The Centers for Disease Control & Prevention is conducting a retrospective review to determine whether intussusception is associated with vaccines other than Wyeth-Ayerst's RotaShield.

FDA Office of Vaccines Research & Review Supervisory Medical Officer Kathryn Carbone, MD, mentioned the study in an update on the rotavirus vaccine at a Sept. 14 meeting of the Vaccines and Related Biological Products Advisory Committee.

CDC will review reports from its Vaccine Safety Datalink, which is similar to FDA's Vaccine Adverse Events Reporting System, in an effort to detect whether other vaccines may be associated with intussusception.

Committee member Mary Estes, PhD, Baylor College of Medicine, pointed out that "many people have raised a question about whether this has been a problem with the live oral polio vaccine....What is being done to look at that?"

Carbone responded that OPV is "being looked at very intensively....There are a few cases showing that intussusception may have been associated with polio vaccine, but I stress association rather than causal association. We're looking at that and other orally delivered vaccines."

Oral polio vaccine is marketed under the tradename Orimune by Wyeth-Lederle. CDC recently advised a move to an inactivated polio immunization schedule (¹ Also see "CDC Advocates All-IPV Immunization Schedule; Combo Development Heats Up" - Pink Sheet, 28 June, 1999.)

Wyeth suspended shipment of its oral rotavirus vaccine July 15 after 15 reports of intussusception since the product's launch in September 1998.

Carbone reported that "as of Sept. 9, 1999, there were 99 cases of intussusception reported to VAERS for children who had received" RotaShield. She said that the increase in reports since July may have been caused by increased awareness and a shift from passive to active reporting.

CDC is conducting a case-control study of rotavirus vaccine-associated intussusception that will enroll 400 patients in a one to four case to control ratio. Enrollment is expected to be complete in October (² Also see "RotaShield Data On Intussusception May Be Ready By October" - Pink Sheet, 19 July, 1999.).

CDC To Review Intussusception Cases With Vaccines Other Than RotaShield

More from Archive

More from Pink Sheet