Use of Rotarix Vaccine Temporarily Suspended
for Non-Safety Reasons
To: Health Care Providers
From: Vermont Department of Health
Date: March 23, 2010
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The U.S. Food & Drug Administration (FDA) today recommended that health care providers temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine.
There is no evidence that this finding poses a safety risk.
The agency recently became aware that an independent U.S. academic research team, using a novel technique, has 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.
In April 2009, the Vermont Department of Health, in consultation with the Vermont Immunization Advisory Committee, decided to switch from the three-dose RotaTeq vaccine to the two-dose Rotarix vaccine. We currently supply the Rotarix vaccine to provider practices.
During this temporary suspension, the Health Department will supply RotaTeq vaccine. The Centers for Disease Control & Prevention (CDC) supports this action, and anticipates there will be adequate supplies of RotaTeq during the next four to six weeks while FDA gathers more information.
Patients who have had one dose of Rotavix vaccine should complete the vaccination series with two doses of RotaTeq vaccine.
For FDA’s news release and more information: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm
We will keep you updated as more information is available. If your practice has any questions or concerns, contact the Vermont Department of Health’s Immunization Program at (802) 863-7638 or firstname.lastname@example.org.