A previous rotavirus vaccine (RotaShield, Wyeth Laboratories) was withdrawn from the market because of an increased risk of intussusception, a potentially lethal problem in which the intestine telescopes into itself.
Dr. Miguel O'Ryan, from the University of Chile in Santiago, and participants in the Human Rotavirus Vaccine Study evaluated GlaxoSmithKline's rotavirus vaccine, Rotarix, in more than 60,000 infants in 11 Latin American countries and Finland. At approximately 2 and 4 months of age, the infants were given oral doses of the vaccine or inactive "placebo".
During the first 100 days after the first dose, there were no significant differences in the rates of intussusception.
Within a subset of approximately 20,000 patients followed until 1 year of age, the vaccine reduced the rate of severe rotavirus infection by 84.7 percent. The vaccine also reduced the need for hospitalization by 42 percent during the first 100 days.
In the second article, Dr. Penny M. Heaton, from Merck Research Laboratories in West Point, Pennsylvania, and the Rotavirus Efficacy and Safety Trial Study Team evaluated Merck's rotavirus vaccine called RotaTeq. Again, the study included more than 60,000 infants.
As with Rotarix, there was no significant difference between groups in rates of intussusception.
"The vaccine reduced the combined (rate) of hospitalization or emergency department care for...rotavirus (infection) by 94.5 percent," Heaton's group reports. The vaccine was associated with a 58.9 percent reduction in rotavirus-related hospitalizations after the first dose.
Both research teams advocate continued monitoring for safety.
"As vaccines become licensed and used in the United States and Europe, we should expect to see a substantial reduction in winter hospitalizations, visits to doctors and clinics, and parents' workdays lost due to childhood diarrhea," write Dr. Roger I. Glass and Umesh D. Parashar, from the US Centers for Disease Control and Prevention in Atlanta, in an accompanying editorial.
They add: "With the successful introduction of rotavirus vaccines in industrialized countries, the global health community will be charged with expediting the availability of these lifesaving vaccines at an affordable price in the developing world."
SOURCE: The New England Journal of Medicine, January 4, 2006.