Gardasil for your son?
More than 30 types of the human papillomavirus (HPV) can infect the genital areas of women and men, causing genital warts and even cancer. Since 2006, the HPV vaccine Gardasil has been recommended for women and girls as young as nine to primarily prevent cervical cancer. The FDA is now considering approval of Gardasil for men and boys for the prevention of genital warts.
HPV is pervasive
Each year about six million Americans are diagnosed with a type of HPV, which is transmitted through sexual intercourse and even oral sex. The HPV types 6 and 11 are responsible for approximately 90 percent of genital warts cases. Upwards of one million people (both males and females) have visible genital warts at any point in time. HPV types 16 and 18 are linked to 70 percent of the cases of cervical cancer in women.
HPV can be deadly for men
Men and women can have HPV and not even know it, particularly with the strains of HPV that do not cause genital warts. Women are usually alerted when they get their annual pap smears. Conversely, there are currently no routine HPV screening methods in place for men. Genital warts help with detection but the biggest danger is non-wart manifestation of HPV.
"HPV types 16 and 18 cause anal, penile, and some head and neck cancers in men," warns Dr Anna R. Giuliano of the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida.
Gardasil for men and boys
Looking for a way to protect the male population from contracting HPV, Merck conducted a study last year on the effectiveness of Gardasil on preventing HPV in men.
"Vaccine efficacy in males was evaluated in a randomized, double-blind, placebo-controlled trial," explains Dr Guiliano. "The 4,000-patient study showed Gardasil was 90 percent efficacious against HPV 6- and 11-related external genital warts."
Men and women benefit from HPV vaccine
When administered before sexual activity begins, Gardasil can reduce the risk of HPV. Having both men and women vaccinated can further reduce the risk of HPV transmission, genital warts and cancer, particularly since men may be unaware that they have the disease.
"Vaccination of men with Gardasil will have a direct benefit to men by reducing the types of infection that cause genital warts, and cancers of the penis, anal canal and head and neck region," says Dr Guiliano. This means it will also lower women's risk of exposure to and dangers of HPV.
Dangers of the HPV vaccine for men
No drug or vaccine comes without the risk of side effects. According to Dr Guiliano, some men have reported low-grade fevers, pain at injection site, and mild swelling in the arm that received the vaccine. However, the vaccine has been shown to be safe and well tolerated in males aged 16 to 26 years old.
Approval of Gardasil for men
The FDA's Vaccines and Related Biological Products Advisory Committee reviewed data supporting Gardasil use in males and voted to recommend the approval of Gardasil in males for the prevention of genital warts. They are recommending Gardasil for use in boys and men 9 through 26 years of age. The FDA is not bound by the Advisory Committee's recommendation but takes it into consideration. Dr Guiliano says, "We expect the final FDA decision on licensure of Gardasil for men to occur shortly, possibly by the end of October."
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