FDA Advisory Committee Concludes Cervical Cancer Vaccine is Safe and Effective

FDA Advisory Committee Concludes Cervical Cancer Vaccine is Safe and Effective

A U.S. Food and Drug Administration (FDA) Advisory Committee has concluded that Gardasil®, an investigational cervical cancer vaccine, appears to be safe and effective. This information was published in a press release by Merck & Co.

Human papillomavirus (HPV) is a sexually transmitted infection that is the primary cause of cervical cancer. Different types of HPV are classified as “low-risk” or “high-risk” based on how likely they are to cause cervical cancer.

While several types of HPV have been linked with cervical cancer, HPV types 16 and 18 are thought to account for roughly 70% of all cervical cancer cases. High-risk types of HPV also contribute to the development of precancerous changes to the cervix known as cervical intraepithelial neoplasia (CIN). High-grade CIN (CIN2 and CIN3) can progress to cancer if not treated.

Gardasil is an investigational vaccine that protects against infection with HPV types 16 and 18, as well as two types of HPV linked with genital warts (HPV types 6 and 11). Gardasil is not intended to treat HPV in individuals who are already infected.

An application for approval of Gardasil was submitted to the FDA by Merck & Co in December 2005. The FDA expects to complete its review of the application by June 8, 2006. As part of this process, information about the safety and efficacy of the vaccine was reviewed by one of the FDA’s advisory committees.

Based on review of evidence from phase II and phase III clinical trials, the advisory committee agreed on the following points:

  • Gardasil appears to be safe and effective against HPV 16- and HPV 18-related cervical cancer, as well as precancerous changes to the cervix, vulva, and vagina.
  • Gardasil appears to be safe and effective against other conditions related to HPV types 6, 11, 16, or 18, including genital warts.

The FDA will consider the committee’s conclusions when making its final decision about approval of the vaccine.

The President of Merck Research Laboratories notes. “If approved, Gardasil will be the first and only vaccine to prevent cervical cancer and other HPV-related diseases.”

Reference: Merck & Co. Research and Development News. FDA Advisory Committee Votes Unanimously that Clinical Data Support the Efficacy and Safety of GARDASIL®, Merck’s Investigational Cervical Cancer Vaccine. May 18, 2006. Available at http://www.merck.com/newsroom/press_releases/research_and_development/2006_0518.html (Accessed May 22, 2006).

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