Doctors explore expanding age groups for HPV vaccine

Some physicians are already administering this shot off-label to women older than 26, and studies are ongoing.

By Victoria Stagg Elliott, AMNews staff. Dec. 25, 2006.

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.