Studies: New vaccines good protection against rotavirus

Thursday, January 5th 2006, 9:50 am
By: News On 6

TRENTON, New Jersey (AP) _ Two new vaccines appear safe and very effective against rotavirus, a major diarrheal killer of young children in poor countries, two huge studies show.

The impressive results prompted two U.S. government doctors to call for making routine immunization ``a global priority.''

Rotavirus, which causes diarrhea and dehydration, leads to more than 2 million hospitalizations and half a million deaths a year, mostly in developing countries. In the United States, the virus sickens about 2.7 million children younger than 5, sends up to 70,000 to the hospital and causes 20 to 70 deaths each year.

In 1999, a different rotavirus vaccine, made by Wyeth, was pulled from the U.S. market after it was linked to a small increase in intussusception, a rare, life-threatening blockage or twisting of the intestine.

The new vaccines, developed by the drugmakers that ran the studies, Merck & Co. and GlaxoSmithKline Biologicals, did not increase cases of the disorder. The studies, each including about 60,000 children, were reported in Thursday's New England Journal of Medicine.

The two studies found each vaccine prevented at least 98 percent of severe cases of gastroenteritis, or intestinal inflammation.

``It's a huge advance,'' said Dr. Peter Wenger, associate professor of preventive medicine, community health and pediatrics at University of Medicine and Dentistry of New Jersey in Newark. He was not involved in the research.

He said nearly all U.S. children get rotavirus at some point. In developing countries, where many children are malnourished and have other infections, ``this pushes them over the edge.''

Drs. Roger I. Glass and Umesh D. Parashar of the U.S. Centers for Disease Control and Prevention wrote in an editorial that the new vaccines are impressive enough that routine immunizations should be done worldwide. Still, babies getting the vaccines should be monitored to ensure there's no risk of intussusception, they wrote.

Merck's RotaTeq, a genetically engineered, three-dose oral vaccine, protects against five common rotavirus strains. The company's study, on infants 6 to 12 weeks old in the United States, Taiwan and nine countries in Europe and Central America, found RotaTeq prevented 74 percent of all gastroenteritis caused by rotavirus, cut hospitalizations by 95 percent and spared parents lost time from work.

Merck, awaiting U.S. Food and Drug Administration approval to sell RotaTeq, plans this year to test it in Africa and Asia.

GlaxoSmithKline's Rotarix, a two-dose oral vaccine, was studied in infants 6 weeks and older in Finland and 11 Latin America countries. It protected them against 85 percent of serious gastroenteritis from rotavirus, reducing hospitalizations by 42 percent. While Rotarix targets one rotavirus strain, it was found to protect against several common ones.

Rotarix was approved for sale last year in 12 Latin American countries, Singapore and the Philippines. The maker plans to apply for U.S. approval.