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Rotavirus Vaccine Recommendation Withdrawn Due to Risk of
Intussusception
Since the availability of the rotavirus vaccine and July 7, 1999, 15 cases of
intussusception (a bowel obstruction in which one segment of bowel becomes
enfolded within another segment) were reported to the Vaccine Adverse Event
Reporting System (VAERS). VAERS is a passive surveillance system operated by
the Food and Drug Administration (FDA) and Centers for Disease Control and
Prevention (CDC). Vaccine manufacturers are required to report to VAERS any
adverse event reported to them, and health-care providers are encouraged to
report any adverse event possibly attributable to a vaccine.
Before the rhesus rotavirus vaccine-tetravalent (RRV-TV) (RotaShield) was
licensed for use in the United States, five cases of intussusception had
occurred among 10,054 vaccine recipients and one of 4,633 controls, a
difference that was not statistically significant. On the basis of these
data, intussusception was included as a potential adverse reaction on the package
insert.
On October 22, 1999, the Advisory Committee on Immunization Practices (ACIP)
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 it 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.
Reference
Intussusception among recipients of rotavirus vaccine —
United States, 1998-1999, MMWR
48(27):577-581, July 16, 1999
Withdrawal of rotavirus vaccine recommendation, MMWR
48(43): 1007, Nov 5, 1999.
Additional Information
Rotavirus
Vaccine Drug Card Update
See Chapter 10 in Essentials
of Pediatric Nursing, 5th edition.
See Chapter 12 in Nursing
Care of Infants and Children, 6th edition.
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