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FDA Licenses Cervical Cancer Vaccine

June 9, 2006

Cervical Cancer • FDA Approves Expanded Uses for Gardasil • Study Finds HPV Infection Common in U.S. • FDA Licenses Cervical Cancer Vaccine • Someday: A Home Test for Cervical Cancer • Merck: Gardasil Blocks Cervical Cancer • Circumcision May Protect Against Cervical Cancer

The Food and Drug Administration has approved Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18.

The vaccine, which is manufactured by Merck & Co., Inc., is approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA's priority review process -- a process for products with potential to provide significant health benefits.

HPV is the most common sexually-transmitted infection in the United States. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives.

"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," said Alex Azar, Deputy Secretary, U.S. Department of Health and Human Services (HHS). "HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans."

On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women; and is estimated to cause over 470,000 new cases and 233,000 deaths each year.

For most women, the body's own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer. Other HPV types can cause genital warts.

The vaccine is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 percent of genital warts.

Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period. Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine. However, females are not protected if they have been infected with that HPV type(s) prior to vaccination, indicating the importance of immunization before potential exposure to the virus.

Also, Gardasil does not protect against less common HPV types not included in the vaccine, thus routine and regular pap screening remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops.

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs.

"The development of this vaccine is a product of extraordinary work by scientists as well as by FDA's review teams to help facilitate the development of very novel vaccines to address unmet medical needs. This work has resulted in the approval of a number of new products recently, including Gardasil, which address significant public health needs," he added.

The safety of the vaccine was evaluated in approximately 11,000 individuals. Most adverse experiences in study participants who received Gardasil included mild or moderate local reactions, such as pain or tenderness at the site of injection.

The manufacturer has agreed to conduct several studies following licensure, including additional studies to further evaluate general safety and long-term effectiveness. The manufacturer will also monitor the pregnancy outcomes of women who receive Gardasil while unknowingly pregnant. Also, the manufacturer has a study underway to evaluate the safety and effectiveness of Gardasil in males.

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