CDC Recommends Postponement of Rotavirus Vaccine Due
to Bowel Obstruction Among Some Infants.
ATLANTA, GA July 15, 1999 (www.SafetyAlerts.com) - The Center for Disease Control in
Atlanta, GA is recommending that healthcare providers and parents postpone use of
the rotavirus vaccine for infants, at least until November 1999. This Recommendation
is 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
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
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.
According to the CDC, 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
The symptoms of intussusception are persistent
vomiting, bloody stools, black stools, abdominal bloating or severe colic pain.
Parents and caretakers of infants should contact their health care provider if a child
displays these symptoms. Health care providers should be aware of the possible increased
risk and consider this diagnosis among children presenting these symptoms.
According to studies done prior to the Food and
Drug Administration (FDA) license of 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
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/vaers.htm.
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