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New vaccines pack punch against rotavirus

Studies of two vaccines promise protection against the gastrointestinal illness that affects millions of the world's children each year.

By ASSOCIATED PRESS
Published January 31, 2006

TRENTON, N.J. - 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 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 a half-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.

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 the New England Journal of Medicine.

The two studies found that 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."

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 time lost 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.

[Last modified January 30, 2006, 16:50:05]