FDA Consulting To Help With Preventative For Genital Warts In Men
Human Papillomavirus or HPV can cause genital warts, penile and anal cancer in males. Whilst doctors diagnose the cancers very rarely, genital warts affect 200 in every 100,000 males in the US every year. An FDA advisory committee has recently voted to recommend a new HPV virus for use in men aged between 19 and 26.
HPV is sexually transmitted and four strains of the virus are targeted by the Gardasil vaccine. 90% of genital warts are caused by strains 6and 11 whilst strains 16 and 18 are responsible for 70 % or cervical cancer cases in women.
The FDA advisory committee which debated the use of the vaccine voted 7 to 0 with one abstaining vote that data from the Gardasil clinical trial supported its effectiveness in the prevention of genital warts in men aged 19 to 26, and 7 votes to 1 that the vaccine was safe for men in the same age range. The clinical trials that the committee were reviewing covered 5000 men aged between 19 and 26 across a number of countries including the US. There were three trials in total.
Three shots were given to each participant over a 6 month period, tested against a placebo group. Independent doctors checked for HPV in all of the participants. Gardasil’s effectiveness was 89% in men who had never experienced HPV before.
There were no serious side effects seen from taking the Gardasil HPV vaccine so it is likely that the FDA will follow the recommendation of its committee although it doesn’t have to. The matter will be decided after FDA consulting with qualified and experienced members. Gardasil is already used as an HPV vaccine in females aged between 9 and 26 as a preventative of cervical cancer. Additionally, no serious health problems have been found so far in the countries where boys already receive the HPV vaccine.





