June 8, 2006 --
Gardasil, a vaccine against the virus that causes most cervical cancers,
most cancers of the vagina and vulva, and genital
warts, won FDA approval today.
"FDA approval of the
HPV vaccine, the first vaccine targeted specifically to preventing cancer,
is one of the most important advances in women's health in recent years,"
states the American Cancer Society in a news release.
The vaccine protects against infection from four strains of the human
papilloma virus, or HPV. Two of these strains, HPV-16 and HPV-18, account for
about 70% of cervical cancers. The other two strains covered by the vaccine,
HPV- 6 and HPV-11, account for about 90% of genital warts.
"Gardasil is a major health breakthrough -- the first vaccine specifically
designed to prevent cancer -- and is approved to prevent not only cervical cancerbut also genital
warts," says Kevin Ault, MD, leader of Gardasil clinical trials at
Atlanta's Emory University, in a Merck news release.
The vaccine is approved for 9- to 26-year-old girls and women. While it is
almost always females who get HPV-related cancer, the virus is spread by both
men and women during sexual contact. And both men and women are susceptible to
genital and rectal warts, which can lead to cervical changes and abnormal Pap
smears in women.
Gardasil is not approved for use by boys and men. Clinical trials evaluating
Gardasil vaccination of boys and men are underway, a Merck spokesperson tells
In clinical trials reported so far, the vaccine has been extremely
effective. It appears to be 100% effective in protecting against the HPV-16 and
HPV-18 strains. It also seems extremely safe. One reason is that the vaccine
isn't a live virus, but a virus-like particle. This means it's an empty shell,
with immunity-stimulating particles on the outside and no viral machinery on
HPV expert Jessica Kahn MD, MPH, associate professor of pediatrics at
Cincinnati Children's Hospital Medical Center, says she's planning to have her
teenage daughter vaccinated.
"What we parents most want to know about the vaccine is whether it is safe,
and whether it is effective," Kahn tells WebMD. "All data show it to be one of
the safest vaccines ever tested. And it is highly effective."
To be effective, Gardasil must be given in three doses over six months (the
second dose is given two months after the first; the third dose six months
after the first). It's not yet clear whether a person will receive lifelong
immunity. In tests checking for presence of the virus so far, the vaccines
remain protective for four years and counting. For preventing vaginal and
vulvar cancer, the vaccines have been
protective for at least two years.
The wholesale price for Gardasil will be $120 per dose; $360 for all three
There's a second vaccine in the works: Cervarix, from GlaxoSmithKline.
Cervarix targets only two HPV strains, HPV-16 and HPV-18, the ones most
commonly linked to cancer as opposed to genital
warts. GlaxoSmithKline says it plans to seek FDA approval for Cervarix
by the end of the year. Early studies find that this vaccine, too, is extremely
safe and effective.
Both Merck and GlaxoSmithKline are WebMD sponsors.