Gardasil proves effective for women over indicated age

WHITEHOUSE STATION, N.J. Gardasil, a vaccine that fights four types of the human papillomavirus, prevented 91 percent of cases against HPV-related issues in women older than the current indication of 26, according to new data presented at the 24th International Papillomavirus Conference in Beijing, China.

The primary results evaluated women who were free of infection from at least one vaccine HPV type when they began the study, and who remained free of infection with the relevant HPV type(s) until they completed the three-dose vaccination regimen.

“Women remain at significant risk for acquiring HPV infections and developing HPV-related diseases throughout their lifetime,” said Eliav Barr, executive director of Biologics Clinical Research and head of the HPV Vaccine Program at Merck Research Laboratories. “These data build on the clinical program for Gardasil and will help us to understand the potential benefit that Gardasil may have in women through age 45.”

Gardasil, approved by the FDA in 2006, is recommended for use by girls and women ages 11 to 26. The vaccine is designed to protect against the four HPV types (6, 11, 16 and 18) that cause the most disease, including 70 percent of cervical cancer cases and 90 percent of cases of genital warts.

Merck will submit these data to the U.S. Food and Drug Administration before the end of the year to seek an indication for women through age 45.

The primary analysis of the study was conducted among women who were free of infection with at least one of the relevant HPV types at the start of the trial (baseline), remained free of infection with the relevant type(s) throughout the course of the vaccination period, and who received all three doses of vaccine and placebo.