Vaccine Information

Entry last updated: 06/19/2007

- Understanding the Disease
- Available Vaccines
- History of the Vaccine
- Who Should and Should Not Receive the Vaccine
- Dose Schedule
- Effectiveness of the Vaccine
- Known Side Effects
- Related Issues
- Key References and Sources of Additional Information
- CDC Vaccine Information Statement

Understanding the Disease

Rotavirus is an intestinal virus that infects virtually all children by three years of age. It is the most common cause of diarrhea in children, including hospital-acquired diarrhea, and childcare center outbreaks are common. The illness often also includes fever and vomiting, lasting 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 U.S., rotavirus results in the hospitalization of 50,000 infants younger than two years of age. 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

History of the Vaccine

The rotavirus vaccine currently available, Rotateq® is a new vaccine released in 2006. The previously released rotavirus vaccine, RotaShield®, was withdrawn from the market in 1999.

RotaShield®, was a reassortant rhesus-human rotavirus vaccine tetravalent (RRV-TV), that was licensed by the Food and Drug Administration (FDA) in August 1998. However, in July 1999, after approximately 1 million children had been immunized with the vaccine, the CDC recommended that use of the rotavirus vaccine be suspended because of 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 (or less) infants vaccinated, three times higher than for the 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 That vaccine was voluntarily withdrawn from the market by the manufacturer in October 1999.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 are not at continuing risk of developing intussusception.

A new pentavalent human-bovine reassortant rotavirus vaccine, RotaTeq®, was licensed by the Food and Drug Administration in 2006 for use in the United States. In a study of more than 68,000 children, the risk of intussusception was similar in RotaTeq® vaccine and placebo recipients.

Who Should and Should Not Receive this Vaccine

Who should receive the rotavirus vaccine?

• All full term infants should begin the 3-dose series between the ages of 6-12 weeks of age and the series should be completed by 32 weeks of age (see Dose Schedule below).
• 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 3-dose vaccine series should not be initiated after 12 weeks of age and vaccine should not be administered after age 32-weeks because of insufficient data on vaccine safety in these other age groups.
• 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.
• Guidelines are available for children who are immunocompromised and for infants who have received blood products
• There is no safety information related to the administration of vaccine to infants with gastroenteritis. It is recommended that rotavirus vaccine not be administered to infants with acute, moderate-to-severe gastroenteritis but be considered for administration to infants with mild gastroenteritis if the delay might make the child ineligible for vaccination because of age.
• 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. If your child has diarrhea or vomiting, you should wait until recovery to get the vaccine.

Dose Schedule

Children should get 3 doses of rotavirus vaccine:

First Dose: 6-12 weeks of age
Second Dose: 4-10 weeks after the first dose
Third Dose: 4-10 weeks after the second dose but prior to 32 weeks of age

Rotavirus vaccine may be given at the same time as other childhood vaccines. Infants who are being breastfed can receive the rotavirus vaccine too.

Effectiveness of the Vaccine

The efficacy of RotaTeq® was evaluated in two large clinical trials. After three doses the vaccine was 74% effective against rotavirus gastroenteritis of any severity and 98% effective against severe rotavirus gastroenteritis.

In another study, the vaccine reduced the incidence of office visits by 86%, emergency room visits by 94% and hospitalizations for rotavirus gastroenteritis by 96%.

Known Side Effects

Children are slightly (1-3%) more likely to have 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 this vaccine.

Related Issues

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

The risk for intussusception after vaccination with RotaTeq® was evaluated in 71,725 persons enrolled in phase III efficacy trials. Those who received the vaccine were not at an increased risk of developing the disease than those in the control group. However, additional postlicensure data will be needed to confirm that this vaccine is not associated with intussusception at a low rate.

In June 2007, the CDC reported the following:

"The FDA reports that five cases of Kawasaki disease have been identified in children less than 1 year of age who received the RotaTeq vaccine during clinical trials conducted before the vaccine was licensed. Three reports of Kawasaki disease were detected following the vaccine’s approval in February 2006 through routine monitoring using the Vaccine Adverse Event Reporting System (VAERS). After learning about these Kawasaki disease reports, CDC identified one additional unconfirmed case through its Vaccine Safety Datalink (VSD) Project. The vaccine label has been revised to notify healthcare providers and the public about the reports of Kawasaki disease following RotaTeq vaccination. The number of Kawasaki disease reports does not exceed the number of cases we expect to see based on the usual occurrence of Kawasaki disease in children. There is not a known cause-and-effect relationship between receiving RotaTeq or any other vaccine and the occurrence of Kawasaki disease."

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 www.vaers.hhs.gov

Key References and Sources of Additional Information

• Parashar UD, Alexander JP, Glass RI (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. 
• Vesikari T, Matson DO, Dennehy P, et al. (2006) Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med, 354 (1), 23-33.
• Glass R and Parashar UD. (2006) The promise of new rotavirus vaccines. New England Journal of Medicine, 354 (1), 75-77.

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