Gardasil, the vaccine that protects against the cervical-cancer-causing human papilloma virus, may soon be approved for women over age 27. New clinical trial data involving more than 3,800 women ages 24 to 45 showed that the shot was nearly 90 percent effective at preventing persistent HPV infections—which are sexually transmitted—over the study's four-year duration, according to manufacturer Merck, which released the study today. (The vaccine protects against two strains of the virus responsible for 70 percent of cervical cancers and two strains that cause genital warts.)
Merck is hoping that the Food and Drug Administration will grant the company permission to expand its product label to include women over 27; it's currently approved only for those ages 9 to 26. The agency deferred a decision on Merck's application for expanded use in June 2008 and again last year. The FDA asked Merck for longer-term efficacy data out to four years, according to Merck spokesperson Pamela Eisele. She says the company expects an FDA decision by June.
Single women could benefit big time from an expanded approval of this vaccine—especially if they're back on the dating scene after a long hiatus. Many, warned by their doctors against the risk of HPV infections, are currently footing the bill for the $360 cost of the three injections since insurance usually won't cover vaccines or drugs that doctors administer "off label." In a previous interview, gynecologist Diane Harper, who conducted some of the earlier Merck trials, told me that half of the women she inoculates are in their 30s, 40s, or 50s; many are engaging in sex with new partners after divorcing or being widowed. While the vaccine doesn't do any good against active infections that might persist for years, it can protect against new infections transmitted by, well, new partners. (HPV infections clear up on their own about 75 to 95 percent of the time. )
And there's some evidence that it also protects against anal cancer—which killed Farrah Fawcett—most cases of which are caused by HPV. Another study released today by Merck found that Gardasil was 78 percent effective at protecting against anal precancers associated with HPV transmission in men ages 16 to 26 who have sex with men. While the study was conducted only in men, the data suggest that the vaccine could also protect against HPV transmission in women who engage in anal sex with men. And, as my colleague Bernadine Healy previously reported, HPV can also be transmitted via oral sex and may be responsible for a significant percentage of head and neck cancers.