The world's first cervical cancer vaccine is likely to arrive shortly in physicians' offices across the nation, thanks to two recent federal government endorsements. The vaccine represents an important public health advance for women in the United States, by promising to significantly reduce the incidence of cervical cancer, which currently affects nearly 10,000 women and results in 3,700 deaths each year. The vaccine is expected to have a far greater impact in resource-poor developing countries, where the incidence rates of cervical cancer are higher and where the disease is far more lethal.
On June 8, the U.S. Food and Drug Administration (FDA) approved the vaccine, known as Gardasil, as safe and effective for use among females aged 9–26. Manufactured by Merck & Company, the vaccine is virtually 100% effective in preventing infection with the types of human papillomavirus (HPV) associated with 70% of all cervical cancer cases and 90% of all cases of genital warts. HPV is an extremely common sexually transmitted infection that can lead to cervical cancer in the small proportion of cases in which a persistent infection is left untreated over many years. To achieve maximum effectiveness, the vaccine should be administered to girls and young women prior to initiation of sexual activity (related article, Winter 2006, page 6).
Three weeks after the FDA's approval, the federal Advisory Committee on Immunization Practices (ACIP), affiliated with the Centers for Disease Control and Prevention, exercised its authority to issue recommendations regarding vaccine administration and to maintain the nation's schedule of recommended vaccines. According to ACIP, the vaccine should be routinely administered to all girls aged 11–12, and to those as young as nine at a physician's discretion. In addition, ACIP recommended that two other groups of girls and women receive the vaccine: those aged 13–26 who have not been vaccinated, and those who have had abnormal Pap smears, genital warts or certain other conditions. Furthermore, ACIP voted to include Gardasil in the federal Vaccines for Children program, which provides free vaccines to certain low-income uninsured and underinsured children.
Immediately following the ACIP proceedings, at least two major nationwide insurers, Aetna and WellPoint, announced that they will cover the vaccine for the categories of girls and women included within the ACIP recommendations. In addition, Merck has announced a patient assistance program designed to provide free vaccines to uninsured adults with limited incomes visiting private physicians. (To receive free vaccines, patients will need to complete and fax forms from participating doctors' offices for processing by Merck during the patients' visit.) Still, significant barriers to ensuring universal uptake of the vaccine remain: therelatively high cost of the vaccine, which is expected to run $360 for the full three-dose course; the difficulty of providing individuals with the required three shots over a six-month period; and the historic challenge of reaching the target population—adolescents—through immunization programs. It will be up to the states to decide whether the vaccine will be required for students to enroll in school.
In a related development, a study published in June in the New England Journal of Medicine found that consistent condom use reduces the risk of HPV infection—something which had been an open question due to the fact that HPV is transmitted through skin-to-skin contact rather than through bodily fluids. According to the study, which followed more than 80 female college students at the University of Washington in Seattle who had recently become sexually active, those whose male partners used condoms every time they had sexual intercourse had less than half the infection rate of those whose partners used condoms less than 5% of the time. The study should help put to rest long-standing questions raised in both political and public health circles about condoms' ability to offer protection against HPV infection. —Cynthia Dailard
