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Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
Date:3/22/2010

ost children vaccinated in the United States received RotaTeq.

"In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine," said Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention.  "We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known."

FDA will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present.  The agency is assessing current vaccine testing methods.  In four to six weeks, FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

FDA will provide updates to patients, providers, and the general public as more information becomes available.  The agency will also continue to communicate with the World Health Organization and counterpart regulatory agencies in other countries.

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SOURCE U.S. Food and Drug Administration
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