Rotaviruses are the main cause of severe dehydrating diarrhoea in young children worldwide, accounting for 125 million cases of diarrhoeal disease with more than 800 000 associated deaths.
ROTAVIRUS VACCINE
Rotaviruses
are the main cause of severe dehydrating diarrhoea in young children worldwide,
accounting for 125 million cases of diarrhoeal disease with more than 800 000
associated deaths (Greenberg, Matsui and Loutit, 1999). Estimates vary; but in
the United States, rotavirus is a common cause of severe gastroenteritis in
children where it accounts for 50 000–65 000 hospi-talisations and for 20–70
deaths per annum (Green-berg, Matsui and Loutit, 1999; US Department of Health and
Human Services, 1999a).
In
1998, a tetravalent rhesus-based rotavirus vaccine was licensed in the United
States for the vaccina-tion of infants. During the following 11 months, 15
cases of radiographically confirmed intussusception in vaccinated infants were
reported to the United States Vaccine Adverse Events Reporting System (US
Department of Health and Human Services, 1999a). Of the 15, most (87%)
developed intussusception following the first dose of the three-dose
vaccina-tion schedule. Eight of the children required surgical reduction, and
one required the resection of part of the distal ileum and proximal colon.
Following review of the data, it was concluded that intussusception occurred
with a significantly increased frequency after rotavirus vaccination (US
Department of Health and Human Services, 1999b). Recommendations to vacci-nate
infants in the United States were subsequently withdrawn.
The
above reports of intussusception prompted an investigation to further evaluate
the potential association with the vaccine (Murphy et al., 2001). Infants aged at least 1 month, but less than 12
months, and who were hospitalised in 19 states of the United States between 1
November 1998 and 30 June 1999 were identified. Of 446 infants with
intussusception, 429 were eligible to be included in a case–control analysis
with 1763 matched controls. Four hundred and thirty-two of the 446 infants were
also included in a case–series analysis. Among the infants with
intus-susception, 17.2% had received the rotavirus vaccine compared with 12.8%
of the controls (p =
0.02). There was an increased risk of intussusception for 3–14 days after the
first dose of the vaccine. Case– series analysis showed the risk was also
increased following the second dose of the vaccine, although this was smaller
than the risk after the first dose. The authors concluded that the strong
association between the rotavirus vaccine and intussusception supports the
existence of a causal relationship.
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