CDC Panel Recommends HPV Vaccine
CDC's Advisory Committee on Immunization Practices on Thursday unanimously voted to recommend that all girls ages 11 and 12 receive Merck's human papillomavirus vaccine Gardasil, the Washington Post reports. ACIP drafts recommendations and schedules for the administration of vaccines in the U.S. (Brown, Washington Post, 6/30).
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.
Gardasil also protects against vaginal and vulvar cancers, two other gynecological cancers that are linked to HPV, according to a study presented in Atlanta at a meeting of the American Society of Clinical Oncology (California Healthline, 6/29).
The ACIP recommendation also allows for girls as young as nine to receive the vaccine and recommends that girls and women ages 13 to 26 receive Gardasil. Although the vaccination should be given before a girl begins sexual activity, sexually active girls and women still should receive Gardasil, the recommendation says (CDC release, 6/29).
Two of the 15 ACIP members abstained from the vote because they have worked on Merck-funded studies, according to the AP/Forbes (Stobbe, AP/Forbes, 6/29).
HHS is expected to approve ACIP's recommendation, a move that would make Gardasil the first recommended childhood immunization that aims to prevent a sexually transmitted infection, the first to target a single sex and the first with the primary purpose of preventing cancer, the Post reports.
ACIP also recommended that Gardasil be covered by the federal Vaccines for Children Program, which provides no-cost immunizations to children covered by Medicaid, Alaska-native and American Indian children and some uninsured and underinsured children. According to the Post, about 40% of U.S. children receive vaccines through the program (Washington Post, 6/30).
If HHS approves ACIP's recommendations, it would "all but commi[t]" the federal government to buying Gardasil for up to seven million girls at a price that could be more than $2 billion, the New York Times reports (Harris, New York Times, 6/30).
According to the Wall Street Journal, ACIP's vote also "makes it highly likely" that Gardasil will be covered by private insurers (Corbett Dooren, Wall Street Journal, 6/30). At least two national health insurers, Aetna and WellPoint, said they will follow ACIP's recommendation and cover Gardasil (Gellene, Los Angeles Times, 6/30).
Kaiser Permanente officials said they hope to supply and cover the vaccine by this fall (Allday, San Francisco Chronicle, 6/30).
Merck said shipments of Gardasil were already being delivered to physicians and clinics (Fujimori, Charlotte Observer, 6/30).
Anne Schuchat, director of CDC's National Center for Immunizations and Respiratory Diseases, said Gardasil "is a major advance in the prevention of genital HPV and cervical cancer," but added that "it will not replace other prevention strategies, such as cervical cancer screening for women or protective sexual behaviors."
A CDC official said she expects the agency to publish the full recommendations within a few months in the Morbidity and Mortality Weekly Report (Reichard, CQ HealthBeat, 6/29).