Vaccine protects against HPV types linked with most cervical cancers in addition to those found with the majority of genital warts.

Research Triangle Park, NC, June 8, 2006 –
The Food and Drug Administration announced today its expedited approval for the first vaccine against human papillomavirus – HPV – the viruses that cause cervical cancer and genital warts. This approval opens the door for new programs to reduce cervical cancer among women in the United States and around the world. The vaccine, named Gardasil®, was developed by Merck & Co.

“Now that this vaccine is approved, the medical and public health community must address usage recommendations,” stated Dr. James Allen, President of the American Social Health Association (ASHA). “The vaccine is most effective if all three doses are administered before a woman is exposed to HPV, which often happens shortly after she becomes sexually active.”

On June 29, the Advisory Committee on Immunization Practices (ACIP), an advisory committee to the Centers for Disease Control and Prevention (CDC), voted to recommend Gardasil be given routinely to girls 11-12 years old, with discretionary use for those as young as age 9. The committee also recommended that Gardasil be used for women ages 13-26 who have not previously received the vaccine.

“The next big challenge with this vaccine will be to assure widespread availability and use,” explains Deborah Arrindell, Vice President of Policy for ASHA. “Some people may be reluctant to receive the vaccine or to approve their young daughters receiving it because of the stigma associated with sexually transmitted infections. We need to overcome these concerns and protect all our young women,” urges Ms. Arrindell.

Even with the approval of these vaccines, much work remains to be done, however. “Despite the great promise of these vaccines, many adult women will not receive them and will remain at risk of cervical cancer,” warns Dr. Allen. “These women need to have regular comprehensive cervical cancer screening. In addition, since strains of HPV other than 16 and 18 cause 30% of cervical cancers, even women who have received the vaccines will need to be screened in the future.”

The two most common HPV types linked to 70% of cervical cancer – types 16 and 18 – are included in the vaccine. Cervical cancer is virtually always associated with “high risk” types of the human papillomavirus (HPV), a common sexually transmitted infection to which most people are exposed at some point in their lives.

In clinical trials on thousands of women, the vaccine developed by Merck and Company, known as Gardasil®, has shown near 100% efficacy in protecting women from both persistent infection and high-grade cervical diseases associated with HPV 16 and 18, the types found with nearly 70% of cervical cancers. Gardasil® is a quadrivalent vaccine that also protects against HPV 6 and 11, the types found with 90% of cases of genital warts.

Cervical cancer affects about 10,000 women each year in the U.S., according to the American Cancer Society, and is expected to lead to approximately 3,700 deaths this year. Worldwide the burden is even greater: the World Health Organization estimates 80% of cervical cancer cases occur in developing countries.

Other companies are also researching HPV/cervical cancer vaccines. GlaxoSmithKline is developing a bivalent vaccine, Cervarix™, whichin studies has been effective at protecting women from infection and diseases linked to HPV 16 and 18. GSK is expected to submit Cervarix™ for FDA approval in December of this year.