The FDA announced Monday that it is recommending that healthcare practitioners temporarily suspend use of GlaxoSmithKline's Rotarix while the agency learns more about components of a benign extraneous virus detected in the vaccine. No signs of the virus were detected in an analysis of Merck & Co.'s RotaTeq vaccine, the FDA stated.
The decision was made after independent researchers identified DNA from porcine circovirus 1 (PCV1) in the vaccine. Follow-up tests conducted by the FDA and GlaxoSmithKline confirmed that the viral components, which are not known to cause illness in humans or animals, have been present since the early stages of the vaccine's development, including during clinical testing.
FDA commissioner Margaret Hamburg noted that while "there is no evidence at this time that there is a risk to patients who have received this vaccine," the agency will convene an expert advisory committee in four to six weeks to make additional recommendations on the use of rotavirus vaccines.
The European Medicine's Agency's (EMA) Committee for Medicinal Products for Human Use previously reviewed information on the presence of the virus and on March 17 ruled that no action was necessary at this point. However, the agency on Monday requested that the drugmaker "provide further information as a matter of urgency." The agency also called for a meeting of experts on March 23 and 24.
Rotarix had global sales of $440 million in 2009, including $118 million in the US.
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