The vaccine, which is supposed to protect infants against rotavirus, doesn’t appear to be associated with an increased risk of a potentially life-threatening intestinal problem known as intussusception, according to information compiled by federal health officials, Dow Jones reports.

The FDA and CDC have been tracking Rotateq for any links after another rotavirus vaccine by Wyeth was withdrawn in 1999 over links to an increased rate of intussusception, which is a twisting or obstruction of the intestine that can be fatal. Rotateq was approved for use in infants in 2006 and is designed to protect against rotavirus, a common gastrointestinal illness in children that can cause severe diarrhea and vomiting. The vaccine is administered to infants in three doses, usually at two, four and six months of age.

The FDA issued a public health notice earlier this year saying it had received 28 reports of intussusception and asked health-care providers to be certain to report any suspected cases of the intestinal problem. At the time, the FDA said the intussusception rate was not higher than the rate that would be expected to occur among non-vaccinated infants.

According to a presentation o be presented tomorrow to the CDC’s Advisory Committee on Immunization Practices, there were 160 confirmed cases reported to the vaccine adverse event reporting system out of 9.1 million doses distributed between March 2006 and Aug. 31, 2007. That rate is lower than what would be expected in the general population not receiving Rotateq. Of the 160 cases, 47 were reported within 21 days after receiving one of the three recommended doses. The number of expected cases in a same size group of infants not vaccinated would be about 150.

Another study of Rotateq’s safety, which is included in a broader look at vaccine safety that involves 90,000 infants born annually who are part of the CDC’s vaccine safety datalink program that looks at children’s vaccines, showed “observed intussusception rates are not greater than expected” and there’s “no evidence of increased risk” after 100,000 vaccinations with Rotateq. The vaccine safety datalink review looked at 111,521 Rotateq vaccinations given between May 21, 2006, and Oct. 6, 2007, and found there were three reports of intussusception.

Rotateq is currently the only rotavirus vaccine on the U.S. market but the FDA is currently reviewing an application from GlaxoSmithKline PLC (GSK) to sell a similar vaccine in the U.S. That vaccine, Rotarix, is designed to be administered in two doses to infants.

Source: CNNMoney/Dow Jones