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FDA revises recommendations for rotavirus vaccines

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The FDA has revised recommendations for rotavirus vaccines and determined that the use of Rotarix (GlaxoSmithKline) may be resumed and the use of Rotateq (Merck) may be continued, according to a press release.

Evaluation of information from laboratory results provided by the manufacturers and the FDA, a thorough review of existing literature and input from scientific and public health experts informed the decision.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee convened on May 7, 2010 to discuss the vaccines, and information from that meeting was taken into account by FDA officials. Panel members noted the strong safety profiles of both vaccines and the robust data from clinical trials involving vaccine recipients. It was also cited that the FDA has no evidence of safety risks associated with porcine circovirus types 1 and 2 in humans.