiency or following transplantation can experience severe and potentially fatal rotavirus gastroenteritis.
    • Infants who have received blood products should have the vaccine postponed for 6 weeks unless that delay might make the child ineligible for vaccination because of age.
    • Both children and adults who are immunocompromised because of congenital immunodeficiency or following transplantation can experience severe and potentially fatal rotavirus gastroenteritis. Prolonged infection with vaccine rotavirus virus has also been reported in immunocompromised children.
    • There is no safety information related to the administration of vaccine to infants with pre-existing gastrointestinal disease but vaccine might be considered for these infants if they are not receiving immunosuppressive drugs.
    • People who are moderately or severely ill should consult with their physician before receiving any vaccine.

    Dose Schedule

    Roateq is administered at 2, 4 and 6 months of age and RotaRix is administered at 2 and 4 months of age. The first dose of rotavirus vaccine should be given between the ages of 6 and 14 weeks, 6 days. The vaccine series should not be started in children who are 15 weeks of age or older. Doses should be given at least 4 weeks apart. The final dose of rotavirus vaccine should be given before 8 months of age.

    Rotavirus vaccine may be given at the same time as other childhood vaccines.

    The rotavirus vaccination series should be completed with the same product whenever possible. Vaccination should not be delayed, however, if the product used for a prior dose is unknown. In this setting, the series should be completed with the product available and a total of three doses should be given.

    Effectiveness of the Vaccine

    Both RotaTeq and RotaRix have been shown to be effective against rotavirus gastroenteritis of any severity and both have high efficacy against severe rotavirus gastroenteritis.

    Known Side Effects

    Children may be more likely to experience mild, temporary diarrhea or vomiting within 7 days after getting a dose of rotavirus vaccine than children who have not gotten the vaccine.

    No moderate or severe reactions have been associated with these vaccines.

    Related Issues

    Infants living in homes with pregnant women can be vaccinated as most women will already be immune to rotavirus, immunizing the child will reduce the women’s risk of exposure to rotavirus, and there is no evidence that rotavirus infection during pregnancy is a risk to the fetus.

    Vaccine should not be readministered after regurgitation or spiting out of a vaccine dose.

    The risk for intussusception after vaccination with RotaTeq® or RotaRix® was evaluated in many thousands of children during the clinical trials preceding licensure. Those who received the vaccine were not at an increased risk of developing the disease than were those in the control group. However, additional postlicensure data are being collected to confirm that these vaccines are not associated with intussusception at a very low rate.

    Some cases of Kawasaki disease were identified in children less than 1 year of age who had received the RotaTeq vaccine during clinical trials conducted before the vaccine was licensed. The number of Kawasaki disease reports does not exceed the number of cases expected to be seen based on the usual occurrence of Kawasaki disease in children. The FDA encourages all healthcare providers and other individuals to report any post-immunization cases of Kawasaki disease or other severe adverse events to the Vaccine Adverse Event Reporting System (VAERS). For a copy of the vaccine reporting form, call 1-800-822-7967 or report online to

    Key References and Sources of Additional Information

    • Centers of disease Control and Prevention. (2006). Prevention of Rotavirus Gastroenteritis Among Infants and Children: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR August 11, 2006 / 55(RR12); 1-13.
    • CDC. (2008). ACIP Provisional recommendations for the prevention of rotavirus gastroenteritis among infants and children.
    • CDC.(2008). Rotavirus surveillance – worldwide, 2001-2008. MMWR 57(46); 1255-7.
    • Food and Drug Administration. (2010). Update of recommendations for the use of rotavirus vaccines.

    CDC Information