Will HPV vaccine become routine for all women?

Last June the Food & Drug Administration approved a new vaccine, Gardasil (Merck & Co.), which studies show to be highly effective against major types of human papillomavirus (HPV). Now comes the hard part: actually getting it to girls and women.

The Advisory Committee on Immunization Practices (ACIP) has recommended routine HPV vaccination for girls ages 11 to 12, with three doses of the quadrivalent vaccine. It's thought to be almost 100% effective against the four strains it targets if given prior to exposure to those viruses. But because most people are exposed to HPV through sexual activity, the committee said it ideally should be given before the onset of intercourse. However, the committee also recommends vaccinating women up to age 26, because most women will not be infected with all four viruses by that age.

"If we don't mandate it, I guarantee you that the women who die of cervical cancer in the United States are going to continue to die of cervical cancer," he said, referring to proposals to require HPV immunization as a condition of school attendance for girls. "And we won't be saving any lives and we won't be saving any money."

He also warned that, in efforts to get to underserved populations, "social and cultural issues are by far more important than money issues. And we, as yet, have not developed a proper strategy to effectively deal with this problem."

As an illustration of the barriers, Felix pointed to his studies on intense efforts to offer Pap smear screening, which showed that attendance by women who are not traditionally served by the medical community is "very, very poor, even when we go to their communities, even when we do it for free."

As Eileen Dunne, M.D., MPH, medical epidemiologist for the Centers for Disease Control & Prevention, who specializes in HPV, stressed, "Reaching adolescents with a three-dose schedule is challenging." She pointed to studies which found that adolescent care is disjointed. Young people make few preventive care visits, they go to a variety of providers for those visits, and the visits decline after they are 17 years old.

Financing will be a ubiquitous barrier, agreed most speakers at the meeting. Dunne noted that the vaccine's catalog price is $120 per dose, and the federal Vaccines for Children (VFC) program has contracted to buy it at $96. And even before the advent of HPV vaccine, the cost of giving one child all the recommended vaccines-even under the federal contract price-had skyrocketed from $155 in 1995 to $837 in 2006, due mostly to newly recommended vaccines.

Dunne said that the VFC, which covers Medicaid-eligible, uninsured, or underinsured children and Native American or Alaskan native children, pays for about 42% of all vaccine doses for children in this country. But, she added, the current numbers of VFC providers are insufficient to reach all eligible adolescents.

In addition, Dunne noted, because adolescents are more likely than other children to be uninsured, "the administrative costs that may come out of pocket definitely create a barrier for adolescent visits."

Meanwhile, say some physicians, the $360 price for the three doses is inducing fear on the private side also. Some pediatricians are noting that the doses must be purchased ahead of time with no certainty of how many will actually be used.