FDA Consulting And New Vaccine For Genital Warts
Males who get penile cancer, anal cancer or genital warts suffer from an infection known as human Papillomavirus or HPV. Penile and anal cancers are rare however genital warts affect 200 in every hundred thousand men. An FDA advisory committee has recently voted to recommend a new HPV virus for use in men aged between 19 and 26.
The Gardasil vaccine targets four strains of HPV, strains 6, 11, 16 and 18, which can be transmitted sexually from male carriers to their sexual partners. 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 vaccine was voted 7 to 0 with an absent vote that it should be recommended to the FDA and 7 to 1 that it was safe for men aged 19 to 26. 5000 men in the age category were tested in clinical trials across the world. Three trials were reviewed in total.
Over a six month time span the participants were given three shots of the Gardasil vaccine whilst the test group were given three shots of a placebo. They were medically tested for the HPV infection by independent healthcare officials. In those participants who had never been exposed to genital warts, Gardasil’s effectiveness was 89%, but this figure was reduced in those who had previously been exposed to the infection.
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. FDA consulting will determine whether the advisory committees’ recommendations will be followed. Cervical cancer is prevented in females aged between 9 and 26 by using a Gardasil HPV vaccine. Some countries are also already using the Gardasil vaccine in boys and there have been no safety issues reported in any reports surrounding the vaccine.
