The Pharmaceutical Journal
Vol 276 No 7384 p66
21 January 2006

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Rotavirus research shows promising results

Promising results from trials of new rotavirus vaccines have been published (New England Journal of Medicine 2006:354:11 and 23).

In 1999, a year after its launch, a rotavirus vaccine (RotaShield; Wyeth) was withdrawn from the US market because of a risk of intestinal intussusception, which can be life threatening. Two new vaccines have been developed and these studies examine their efficacy and safety.

Over 60,000 infants in the US and Finland were given Rotateq (Merck), a live oral pentavalent vaccine, or placebo. Intussusception occurred in six vaccine recipients and five placebo recipients (adjusted relative risk 1.6; 95 per cent confidence interval, 0.4–6.4) within 42 days after any dose.

In addition, the vaccine reduced hospital visits and admissions related to rotavirus by 94.5 per cent, and clinic visits for rotavirus gastroenteritis were also reduced. Compared with placebo, the vaccine’s efficacy against rotavirus gastroenteritis was 74 per cent (95 per cent CI, 66.8–79.9) and against severe gastroenteritis was 98 per cent (95 per cent CI, 88.3–100).

In the second study, over 60,000 infants in Latin America and Finland were given Rotarix (GlaxoSmithKline), a monovalent vaccine derived from the most common human rotavirus, at two and four months. Six vaccine recipients and seven placebo recipients had intussusception within 31 days of receiving either dose (P=0.78).

The vaccine’s efficacy against severe rotavirus gastroenteritis and against rotavirus-associated admissions to hospital was 85 per cent compared with placebo (P<0.001).
The author of an accompanying editorial (ibid, p75) notes that the trials leave open the question of whether vaccines might cause intussusception if administered to infants over three months of age and suggests that a system of surveillance should be put in place after licensing to monitor its occurrence.