Selections from Journal Watch Pediatrics and Adolescent Medicine Copyright © 2006 Massachusetts Medical Society. All rights reserved.

Rotavirus Vaccines Are Coming Soon

▸ Rotavirus disease kills nearly half a million children annually in developing countries, and it is a leading cause of hospitalization among infants and children in the U.S. In 1999, the first licensed rotavirus vaccine was withdrawn from the market because it was associated with intussusception (estimated rate, 1/10,000 recipients). Now, results are available from two industry-supported, randomized, placebo-controlled clinical trials of new rotavirus vaccines.

Rotarix, a monovalent vaccine derived from the most common rotavirus strain, was tested in 63,225 infants in Latin America and Finland. Compared with placebo, two active oral doses given at ages 2 months and 4 months reduced severe rotavirus gastroenteritis and rotavirus-associated hospitalization by 85%. Numbers of intussusception cases within 100 days after the first dose were similar in the two groups (9 in the vaccine group and 16 in the placebo group).

Rotateq, a pentavalent human-bovine reassortant vaccine, was tested in 68,038 infants in the U.S., Europe, Latin America, and Taiwan. Compared with placebo, three active oral doses, given 4 to 10 weeks apart, beginning between 6 and 12 weeks after birth, were highly efficacious, reducing rotavirus-associated gastroenteritis and hospitalization or emergency department visits by 95% at 14 or more days after the third dose. Efficacy against rotavirus-associated gastroenteritis covered by the vaccine (through the first full rotavirus season after vaccination) was 74%. Again, rates of intussusception were similar in the vaccine and placebo groups.