Vaccines and Preventable Diseases:
Rotavirus Vaccine - Questions & Answers
How is the vaccine given?
The RotaTeq® vaccine is a liquid given by mouth, rather than by a shot. Three doses of vaccine are needed to provide good protection.
At what age should children receive rotavirus vaccine?
The first dose of RotaTeq® vaccine should be given between 6-12 weeks old and two additional doses are given at 4-10 week intervals. Children should get all three doses before 32 weeks old. There is insufficient data on the safety and efficacy of PRV in infants outside of these age ranges.
How well does rotavirus vaccine work to prevent rotavirus disease?
Overall, approximately 72,000 healthy infants were studied worldwide in randomized placebo-controlled studies to look at both the safety of RotaTeq® and how well it works. The data showing how well RotaTeq® prevents rotavirus gastroenteritis comes from almost 7,000 of these infants from the United States and Finland. In these studies, RotaTeq® prevented 74 percent of all rotavirus gastroenteritis cases and 98 percent of the severe cases. In addition, RotaTeq™ reduced the need for hospitalization for gastroenteritis due to rotavirus by 96 percent.
For full details, consult the MMWR article dated August 11, 2006 (Volume 55): Prevention of Rotavirus Gastroenteritis Among Infants and Children.
Also, consult AAP's
guidelines on use of rotavirus vaccine 
(exit)
Who should not be vaccinated?
Your healthcare provider is the best source of information on the benefits and risks of vaccines. Before your child receives a dose of any vaccine, discuss with your healthcare provider any health problems that your child may have and any medications that your child is currently taking or has been prescribed. Also, discuss any concerns you might have about vaccination. Infants who are allergic to any of the ingredients of the vaccine or who have an allergic reaction after getting a dose of the vaccine should not be vaccinated. Tell your doctor about any allergies your child has.
There may be other children who should not receive the vaccine, so talk with your doctor if your child has any chronic disease.
Can the vaccine be given with other vaccines?
In the studies, RotaTeq® was administered with diphtheria and tetanus toxoids, acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine, and pneumococcal conjugate vaccine. RotaTeq® did not interfere with the immune response of these vaccines. However, not enough data is available to confirm that RotaTeq® does not interfere with childhood vaccines that prevent pertussis when they are given at the same time. Additional studies will be conducted to address this question.
Does the vaccine contain mercury or thimerosal?
No. The vaccine does not contain thimerosal or any other preservative.
Is this the same vaccine for rotavirus that was taken off the market because of problems?
No, this is not the same vaccine. In the 1999, a different version of rotavirus vaccine was removed from the market after it was found to be associated with a rare type of bowel obstruction called intussusception. RotaTeq® is a different vaccine than the vaccine (RotaShield®) removed from the market because of problems with bowel obstructions. There is no evidence that this vaccine will cause intussusception. It is made differently and its safety was assessed in a large study involving more than 70,000 children before the vaccine was licensed.
CDC and FDA will continue to very closely monitor this vaccine to ensure there are no problems.
How do you know it does not cause intussusception?
A large study of over 70,000 children, designed specifically to assess a risk of intussusception similar to what was found for the previous rotavirus vaccine, was conducted before licensure of RotaTeq®. In that study, there was no association found between the vaccine and an increased risk of intussusception. While these safety data from the clinical trials are reassuring, the safety of RotaTeq™ will be monitored closely post licensure as larger numbers of infants are vaccinated.
How will safety of this vaccine be monitored after licensure?
Following licensure and use of all vaccines in the United States, safety is closely monitored by the FDA and CDC through the Vaccine Adverse Event Reporting System (VAERS). This will also occur for RotaTeq®. These agencies will be closely monitoring for any intussusception cases reported to VAERS. Additionally, in order to further observe RotaTeq® for the potential that it could be associated with increased rates of intussusception or other serious adverse events, the manufacturer, Merck and Co., Inc., has committed to conducting another study after licensure of approximately 44,000 children, and CDC will also conduct a large study in its Vaccine Safety Datalink Program (VSD), which evaluates vaccine safety among approximately 80,000 U.S. infants every year. Also, for the first three years of licensure, the manufacturer will report cases of intussusception to FDA within 15 days of receiving them, and all other serious side effects on a monthly basis. Although there is no evidence to date that RotaTeq™ causes intussusception, this aggressive post-licensure monitoring should enhance our ability to detect this risk.
What is intussusception?
Intussusception is a rare blockage or twisting of the intestine, which can be life-threatening. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine. Because the two walls of the intestines press against each other, this causes inflammation, swelling, and eventually decreased blood flow. If it is not detected early, internal bleeding, a hole in the intestines and infection in the abdomen may occur because the intestinal tissue has died from the decreased blood flow. With prompt detection and treatment, almost all patients fully recover. Although persons of any age can get intussusception, it is most common among infants in the first year of life and occurs spontaneously in approximately 1 in 2,000 healthy young infants and children per year. For more details on intussusception...
How can I report a serious side effect of RotaTeq® or other vaccine?
Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and the CDC. For a copy of the vaccine reporting form, call 1-800-822-7967 or report online to www.vaers.hhs.gov (exit)
Return to main Rotavirus Vaccination page
Content last reviewed on April 16, 2006
Content Source: National Center for Immunization and Respiratory Diseases