FDA OKs New HPV Vaccine Cervarix
Cervarix Is Second Human Papillomavirus Vaccine Approved to Help Prevent Cervical Cancer
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
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
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
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.