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Rotavirus Vaccine
FACT SHEET
The Advisory Committee on Immunization Practices (ACIP) decided that
Rotashield, the only U.S.-licensed rotavirus vaccine, should no longer be recommended
for infants in the United States. This action was based on the
results of an expedited review of scientific data presented to the ACIP by CDC
in cooperation with the FDA, NIH, and Public Health Service officials, along
with Wyeth-Lederle. Data from the review indicated a strong association
between Rotashield and intussusception (bowel obstruction) among some infants
during the first 1-2 weeks following vaccination. Use of the vaccine was
suspended in July pending the data review by the ACIP. Parents should be
reassured that their children who received rotavirus vaccine before July and
remain well are not at increased risk for intussusception now.
Rotavirus is a severe
diarrheal illness in childhood that accounts for more than 500,000 physician
visits and approximately 50,000 hospitalizations each year among children less
than 5 years of age. Symptoms include fever, an upset stomach and vomiting
followed by diarrhea which may lead to dehydration. This results in $264
million in direct medical costs and $1 billion in total costs to society.
Rotavirus illness remains a serious health concern for
young children in the United States. Without a vaccine, it is very important
that parents and health care providers quickly recognize and treat severe cases
of childhood diarrhea.
What You Should Know
- The Federal government, including the Centers for
Disease Control and Prevention (CDC) and the Food and Drug Administration
(FDA) play a vital role in monitoring vaccine safety to identify and minimize
vaccine-related injuries.
- To report a health problem following vaccination, you or
your health provider can call the Vaccine Adverse Event Reporting System (VAERS)
at 1-800-822-7967.
- Consult your health care provider for more information on the
treatment of severe diarrhea in children.
The series of events that led to ACIP’s decision to no
longer recommend Rotavirus vaccine:
- From September 1, 1998 – July 7, 1999, fifteen
cases of intussusception following rotavirus vaccine were reported to VAERS.
- The Vaccine Adverse Event Reporting System (VAERS)
system showed an increase number of reports of intussusception following
rotavirus vaccination.
- Scientific studies were launched by the CDC to
study this "signal" from VAERS.
- In July 1999, the CDC recommended suspension of
rotavirus vaccine until it could be studied further.
- On October 22, 1999, the ACIP voted to withdraw
its recommendation of the rotavirus vaccine for infants in the U.S. based on a
review of scientific data collected by the CDC.
For more information
Questions and Answers about
Rotavirus and Intussussception
National Immunization Hotline:
English (800) 232-2522
Spanish (800)
232-0233
National Immunization Program web site: http://www.cdc.gov/nip
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