The Pros and Cons of Infant Vaccines

What's Best for Your Baby?

By Dr. Edward R. Rosick

An incident that looms large for members of the NVIC and other vaccine skeptics is the Food and Drug Administration (FDA) approval in 1998 of a new vaccine called RotaShield. This vaccine, produced and marketed by Wyeth Lederle, was said to protect infants against rotavirus, a disease that can cause severe diarrhea in infants.

RotaShield sailed through the FDA approval process with no problems. However, a year after its introduction, RotaShield was voluntarily withdrawn from the market, following numerous reports of a condition called intussusception, which is an extremely painful, possibly deadly process whereby the infant's intestines become twisted and obstructed. By September of 1999, there had been 99 reported cases of intussesception in infants given RotaShield. Two of those babies died.

Later investigation of the vaccine revealed that there had been an increased risk of intussusception seen in pre-market trials, yet this information was not required to be given to parents whose infants were given the vaccine. It was also discovered that three out of five members of an FDA advisory committee voting to approval the vaccine in December of 1997 had ties to pharmaceutical companies developing rotavirus vaccines.

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