While cytologists and pathologists across the nation are working to understand how cervical cancer vaccines will affect the future of cytology, Merck and GlaxoSmithKline are working to broaden the reach of their HPV vaccines.

GARDASIL, Merck & Co. Inc., Whitehouse Station, NJ
In September, the FDA expanded Merck's GARDASIL approval for prevention of vulvar and vaginal cancers caused by HPV types 16 and 18.¹ Three studies demonstrating the efficacy and safety of GARDASIL in more than 15,000 patients contributed to the approval.

The American Cancer Society estimates HPV types 16 and 18 account for 40-50 percent of vulvar cancers and 70 percent of vaginal cancers.¹

"Each year in the U.S., thousands of women are diagnosed with vulvar or vaginal cancer, which can be devastating to these women, their families and friends," said Sharmila Makhija, MD, director, gynecologic oncology, Emory University, Atlanta.¹ "With GARDASIL and other preventive measures, we have the tools available right now to help reduce the burden of these cancers in the years to come."

Merck is pleased with the FDA decision, as it "provides physicians and their patients with another important reason to consider vaccination," according to Richard M. Haupt, MD, MPH, executive director, Clinical Research, Merck Research Laboratories.¹

GARDASIL is now approved for preventing cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18 in girls and young women 9 through 26 years of age.¹

First approved by the FDA in 2006, GARDASIL's safety and efficacy have been studied for more than a decade in more than 25,000 patients. Through June 2008, Merck distributed more than 30 million doses of GARDASIL worldwide, with 18 million doses distributed in the United States.¹

Gardasil's label has also been revised to note presently available information is insufficient to support use beyond the current FDA-approved age: 26.² Also, new information has been added showing Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.²

Additionally, the label for GARDASIL now includes data through 5 years from the extension phase of a pivotal Phase II study of 551 women showing GARDASIL was 100 percent effective in preventing overall cervical and genital disease related to HPV types 6, 11, 16 and 18 among patients who were naïve to the relevant HPV types through 1 month post dose three.¹

At the completion of all pivotal clinical studies conducted in more than 20,500 young women aged 16 to 26 with a duration of follow-up of between 3 to 5 years, GARDASIL demonstrated 98 percent efficacy against cervical cancers caused by HPV types 16 and 18 in women not previously exposed to the relevant HPV type.¹

While Gardasil is not yet approved for males, Merck currently has a study underway to see if it is safe and effective for them. Once the study is complete and submitted to FDA, the agency will review the data and decide whether to approve GARDASIL for males.³

Broad private and public health insurance coverage is available for GARDASIL. Health plans covering approximately 98 percent of privately insured people in the U.S. cover the vaccine.¹

GARDASIL was added to the Vaccines for Children  Program in November 2006, providing coverage for many who do not have private health insurance. Merck also provides, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals ages 19 and older who are uninsured and who are unable to afford vaccines, through its patient assistance program.¹

The vaccine (sold in some countries as SILGARD) has been approved in 106 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.¹

As part of the original approval, Merck committed to a safety surveillance study of 44,000 individuals in a managed care organization, assessing short- and long-term safety for all of Gardasil's approved uses.²

In addition to studies aimed at increasing GARDASIL's scope, Merck is also working to increase the number of girls and young women being vaccinated. While the vaccine is being used widely among 11- to 12-year old girls in the U.S., more than 60 percent of them had not been vaccinated as of August.⁴

Merck stresses GARDASIL vaccination does not replace routine cervical cancer screening.

Cervarix, GlaxoSmithKline, plc. Brentford, Middlesex, United Kingdom
GlaxoSmithKline's (GSK) cervical cancer vaccine candidate, Cevarix, has yet to be approved by the FDA.

GSK has submitted its response to questions the FDA posed in December 2007.⁵ Additionally, the company decided to augment its FDA application with data from its Phase III pivotal efficacy study, HPV-008. GSK anticipates submitting these data in the first half of 2009.⁵

Barbara Howe, MD, GSK vice president and director, North American Vaccine Development, said they expect the final results to strengthen the U.S. label for Cervarix.  "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S."