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FDA Approves Cervical Cancer Vaccine

FDA Approves Cervical Cancer Vaccine

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s human papillomavirus bivalent (types 16 and 18) vaccine, recombinant (Cervarix) for the prevention of cervical precancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10–25).

Women are at risk of HPV infection and cervical cancer throughout their lives. Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer. While the majority of cervical cancers in North America are caused by HPV types 16 and 18, approximately 25% of all cervical cancers are caused by other oncogenic HPV types. Infection with cancer-causing virus types can lead to abnormal Pap tests, cervical precancers, and cervical cancer.

Cervarix was shown to be 93% efficacious in the prevention of cervical precancers (cervical intraepithelial neoplasia 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. Cervarix is contraindicated in patients with severe allergic reactions to any component of the vaccine. The vaccine is not recommended for use in pregnant women.

CDC Advisory Recommendation
Following the approval, the US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) recommended that Cervarix be given to girls and young women to protect against cervical precancers and cervical cancer caused by oncogenic HPV 16 and 18. The ACIP specifically recommended the vaccine for routine administration among 11- and 12-year-old girls. In addition, the recommendation includes a catch up for girls and young women who have not previously been vaccinated, which for the approved age range for Cervarix includes 13- to 25-year-old girls and young women.

Additionally, the ACIP unanimously recommended to provide funding for Cervarix from the Vaccines for Children (VFC) program. The federally funded program provides vaccines at no cost to children up through 18 years of age who might not otherwise be vaccinated because of inability to pay. Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the ACIP.

Cervarix is expected to be commercially available in the United States in late 2009.

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