FDA approves Merck's rotavirus vaccine

WASHINGTON - The U.S. Food and Drug Administration has approved a vaccine that is aimed at preventing severe diarrhea in children. The vaccine called RotaTeq is manufactured by Merck Co. and is directed against rotavirus, which causes severe diarrhea, fever and vomiting that could result in severe dehydration.
Posted : Tue, 07 Feb 2006 00:08:00 GMT
By : Abdul-Salaam Masheer
Category : Health
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WASHINGTON - The U.S. Food and Drug Administration has approved a vaccine that is aimed at preventing severe diarrhea in children. The vaccine called RotaTeq is manufactured by Merck Co. and is directed against rotavirus, which causes severe diarrhea, fever and vomiting that could result in severe dehydration.

The rotavirus infection is also called "winter diarrhea" since it usually strikes in the winter months between November and April. The FDA's Center for Biologics Evaluation and Research tested RotaTeq and found that it was able to ward of 98 percent severe infections and 96 percent of hospitalizations caused by the virus, said Jesse Goodman, the center's director.

But Merck has put a price tag of $187.50 for three oral doses f the vaccine, which makes this the most expensive vaccine ever sold. This could also prompt some state health departments to rethink on their pledge of vaccinating every child "regardless of the income."

Kristen Ehresmann, the immunization manager at the Minnesota Department of Health agrees, "If there aren't increased funds to cover the in-between groups, we are going to reach a point where it's no longer possible to immunize all children," she said. Officials quietly admit that RotaTeq could be out of reach for them and hence many children would have to go without it.

Rotavirus infections typically affect children intensely during the first four to nine months. The infection causes so much vomiting that it is not possible to replenish all fluid at times leading to fatalities.

Merck's vaccine is the first to show some promise against combating an infection that causes 55,000 hospitalizations of children each year. Merck's vaccine was proved to be effective after a trial of 70,000 children proved its usefulness in combating the infection.

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