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Children's Vaccines Health Center

Rotavirus Vaccine Not Linked to Risk of Intestinal Disorder

Large Study Shows No Link Between Vaccine and Intussusception
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WebMD Health News
Reviewed by Laura J. Martin, MD

Feb. 7, 2012 -- Despite studies showing that the rotavirus vaccine can reduce the number of children hospitalized for severe diarrhea, some U.S. doctors are slow to embrace it for fear that this vaccine may increase an infant’s risk of a life-threatening bowel blockage (intussusception).

It’s a case of once bitten, twice shy. An earlier rotavirus vaccine, RotaShield, was pulled from the market because it increased risk for intussusception. Some studies in Latin America also suggested a connection.

Now a large study of close to 800,000 doses given to infants in the U.S. suggests that the RV5 rotavirus vaccine that is currently available does not appear to increase this risk. The findings appear in the Journal of the American Medical Association.

Rotavirus is a common cause of diarrheal illness, especially in children. Symptoms include:

  • Fever
  • Abdominal pain
  • Vomiting
  • Diarrhea

Rotavirus infection ranges from  mild to severe. It is spread easily from child to child via hand-to-mouth contact.

The CDC recommends that infants get vaccinated for rotavirus. There are two available rotavirus vaccines. The RotaTeq (RV5) vaccine is given in three doses at ages 2 months, 4 months, and 6 months. The Rotarix (RV1) vaccine is given in two doses at 2 months and 4 months. The new study looked at the RotaTeq vaccine.

Study Details

Irene M. Shui, ScD, of Harvard Medical School and Harvard Pilgrim Health Care Institute in Boston, and colleagues analyzed intussusception risk among infants aged 4 to 34 weeks who received the RV5 rotavirus vaccine from May 2006 to February 2010.

The study included 800,000 doses of the vaccine, and more than 300,000 first doses. Researchers focused on the first one to seven days after infants received their first dose of the vaccine. This is the period when risk of intussusception is highest. They also analyzed data for up to 30 days after the infants received the vaccine.

Infants who received the rotavirus vaccine were no more likely to develop intussusception than infants who received other recommended childhood vaccines during the same time period. “The findings of our study strengthen the evidence base in favor of vaccination for effective control of severe childhood rotavirus disease,” researchers conclude.

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