This year the FDA and CDC approved a new vaccine, RotaTeq manufactured by Merck, for the prevention of rotavirus in infants.
Rotavirus is the number one cause of diarrhea in the US and the world. In the US more than 400,000 cases of diarrhea are attributed to the virus. More than 50,000 cases will need hospitalization due to the severe dehydration that can occur.
The RotaTeq vaccine is approved for infants age 2, 4, and 6 months. It is an oral vaccine. After its inception this year a high number of intussesception cases were reported in infants recently given the vaccine.
Intussesception results in bowel obstruction after the intestine twists and telescopes into itself. It can be treated without complications in early stages, but if missed often bowel perforation, infection, and even death can occur.
In response the FDA issued a warning for healthcare providers to be aware of possible complications. But they did not pull the vaccine because the relationship was not clear. Both the FDA and CDC launched an investigation to determine if the vaccine was safe for infants.
They have concluded that the cases of intussesception did not exceed the usual number of cases in the general population and that the vaccine administration is not connected to the intussesception cases that were reported.
Posted by Dr. Christina Gutierrez on March 19, 2007 05:17 PM
