CDC Recommends Postponement of Rotavirus Vaccine for Infants

CDC recommends that healthcare providers and parents postpone use of the rotavirus vaccine for infants, at least until November 1999, based on early surveillance reports of intussusception (a type of bowel obstruction that occurs when the bowel fold in on itself) among some infants who received rotavirus vaccine. Although intussusceptions occur among infants who have not received rotavirus vaccine, CDC will be collecting additional data in the next several months that may indicate more clearly whether the rotavirus vaccine increases the risk of intussusception. The recommendation is being made with the consideration that rotavirus season is still 4-6 months away in most parts of the United States.

An estimated 1.5 million doses of rotavirus vaccine have been administered to infants since it was licensed on August 31, 1998. As of July 7, 1999, the Vaccine Adverse Event Reporting System (VAERS) has received 15 reports of intussusception. The rate of intussusception among children receiving the rotavirus vaccine appears to be increased in the first 2 - 3 weeks after vaccination. Parents and caretakers of infants should contact their health care provider if the child develops symptoms of intussusception (persistent vomiting, bloody stools, black stools, abdominal bloating or severe colic pain). Health care providers should be aware of the possible increased risk and consider this diagnosis among children presenting these symptoms. Parents and health care providers should report intussusception and other adverse events following vaccination to VAERS. VAERS reporting forms and information can be requested 24 hours a day by calling (800)822-7967 or accessing the World Wide Web at: http://www.cdc.gov/nip/vacsafe/default.htm.

In studies done before the Food and Drug Administration (FDA) licensed rotavirus vaccine for use in the United States, intussusception was noted among 5 of approximately 10,000 vaccine recipients. This number was not significantly higher than among placebo recipients in the studies. However, the Advisory Committee on Immunization Practices (ACIP), in its recommendation for routine rotavirus vaccination of infants, indicated that postlicensure surveillance was needed for intussusception and any other rare adverse events that might occur following receipt of the vaccine.

Rotavirus is the most common cause of severe diarrhea in children in the United States. Virtually all children have one or more rotavirus infections in the first 5 years of life. Each year in the United States, rotavirus is responsible for approximately 500,000 physician visits and 50,000 hospitalizations. Severe diarrhea and dehydration occur primarily among children 3 months to 35 months of age. It is a seasonal disease in the United States with the vast majority of the disease occurring in the winter and spring months.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES