I thought this would be of interest to list members - it is from this weeks
MMWR - the full text is available at the web address shown.
Intussusception Among Recipients of Rotavirus Vaccine
--- United States, 1998-1999
Editorial Note: Rotavirus is the most common cause of severe gastroenteritis
infants and young children aged <5 years in the United States, resulting in
500,000 physician visits, 50,000 hospitalizations, and 20 deaths each year.
Worldwide, rotavirus is a major cause of childhood death, accounting for an
600,000 deaths annually among children aged <5 years. Rotavirus vaccines
opportunity to reduce substantially the occurrence of this disease ( 1 ).
In prelicensure studies, five cases of intussusception occurred among 10,054
recipients and one of 4633 controls, a difference that was not statistically
( 5 ). Three of the five cases among vaccinated children occurred within 6-7
of receiving rotavirus vaccine. On the basis of these data, intussusception
included as a potential adverse reaction on the package insert, and the ACIP
postlicensure surveillance for this adverse event following vaccination
( 1 ).
Because of concerns about intussusception identified in prelicensure trials,
data were analyzed early in the postlicensure period. The number of reported
case-patients with illness onset within 1 week of receiving any dose of
vaccine is in the expected range; however, because reporting to VAERS of
events following vaccination is incomplete ( 6 ), the actual number of
cases among RRV-TV recipients may be substantially greater than that
In response to the VAERS reports, a preliminary analysis of data from an
postlicensure study at NCKP was performed, and a multistate investigation
to determine whether an association exists between administration of RRV-TV
and intussusception in infants. Preliminary data from Minnesota and from
suggest an increased risk for intussusception following receipt of RRV-TV.
rates of intussusception among recently vaccinated children were similar in
both studies. However, the number of cases of intussusception among
is small at both NCKP and in Minnesota, and neither study has adequate power
establish a statistically significant difference in incidence of
vaccinated and unvaccinated children. Available data suggest but do not
causal association between receipt of rotavirus vaccine and intussusception,
studies are ongoing.
Although neither these studies nor the VAERS reports is conclusive, the
of findings from these three data sources raises strong concerns. Because
data are anticipated within several months and rotavirus season is still 4-6
away in most areas of the United States, CDC recommends postponing
of RRV-TV to children scheduled to receive the vaccine before November 1999,
those who already have begun the RRV-TV series. Parents or caregivers of
who have recently received rotavirus vaccine should promptly contact their
provider if the infant develops symptoms consistent with intussusception
persistent vomiting, bloody stools, black stools, abdominal distention,
colic pain). Health-care providers should consider intussusception in
infants who have
recently received RRV-TV and present with a consistent clinical syndrome;
may increase the probability that the intussusception can be treated
without surgery. Vaccine providers, parents, and caregivers should report to
VAERS intussusception and other adverse events following vaccination.
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