Gardasil – The HPV Solution?
Gardasil – The HPV Solution?
HPV or Human Papillomavirus currently infects over 20 million individuals worldwide with over 6 million new patients being added to that list every year. There are over 130 different types of HPV. Many types are completely asymptomatic and other types cause common warts. But HPV types 16 and 18 cause cervical cancer that leads to the death of over 100,000 women every year. And HPV types 6 and 11 cause an uncomfortable and sometimes painful sexually transmitted disease known as Genital Warts. So, research on developing a vaccine to prevent HPV infection began in the 1980s. In 1993, the US National Cancer Institute was able to generate in their laboratory a non-infectious virus-like particle that would activate the immune system against HPV. Merck & Company began conducting clinical trials with over 12,000 women. In February of 2006, the trials were terminated due to the overwhelming success of the HPV vaccination. The study found that the vaccine was 100% effective in preventing the strains of HPV that cause cervical cancer and 99% effective in preventing the strains that cause genital warts.
In June of 2006, the US Food and Drug Administration approved Gardasil for use in women for cervical cancer prevention. It was approved in September of 2008 for the prevention of vaginal and vulvar cancers in women. Gardasil is made up of mainly two components. The vaccine contains a non-infectious four-part genetically engineered substance made from a highly purified protein shell that surrounds the nucleus of the HPV types 6, 11, 16, 18. It combines that with a substance that contains aluminum to help the vaccine have a higher immune response. The vaccine is administered by injection into a body muscle and has a white, cloudy appearance. The patient is given three injections over a period of six months at two-month intervals. Gardasil does not cure HPV, but it can prevent the infection from taking place in the first place, thereby offering protection from nearly all cervical cancers, genital warts, and some vaginal cancers.
At present, the Gardasil vaccine is only approved for women ages 12 to 26. The cervical cancer vaccine works best when the patient has not been infected with any of the HPV types, so vaccination is encouraged in girls aged 9 and up before they become sexually active. But HPV also causes penile cancer and genital warts in men. So Merck & Company began clinical trials on men ages 16 to 26. The study concluded that the participants were 90% less likely to develop penile cancer and genital warts associated with HPV after receiving the vaccine. Side effects were minor and generally the same as for women, with redness or swelling at the injection site, slight fever, and nausea. Merck & Company submitted an application with the US Food and Drug Administration in December of 2008 for a license to market the vaccine for use in males. A decision by the FDA could take anywhere from months up to a year or longer.
The cost of the vaccine is $360 for three doses or $120 per dose spread out over six months. But some doctor’s offices may charge more with added fees or maybe even a profit markup on the vaccine itself. About 96% of the health plans that are offered in the United States cover the cost of the Gardasil vaccine for girls. But even if a particular health insurance plan does not cover the cost of the vaccine, then there are other options available for assistance in this regard. Merck and Company offer a program whereby an individual can receive the vaccine for free. There are other government programs as well that will assist in paying for the vaccine.
US Food and Drug Administration