Oral Rotavirus Vaccine Linked to Intestinal Blockage

Feb. 26, 2001 (Ivanhoe Newswire) -- An oral rotavirus vaccine formerly approved by the Food and Drug Administration (FDA) may cause a form of intestinal blockage, known as intussusception, in healthy infants.

Rotavirus causes severe inflammation of the stomach and intestinal lining and affects some 3.5 million young children in the United States each year. The most serious cases of infection account for 50,000 hospitalizations and 20 deaths in the United States annually, though children in developing countries are at greatest risk for severe rotaviral illness.

On August 31, 1998, the FDA approved the tetravalent rhesus-human reassortment rotavirus vaccine (RRV-TV) for infants and recommended doses at 2, 4, and 6 months of age. Use of RRV-TV was later suspended when an increased occurrence of intussusception was reported among recently vaccinated infants. Intussusception is caused by the inward folding of one segment of the bowel into another.

To assess whether a connection exists between RRV-TV and intussusception, investigators from the Centers for Disease Control and Prevention in Atlanta performed analyses of the medical records and histories of infants with intussusception and healthy infants of the same age. Of these subjects, 17.2 percent of infants with intussusception and 12.5 percent of healthy infants were previously vaccinated with RRV-TV.

The findings, reported in the current issue of the New England Journal of Medicine, support an increased risk of intussusception three to 14 days after the first dose of the vaccine. The authors of the report estimate that a national program of vaccination with RRV-TV would result in one case of intussusception due to the vaccine for every 4,670 to 9,474 infants vaccinated.

Authors of the study conclude, “The strong association between vaccination with RRV-TV and intussusception among otherwise healthy infants supports the existence of a causal relation. Rotavirus vaccines with an improved safety profile are urgently needed.”

Copyright © 2001 Ivanhoe Broadcast News, Inc.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.