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Rotavirus Vaccines Are Coming Soon

Promising results for two new rotavirus vaccines

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cause of hospitalization among infants and children in the U.S. In 1999, the first licensed rotavirus vaccine was withdrawn from the market because it was associated with intussusception (estimated rate, 1/10,000 recipients).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.

Comment: These results are enormously gratifying. Rotavirus vaccines could substantially reduce childhood mortality in developing countries and health care use in the U.S. However, editorialists caution that we don’t know how effective the vaccines will be in the poorest countries where other factors, such as malnutrition, affect efficacy, or whether other rotavirus serotypes will affect success. Further, is sufficient political and economic support obtainable to make these vaccines available in countries where they are most needed? Only time will tell. Both vaccines await FDA approval.

— Howard Bauchner, MD

Published in Journal Watch Pediatrics and Adolescent Medicine January 27, 2006

Citation(s):

Ruiz-Palacios GM et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006 Jan 5; 354:11-22.

• Original article (Subscription may be required)
• Medline abstract (Free)

Vesikari T et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006 Jan 5; 354:23-33.

• Original article (Subscription may be required)
• Medline abstract (Free)

Glass RI and Parashar UD. The promise of new rotavirus vaccines. N Engl J Med 2006 Jan 5; 354:75-7.

• Original article (Subscription may be required)
• Medline abstract (Free)