Cervical-Cancer Vaccine Backed By Panel

A federal vaccine advisory panel unanimously recommended that 11- and 12-year-old girls receive a new vaccine designed to protect against cervical cancer. (information source: www.chartsbank.com/PipelineList.aspx )

The Advisory Committee on Immunization Practices -- which advises the Centers for Disease Control and Prevention concerning vaccination matters -- said the vaccine, Gardasil, by Merck & Co., should be added to the routine vaccination schedule for children and adolescents.

The vaccine protects against four strains of the human papillomavirus, or HPV, two of which account for about 70% of cervical-cancer cases and two that account for about 90% of genital warts.

The panel's vote makes it highly likely that the vaccine will be covered by the nation's private insurers. After the vote, at least one large health insurer, WellPoint Inc., said it will cover the vaccine.

The panel also voted to add the vaccine to a federal program that pays for vaccines for uninsured or low-income children up to age 19. The Vaccines for Children program covers the cost of vaccinating as much as 50% of the childhood population in the U.S. and doled out roughly $1.7 billion in funds last year, CDC officials said. The cost of adding Gardasil to the program could be significant. Merck has priced the vaccine at $120 per dose for a three-dose regimen.

While the government is expected to receive a discount on the vaccine, as many as one million 11- and 12-year-old girls could be eligible for funding under the federal vaccine program. Even if just 20% of them receive the vaccine in the first year, as CDC officials estimate, that could cost as much as $72 million.

The panel also said that doctors could vaccinate girls as young as 9 years old and that girls and women ages 13 to 26 should receive the vaccine even if they already have become sexually active. Federal funds could be used for children up to age 19 if they qualify.
If study data show the vaccine protects against HPV infection in males and in women older than 26, the CDC's vaccination recommendations will likely follow suit, said Anne Schuchat, director of CDC's National Immunization Program.

The panel recommendations go to the CDC director and the Secretary of Health and Human Services for final approval, which is expected in the next few months.