Sept. 9, 2009 -- An FDA advisory committee today backed the approval of Cervarix, which could become the second vaccine against human papillomavirus (HPV) to help prevent cervical cancer.
Cervarix targets two HPV strains, HPV 16 and HPV 18, which are leading causes of cervical cancer. The vaccine also contains an adjuvant, which is designed to enhance the immune system's response against those HPV strains.
After reviewing data from clinical trials of Cervarix, the FDA advisory committee voted 12 to 1 that data from clinical trials show Cervarix to be effective at preventing cervical cancer related to HPV 16 and HPV 18 in females ages 15-25. The committee also voted 11 to 1 that Cervarix appears safe for use in females ages 10-25.
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 background information posted earlier on its web site, the FDA states that Cervarix has been shown to be effective at preventing cervical cancer associated with HPV 16 and/or HPV 18 in teens and women up to age 25 who hadn't been exposed to those HPV strains.
In the vaccine's clinical trials, participants got either three doses of Cervarix or a placebo over six months. Both groups had similar rates of serious adverse events or death, the FDA notes. "No patterns indicating a potential safety signal were discernible among the serious adverse outcomes," the FDA states.
However, the FDA has asked for a pregnancy registry to track miscarriage in women who get Cervarix around the time of conception, due to an "imbalance" in the proportion of those women who miscarried.
There is no proof that those miscarriages were due to the vaccine. Some of those miscarriages took place in countries were abortion is illegal, and the FDA notes that it's not clear if those were actually elective abortions that were reported as miscarriage.
The FDA also wants post-marketing studies to track any cases of autoimmune diseases (such as multiple sclerosis) and musculoskeletal conditions (including arthritis and fibromyalgia) in patients who get Cervarix. Again, there is no proof showing the vaccine caused rare cases of those conditions in clinical trial participants; in fact, the associations weren't significant.
Cervarix is already approved in nearly 100 countries, including members of the European Union, Australia, Brazil, South Korea, Mexico, and Taiwan, according to a news release from GlaxoSmithKline, the drug company that makes Cervarix.
It's now up tothe FDA to make the final decision on whether to approve Cervarix. The FDA often follows the recommendations of its advisory panels but is not required to do so.
Cervarix and Gardasil are both given by a series of three shots spread over six months. No head-to-head studies have been done comparing the effectiveness of Cervarix and Gardasil.