The FDA has approved Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant, from GlaxoSmithKline) for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and women 10–25 years of age. The approval of Cervarix was based on data from clinical trials in more than 30 countries involving a diverse population of nearly 30,000 girls and young women. Cervarix was shown to be 93% efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia [CIN] 2+ or adenocarcinoma in situ [AIS]) 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.

Cervarix is expected to be available in late 2009.

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