CDC Panel Recommends HPV Vaccine Cervarix for Girls, Optional Gardasil Vaccination for Boys

October 22, 2009 — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices on Wednesday recommended GlaxoSmithKline's human papillomavirus vaccine, Cervarix, for routine use in vaccinating girls and young women to prevent cervical cancer, the AP/New York Times reports (Stobbe, AP/New York Times, 10/21). GSK said the panel recommended routine administration of Cervarix to protect against cervical cancer in girls ages 11 and 12, as well as girls and women ages 13 through 25 who have not been vaccinated (Richwine, Reuters, 10/21). CDC will need to adopt the new recommendation to make it part of official advice to U.S. physicians (AP/New York Times, 10/21). FDA approved Cervarix last week for use in girls and women ages 10 through 25 to prevent cervical cancer.

Since 2006, Merck's HPV vaccine, Gardasil, has been approved for use in girls and women to prevent two strains of HPV -- types 16 and 18 -- that cause about 70% of cervical cancer. Gardasil also protects against two other strains of HPV that cause 90% of genital warts (Women's Health Policy Report, 10/19).

The panel discussed whether to indicate a preference for one vaccine over the other, particularly because Gardasil also protects against genital warts. The panel decided to refrain from stating a preference. Lauri Markowitz, a CDC HPV expert, said the panel "wanted to facilitate a market for both vaccines."

According to the AP/Times, the members of the panel also discussed the cost-effectiveness of Cervarix, with costs about $385 for a three-dose series. Gardasil costs about $390 for a three-dose series. The vaccine is most effective when administered to girls before they become sexually active. According to Harrell Chesson, a CDC economist, some cost-effectiveness studies have indicated that Cervarix should be priced about $100 less than it currently is because it does not protect against genital warts. Some experts said that some patients and physicians may opt for Cervarix instead of Gardasil because it is slightly less expensive.

The AP/Times reports that there have been no studies examining whether Cervarix and Gardasil can be considered interchangeable during the vaccination series, such as if a girl receives Gardasil for the first dose of the vaccine and Cervarix for the second or third dose. Neither vaccine is recommended for pregnant women (AP/New York Times, 10/21).

Panel Recommends Optional Vaccination for Boys

The CDC panel also recommended optional vaccination with Gardasil for boys and young men to protect them from genital warts, although they stopped short of recommending its routine use in boys, as CDC recommends for girls, the Times reports. FDA approved Gardasil for use in boy and men ages nine through 26 last week.

CDC panel members questioned the cost-effectiveness of vaccinating boys as a way to protect their future sex partners from HPV and the cancers it can cause. Some panel members were concerned about the appropriateness of recommending a vaccine for men to prevent genital warts, which are not life-threatening, the Times reports. Chesson said that it would be more cost-effective to increase vaccination rates among girls than among boys. About 37% of girls ages 13 through 17 started the Gardasil vaccine series last year, according to a recent federal survey.

Richard Haupt, Merck's director of research for Gardasil, told the Times in September that vaccinating boys and men could reduce the prevalence of HPV and ultimately lower the number of HPV-related cancers in men and women. He noted that genital warts are a significant problem in themselves and estimated that there are at least 250,000 new cases in men annually in the U.S. Each case typically results in three visits to a doctor, Haupt said. According to the Times, Gardasil prevented 89% of genital warts in a Merck-sponsored clinical trial of about 4,000 young men (Singer, New York Times, 10/22). Pam Eisele, a spokesperson for Merck, said that about 75% to 80% of men and women will contract one or more types of HPV in their lives. "As such, we believe there is value in vaccinating both young men and women with Gardasil," she added (Randall/Pettypiece, Bloomberg/Philadelphia Inquirer, 10/22).

According to the Times, the new recommendations allow doctors and clinics to administer the vaccine to boys and men ages nine through 26 at their discretion. In addition, some health insurers might decline to cover the shots, the Times reports (New York Times, 10/22). The CDC panel recommended covering the costs of Gardasil for boys ages nine through 18 who are beneficiaries of the federal Vaccines for Children program, which pays for vaccinations for uninsured children, those enrolled in Medicaid or who meet other criteria (AP/New York Times, 10/21).

The Times reports that the panel said it would examine Gardasil's effectiveness in preventing HPV-related male cancers, such as anal and penile cancers, at its next session in February, when more data are expected to be available. A Merck spokesperson said the company plans to present studies in 2010 on the efficacy of Gardasil against anal pre-cancers in men who have sex with men (New York Times, 10/22).