The Food and Drug Administration (FDA) announced on June 8, 2006 its expedited approval for the first vaccine against human papillomavirus – HPV – the viruses that cause cervical cancer and genital warts. The vaccine prevents infection with HPV types 6,11,16 and 18. HPV types 6 and 11 cause about 90% of genital warts. HPV types 16 and 18 cause about 70% of cervical cancers.

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.

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 approval for 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.

CLUW, which has its own cervical cancer education and awareness program, Cervical Cancer Prevention Works, testified in support of approval for the vaccine at the FDA hearing in Gaithersburg, MD in May. It also submitted written testimony to ACIP. In both cases, CLUW additionally stressed that "regular screening is women's first and primary weapon against this disease" and urged that "any communication to women, and to their healthcare providers – about cervical cancer prevention – needs to emphasize the importance of ongoing screening." When the June 29 announcement was made, CLUW reiterated that message.

"The next big challenge with this vaccine will be to assure widespread availability and use," explains Deborah Arrindell, Vice President of Policy for the American Social Health Association (ASHA). "It is critical that women and girls have access to this life-saving vaccine regardless of income," urges Arrindell.

CLUW urges union members who are parents of girls in the approved age group to ask their health provider for the vaccine for their daughters and if it is not yet covered to urge their union to have their insurance plan cover it. Merck's vaccine consists of three shots totaling $360.

Even with the approval of the vaccine – and its great potential – CLUW, like ASHA, continues to be concerned that many adult women will not receive the vaccine and will remain at risk of cervical cancer.

Women need to have regular comprehensive cervical cancer screening, including Pap and HPV tests when appropriate.  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 continue to be screened.

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™, which in 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.

For additional information about the vaccine, see www.cdc.gov/std/HPV/STDFact-HPV-vaccine.htm.