Gardasil's+Efficacy+in+Preventing+HPV+Infection

=Introduction:= toc Our wiki page trys to answer the following research question: What is the Gardasil vaccine and HPV, and what is the effectiveness upon vaccination towards cervical cancer?

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What is Gardasil?
[|Gardasil]is a vaccine that helps prevent four different types of HPV and can be given to both males and females. The vaccine should not be given to anybody with an allergy to yeast or any component of the vaccine. In order to be most productive, the FDA recommends the vaccine is given prior to sexual maturity. This vaccine was approved by the FDA on June 8, 2006.

Females
Gardasil helps protect against two types (16 and 18) of HPV that are known to cause 75% of all cervical cancer cases. It protects against another two types (6 and 11) of HPV that are known to cause 90% of genital warts cases. Gardasil also helps protect against 70% of vaginal cancer cases and as much as 50% of vulvar cancer cases; both of these are caused by HPV types 16 and 18. The vaccine can be given to females between the ages of 9 and 26.

Males
Gardasil helps protect against HPV types 6 and 11, which cause 90% of genital warts cases. The vaccine can be given to males between the ages of 9 and 26.

What is HPV?
HPV, otherwise known as Human Papillomavirus, is a group of over 150 related viruses; over 40 HPV types are sexually transmitted through genital contact. HPV causes papillomas, small benign tumors, that can be found in the throat or genitals for sexually transmitted HPV types. High-risk HPV viruses such as types 16 and 18 may form precancerous lesions that can lead to invasive cancer. HPV caused about 561,200 new cancer cases in the world in 2002. About 6.2 million new HPV infections happen every year in the US, but only 10% of those develop into dysplasia. Types 16 & 18 are both high-risk strains and together cause about 70% of cervical cancer.

What is cervical cancer?
Cervical cancer is cancer of the cervix, which is the lower part of the uterus that connects to the vagina; it can be prevented by having regular [|Pap smears]. There are two main types of cervical cancer: [|squamous cell carcinomas] and [|adenocarcinomas]. Everyday in the US, about 30 women are diagnosed with cervical cancer and 11 die from it. Cervical cancer is the 12th most common cancer and the fifth most deadly cancer among women.

What are genital warts?
Genital warts are soft, wart-like growths on the skin and mucus membranes of the genitals in men and women. Genital warts are a type of sexually transmitted infection (STI). There is approximately one new case of genital warts every minute in the US and about 2 out of 3 people will get it upon having genital contact with someone infected. Genital warts are usually flesh-colored growths that can be raised or flat, small or large, and alone or in clusters. In females, warts can grow inside a woman’s vagina, or on the cervix, making them hard to see. In males, they can appear on the surface of the penis or groin. Treatment for genital warts can be a painful process and can involve cutting, freezing, or burning the warts. Even after treatment, genital warts can come back.

What is vaginal cancer?
Vaginal cancer is a cancerous tumor or abnormal growth of tissue located in the vagina, which is a female reproductive organ. Secondary vaginal cancer occurs when another cancer, such as cervical cancer, metastasizes to the vagina. Primary vaginal cancer is very rare but it occurs mostly in squamous cells or as an adenocarcinoma, melanoma, or sarcoma.

What is vulvar cancer?
Vulvar cancer occurs on the outer surface of the female genitalia called the vulva, which surrounds the urethra and vagina. This region also includes the clitoris and labia. It commonly forms as a lump/sore and causes itching and pain. = = =Results:=

Adverse Side Effects
There have been over 33 million doses of the vaccine given as of February 14, 2011. VAERS is a database that keeps record of adverse effects occurring after vaccination. The database shows that 18,354 adverse effects have been reported; however, only 8% are considered serious effects. The serious effects included Guillain-Barre Syndrome, a rare neurological disorder that causes muscle weakness, blood clots and death. None of these effects have been linked to reception of the vaccine. The most common side effect reported was a headache.

People who received the Gardasil vaccine were asked about their adverse effects and compared to a control group who either received a placebo shot or another control shot. The data shows that it is more likely that these adverse effects were associated with receiving a shot rather than an effect of the content of the Gardasil vaccine.

As of the end of 2007, only 25% of females aged 13-17 had gotten at least one of the three doses of the vaccine. The Teen National Immunization Survey found similar proportions in all of the groups that they surveyed.

Cost and Coverage
The cost for the Gardasil vaccine is $360 for the three complete doses. It is generally covered by insureance programs, inclusing the Vaccines for Children Program run by Medicaid. It helps in providing immunizations to children 18 and under who whould otherwise not be able to get immunized. Also, complete compliance with the vaccine could reduce the number of terminal cervical cancer cases two thirds. It would also save money long-term because of the costs associated with screening for cervical cancer. (The vaccine costs $120 per dose .)

Gardasil consists of a 3-dose series. If one were to take the first dose now, then he/she would take the second dose 1-2 months after the first dose, and then take the third dose 6 months after the first dose.

Population Impediments
The National Provider Survey found in 2008 that the most common reason for parents to defer vaccination of their children was because they felt the drug was too new. Many people also mentioned that they refused the vaccination because of financial reasons. The study also found that only about half of the family practitioners and pediatricians surveyed were recommending the vaccine to children 11-12 years old. Although they did strongly recommend it to patients aged 16-18, since the drug is supposed to be a preventative measure, one would desire to have people vaccinated prior to an opportunity for exposure to an HPV virus.

Although full usage of the vaccine would reduce the number of cervical cancers, the need for screening would still be necessary. There are many other types of HPV that can cause cervical cancer that the vaccine would not protect against.

Efficacy
Although a clinical trial done in Costa Rica showed that the vaccine did not aid in clearing the virus, people who have been previously diagnosed with HPV should still get the vaccine because it can prevent them from contracting the four types of HPV targeted by the vaccine.

Thus far, data has only been collected on the length of coverage of the vaccine. Clinical trials in Costa Rica show that the vaccine is still effective after 4 years. They are currently working on a clinical trial in which they are seeing if the vaccine is still effective after 10 years. They are doing screenings every two years to see whether the vaccine is still working for the women who received it. They are comparing these individuals to a control group that does not receive the vaccine to determine whether the vaccine has long term efficacy .This information will help provide information on whether booster shots will be necessary to maintain protection.

  =Conclusion=  Based on the information provided by the FDA and CDC, Gardasil is considered to be a safe and effective vaccine, and its benefits outweigh its risks.