The Pharmaceutical Journal Vol 267 No 7170 p537-541
20 October 2001

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Rotavirus vaccine not linked to bowel complaint

A vaccine that was withdrawn from the market because of reports of intussusception (a condition where the lining of the bowel folds in on itself causing a blockage) is not associated with an increased incidence of this adverse event, say American researchers.

Supplies of Rotashield, a rotavirus vaccine, were withdrawn from the United States in 1999 because of fears of a link between its use and increased intussusception rates in infants (PJ, 30 October, 1999, p702). However, researchers writing in The Lancet say that admissions to hospital to rectify intussusception did not increase during the period of Rotashield availability and that overall, the incidence of intussusception was lower than before the vaccine was available. For a subset of infants aged 45 to 210 days (the age at which vaccination was considered optimal), a slight increase of 1-4 per cent in the incidence rate was observed. The researchers point out that this contrasts with the projected increase of 23-100 per cent estimated around the time of the vaccine’s withdrawal.

Rotashield does not have a license for use in the United Kingdom but remains licensed for use elsewhere. However, since its withdrawal from the US market, the vaccine has been unavailable worldwide. The researchers point out that this is despite benefit:risk ratios presumed to favour its use in developing countries with high mortality associated with rotaviral infections. They conclude: “Policy makers should consider our finding.” (2001;358:1224.)

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