- Rotavirus infection causes 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 severe
dehydration in the U.S. Rotavirus illness has been estimated to result in $264
million in direct medical costs and $1 billion in total costs to society.
- Rotavirus illness is a serious health concern for young children in the United
States. Because there is currently no available vaccine, it is important that
parents and health care providers quickly recognize and treat severe cases of
- Parents need to be sure to consult their health care provider for more information
on the treatment of severe diarrhea in children.
- The rotavirus vaccine (RotaShield�) was licensed by the Food and Drug
Administration (FDA) on August 31, 1998. On October 22, 1999, the Advisory Committee
on Immunization Practices (ACIP) voted to withdraw its recommendation for RotaShield�,
due to an association between the vaccine and intussusception (a rare condition that
can cause a blockage of the intestines). The decision was based primarily on the
results of studies conducted by the Centers for Disease Control and Prevention
(CDC), which suggested an association between the vaccine and intussusception. The
RotaShield� vaccine was withdrawn from use by its manufacturer.
- The series of events that led to ACIP�s decision to no longer recommend
- From September 1, 1998 to July 7, 1999, about 15 Vaccine Adverse Event
Reporting System (VAERS) reports were filed for cases of intussusception
occurring shortly after administration of RotaShield�.
- VAERS showed an increase in the number of reports of intussusception following
rotavirus vaccination. The number of reports was greater than would have been
expected based on the rate of intussusception in infants in the U.S.
- Scientific studies were launched by the CDC to
study this "signal" from VAERS.
- In July 1999, the CDC recommended suspension of immunization until it could be
- On October 22, 1999, the ACIP voted to withdraw its recommendation of
RotaShield� vaccine for infants in the U.S. based on a review of scientific
- The CDC conducted a case-control study that linked vaccination with Rotashield�
to increased risk of intussusception, particularly after the first dose. These
results are published in the New England Journal of Medicine, 2001, Volume 344,
pages 564 to 572. Additional studies are underway to further investigate.
Ensuring Vaccine Safety
CDC, National Immunization Program: http://www.cdc.gov/nip
- The Federal government, including the CDC and FDA, plays 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 care provider
can call VAERS at (800) 822-7967 to receive a reporting form. Forms can also be
downloaded from the internet at: www.vaers.org.
Last updated: August 2001