FDA OKs New HPV Vaccine Cervarix

Oct. 16, 2009 -- The FDA today approved the human papillomavirus (HPV) vaccine Cervarix for use in girls and young women ages 10-25 to help prevent cervical cancer.

Cervarix targets two HPV strains, HPV 16 and HPV 18, which are leading causes of cervical cancer. Cervarix is approved to help prevent cervical precancers and cervical cancers associated with those two types of HPV.

HPV infection is common; the virus is sexually transmitted. Most women who get infected don't develop cervical cancer, and there are other causes of cervical cancer.

In clinical trials, Cervarix was shown to be 93% effective in preventing cervical precancers associated with HPV 16 or HPV18 in women with no evidence of current or previous infection with one of those two HPV types, according to GlaxoSmithKline, the drug company that makes Cervarix.

Cervarix is the second FDA-approved HPV vaccine. In June 2006, the FDA approved the first HPV vaccine, Gardasil, which targets four strains of HPV: HPV 6, HPV 11, HPV 16, and HPV 18.

In September, an FDA advisory committee recommended the approval of Cervarix.

No head-to-head studies have been done comparing the effectiveness of Cervarix and Gardasil.

GlaxoSmithKline states that Cervarix is expected to available in the U.S. in late 2009.

Cervarix should not be given to women who are pregnant. In keeping with the FDA's request, GlaxoSmithKline has agreed to create a pregnancy registry to follow pregnancies in women who receive Cervarix inadvertently during pregnancy. GlaxoSmithKline will also conduct postmarketing studies to assess the risk of miscarriage in women who become pregnant around the time of vaccination with Cervarix, and other studies to gauge the chances of developing autoimmune disease following vaccination with Cervarix.