New vaccine shows promise against deadly rotavirus

Monday, November 1, 2004

WASHINGTON -- A new vaccine against rotavirus, the diarrheal infection that kills millions of children worldwide, doesn't appear to raise the risk of serious bowel blockages that caused a previous vaccine to be pulled from the market five years ago, doctors reported Sunday.

The new vaccine, Rotarix, was recently licensed in Mexico and is expected to go on sale there this year. Its maker, Belgium-based GlaxoSmithKline Biologicals, plans to seek similar approvals throughout Latin America, Asia and Europe, and to launch a study in the United States aimed at getting it approved for American infants.

Doctors tested the vaccine in more than 63,000 infants in Latin America and Finland and reported results Sunday at an American Society for Microbiology meeting.

Six babies who got the vaccine developed the bowel problem, as did seven in a comparison group who got a dummy vaccine, suggesting no extra risk beyond what would normally occur.

"This is such terrific news," said Dr. Bruce Innis, a Glaxo research and development official. "For the first time, we have clear evidence that this new vaccine is not associated with a significantly increased risk."

A safe vaccine is critically needed, said Dr. James Hughes of the federal Centers for Disease Control and Prevention. Rotavirus hospitalizes tens of thousands of babies and toddlers in the United States and kills several dozen, but is a much more serious problem in poor countries.

"Diarrhea is among the top five killers worldwide," Hughes said.

The previous vaccine, RotaShield, was withdrawn by its maker, Wyeth, in 1999 after 20 out of 1 million infants in the United States developed the potentially fatal twisted bowel condition within a month of getting the vaccine.

Critics argued that Rotashield should still be sold in poor countries because it saved far more lives than those claimed by the bowel problem. But the risks were considered unacceptably high in the United States, where good medical care makes rotavirus less often fatal.

Another drug company, Merck & Co., also is developing a new rotavirus vaccine.

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