The HPV vaccine, Gardasil, is FDA-approved for use in females ages 9-26. Some of my patients who are older than 26 would like to get the vaccine, and they wonder why it is not approved for their age group.
Now, a new study from the National Institute of Cancer in Bogota, Columbia suggests that the vaccine may be effective for some women up to age 45.
Approximately 1600 women ages 24-45 received all three doses of the vaccine and were compared to a similar group of women who got placebo shots. Women in both groups had no history of genital warts or cervical disease. They also tested negative for the HPV types 6,11,16 and 18 covered by the vaccine.
After 2 years of followup, more than 90% of vaccinated women tested negative for the HPV vaccine subtypes. Only 4 of 1615 vaccinated women had evidence of persistent HPV infection by any of the four subtypes. 41 of 1607 women in the placebo group had persistent HPV infection.
The study also looked at a mixed population of women in the same age group, some of whom had previous or current HPV infection. In that group, the vaccine effectiveness was less than 30%.
The HPV vaccine has the greatest medical and cost-effectiveness when given to adolescents and young women who have not yet become sexually active. With no prior HPV exposure, this group gets the full benefit of the vaccine's protection against cervical cancer and genital warts. Teens also have a more robust immune response to the vaccine than older women.
However, some women in their later twenties and older have had minimal or no exposure to HPV and could benefit from vaccination. If other studies confirm that HPV vaccination is beneficial for a broader age group, the FDA may extend approval to those women.
For now, when we vaccinate women 27 and above for HPV, it is an off label (not FDA-approved), but still acceptable, use of Gardasil. Even though the FDA has not yet approved the vaccine for these women, physicians can use their judgment and offer the vaccine to informed, older women who request it.
