0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
From the Centers for Disease Control and Prevention |

Withdrawal of Rotavirus Vaccine Recommendation FREE

JAMA. 1999;282(22):2113-2114. doi:10.1001/jama.282.22.2113-JWR1208-2-1.
Text Size: A A A
Published online

MMWR. 1999;48:1007

In July 1999, CDC recommended that health-care providers and parents postpone use of the rhesus rotavirus vaccine-tetravalent (RRV-TV) (RotaShield®,* 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 ≤5 years.

ARTICLE INFORMATION

*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.

Figures

Tables

References

Letters

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles
Vaccines against poverty. Proc Natl Acad Sci U S A Published online Aug 18, 2014.;