Rotarix Vaccine Potential Issues and Problems
In March of 2010 the Food and Drug Administration (FDA) notified health care professionals that it was the recommendation of the FDA to temporarily suspend the use of the Rotarix vaccine Rotarix is a vaccine given to children to prevent rotavirus disease.
The FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. Right now there is no known evidence that the PCV1 virus causes disease in humans nor that there is a safety risk with the vaccine. The recommendation to suspend the use of the Rotarix virus was a precaution by the FDA while it investigates the situation. It is expected that the FDA will make further recommendations regarding the use of this vaccine in the next four to six weeks.
Rotavirus is a virus that causes severe diarrhea and dehydration in young infants. There are two vaccines for rotavirus available currently in the US – Rotarix and RotaTeq. If your child received his or her first vaccine of Rotarix the Centers for Disease Control (CDC) have indicated that the vaccine series can be completed using RotaTeq (two additional doses).
Since available evidence supports the safety of Rotarix the FDA has stated that no medical follow up is necessary for patients who have received this vaccine.