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Children's Vaccines Health Center

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How Your Vaccines are Approved

Vaccine approval process questioned after rotovirus recall.

Why the Vaccine Was Approved -- Then Withdrawn continued...

According to David O. Matson, M.D. -- Associate Director of the Virginia Medical School's Center for Pediatric Research -- intussusception occurs at a rate of about 50 per 100,000 children who are vaccinated with the rotavirus vaccine in the first year of life -- an extremely low rate. A study to detect potentially dangerous events at such a low rate would require more than 50,000 participants, and would cost the vaccine manufacturer about $2,000 per participant.

Matson notes that the rotavirus vaccine is the first vaccine recommended for routine use in children that has ever been withdrawn.

More Parent Involvement Needed

The withdrawal of the rotavirus vaccine is making parents wonder whether they should be asking more questions about other vaccines their children are getting -- and rightly so.

"Parents need to educate themselves about new vaccines coming out, and weigh the pros and cons with their pediatricians when appropriate," says Richard Zimmerman, M.D., a family physician at the East Liberty Family Health Care Center in Pittsburgh, PA. Zimmerman had planned to have his daughter, now six months old, immunized with the rotavirus vaccine until the CDC withdrew its endorsement. "For vaccines against diseases of moderate severity, such as rotavirus, more joint parent-physician decision-making is needed."

Meanwhile, many physicians remain hopeful that the rotavirus vaccine may be reintroduced, for it's the first vaccine to be introduced to fight this uncomfortable and potentially dangerous illness. "The entire picture isn't yet filled in," says Matson. "The study responsible for the vaccine's withdrawal likely represents the extreme end of the true risk of the adverse events after rotavirus immunization. A closer estimate will come from more studies currently under way."

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