Merck Cervical Cancer Vaccine Cleared for Use in Girls, Women
June 9, 2006
On Thursday, the Food and Drug Administration approved Gardasil, the first vaccine to prevent cervical cancer, for use by females ages 9-26. Merck & Co.'s vaccine protects against human papillomavirus (HPV) strains 16 and 18, which account for about 70 percent of cases of cervical cancer, and strains 6 and 11, which account for 90 percent of genital wart cases. Studies showed it also offers protection against cases of vaginal and vulvar cancer linked to HPV infection.
Merck's study of Gardasil in more than 20,000 girls and women up to age 26 found the vaccine prevented precancerous lesions and cervical cancer. The company also researched the vaccine in boys ages 9-15, but that data only tested Gardasil's ability to induce immune responses in boys. Such studies are continuing, since HPV can cause genital warts and head and neck cancer in men, and since men can transmit HPV to women. FDA said it needs further information on the vaccine's effectiveness before it can approve Gardasil's use by males.
Next, the vaccine goes before a federal panel that advises CDC. The panel is expected to make recommendations about who should receive the vaccine and when. Although the panel is likely to be influenced by the FDA's recommendation, it could also recommend that boys receive the vaccine.
States will then decide whether to add Gardasil to the list of required vaccines for public school students. In the United States the vaccine will likely be given to 11- or 12-year-old girls. Ideally, people should be vaccinated before the onset of sexual activity, since it can take years after HPV exposure for cancers and genital warts to develop.
According to the American Cancer Society, about 9,710 cases of invasive cervical cancer are expected to be diagnosed this year. ACS estimates about 3,700 women will die from the disease.
Wall Street Journal
06.09.2006; Jennifer Corbett Dooren
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.