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Withdrawal of Rotavirus Vaccine Recommendation

In July 1999, CDC recommended that health-care providers and parents postpone use of the rhesus rotavirus vaccine-tetravalent (RRV-TV) (RotaShield[Registered]*, Wyeth Laboratories, Inc., Marietta, Pennsylvania), for infants, at least until November 1999. This action was based on reports to the Vaccine Adverse Event Reporting System of intussusception (a type of bowel obstruction that occurs when the bowel folds in on itself) among 15 infants who received rotavirus vaccine. Also at that time, the manufacturer, in consultation with the Food and Drug Administration, voluntarily ceased further distribution of the vaccine.

On October 22, 1999, the Advisory Committee on Immunization Practices (ACIP), after a review of scientific data from several sources, concluded that intussusception occurs with significantly increased frequency in the first 1-2 weeks after vaccination with RRV-TV, particularly following the first dose. Therefore, ACIP no longer recommends vaccination of infants in the United States with RRV-TV and withdraws its recommendation that RRV-TV be administered at 2, 4, and 6 months of age. Children who received rotavirus vaccine before July and remain well are not now at increased risk for intussusception.

Rotavirus remains the cause of a substantial health burden for children in the United States. It accounts for 20-40 deaths annually, and greater than 50,000 hospitalizations from severe diarrhea and dehydration. Vaccination against rotavirus would be the optimal means to prevent such illnesses. RRV-TV was recommended because it was shown in prelicensure trials to be a safe and effective vaccine. In those trials, RRV-TV prevented rotavirus in at least 50% of cases of diarrhea and almost all of the hospitalizations. Postlicensure evaluation, however, has identified intussusception as an uncommon, serious adverse event associated with the vaccine.

The relation between intussusception and RRV-TV merits further research. The findings could impact directly on use of this and other rotavirus vaccines. In addition, the worldwide burden of rotavirus disease remains substantial. Thus, the ACIP's decision may not be applicable to other settings, where the burden of disease is substantially higher and where the risks and benefits of rotavirus vaccination could be different.

In the United States, rotavirus remains the primary cause of parents seeking health care for children with severe dehydrating diarrhea, particularly during the winter. Because of the withdrawal of this vaccine recommendation, the ACIP recommends that educational efforts be directed at parents and health-care providers to help parents prevent dehydration and to recognize and immediately seek medical care for severe diarrhea in children. These efforts should focus on the early diagnosis and treatment of severe dehydration from diarrhea, particularly among infants and children aged less than or equal to 5 years.

* Use of trade names and commercial sources is for identification only and does not imply endorsement by CDC or the U.S. Department of Health and Human Services.

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Page converted: 11/4/1999


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