For Immediate Release
March 22, 2010

KDHE Office of Communications, 785-296-0461

Kansas responds to FDA recommendation to temporarily suspend use of Rotarix Vaccine

FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More

The Kansas Department of Health and Environment (KDHE) was notified today by the Centers for Disease Control and Prevention (CDC) that the Food and Drug Administration (FDA) is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the FDA learns more about components of an extraneous virus detected in the vaccine.  There is no evidence at this time that this finding poses a safety risk.

The FDA recently became aware that an independent U.S. academic research team found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline.  PCV1 is not known to cause illness in humans or other animals.  In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq (manufactured by Merck), has not detected components of PCV1.

"Currently, there is no evidence that there is a safety concern,” Dr. Jason Eberhart-Phillips, State Health Officer, said. “We are relaying this information to Kansans so that the public and clinicians are aware of information recently received by FDA about the Rotarix vaccine. While this vaccine is being studied by the FDA, clinicians are currently being encouraged to use the RotaTeq vaccine.”

Rotarix and RotaTeq are given orally to infants under the age of eight months to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries.  FDA licensed RotaTeq in 2006 and Rotarix in 2008.  Most children vaccinated in the United States received RotaTeq.

“Currently, there is no recall of the vaccine being conducted by the FDA,” Sue Bowden, Director of the Kansas Immunization Program at KDHE said. “Clinicians are encouraged to suspend its use while the FDA studies this further.”

 For more information visit FDA's Update on Rotarix Vaccine page.