ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may soon consider whether routine human papillomavirus vaccination should be recommended for males aged 9–26 years, but it does not seem likely that a catch-up dose will be recommended for women who are older than 26.
The HPV vaccine (Gardasil, Merck & Co.) is licensed for males aged 9–26 years for prevention of genital warts associated with HPV-6 and -11, in addition to being routinely recommended for girls aged 11–12 years and for those aged 13–26 who have not already been vaccinated. Data also show that the vaccine has 75% efficacy for preventing anal intraepithelial neoplasia grades 2 and 3 in males, Dr. Lauri Markowitz of the center's HPV working group reported to the committee.
A review by the Food and Drug Administration, which is considering a supplemental biologic license application by Merck for the latter indication, is not expected to be complete before the next ACIP meeting in October, but the working group is reviewing vaccine trial data and cost-effectiveness data on male vaccination, and plans to present its findings at that meeting.
Specifically, the group is looking at cost-effectiveness based on different coverage assumptions. From currently available data, vaccination of males does not appear to be cost effective when female vaccination coverage is high, but it may be more cost effective if female vaccination coverage is low, said Dr. Markowitz, who is also with the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention at the CDC.
The group is also looking at epidemiology and cost-effectiveness data in men who have sex with men, and at the feasibility of reaching men who have sex with men when they would benefit most from vaccination. These findings will also be presented at the October meeting.
Dr. Markowitz noted that ACIP had previously stated that the HPV vaccine “may be given” to males aged 9–26 years, but did not include the HPV vaccine in the routine vaccination schedule for this population.
She added that most working group members are opposed to a catch-up dose in women over age 26 on the basis of currently available data. ACIP first considered vaccination in women in this group in 2008, and Merck submitted a supplemental biologic license application to the FDA in 2009 for that indication. That application remains under review.
National Immunization Survey data show that 25% of girls aged 13–17 years received at least one HPV vaccine dose in 2007 and 37% received it in 2008. Additional data on vaccination rates, vaccine safety, and private insurance coverage will be presented at the October meeting, Dr. Markowitz said.
Disclosures: Dr. Markowitz said that she has no relevant conflicts of interest.