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3l.8 What is the relationship between the rotavirus vaccine and intussusception?




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This article is from the Childhood Vaccinations FAQ, by Lynn Gazis-Sax lynng@alsirat.com with numerous contributions by others.

3l.8 What is the relationship between the rotavirus vaccine and intussusception?

15 cases of intussusception, possibly associated with administration
of the rotavirus vaccine, have been reported to VAERS. These cases
were analyzed in "Intussusception Among Recipients of Rotavirus
Vaccine -- United States, 1998-1999," MMWR 48(27);577-581, 1999,
Centers for Disease Control.

VAERS reports of intussusception were reviewed, and parents or
guardians or health-care providers contacted by phone for clinical and
demographic data. Data on vaccine distribution was also obtained from
the manufacturer.

13 of the 15 developed intussusception after the first dose, and 12 of
the 15 developed symptoms within a week of receiving any
dose. Intussusception confirmed radiologically in all. 8 needed
surgical reduction. All recovered. 14 were spontaneous reports, and
one was obtained through active postlicensure surveillance. According
to the report, "The manufacturer had distributed approximately 1.8
million doses of RRV-TV as of June 1, 1999, and estimated that 1.5
million doses (83%) had been administered. Given this information,
14-16 intussusception cases among infants would be expected by chance
alone during the week following receipt of any dose of RRV-TV.

As part of a preliminary analysis of postlicensure adverse events,
cases of intussusception during December 1, 1998-June 10, 1999 were
identified in Northern California and Minnesota, and the rate in
vaccinated and unvaccinated children was compared. Vaccinated children
showed a statistically higher incidence of intussusception.

A further announcement by the FDA, made on September 14, 1999,
reported that the number of cases of intussusception that may be
related to the rotavirus vaccine (15 as of July 7), is now up to 99,
including two deaths. The FDA's Dr. Kathryn Carbone, one of the
initial reviewers of the rotavirus data, reported to a gathering of
the FDA's Vaccines and Related Biological Products Advisory Committee
that all these cases are still under investigation, and it is not
clear yet whether the two deaths or the other cases were caused by the
vaccine.

Further study is being done.

 

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