Jan. 4, 2006 -- Two new vaccines against rotavirus, which causes potentially deadly diarrhea, have shown success in clinical trials.
"After a long period of waiting, the time for a rotavirus vaccine may have finally arrived," states an editorial in the journal.
Rotavirus takes a grim toll. Consider these global statistics on the virus:
- No. 1 cause of diarrhea-related hospitalizations and deaths in babies and young children
- Causes 2 million hospitalizations annually
- Blamed for nearly half a million deaths annually
Those numbers are cited by the research teams that studied the two vaccines. Each team gives slightly different numbers for rotavirus' impact, but they agree that the rotavirus is a huge threat to the world's children, especially in developing countries.
Rotavirus is common, and it isn't always deadly. However, it can cause dehydration that proves fatal.
The Rotarix researchers studied more than 63,000 infants in Finland and 11 Latin American countries. The Rotateq team studied more than 68,000 babies in Finland and the U.S., including Native Americans.
In each trial, babies either got real or fake vaccines (with parental consent). The real vaccines were better at curbing the rotavirus and were called highly effective at preventing illness from rotavirus, leading to fewer hospitalizations.
Unlike an earlier rotavirus vaccine that was pulled from the market, the two new vaccines did not show an increased risk for intussusception, an emergency condition when the intestine folds into itself like a telescope. This can result in intestinal blockage due to swelling and inflammation at the site of the intussusception. It is more commonly seen in very young children less than 2 years old and rarely seen in adults.
The results are "promising," write the editorialists. Still, they state that "hundreds of thousands of children will need to be immunized before a clean bill of health can be given to these vaccines." The editorialists included the CDC's Roger Glass, MD, PhD.
Rotarix is made by GlaxoSmithKline Biologicals. Rotateq is made by Merck. Each company sponsored the trial for its vaccine; the two vaccines were not directly compared. GlaxoSmithKline and Merck are WebMD sponsors.
The Rotarix researchers included Guillermo Ruiz-Palacios, MD, of Mexico's Instituto Nacional de Ciencas Medicas y Nutricion.
Doctors working on the Rotateq study included Timo Vesikari, MD, of Finland's University of Tampere Medical School.