Rotavirus Vaccine

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Chapter: Pharmacovigilance: Gastrointestinal ADRs

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 Recommendations to vacci-nate infants in the United States were subsequently withdrawn.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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