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How Your Vaccines are Approved

Vaccine approval process questioned after rotovirus recall.

WebMD Feature The immunization rate for children is at an all-time high of 80%, according to the Centers for Disease Control and Prevention (CDC). But in light of the recent withdrawal from the market of a vaccine against rotavirus, should parents be more leery of the process by which vaccines are approved?

"My daughter was constipated for months after she received the rotavirus vaccine at the age of 2 months," says Amy Blackmon of Port Saint Lucy, Fla. "When I heard that there were bad reactions to a vaccine that my doctor had recommended, it made me think I should know more about other immunization shots my daughter is getting."

Rotavirus infection causes diarrhea, vomiting, and mild fever. Nearly all children have at least one bout by the age of three. The American Academy of Pediatrics reports that each year up to 50,000 children and adults are hospitalized because of the virus, and that 20 to 40 people die from it.

Why the Vaccine Was Approved -- Then Withdrawn

The rotavirus vaccine was approved by the U.S. Food and Drug Administration in fall 1998. But by the following July the CDC was recommending that the vaccine not be used -- based on a rise in the number of cases of a type of bowel obstruction called intussusception among children who had received the vaccine.