Rotavirus vaccines: new drug. Rotavirus infection: one case of severe diarrhoea prevented per 100 vaccinated infants.

(1) Each year in France, diarrhoea caused by rotavirus kills about 10 infants under three years of age and leads to about 210 hospitalisations per 100 000 children under 5 years of age. (2) Two new oral rotavirus vaccines designed for immunisation during infancy are marketed or shortly to be marketed in France for the first time; one is based on a human strain and the other on both bovine and human strains. (3) The vaccine based on a human strain has been tested in a double-blind placebo-controlled trial involving about 63 000 infants. It had no statistically significant impact on mortality but prevented about 10 cases of severe diarrhoea per 1000 vaccinated infants during the following year. Other, smaller trials provided similar results. (4) In two double-blind placebo-controlled trials involving a total of about 70 000 infants, the human-bovine vaccine prevented about 16 cases of severe diarrhoea per 1000 vaccinated infants during the year following vaccination. As with the human vaccine, there was no impact on mortality. (5) An analysis of data on 60 000 to 70 000 infants immunised with each vaccine showed no increase in the risk of acute intestinal intussusception, a severe adverse effect observed with another rotavirus vaccine that was marketed in the 1990s in the United States (but not in France). This product has since been withdrawn from the market. (6) The two new rotavirus vaccines do not appear to have more adverse effects than placebo. (7) Rotavirus vaccination does not seem to reduce the efficacy of other vaccines. (8) Vaccination is simpler with Rotarix than with Rotateq, requiring two oral doses instead of three. However, Rotarix is sold in kits containing a vial of powder, a prefilled solvent syringe, and a syringe-bottle adaptor, creating a risk that this vaccine might be accidentally injected instead of being given orally. (9) In practice, rotavirus vaccination during infancy is not a public health priority in western countries. Vaccination of individual infants may be useful, especially when access to healthcare may be difficult.