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FDA Approves Rotavirus Vaccine

February 6, 2006

The U.S. Food and Drug Administration (FDA) has approved a vaccine to protect young children from rotavirus infections, which can lead to vomiting, diarrhea, and severe dehydration.

The vaccine, called RotaTeq, would be given as a liquid during regular vaccinations in three doses at ages 2, 4, and 6 months. RotaTeq is not yet on the routine childhood immunization schedule developed by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the Centers for Disease Control (CDC) to protect kids and teens from certain illnesses. The CDC will decide later this month whether to recommend that RotaTeq be added to the regular immunization schedule. To get the most current information on the vaccine, talk with your child's doctor.

Rotavirus infections are highly contagious. Children commonly get the infection by putting their fingers in their mouths after touching something that has been contaminated by infected stool. People who care for children, including health-care and child-care workers, can also spread the virus, especially if they do not wash their hands after changing diapers.

Rotavirus most often infects infants and young children. In the United States, rotavirus infections cause about 3 million cases of diarrhea and 55,000 hospitalizations for diarrhea and dehydration in kids under age 5 each year. Outbreaks of rotavirus infection typically occur during the winter months.

Although these infections cause relatively few deaths in the United States, diarrhea caused by rotavirus results in hundreds of thousands of deaths worldwide every year, particularly in developing countries where kids cannot get adequate medical care.

In October 1999, a rotavirus vaccine was taken off the market because it was linked to an increased risk for intussusception, a type of bowel obstruction in young infants. RotaTeq does not appear to increase the risk of developing this problem.

What it Means to You

If you have questions about whether the rotavirus vaccine is appropriate or available for your child, talk with your child's doctor.

There are steps you can take to help limit the spread of rotavirus infection in your house. If your child is infected, keep him or her home from child-care groups until the diarrhea has stopped. If you are caring for your child who has diarrhea, it's important to wash your hands frequently, particularly after going to the bathroom, caring for another child, and before preparing and serving food to anyone else.

Signs of a rotavirus infection include fever, nausea, and vomiting, often followed by abdominal cramps and frequent, watery diarrhea. If your child has these symptoms, keep a careful watch for signs of dehydration, which include increased thirst, irritability, restlessness, lethargy, sunken eyes, a dry mouth and tongue, dry skin, fewer trips to the bathroom to urinate, and (in infants) a dry diaper for several hours. Contact your child's doctor immediately if your child shows signs of dehydration, or if you have any other concerns.

Reviewed by: Steven Dowshen, MD
Date reviewed: February 2006



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