May 9, 2007 -- The
Gardasil vaccine is extremely effective in protecting women against
precancerous lesions caused by the human papillomavirus types (HPVs) that cause
70% of cervical cancers and most cases of genital
That's the good news from two huge, international clinical trials. The
not-so-good news: Among sexually experienced 15- to 26-year-old women -- some
of whom already have HPV
infection -- the vaccine is far less effective in protecting against dangerous
The FUTURE 1 trial enrolled nearly 5,500 women aged 16 to 24. The FUTURE II
trial enrolled more than 12,000 women aged 15 to 26. Three-year results from
both trials appear in the May 10 issue of The New England Journal of
Gardasil protects against HPV that is spread mainly during sex. Women often
get HPV infections soon after beginning sexual activity, although most HPV
infections will not develop into cancer. So the best time to get the
vaccine is in the pre-teen years, before age 13.
Or even sooner: The FDA has approved Gardasil for 9- to 26-year-olds, and
the CDC has added it to the childhood vaccination schedule. Several states are
HPV vaccination mandatory for public school attendance, although all of
these measures allow parents to opt out.
In the current studies, the vaccine looked very safe -- and very effective,
says FUTURE II investigator Kevin Ault, MD, associate professor of gynecology
and obstetrics at Atlanta's Emory University.
"The vaccine's efficacy is the biggest news," Ault tells WebMD. "In FUTURE
I, it was 100% effective in preventing precancerous lesions and genital warts,
and in FUTURE II it was 98% effective in protecting against high-grade,
precancerous cervical lesions."
Ault's numbers reflect the vaccine's effectiveness against the four HPV
strains included in the vaccine -- including cervical-cancer-causing HPV-16 and
But these are only two of the 15 HPV strains known to cause cervical cancer.
An editorial accompanying the studies notes that overall, the vaccine was no
more than 20% effective in protecting women against high-grade precancerous
"This gives us a glimpse of what to expect from vaccinating a generation of
15- to 26-year-olds regardless of their sexual exposure," the editorial's
co-author, Karen Smith-McCune, MD, tells WebMD. "In that general population,
looking at all women who got the vaccine with all types of HPV exposure,
efficacy in reducing precancer was modest -- 17% fewer cases of precancer in
vaccinated women vs. the placebo group. And if you look at the most significant
precancer, grade 3, there is no significant reduction among vaccinated
Smith-McCune is associate professor of obstetrics and gynecology at the
University of California, San Francisco. She's also the mother of two
"I am not having my daughters vaccinated because the proven method of
reducing their risk with regular Pap screening is very effective," she says.
"In the absence of safety and efficacy data in the 11- to 12-year-old age
group, and the unknown long-term effect of this vaccine in all age groups, it
is too soon to recommend this vaccine."