FDA Issues Public Health Notice on RotaTeq Vaccine

The Food and Drug Administration (FDA) today issues a public health warning on the RotaTeq vaccine after 28 cases of intussusception were reported after administration of the Rotavirus, Live, Oral, Pentavalent vaccine manufactured by Merck. Of the 28 cases 16 resulted in intestinal surgeries for infants.

The cases of intussusception here reported to the Vaccine Adverse Event Reporting System (VAERS) as occurring after dose 1, dose 2, and dose 3 of the vaccine. Half of the cases happened within 21 days of administration. Intussusception is a serious and potentially life-threatening condition caused when one portion of the intestine twists into a nearby portion causing blockage. Though VAERS has no reports of death caused by intussusception the FDA states that there may be more cases that are not know about yet. Adverse reactions to vaccines are not always reported because many parents do not know that their child's illness could be a reaction. Parents are urged to contact their child's doctor immediately if their children show signs of stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements as these could be symptoms of intussusception.

An earlier rotavirus vaccine, Wyeth's RotaShield, was pulled from the U.S. market in 1999 after it was linked to a small increase in intussusception. FDA and the CDC will continue close monitoring of intussusception and other adverse events associated with RotaTeq, though they are not pulling it off of the market at this time.

Merck has not commented on the health notice yet, though Merck is conducting a post-marketing study of approximately 44,000 infants, and the CDC Vaccine Safety Data Link is conducting a post-marketing study of approximately 90,000 infants.

RotaTeq was approved by the FDA in February 2006. At the time, the FDA and Merck said trials of the vaccine indicated it did not increase the risk of intussusception. Currently the FDA says it is unknown right now whether RotaTeq is directly to blame for the cases or if it is coincidental. Intussusception can occur spontaneously. A study in the Vol. 106 No. 6 December 2000 of PEDIATRICS on intussusception shown that most causes for spontaneous intusussception was known, though infant whose mothers were younger than 20 years old, nonwhite, unmarried, and had less than a high school degree were at an increased risk for the condition. Some children with intusussception have a predisposing anatomic condition or have developed the disease after an operation. The study also shows that rates for intussusception are decreasing in the U.S.