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The Food and Drug Administration on Friday approved
Merck & Co.’s cervical cancer vaccine Gardasil to prevent vulvar and
vaginal cancers.
In 2006, FDA gave its approval for Gardasil
use in girls and women aged 9-26 to prevent infections with four strains of the
human papillomavirus, or HPV, which causes most genital warts and cervical
cancers. There are over 100 different strains of the human papillomavirus and
about 40 of them trigger to genital infections. Of those 40, about half can
cause cancer. The vaccine is efficient only regarding the prevention of four
types of the virus that may lead to 90 percent of genital warts and 70 of
cervical cancer. Two of those HPV strains can also cause some vulvar and
vaginal cancers.
The CDC recommends Gardasil for all girls
aged 11-12, as most girls of this age are not yet sexually active and will
achieve a maximum protection. Girls can get Gardasil when they’re as young as
9. A recent study carried out by the Harvard School of Public Health concluded
that, if the vaccine is administered to females before they become sexually
active, the measure proves very cost-effective in terms of preventing the
cancer.
The cancers of the vagina and the vulva
affect more than 5,000 women annually in the United States, according to Merck.
The study carried out by Merck, which
followed more than 15,000 women from its earlier cervical cancer studies for an
additional two years concluded that none of the vaccinated women developed
HPV-related precancers in the vagina or vulva. But the benefits were seen only
in women who hadn’t been infected with HPV before getting the vaccine.
“There is now strong evidence showing that
this vaccine can help prevent vulvar and vaginal cancers due to the same
viruses for which it also helps protect against cervical cancer,” Jesse L.
Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and
Research, says in a news release.
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