In developing countries, rotavirus infection kills more than 600,000 children each year.(file photo)
BEIJING, Feb.6 (Xinhuanet) --The U.S. Food and Drug Administration (FDA) Friday approved a new vaccine that protects against rotavirus, a stomch flu, that causes a severe form of diarrhea in babies and children.
Studies showed that the vaccine, RotaTeq, from Merck & Co., prevented 98% of severe infection and 96% of hospitalizations caused by rotavirus, according to Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.
Rotavirus infection, also called "winter diarrhea" because it tends to occur between November and April in the USA, causes fever, vomiting and watery diarrhea that can quickly lead to dehydration. It is the most common cause of diarrhea in young children, and by age 2, most children in the USA have had it. Few of the children die, but more than 55,000 each year need to be hospitalized, says the Centers for Disease Control and Prevention (CDC).
In developing countries, the CDC says, rotavirus infection kills more than 600,000 children each year.
The vaccine is a liquid that can be given by mouth in three doses from age 6 weeks to 32 weeks. The Advisory Committee on Immunization Practices, which makes vaccine recommendations to the CDC, is scheduled to vote this month on whether to advise adding RotaTeq to the list of vaccines that are given to babies routinely.
A previously licensed rotavirus vaccine was withdrawn in 1999 after it was linked to an increased risk for a dangerous bowel obstruction called intussusception.
To detect any sign of intussusception or other unwanted health effects, studies of the new vaccine were among the largest ever done; they involved more than 72,000 babies. No serious side effects were observed in babies who were given the vaccine compared with those who received a placebo, Goodman says.(Agencies)
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