FDA Panel Backs New HPV Vaccine Cervarix
If Approved, Cervarix Would Become Second Vaccine to Target Human Papillomavirus
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
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
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
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
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 to the 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.
The FDA approved the first HPV vaccine, Gardasil, in June 2006 for use in
girls and women ages 9 to 26. Gardasil targets four strains of HPV: HPV
6, HPV 11, HPV 16, and HPV 18.
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.