A Food and Drug Administration advisory panel recommended yesterday that the FDA approve the expansion of Gardasil use to boys and men between the ages of 9 and 26 and also approve Cervarix, a human papillomavirus (HPV) vaccine, for use in women.
Anna Giuliano, a scientist who led a trial of Gardisil in men, told CNN, “the data clearly demonstrates that there was a benefit to men in receiving Gardasil. Overall, we saw a 90 percent reduction in disease – genital warts and pre-cancerous lesions — caused by HPV in men and an 89 percent reduction in genital warts incidence…if we can reduce infection and related diseases in men, we have the potential to have a much broader public health impact by reducing the overall burden of infection and disease in the community at large.”
Gardasil is an HPV vaccine produced by Merck & Co. that protects against about 70 percent of the HPV strains that are linked to cervical cancer and against two strains that cause genital warts, according to the Associated Press. It was approved for use in girls and women between the ages of 9 and 26 in 2006.
Cervarix protects against the same cervical cancer-linked HPV strains as Gardasil, but not the two strains associated with genital warts. It was originally submitted for approval from the FDA in 2007 by SmithKlineGlaxo, but was rejected due to concern that it could lead to miscarriages in pregnant women. The advisory panel’s recommendation is that the vaccine “be marketed with the usual caveat that it shouldn’t be used during pregnancy,” panel member Dr. Kenneth Noller told the Los Angeles Times.
