Merck & Co., Inc., has announced that the US Food and Drug Administration (FDA) has accepted and designated as priority a review of GARDASIL, a vaccine against types 6, 11, 16, and 18 of the human papillomavirus (HPV), which is strongly associated with cervical cancer and similar diseases. GARDASIL is currently approved for use in females between the ages of 9 and 26. Merck’s current request for review is to obtain approval for the vaccine in women aged 27 through 45.

The vaccine is administered to prevent the development of certain medical conditions associated with the HPV, including cervical cancer, dysplastic or precancerous lesions, and genital warts caused by the specified strains of the virus. The risk of HPV infection and the diseases associated with it remains throughout a woman’s life.

GARDASIL is not approved for treatment of active genital warts, cervical cancer, or certain other diseases associated with HPV. Infection from a strain of HPV not included in the current vaccine may lead to disease development.

For full effectiveness, GARDASIL is injected in the arm or upper thigh three times over a period of six months. About 1% of the patients receiving the vaccine report pain, swelling, itching, or redness at the injection site and some also experience nausea, dizziness, and fainting.

GARDASIL is included in all 55 immunization projects in operation under the US Vaccines for Children (VFC) Program. In addition, Merck’s own patient assistance program provides GARDASIL and other vaccinations free of charge in private clinics and doctors’ offices to uninsured patients age 19 or older and to those who cannot afford vaccines.

GARDASIL is approved for use in 100 countries, including the US and 27 members of the European Union, Canada, Australia, New Zealand, Mexico, Brazil, and Taiwan. In some areas, it is marketed under the brand name SILGARD.

The nonprofit organization, PATH, funded by the Bill & Melinda Gates Foundation, will be receiving free GARDASIL vaccines for impoverished nations. As a part of the 2007 Clinton Global Initiative, three million doses of GARDASIL will be going to nations with the lowest incomes. Developing nations will be able to purchase GARDASIL and all Merck’s newer vaccines at cost.

Each year in the US, almost 6.2 million men and women are infected with HPV; approximately 20 million are currently diagnosed. HPV types 16 and 18 are associated with 70% of all cervical cancer cases while HPV 6 and 11 are associated with almost 90% of all cases of genital warts.

Cervical cancer, the #2 cause of cancer death in women around the world, is diagnosed almost 500,000 times each year and 280,000 die from it each year.

In the US, there are about 11,000 new diagnoses of cervical cancer and 3,600 deaths each year. Six thousand cases of vaginal or vulvar cancer are diagnosed. The US spends about $5 billion each year for HPV screening and treatment. HPV 16 and 18 are responsible for most of these cases.

The presence of genital warts can lead to abnormal Pap results. Each year, there are about 1 million new cases of genital warts diagnosed and 32 million globally. In the US alone, about 4.7 million Pap results are abnormal in any given year, at least 3 million of which are associated with HPV.

Source: Merck