CDC's Advisory Committee on Immunization Practices -- which drafts recommendations and schedules for the administration of vaccines in the U.S. -- on Thursday is expected to vote on whether to recommend 11- and 12-year-old girls receive Merck's human papillomavirus vaccine Gardasil, the Atlanta Journal-Constitution reports (Young, Atlanta Journal-Constitution, 6/29). FDA earlier this month approved Gardasil -- which is given in three injections over six months and will cost $360 -- for sale and marketing to girls and women ages nine to 26. According to Merck, Gardasil in clinical trials has been shown to be 100% effective in preventing infection in women who do not already have HPV with strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases (Kaiser Daily Women's Health Policy Report, 6/19). Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that also are linked to HPV, according to a study presented in Atlanta at a meeting of the American Society of Clinical Oncology (Kaiser Daily Women's Health Policy Report, 6/9). ACIP's HPV vaccine group has recommended giving the vaccine to girls ages 11 and 12. The 15-member ACIP also is expected to consider recommending Gardasil for girls and women ages 13 to 26 (Kaiser Daily Women's Health Policy Report, 6/19).
Expected Recommendations, Reaction
According to Long Island Newsday, states decide who is required to be vaccinated but often look to CDC for guidance (Kerr, Long Island Newsday, 6/27). ACIP is not expected to recommend whether schools should require girls to receive Gardasil, the AP/Seattle Post-Intelligencer reports. Some conservative groups, such as the Family Research Council, oppose making Gardasil a vaccination required in schools, while the Planned Parenthood Federation of America supports such a requirement, according to the AP/Post-Intelligencer (Stobbe, AP/Seattle Post-Intelligencer, 6/28). Some pediatricians have expressed concern that some parents will not have their young daughters vaccinated because the vaccine protects against a sexually transmitted infection, the Fort Worth Star-Telegram reports. However, Linda Klepacki, a sexual health analyst for the group Focus on the Family, said, "We believe it's the parents' right to decide" (Jarvis, Fort Worth Star-Telegram, 6/28). ACIP Chair Jon Abramson said the school requirement issue is moot for the panel until it is able to observe whether enough people are being vaccinated to prevent the spread of HPV (Long Island Newsday, 6/28).
Cost, Insurance Issues
ACIP also is expected to vote on whether the vaccine should be covered by a federally funded program that provides vaccinations for uninsured children and those in low-income families, the Journal-Constitution reports (Atlanta Journal-Constitution, 6/29). According to the Wall Street Journal, insurance providers often follow ACIP's recommendations for covering vaccination costs, but covering vaccinations for all 12-year-old girls could cost the government and insurers $700 million annually. Merck and some other experts say the cost of covering Gardasil could be a "bargain" compared with the costs of screening for and treating cervical cancer, according to the Journal. Treatments for the cancer cost Medicare $1.7 billion in 2005, the Journal reports. Many studies on HPV vaccine costs -- often involving Merck or GlaxoSmithKline, which also is developing a vaccine -- find that giving Gardasil to 12-year-old girls, followed by booster shots five to 10 years later and Pap tests every two or three years would be cost effective. Gillian Sanders, an analyst at Duke Clinical Research Institute, conducted studies that find about 70% of girls need to be vaccinated to significantly decrease cervical cancer prevalence. However, cost-effective models can give a wide range of results depending on what data are included or excluded, Marthe Gold, a professor at City College of New York, said. In addition, there are unpredictable factors, such as whether new HPV strains could develop if some strains are eliminated or for how long Gardasil will remain effective, the Journal reports (Wang, Wall Street Journal, 6/29). Gardasil in studies has been shown to be effective for at least three-and-a-half years, according to Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research (Kaiser Daily Women's Health Policy Report, 6/9).
Related Opinion Piece
ACIP should rebuff efforts by a "far-right political agenda" and recommend that Gardasil be "universally administered" to girls ages 11 and 12, Julie Kay -- attorney for Legal Momentum, a legal advocacy organization for women and girls -- writes in a Los Angeles Times opinion piece. Even though many states allow exemptions for vaccination requirements for religious or philosophical reasons, "extremist social conservatives" are "stealthily undermin[ing]" Gardasil's potential efficacy by opposing "mandatory vaccinations," Kay says. "Inoculation against HPV is particularly important for ensuring that girls and women who are victims of rape or incest are protected from contracting the potentially deadly virus," Kay writes, adding, "To be truly effective, the vaccine, like sexuality education, must be given to all teens well before any become sexually active" (Kay, Los Angeles Times, 6/29).
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