Pharmaceutical Business review

CDC Advisory Committee Recommends GSK’s Cervarix

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that GlaxoSmithKline’s (GSK) Cervarix be given to girls and young women to protect against cervical pre-cancers and cervical cancer, caused by oncogenic HPV 16 and 18.

Reportedly, the ACIP specifically recommended Cervarix 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 13-25 year old girls and young women.

The company said that on October 16, 2009 FDA has approved Cervarix 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 young women (aged 10-25).

Additionally, the ACIP unanimously recommended to provide funding for Cervarix from the Vaccines for Children (VFC) program. Cervarix is expected to be commercially available in the US in late 2009.

Barbara Howe, vice president and director of North American vaccine development at GSK, said: “It’s estimated that this year, ten women will die every day from cervical cancer in the US. The ACIP recommendation for Cervarix underscores how important it is for girls and young women to be vaccinated to help reduce the burden of this devastating cancer.”