FDA Backs Glaxo's Vaccine Cervarix for Women
Wed, 09/09/2009 - 10:43am
WASHINGTON (AP) — Federal health officials favor approving GlaxoSmithKline's long-delayed vaccine Cervarix to prevent the leading cause of cervical cancer in U.S. women. The Food and Drug Administration's vaccine panel voted overwhelmingly that the vaccine appears safe and effective for girls and women ages 10 to 25. If the FDA follows the group's advice, Glaxo would begin competing against Merck's vaccine Gardasil, which has controlled the U.S. market since 2006. Cervarix's launch was delayed in 2007 when the FDA said it needed more data on the vaccine. Panelists say newer studies suggest the vaccine is safe, but they recommend follow-up studies to monitor miscarriages and muscular problems reported by a small number of patients.