Gardasil Closer to Being Approved for Males

In France on Thursday, the European Research Organization on Genital Infection and Neoplasia conference was being held and one of the presentations was to be the effectiveness of the human papillomavirus (HPV) vaccine on males. The HPV vaccine Gardasil was approved in 2006 for girls and young women between the ages of 9 and 26 has proved extremely popular among American females and has yet to be approved for males.

In the past year, one fourth of women in the United States alone have been vaccinated against the human papillomavirus and with recent data showing that before the availability of the vaccine, 25,000 cases of HPV were reported, making it easier to show its effectiveness in the future.

With the progress of Merck’s Gardasil being made for young females, women ages 27 to 45 are now up for approval by the Food and Drug Administration (FDA) and men have since been left out of the loop in regards to a need for the vaccine. Recently Gardasil was approved to prevent other cancers besides cervical including those anal and penile cancers that would be relevant to men. The H. Lee Moffitt Cancer Center and Research Institute of Tampa, Florida, conducted this new study, sponsored by Gardasil’s maker Merck, in order to test the prevention of genital warts and other lesions caused by HPV in men.

The Institute found that the vaccine prevented lesions and genital warts caused by sexual contact in 90 percent of the HPV-related cases in men. The research group included approximately 4,000 young men between the ages of 16 and 26 using either a placebo or a vaccine and then checked every six months. Of the 4,000 males in the study, 3,400 were heterosexuals up to age 23 and another 600 were homosexual up to age 26. The vaccine is only effective, however, if the volunteer has not already been exposed to HPV, which tends to have a lower risk at a younger age.

Once more data is available Merck will release it following up this ongoing study of HPV in males. Using blood samples, Gardasil protected fewer than half of HPV in the blood and about 90 percent of genital warts and precancerous markers. In a telephone interview, Anna Giuliano, the epidemiology department chair at Moffitt and head of the study says, “We see 90.4 percent efficacy is reducing external genital lesions in males related to these four types of HPV—6, 11, 16, 18." Three cases of genital warts were found among the Gardasil group versus 31 cases in the placebo group. Giuliano continues to say that this study isn’t over and is still in its early stages, "This opens up some really important questions for further research…. The cancers in men, which are HPV related are really only now being understood."

Merck continues to plan ahead, hoping to submit an application for United States FDA approval by the end of the year starting in males from age 9 to 26, because of it’s effectiveness in vaccinating females by protecting them before sexual activity. "These are the only data evaluating efficacy of any HPV vaccine in preventing disease in males, and were presented for the first time this week," said a statement by Merck pharmaceutical company.

The HPV vaccine, if approved in men, will also be able to tell whether or not it is helpful in preventing the spread of the virus between male and female partners.

As exciting as this news is for Merck and potentially for males once approved, there is no guarantee that the vaccine will be as popular as the female version. The safety of Gardasil has yet to be proven and vaccinating young boys before the risk may not reassure parent’s worries. Guiliano says, this new evidence carries with it, “a wonderful opportunity to prevent illness.” Let’s hope the actual effectiveness of illness prevention is more important to Merck and safer for all young people being exposed than vaccinating purely for the sake of possibility.