Questions & Answers

Click here for a fully formatted PDF version of these Qs & As.

When did a rotavirus vaccine become available?
A vaccine to prevent rotavirus gastroenteritis was first licensed in August 1998 but was withdrawn in 1999 because of its association with intussusception (intestinal blockage).

In February 2006, the Food and Drug Administration approved a new rotavirus vaccine, RotaTeq.

What kind of vaccine is it?
RotaTeq is a live vaccine. It is a combination between a cow rotavirus and human rotavirus. The vaccine contains five different rotavirus strains.

How is this vaccine given?
The RotaTeq vaccine is a liquid given by mouth.

Who should get this vaccine?
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants with three doses of rotavirus vaccine.

What is the recommended schedule for getting this vaccine?
Children should get 3 doses of rotavirus vaccine, at age 2 months, age 4 months, and age 6 months. The first dose should be given between age 6-12 weeks and the two additional doses are given at 4-10 week intervals. Children should get all three doses by age 32 weeks.

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

Should an infant who has already been infected with rotavirus still be vaccinated?
Infants who have recovered from a rotavirus infection may not be immune to all five serotypes present in the vaccine. These infants should complete the three-dose series if they can do so by age 32 weeks.

How safe is this vaccine?
Clinical trials to determine the safety and effectiveness of this vaccine involved more than 70,000 infants age 6-12 weeks in 11 countries. There was not a clinically significant difference in the incidence of vomiting, diarrhea, fever, irritability, or poor feeding in children who got the vaccine versus those who didn't.

Because of the association of the earlier rotavirus vaccine with intestinal blockage, a study designed specifically to assess a risk of intussusception was conducted before licensure of RotaTeq. The vaccine was given to 35,000 children and another 35,000 were given a placebo (salt water). There was no difference in the incidence of intestinal blockage between the two groups.

In addition, the safety of this vaccine is being monitored after licensure (as with all vaccines) by FDA and by CDC through the Vaccine Adverse Event Reporting System. In addition, the manufacturer, Merck and Co., Inc., has committed to conducting another study of approximately 44,000 children, and CDC will also conduct a large study in its Vaccine Safety Datalink Program, 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.

As a result of this aggressive monitoring, on February 13, 2007, the FDA released a report on the number of intussusception cases reported since RotaTeq licensure. The number reported fell within what was expected and gives assurance that the vaccine does not pose an elevated risk for intussusception. To read the report, go to: http://www.fda.gov/cber/safety/phnrota021307.htm To read a CDC Q&A about the report, go to: http://www.cdc.gov/od/science/iso/concerns/rotavirus.htm

How effective is this vaccine?
Rotavirus vaccine is very effective against rotavirus disease. Studies indicate the vaccine will prevent about 74% of all rotavirus cases, about 98% of severe cases, and about 96% of hospitalizations due to rotavirus. The vaccine will not prevent diarrhea or vomiting caused by other viruses.

What side effects have been reported with this vaccine?
Children are slightly (1%-3%) more likely to have mild, temporary diarrhea or vomiting within 7 days after getting a dose of vaccine than children who did not get the vaccine.

Moderate or severe reactions have not been associated with this vaccine.

Who should NOT receive rotavirus vaccine?
Any child who has had a severe (life-threatening) allergic reaction to a dose of rotavirus vaccine should not get another dose.

A child with a severe (life-threatening) allergy to any component of rotavirus vaccine should not get the vaccine.

Although this vaccine has not been associated with intussusception, as a precaution it is suggested that children who have had intussusception should not get rotavirus vaccine as they are at a higher risk for getting intussusception again.

Children who are moderately or severely ill at the time the vaccination is scheduled should probably wait until they recover. This includes children who have diarrhea or vomiting.

Check with your healthcare provider if your child has any ongoing digestive problems; if your child's immune system is weakened because of HIV/AIDS or another disease that affects the immune system; if your child is receiving treatment with drugs such as long-term steroids or treatment for cancer; or if your child has recently had a blood transfusion or received any other blood product.

Can the vaccine cause rotavirus?
No. The vaccine contains attenuated viruses that are reassorted and do not exist in nature. The vaccine may cause mild symptoms similar to those experienced during rotavirus infection but cannot cause rotavirus disease.

Questions and answers about rotavirus disease

Technically reviewed by the Centers for Disease Control and Prevention, May 2007