Rotavirus Vaccine Not Linked to Risk of Intestinal Disorder

Large Study Shows No Link Between Vaccine and Intussusception

By Denise Mann
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:

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.

Reassuring Findings

The new findings are reassuring, says Tamara R. Kuittinen, MD. She is the director of medical education at the department of emergency medicine at Lenox Hill Hospital in New York City.

The vaccine has been helpful in reducing rates of hospitalization for children with rotavirus. Now we know that it does so without increasing the risk of intussusception.

"Intussusception doesn't seem to be, from this study and others, the risk that we thought it was," she says. Kuittinen hopes these findings encourage more people to, at least, consider vaccinating their children.

"Keep in mind, the problems with the original rotavirus vaccine primarily occurred when it was given off-schedule," says Paula Hertel, MD. She is an assistant professor of pediatrics in the section of gastroenterology, hepatology, and nutrition at Baylor College of Medicine in Houston, Texas. There are very explicit guidelines for how to administer this vaccine.

The main message is clear. "This vaccine has decreased the number of infections and hospitalization for rotavirus. I absolutely encourage people to give their children this vaccine," she says.

Hertel practices what she preaches: "My own child received this vaccine, and my colleagues all feel very comfortable with it as well."

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SOURCES: Tamara R. Kuittinen, MD, director, medical education, department of emergency medicine, Lenox Hill Hospital, New York.Paula Hertel, MD, assistant professor, Baylor College of Medicine, Houston.Shui, I.M. Journal of the American Medical Association, 2012.

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