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FDA Approves HPV Recombinant Vaccine, Types 16 and 18 NEW YORK -- October 18, 2009 -- The US Food and Drug Administration (FDA) has approved a human papillomavirus (HPV) bivalent (types 16 and 18) vaccine, recombinant (CERVARIX) for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic HPV types 16 and 18 for use in girls and young women aged 10 to 25 years. The vaccine was shown to be 93% efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination. In a subgroup of clinical trial participants without oncogenic HPV infection at the time of the first vaccination and without evidence of prior exposure to HPV 16 and 18, the vaccine showed an overall efficacy of 70% against pre-cancerous lesions, regardless of HPV type. In an additional analysis that assessed the impact of the vaccine against specific HPV types not included in the vaccine, in women without oncogenic HPV infection with a specific type at the time of vaccination, approximately 89% efficacy was observed in the prevention of precancerous lesions associated with HPV type 31. The most common local adverse reactions and general adverse events in >=20% of clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, joint and muscle aching, and gastrointestinal symptoms. SOURCE: GlaxoSmithKline E-mail this page to a friend or colleague! To print, use this version