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Rotavirus Vaccine

In early 2006, a rotavirus vaccine called RotaTeq was approved by the Food and Drug Administration (FDA) for children under 32 weeks of age. RotaTeq should not be confused with RotaShield, a previous rotavirus vaccine pulled from the market in 1999 due to its association with a rare type of bowel obstruction. While there are potential side effects associated with RotaTeq, the risk of it causing serious health problems is extremely small. The rotavirus vaccine is not right for everyone; some children should not receive the vaccine.

 

Rotavirus Vaccine: An Overview

In February 2006, the US Food and Drug Administration (FDA) licensed a new rotavirus vaccine called RotaTeq®. The RotaTeq rotavirus vaccine is a liquid given by mouth rather than by a shot. Three doses of vaccine are needed to provide good protection.
 

Schedule for the Rotavirus Vaccine

The first dose of rotavirus vaccine should be given between 6 and 12 weeks old, and two additional doses are given at 4- to 10-week intervals. Children should get all three rotavirus vaccine doses before they are 32 weeks old.
 
There are insufficient data on the safety and effectiveness of the rotavirus vaccine in infants outside of these age ranges.
 

Expected Results From the Rotavirus Vaccine

Overall, approximately 72,000 healthy infants were studied worldwide in randomized placebo-controlled studies to look at both the safety of the rotavirus vaccine and how well it works. The data showing how well RotaTeq prevents rotavirus gastroenteritis come from studying almost 7,000 infants in the United States and Finland.
 
In these studies, rotavirus vaccine prevented 74 percent of all rotavirus gastroenteritis cases and 98 percent of the severe cases. In addition, rotavirus vaccine reduced the need for hospitalization for gastroenteritis due to rotavirus by 96 percent.
 
(Rotavirus Vaccine Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;