Doctors explore expanding age groups for HPV vaccine

When Stanley A. Gall, MD, sees a female patient who wants the human papillomavirus vaccine, he gives it to her.

"Each woman has to make a personal decision. My view is that if you have a cervix, you need the HPV vaccine," said Dr. Gall, professor of obstetrics and gynecology at the University of Louisville School of Medicine in Kentucky. He is also the American College of Obstetricians and Gynecologists liaison to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, although he was speaking on his own behalf.

Gardasil, an HPV vaccine manufactured by Merck & Co., was approved June 8 by the Food and Drug Administration for females ages 9 to 26. A few weeks later, ACIP recommended that the vaccine should routinely be offered to 11- and 12-year-old girls. Additionally, approval of another version, Cervarix by GlaxoSmithKline, is pending.

Physicians say, however, that women outside this age range have been asking for this preventive, too. Some clinicians, like Dr. Gall, have started providing it off-label, and studies exploring the possibility are ongoing. GSK has a trial involving its vaccine in women up to age 55. Preliminary results were presented at the June meeting of the American Society of Clinical Oncology indicating it was safe and effective for this age group. Merck also is funding studies to determine if its vaccine will work in women up to age 45.

Those most in favor of expanding the vaccine's age range argue that this demographic is still at risk for HPV-related disease as well as the chance of abnormal Pap smears and required follow-up, which can be costly and stressful.

"People are exposed to HPV through their lifetimes. It's important for all ages to be protected with the vaccine," said Diane Harper, MD, MPH, an HPV vaccine researcher and professor of obstetrics-gynecology and community and family medicine at Dartmouth Medical School in Hanover, N.H.

Also, data from the trials in those who are younger suggests that a history of HPV, which is more likely with increasing age, does not make the vaccine ineffective.

"Clearly it could be a benefit," said Daron Ferris, MD, who also researches this vaccine and is a professor in the departments of family medicine and obstetrics and gynecology at the Medical College of Georgia School of Medicine in Augusta. "And the research that we have done has shown that if you have one HPV type, it still affords protection against the HPV types included in the vaccine."

But while the idea has its backers, many physicians are waiting for the results of this research before moving it into clinical practice.

"The HPV vaccine is a significant advance in women's health," said LeRoy Sprang, MD, clinical professor of obstetrics and gynecology at Northwestern University Feinberg School of Medicine in Chicago. "Once we have more data and it's approved for more mature women, I'd be very happy to use it."

And some who work on vaccination policy are less than sold on the possibility. They counter that, especially since this vaccine costs around $350 for the full series, the biggest bang for the buck is most likely to result from focusing efforts on those who are younger, including teen males, who are also being studied. In addition, risk behavior tends to decline with age, putting older women at less risk, and, although early results have documented an antibody response to the vaccine as women age, it is not as robust as in younger women.

"Ultimately, what I would much rather see is HPV vaccine get into the male population. There's much more potential for a profound effect," said Jonathan Temte, MD, PhD, the American Academy of Family Physicians' ACIP liaison.

Cost issues are especially key, since efforts to vaccinate younger women have been hampered because of problems getting insurers to pay for those already recommended to receive it. In November, the Centers for Disease Control and Prevention added it to the Vaccines for Children Program, and the American Medical Association adopted policy encouraging insurers to pay for it.