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PED-EM-L  July 1999

PED-EM-L July 1999

Subject:

Intussusception Among Recipients of Rotavirus Vaccine (from MMWR)

From:

Richard Gabor <[log in to unmask]>

Reply-To:

Richard Gabor <[log in to unmask]>

Date:

Thu, 15 Jul 1999 17:14:36 -0400

Content-Type:

text/plain

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text/plain (93 lines)

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
   http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4827a1.htm
 
Editorial Note: Rotavirus is the most common cause of severe gastroenteritis
in
infants and young children aged <5 years in the United States, resulting in
approxi-mately
500,000 physician visits, 50,000 hospitalizations, and 20 deaths each year.
Worldwide, rotavirus is a major cause of childhood death, accounting for an
estimated
600,000 deaths annually among children aged <5 years. Rotavirus vaccines
offer the
opportunity to reduce substantially the occurrence of this disease ( 1 ).
In prelicensure studies, five cases of intussusception occurred among 10,054
vac-cine
recipients and one of 4633 controls, a difference that was not statistically
signifi-cant
( 5 ). Three of the five cases among vaccinated children occurred within 6-7
days
of receiving rotavirus vaccine. On the basis of these data, intussusception
was
included as a potential adverse reaction on the package insert, and the ACIP
recom-mended
postlicensure surveillance for this adverse event following vaccination
( 1 ).
Because of concerns about intussusception identified in prelicensure trials,
VAERS
data were analyzed early in the postlicensure period. The number of reported
intus-susception
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
adverse
events following vaccination is incomplete ( 6 ), the actual number of
intussusception
cases among RRV-TV recipients may be substantially greater than that
reported.
In response to the VAERS reports, a preliminary analysis of data from an
ongoing
postlicensure study at NCKP was performed, and a multistate investigation
was initi-ated
to determine whether an association exists between administration of RRV-TV
and intussusception in infants. Preliminary data from Minnesota and from
NCKP also
suggest an increased risk for intussusception following receipt of RRV-TV.
Observed
rates of intussusception among recently vaccinated children were similar in
both studies. However, the number of cases of intussusception among
vaccinated children
is small at both NCKP and in Minnesota, and neither study has adequate power
to
establish a statistically significant difference in incidence of
intussusception among
vaccinated and unvaccinated children. Available data suggest but do not
establish a
causal association between receipt of rotavirus vaccine and intussusception,
and ad-ditional
studies are ongoing.
Although neither these studies nor the VAERS reports is conclusive, the
consis-tency
of findings from these three data sources raises strong concerns. Because
more
data are anticipated within several months and rotavirus season is still 4-6
months
away in most areas of the United States, CDC recommends postponing
administration
of RRV-TV to children scheduled to receive the vaccine before November 1999,
includ-ing
those who already have begun the RRV-TV series. Parents or caregivers of
children
who have recently received rotavirus vaccine should promptly contact their
health-care
provider if the infant develops symptoms consistent with intussusception
(e.g.,
persistent vomiting, bloody stools, black stools, abdominal distention,
and/or severe
colic pain). Health-care providers should consider intussusception in
infants who have
recently received RRV-TV and present with a consistent clinical syndrome;
early diag-nosis
may increase the probability that the intussusception can be treated
success-fully
without surgery. Vaccine providers, parents, and caregivers should report to
VAERS intussusception and other adverse events following vaccination.
 
For more information, send mail to [log in to unmask] with the message: info PED-EM-L
The URL for the PED-EM-L Web Page is:
  http://www.brown.edu/Administration/Emergency_Medicine/ped-em-l.html

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