ACIP Supports 'Permissive Use,' But Not Routine Use, of Gardasil in Males

The CDC's Advisory Committee on Immunization Practices, or ACIP, has recommended against the routine use of quadrivalent human papillomavirus, or HPV, vaccine to prevent genital warts in boys and young men.

Instead, the committee voted during its Oct. 21-22 meeting in Atlanta to support the "permissive use" of Gardasil, Merck & Co. Inc.'s quadrivalent HPV vaccine, leaving decisions on whether to immunize males ages 9-26 years who request the vaccine up to their health care professionals.

However, the committee did recommend that the CDC provide funding for administration of the vaccine through the agency's Vaccines for Children, or VFC, program for males who want to receive it.

Gardasil was approved in 2006 for use in girls and young women ages 9-26 years for the prevention of cervical cancer, vulvar cancer, vaginal cancer and precancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18.

The FDA recently expanded its approval to include use of the vaccine to prevent genital warts in boys and men ages 9-26 years.

According to Doug Campos-Outcalt, M.D., M.P.A., the Academy's liaison to the ACIP, the committee has recommended routine use of the vaccine in adolescent girls and young women because of the protection it offers against both warts and cancer, but the committee did not take that step for boys and young men, in part, because the FDA approved its use in males solely to prevent genital warts.

Gardasil has not been shown to prevent cancer in males, said Campos-Outcalt, who also is associate head of the department of family and community medicine at the University of Arizona College of Medicine, Phoenix, and some ACIP members at the meeting viewed warts primarily as a cosmetic or fairly benign problem that -- except in some rare instances -- was less serious than other vaccine-preventable diseases.

Advocates of vaccinating males against HPV infection counter by saying that doing so would lend further protection to females. However, the concept of vaccinating boys and young men against HPV did not fare well in a recent cost-benefit analysis conducted by researchers from the Harvard School of Public Health and published in BMJ.

The three-dose vaccine series needed to achieve adequate protection in either males or females costs nearly $400.

"The feeling is that effort and money would be better spent in increasing vaccination rates in girls," Campos-Outcalt said.

The ACIP did give a thumbs-up to routine use of Cervarix, the new bivalent HPV vaccine manufactured by GlaxoSmithKline Biologicals, or GSK, that recently was approved by the FDA for the prevention of cervical cancer and precancerous lesions caused by HPV types 16 and 18 in girls and women ages 10-25. The committee also recommended that the CDC provide VFC funding for administration of Cervarix to eligible females.

Like Gardasil, Cervarix is administered in a three-dose series and is similarly priced. Although Cervarix does not protect against the HPV types that cause genital warts, Campos-Outcalt said some patients and physicians may opt for the new product because data provided by GSK indicate that Cervarix produces higher antibody levels than Gardasil, which could lead to a better and longer-lasting immune response.

If the goal is to prevent cervical cancer in females, either Cervarix or Gardasil may be used, said the committee, which further noted that one vaccine could be substituted for the other, if needed, to complete the three-dose series.

Although the ACIP's recommendations are made on a provisional basis, Campos-Outcalt said the CDC typically accepts the committee's recommendations.