FDA Says GSK's Cervarix Effective Against HPV; Gardasil Effective Against Male Warts

September 8, 2009 — An FDA Advisory Committee meeting scheduled for this Wednesday will address GlaxoSmithKline's application for approval of its human papillomavirus vaccine, Cervarix, as well as Merck's vaccine Gardasil for use in males to prevent genital warts, the AP/Detroit Free Press reports. FDA posted related information on its Web site on Friday. Although FDA is not required to follow the panel's recommendation, it usually does (AP/Detroit Free Press, 9/5).

Cervarix is effective 93% of the time in preventing the two strains of the virus that are responsible for most cases of cervical cancer. Like Merck's HPV vaccine, Gardasil, Cervarix protects against HPV strains 16 and 18, which cause about 70% of cervical cancer cases. However, unlike Gardasil, Cervarix does not protect against other HPV types that cause 90% of genital warts. GSK is seeking approval of the vaccine for use in girls and women ages 10 to 25 (Perrone, AP/Detroit Free Press, 9/5). Gardasil is FDA-approved for girls and women ages nine to 26, and the Centers for Disease Control and Prevention recommends routine vaccination for girls ages 11 and 12. The vaccine also is recommended for girls and women ages 13 through 26 who have not yet been vaccinated or who have not received all three doses (Women's Health Policy Report, 8/21).

Cervarix is approved in several European counties. However, U.S. approval was delayed when FDA in 2007 requested additional information after studies showed that individuals who received Cervarix had a higher number of muscular and neurological problems. On Friday, FDA said that outside experts determined that Cervarix did not cause those problems. FDA also noted that data showing a slightly increased number of miscarriages in women receiving Cervarix does "not establish a causal relationship" (AP/Detroit Free Press, 9/5).

Gardasil Prevents Male Genital Warts

Also on Friday, FDA said that Gardasil is effective in preventing male genital warts 90% of the time. According to documents posted online, the vaccine blocks two strains of HPV that cause irregular growths and rare types of cancer in male genitals. A panel of experts will consider Merck's appeal for approval of the vaccine for use in boys ages nine to 26 (AP/Baltimore Sun, 9/5).