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| {{seealso|HPV vaccine}}
| | #REDIRECT [[HPV Vaccine]] |
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| '''Gardasil''' is a vaccine against certain types of the [[human papillomavirus]] (HPV), manufactured by [[Merck & Co.]]. The research that lead to the development of the vaccine began in the 1980's by groups at the University of Rochester, Georgetown University, the [[University of Queensland]], and the US National Cancer Institute. A breakthrough was discovered in 1991 when Ian Fraser and Jian Zhou of the University of Queensland found a way to form non-infectious virus-like particles [[VLPs]], which could also strongly activate the immune system. In 1994, UniQuest, the technology transfer arm of the [[University of Queensland]] licensed this technology to Australia's largest biotechnology firm, CSL (who then licensed to [[Merck & Co.]]). Upon commercialization of the vaccine, controversy involving intellectual property initiated by GSK arose between the inventors. The history of the discovery of this vaccine is described in the following article <ref>[http://jncicancerspectrum.oxfordjournals.org/cgi/content/extract/jnci;98/7/433 Who Invented the VLP Cervical Cancer Vaccines?] McNeil, C., ''Journal of the National Cancer Institute'', 2006, 98(7): 433.</ref> . Two vaccines were developed: Gardasil (which the focus of this review) was attributed to the Australian researchers and [[Cervarix]] to the US researchers.
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| Gardasil is designed to [[HPV vaccine|prevent infection with HPV]] types 16, 18, 6, and 11. HPV types 16 and 18 cause about 70% of HPV-related cervical cancer cases. In addition, some types of HPV, particularly type 16, have been found to be associated with oropharyngeal squamous-cell carcinoma, a form of throat cancer.<ref name=NEJoM>{{cite journal | last = D'Souza | first = Gypsyamber | last2 = Kreimer | first2 = Aimee R. | last3 = Viscidi | first 3 = Raphael | title = Case–Control Study of Human Papillomavirus and Oropharyngeal Cancer | journal = [[New England Journal of Medicine]] | volume = 356 | pages = 1944-1956 | date = May 10, 2007 | year = 2007 | url = http://content.nejm.org/cgi/content/full/356/19/1944}}</ref> HPV types 6 and 11 cause about 90% of genital wart cases. Human papillomavirus (HPV) infection causes virtually all cases of [[cervical cancer]], the 7th most common cause of death from cancer among women worldwide.<ref>Cancer Research UK [http://info.cancerresearchuk.org/cancerstats/geographic/world/commoncancers/?view=PrinterFriendly&a=5441] The most common causes of death from cancer worldwide, 2002 estimates. accessed 22 May 2007</ref>
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| ==Biotechnology==
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| The HPV major [[capsid]] protein, L1, can spontaneously self-assemble into [[virus like particle|virus-like particles]] (VLPs) that resemble authentic HPV [[virion]]s. Gardasil contains recombinant VLPs assembled from the L1 proteins of HPVs 6, 11, 16 and 18. Since VLPs lack the viral [[DNA]], they cannot induce cancer. They do, however, trigger an [[antibody]] response that protects vaccine recipients from becoming infected with the HPV types represented in the vaccine.
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| ==Prevalence of genital HPV==
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| According to the [[Centers for Disease Control]], by the age of 50 more than 80% of American women will have contracted at least one strain of HPV. HPV is highly [[communicable]]. No evidence proves that [[condoms]] do not protect against HPV, but consistent use has been shown to reduce the risk of becoming infected.<ref> New England Journal of Medicine. Condom Use and the Risk of HPV Infection. 2006 Sep 28;355(13):1388–1389.</ref><ref> New England Journal of Medicine. Condom use and the risk of genital human papillomavirus infection in young women. 2006 Jun 22;354(25):2645–54</ref><ref>Sexually Transmitted Diseases. Condom use and other factors affecting penile human papillomavirus detection in men attending a sexually transmitted disease clinic. 2004 Oct;31(10):601–7</ref>
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| All women are encouraged get a yearly [[pap smear]] solely to detect cancer cells caused by HPV.
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| Both men and women are carriers of HPV. To eradicate the disease, men will eventually need to be vaccinated. Studies are being conducted now to determine the efficacy of vaccinating boys with the current vaccine.
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| About 11,000 American women are diagnosed with cervical cancer every year, and about 3,700 die per year of the disease.<ref>[[National Cancer Institute]] SEER [http://seer.cancer.gov/statfacts/html/cervix.html fact sheet on cervical cancer] accessed 30 Mar 2007.</ref>
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| ==Importance of vaccination for public health==
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| The National Cancer Institute writes, "Widespread vaccination has the potential to reduce cervical cancer deaths around the world by as much as two-thirds, if all women were to take the vaccine and if protection turns out to be long-term. In addition, the vaccines can reduce the need for medical care, biopsies, and invasive procedures associated with the follow-up from abnormal Pap tests, thus helping to reduce health care costs and anxieties related to abnormal Pap tests and follow-up procedures (2)." [http://www.cancer.gov/cancertopics/factsheet/risk/HPV-vaccine]
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| ==Safety and efficacy of the vaccine==
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| According to the [[Centers for Disease Control]], the vaccine was tested in over 10,000 females (ages 9 to 26). These studies have shown no serious side effects. The most common side effect is soreness at the injection site. CDC, working with the FDA, will continue to monitor the safety of the vaccine after it is in general use. The vaccine does not contain mercury, thimerosal or live virus.[http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm]
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| The [[National Cancer Institute]] says, "FDA-approved Gardasil prevented nearly 100 percent of the precancerous cervical cell changes caused by the types of HPV targeted by the vaccine for up to 4 years after vaccination." [http://www.cancer.gov/cancertopics/factsheet/risk/HPV-vaccine]
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| ==Clinical trials==
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| Merck & Co. conducted a Phase III study named FUTURE II. This clinical trial was a randomized [[double-blind study]] with one controlled [[placebo]] group and one vaccination group. Over 12,000 women aged 16–26 from thirteen countries participated in the study. Each woman was injected with either Gardasil or a placebo on Day 1, Month 2, and Month 6. In total, 6,082 women were given Gardasil and 6,075 received the placebo.<ref>{{cite web |url=http://www.merck.com/newsroom/press_releases/research_and_development/2005_1006.html |title=Merck's Investigational Vaccine GARDASIL™ Prevented 100 Percent of Cervical Pre-cancers and Non-invasive Cervical Cancers Associated with HPV Types 16 and 18 in New Clinical Study |date=2005-10-06 |accessdate=2007-01-26}}</ref> Merck has tested the vaccine in only a few hundred 11- and 12-year-old girls.<ref>{{cite news|url=http://www.vaccinerx.com/news/cervical-cancer/gardasil-efficacy-questioned-by-experts-says-wall-street-journal-20070416-194-26.html|title=Gardasil Efficacy Questioned by Experts says Wall Street Journal|publisher=Vaccine Rx |date=2007-04-16 |accessdate=2007-04-16}}</ref> On February 27, 2006, the independent Data and Safety Monitoring Board recommended the clinical trials be terminated on ethical grounds, so that young women on placebo could receive Gardasil.<ref>{{cite news |url=http://www.vaccinerx.com/news/cervical-cancer/gardasil-trials-end-on-tuesday-due-to-success-20070227-93-26.html
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| |title=Gardasil Trials End on Tuesday Due To Success |last=ROBERTS|first=J. |publisher=Vaccine Rx |date=2007-02-27|accessdate=2007-02-27}}</ref>
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| ==Administration==
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| The US [[Food and Drug Administration]] (FDA) approved Gardasil on [[June 8]], [[2006]]. Gardasil is currently available.<ref name="FDAapproval">[http://news.yahoo.com/s/ap/20060608/ap_on_he_me/cervical_cancer_vaccine FDA approves cervical cancer vaccine], AP, accessed June 8, 2006</ref> The drug is also approved for use in [[Australia]], [[New Zealand]], [[Canada]], [[Mexico]], [[Croatia]], [[Malaysia]], [[Brazil]], [[Serbia]], and countries of the [[European Union]].
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| Gardasil is given in three injections over six months, namely at enrollment, and two and six months later.
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| On [[June 29]], [[2006]], a panel of experts, the Advisory Committee on Immunization Practices, gave their approval for the vaccination of Gardasil on children as young as nine years old. The ACIP recommended that Gardasil be placed on the childhood immunization schedule at the eleven to twelve year old visit. They also recommended that the vaccine be included in the federal Vaccines for Children Program, which would provide the vaccines free of charge to children under the age of eighteen who are uninsured.<ref>[http://www.redorbit.com/news/science/555590/vaccine_advised_for_girls_age_11_12_gardasil_immunization_prevents/index.html?source=r_science Panel approves Gardasil usage], AP, accessed June 30, 2006</ref>
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| ==Government & public health mandates==
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| {{mergeto|HPV vaccine|Talk:HPV vaccine#Merger proposal|date=August 2007}}
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| According to the American [[Centers for Disease Control]], getting as many girls vaccinated as early and as quickly as possible will reduce the cases of cervical cancer among middle-aged women in 30 to 40 years and reduce the transmission of this highly communicable disease. Unfortunately, there are hurdles to getting this done. These include the limited understanding by many people that HPV causes cervical cancer, the difficulty of getting pre-teens and teens into the doctor’s office to get a shot, and the high cost of the vaccine ($120/dose, $360 total for the three required doses, plus the cost of doctor visits).<ref>http://www.cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm Centers for Disease Control </ref><ref>http://www.cdc.gov/std/HPV/STDFact-HPV-vaccine.htm Centers for Disease Control </ref>
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| One way to bring down the cost of the vaccine and to educate the public on the benefits of vaccination is to make it mandatory for girls entering school. This approach has been taken with vaccines for mumps, measles, rubella, and hepatitis (which is also sexually transmitted) so many state legislators have penned bills that do this. Almost all pieces of legislation currently pending in the states that would make the vaccine mandatory for school entrance have an "[[opt-out]]" policy.
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| ===Australia===
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| In Australia, the Australian government and the PBS (Pharmaceutical Benefits Scheme) has approved the vaccine for use and in 2007 began a nationwide vaccination program free of charge to schoolgirls in years 10, 11 and 12. These programs are run by local councils with funding and vaccine supplies coming from the government. The subsidisation approval process, however, appears to have been heavily influenced by political interference from politicians of all political parties, and by the Prime Minister who publically advised that it would be approved (before approval). In addition, women between 18 and 26 years of age at the time of the first dose may receive the vaccine for free upon request from their [[general practitioner]]. After June 2009, the program will be scaled down to 12–13 year old girls only. Australia also approved Gardasil for boys 9–15 years old, but Australia is not providing government funding for vaccinating boys.<ref>{{cite news |url=http://www.bloomberg.com/apps/news?pid=20601081&sid=adOT2d961UKo&refer=australia |title=Australia to Subsidize Merck Cervical Cancer Vaccine (Update3) |last=Poljak |first=Vesna |coauthors=Daley, Gemma |publisher=[[Bloomberg]] |date=2006-11-29 |accessdate=2007-01-26}}</ref><ref>{{cite website|url=http://www.health.gov.au/internet/standby/publishing.nsf/Content/young-women-faq|title=The National HPV Vaccination Program - Frequently Asked Questions for Young Women|author=[[Department of Health and Ageing (Australia)|The Department of Health and Ageing]]|date=2007-08-13|accessdate=2007-09-28}}</ref>
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| ===Europe===
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| On [[March 26]], [[2007]], early approval was granted in both [[Germany]] and [[Italy]].<ref>{{cite news |url=http://www.vaccinerx.com/news/cervical-cancer/gardasil-merck-hpv-vaccine-gets-german-and-italian-approval-for-girls-20070326-149-26.html |title=Gardasil, Merck HPV Vaccine, Gets German And Italian Approval For Girls |last=Fagbire |first=OJ |publisher=Vaccine Rx|date=2007-03-26 |accessdate=2007-03-27}}</ref>
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| ===South Korea===
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| On [[July 27]], [[2007]], [[South Korea|South Korean]] government approved Gardasil for use in girls and women aged 9 to 26 and boys aged 9 to 15.<ref>{{cite news |url=http://www.msd-korea.com/content/corporate/news/announcement/company22-gardasil.html |title=가다실® 제품 허가 공지 |date=2007-06-27 |accessdate=2007-08-06}}</ref> Approval for use in boys was based on safety and [[immunogenicity]], but not efficacy.
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| ===Legislation in the United States===
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| '''Opt-out policies'''<br />
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| Almost all pieces of legislation currently pending in the states that would make the vaccine mandatory for school entrance have an "[[opt-out]]" policy.<ref>http://www.ncsl.org/programs/health/HPVvaccine.htm</ref>
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| '''Opposition from health insurance companies'''<br />
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| There has been significant opposition from health insurance companies to covering the cost of the vaccine ($360).<ref>http://cancer.about.com/od/hpvvaccine/a/drvaccine.htm</ref><ref>http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=43913</ref><ref>http://www.columbiatribune.com/2007/Jun/20070615Feat001.asp</ref>
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| '''Origins'''<br />
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| [[Texas]] [[Governor]] [[Rick Perry]] issued an executive order on [[February 2]], [[2007]] mandating the vaccine be given to all school girls entering sixth grade, beginning September 2008. This ruling would allow parents to opt out of vaccinating their daughters.<ref>{{cite news |url=http://www.washingtonpost.com/wp-dyn/content/article/2007/02/02/AR2007020201528.html
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| |title=Texas Gov. Orders Anti-Cancer Vaccine |last=PETERSON |first=LIZ AUSTIN |publisher=[[Washington Post]] |date=2007-02-02 |accessdate=2007-02-02}}</ref> On [[February 22]], [[2007]] a group of Texas families filed a lawsuit to stop the executive order.<ref>{{cite news |url=http://www.vaccinerx.com/news/cervical-cancer/cervical-cancer-vaccine-blocked-by-texas-families-20070224-88-26.html
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| |title=Cervical Cancer Vaccine Blocked By Texas Families |publisher=Vaccine Rx |date=2007-02-24 |accessdate=2007-02-24}}</ref> It is to be noted that an [[Executive order (United States)|executive order]] is not a law but rather a recommendation. On [[April 25]], [[2007]], the Texas legislature overruled Governor Perry's order, forbidding mandatory vaccination until at least 2011.<ref>{{cite news |url=http://www.nytimes.com/2007/04/26/us/26texas.html?ref=health
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| |title=Texas Legislators Block Shots for Girls Against Cancer Virus|last=Blumenthal|first=Ralph |publisher=New York Times |date=2007-04-26 |accessdate=2007-04-26}}</ref>
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| '''Successful implementations'''<br />
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| New Hampshire has adopted a voluntary program, in which it supplies the vaccine free of charge to girls between the ages of 11 and 18. Alaska has adopted a similar voluntary program for girls between the ages of 9 and 18. <ref>[http://www.hss.state.ak.us/press/2007/pr053107fed-funding-hpv-vax.htm State Government of Alaska]</ref> This has met with wide acceptance, with many young women requesting the vaccine. South Dakota and Washington are considering similar measures.<ref>{{cite news |url=http://www.nytimes.com/2007/05/12/health/12cancer.html |title=In New Hampshire, Soft Sell Eases Vaccine Fears|last=Belluck|first=Pam |publisher=New York Times |date=2007-05-12 |accessdate=2007-05-15}}</ref>
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| '''State-by-State'''<br />
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| Other states are also preparing bills to handle issuing the HPV Vaccine:<ref>http://www.ncsl.org/programs/health/HPVvaccine.htm</ref>
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| <table border="1" cellspacing="1" cellpadding="3" width="100%"><tr><td valign="top" class="p11">'''State''' </td><td align="left" valign="top" class="p11">'''Proposal''' </td><td align="left" valign="top" class="p11">'''Status''' </td><td align="left" valign="top" class="p11" width="100">'''Opt Out Policy'''</td></tr>
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| <tr><td valign="top" class="p11">'''Alaska''' </td><td align="left" valign="top" class="p11">Voluntary vaccination program </td><td align="left" valign="top" class="p11">Passed</td><td align="left" valign="top" class="p11">N/A</td></tr>
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| <tr><td valign="top" class="p11">'''California''' </td><td align="left" valign="top" class="p11">Bill would have required girls entering the sixth grade to be vaccinated. </td><td align="left" valign="top" class="p11">Withdrawn for further consideration. </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Colorado''' </td><td align="left" valign="top" class="p11">Bill would require 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Connecticut''' </td><td align="left" valign="top" class="p11">Bill would require girls receive a first dose of the vaccine before entering the sixth grade. Allows parents to opt their daughters out on medical or religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''District of Columbia''' </td><td align="left" valign="top" class="p11">Bill would require girls to be vaccinated before they turn 13 to attend school. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Florida''' </td><td align="left" valign="top" class="p11">Bill would have required 11- and 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Died in committee </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Georgia''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated unless parents can't afford the vaccine or object to it on medical or religious grounds. </td><td align="left" valign="top" class="p11">Died in Committee </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Illinois''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Kansas''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Kentucky''' </td><td align="left" valign="top" class="p11">Bill would require girls entering middle school to be vaccinated. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Passed House, to Senate </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Maryland''' </td><td align="left" valign="top" class="p11">Bill would have required girls entering the sixth grade to be vaccinated. </td><td align="left" valign="top" class="p11">Withdrawn </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Massachusetts''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Michigan''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Pending. </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Missouri''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Minnesota''' </td><td align="left" valign="top" class="p11">Bill would require 12-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Mississippi''' </td><td align="left" valign="top" class="p11">Bill would have required girls entering the sixth grade to be vaccinated. </td><td align="left" valign="top" class="p11">Died. Sponsor planning to re-introduce it with an opt-out clause. </td><td align="left" valign="top" class="p11">No</td></tr>
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| <tr><td valign="top" class="p11">'''Nevada''' </td><td align="left" valign="top" class="p11">Bill would require health insurance companies to cover the cost of the vaccine</td><td align="left" valign="top" class="p11">Passed into law</td><td align="left" valign="top" class="p11">N/A</td></tr>
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| <tr><td valign="top" class="p11">'''New Hampshire''' </td><td align="left" valign="top" class="p11">Voluntary program provides vaccine free of charge to girls between the ages of eleven and eighteen. </td><td align="left" valign="top" class="p11">Passed and presently in effect. </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''New Jersey''' </td><td align="left" valign="top" class="p11">Bill would require girls in grades seven through 12 to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''New Mexico''' </td><td align="left" valign="top" class="p11">Bill would require nine- to 14-year-old girls to be vaccinated to attend school. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Passed legislature. Vetoed by governor. </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Ohio''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Oklahoma''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''South Carolina''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the seventh grade or 11 years of age to be vaccinated. Allows parents to opt their daughters out on medical or religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Texas''' </td><td align="left" valign="top" class="p11">Governor issued executive order requiring that girls entering the sixth grade be vaccinated. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Texas legislature overrode executive order and barred mandatory vaccination until at least 2011. </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Vermont''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical, moral or religious grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''Virginia''' </td><td align="left" valign="top" class="p11">Bill requires girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out. </td><td align="left" valign="top" class="p11">Passed the legislature. Goes into effect Oct. 1, 2008; to be implemented in fall of 2009. </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| <tr><td valign="top" class="p11">'''West Virginia''' </td><td align="left" valign="top" class="p11">Bill would require girls entering the sixth grade to be vaccinated. Allows parents to opt their daughters out on medical grounds. </td><td align="left" valign="top" class="p11">Pending </td><td align="left" valign="top" class="p11">Yes</td></tr>
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| </table>
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| <p class="p11">''Source: National Conference of State Legislatures, state legislatures''</p>
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| ==Long-term impact==
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| {{mergeto|HPV vaccine|Talk:HPV vaccine#Merger proposal|date=August 2007}}
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| One unknown property of the vaccines now being researched is their longevity. Since the studies have been of short duration, it is unknown whether the vaccines will last just a few years or for much longer. Further study over time is required to answer this question.
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| 270,000 women died of cervical cancer worldwide in 2002.<ref>Cohen J. 2005. High Hopes and Dilemmas for a Cervical Cancer Vaccine. ''Science'', 308(5722): 618–621.</ref> Acting FDA Administrator Dr. [[Andrew von Eschenbach]] said the
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| vaccine will have "a dramatic effect" on the health of women around the world.<ref name="FDAapproval" /> The [[American Cancer Society]] estimated that 9,700 women would develop cervical cancer in the United States in 2006, and 3,700 would die.<ref>[[National Cancer Institute]] SEER [http://seer.cancer.gov/statfacts/html/cervix.html fact sheet on cervical cancer] accessed 30 Mar 2007 </ref>
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| Merck and [[CSL Limited]] are expected to market Gardasil as a cancer vaccine, rather than an [[Sexually transmitted disease|STD]] vaccine. It remains unclear how widespread the use of the three-shot series will be, in part because of its $360 list price ($120 each for three shots). Merck and CSL have also suggested that governments make vaccination with Gardasil mandatory for school attendance, which has upset some conservative groups.<ref name="FDAapproval" /><ref>[http://news.independent.co.uk/business/news/article755931.ece Moral majority take on GSK and Merck over cancer drugs], accessed June 12, 2006</ref> Many such groups also expressed fears that vaccination with Gardasil might give girls a false sense of security regarding sex and increase their level of promiscuity.<ref>{{cite news |url=http://www.speroforum.com/site/article.asp?idCategory=33&idsub=128&id=5444&t=GARDASIL+vaccine+touted+in+Michigan |title=GARDASIL vaccine touted in Michigan |last=Barillas |first=Martin |publisher=Spero News |date=2006-09-14 |accessdate=2007-01-26}}</ref><ref name="FDAapproval" /><ref>[http://news.independent.co.uk/business/news/article755931.ece Moral majority take on GSK and Merck over cancer drugs], accessed June 12, 2006</ref> There is no scientific evidence to prove this claim. Moreover, HPV is not transmitted solely through sexual contact, but may be transmitted via simple hand to hand contact.<ref>[http://www.nyjournalnews.com/apps/pbcs.dll/article?AID=/20070526/OPINION/705260315/1151 HPV vaccine: It's not about sex, it's about cancer prevention] Epstein M.D., Wendy M. Journal News. Retrieved 05/26/2007. </ref>
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| [[Health freedom movement|Health freedom organizations]] and other critics of the political power of pharmaceutical companies have vocally denounced the mandatory vaccination scheme as Merck's way of using forced drugging to pay for [[Vioxx]] lawsuits.<ref>[http://ahrp.blogspot.com/2007/02/facts-behind-mercks-mandatory-vaccine.html Alliance for Human Research Protection against mandating Gardasil]</ref>
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| Another potential issue is that it is not known whether this vaccine has any long-term adverse side effects. Although it has undergone full FDA trials, some fear that detrimental effects may not appear until years or decades after exposure. {{seealso|vaccine controversy}}
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| Both men and women are carriers of HPV. To eradicate the disease, men will eventually need to be vaccinated. Studies are being conducted now to determine the efficacy of vaccinating boys with the current vaccine. [http://women.webmd.com/news/20060608/cervical-cancer-vaccine-approved]
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| ==Indications==
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| Gardasil is a prophylactic HPV vaccine, meaning that it is designed to prevent the initial establishment of HPV infections. In worldwide clinical analyses, however, women who were already infected with one or more of the four HPV types targeted by the vaccine (6, 11, 16, or 18) were protected from clinical disease caused by the remaining HPV types in the vaccine. For maximum efficacy, it is recommended that girls receive the vaccine prior to becoming sexually active. Since Gardasil will not block infection with all of the HPV types that can cause cervical cancer, the vaccine should not be considered a substitute for routine [[Pap smear]]s. About 11,000 cases of cervical cancer are diagnosed annually in the United States, totalling around 3700 deaths. The lifetime risk of cervical cancer for women in the U.S., estimated by the [[National Cancer Institute]], is 0.73%.<ref>[[National Cancer Institute]] SEER [http://seer.cancer.gov/statfacts/html/cervix.html fact sheet on cervical cancer] accessed 30 Mar 2007.</ref>
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| Fewer HPV infections mean fewer complications from the virus and less time and money spent on the detection, work-up, and treatment of cervical cancer and its immediate precursor, cervical dysplasia. It prevents infertility caused by cervical biopsies and reduces the severe respiratory problems of children who inherit HPV from their mothers. In addition, protection against HPV6 and HPV11 also eliminates 90% of the cases of genital warts. Gardasil also may be useful in preventing [[anal cancer]] caused by HPV types 16 and 18.<ref> [http://www.aidsmap.com/en/news/3429199D-5FE5-4795-B0E6-CD957617C160.asp An HPV vaccine - what it might really mean], Edwin J. Bernard, AIDSmap, [[October 24]], 2005 (Accessed [[June 8]], 2006) </ref> A 2005 study in [[San Francisco]] found that 95 percent of [[HIV]]-infected gay men also had anal HPV infection, of which 50 percent had precancerous HPV-caused lesions.<ref> [http://www.aidsmap.com/en/news/44e54c4a-27d9-45fe-8533-a0e7c70499b8.asp HAART is not reducing risk of anal cancer in gay men], Edwin J. Bernard, AIDSmap, [[August 29]], 2005 (Accessed [[June 8]], 2006)</ref>
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| ==Criticisms==
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| {{mergeto|HPV vaccine|Talk:HPV vaccine#Merger proposal|date=August 2007}}
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| ===Australia===
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| As of [[22 May]] [[2007]], 7 [[Victoria (Australia)|Victorian]] schoolgirls from Sacred Heart Girls' College were briefly hospitalized after receiving an injection of the Gardasil vaccine and were taken to the [[Monash Medical Centre]].<ref>[http://www.smh.com.au/news/health/schoolgirls-ill-after-cervical-cancer-jabs/2007/05/22/1179601385261.html Schoolgirls ill after cervical cancer jabs] - The Sydney Morning Herald</ref><ref>[http://www.news.com.au/heraldsun/story/0,21985,21774321-662,00.html] - Herald Sun</ref> One was temporarily paralysed*. Health authorities do not believe that these are directly related to the vaccine.
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| The following is from the Sunday Morning Herald:
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| <ul>
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| "It is not uncommon for girls of this age group to react to vaccinations in ways that are not necessarily physical in origin."<br />
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| Professor Frazer said there was no reason to be concerned and it was common for young women to faint after receiving injections.
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| "It's not what's in the injection, it's the injection process itself and it's entirely avoidable just by having young girls lie down for a minute or two," he said.<br />
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| "...hospital staff told teachers at the school at the time that the girls' reactions were not related to the vaccination itself"
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| </ul>
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| ===United States===
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| According to the FDA and CDC, the vaccine has only minor side effects, such as soreness around the injection area. The FDA and CDC consider the vaccine to be completely safe. It does not contain mercury, thimerosal or live or dead virus, only [[Virus like particle|virus-like particles]], which cannot reproduce in the human body.<ref>[http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm#hpvvac1] </ref> [[Merck & Co.|Merck]], the manufacturer of Gardasil, will continue to test women who have received the vaccine to determine the vaccine's efficacy over the period of a lifetime.
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| ;Anti-vaccination groups
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| A group called the "[[National Vaccine Information Center]]" released an [http://www.medicalnewstoday.com/medicalnews.php?newsid=63586 article] on Feb 22, 2007, about Gardasil. NVIC is a non-governmental, non-profit organization "dedicated to preventing vaccine injuries and deaths through public education." The NVIC does not conduct scientific research, but is highly critical of most vaccinations, including the influenza[http://www.nvic.org/PressReleases/pr1031flu.htm], chickenpox [http://www.nvic.org/Diseases/Chickenpox.htm], tetanus [http://www.nvic.org/Diseases/tetanus.htm], and the Measles, Mumps and Rubella (MMR) vaccines[http://www.nvic.org/Diseases/mmr.htm]. The NVIC article claims "new analysis of the federal [[Vaccine Adverse Event Reporting System]] reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006." However, reports from the Vaccine Adverse Event Reporting System database are subject to interpretation as explained at the official website: "When evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established... VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine." [34] The NVIC chooses to interpret the information in VAERS to mean that "two thirds of the 385 adverse incidents which the NVIC says are related to Gardasil injections required secondary medical treatment." The FDA does not believe the vaccine causes serious health problems. The NVIC article goes on to say, "event reports to VAERS do[es] not prove causation." At this time, however, the NVIC chooses to draw a causal relationship between Gardasil and what the FDA believes are unrelated illnesses.
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| ;Socially conservative groups
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| The [[conservative]] group [[Judicial Watch]] has also interpreted records from VAERS to mean that Gardasil is responsible for 1637 "adverse effects ranging from minor to serious," and three deaths in the United States between July 2006 and May 2007.<ref>[http://www.theage.com.au/news/business/csl-navigates-adverse-reactions-to-gardasil/2007/05/24/1179601575972.html CSL navigates adverse reactions to Gardasil. The Age. May 25, 2007]</ref> An FDA spokesperson stated that these deaths are not related to the vaccine, and occurred independently of vaccination.<ref>http://www.fda.gov/medwatch/articles/vaers/vaersce.pdf</ref>
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| ===Canada===
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| A recent opinion article by Abby Lippman PhD, Ryan Melnychuk PhD, Carolyn Shimmin BJ, and Madeline Boscoe RN DU published in the ''Canadian Medical Association Journal'' on August 1, 2007 argues that there remain a number of unanswered questions about the HPV vaccine, and that a universal vaccination program in Canada "is premature and could have unintended negative consequences." They also said "we must be certain that spending an estimated $2 billion to vaccinate a population of girls and women in Canada who are already mostly well protected by their own immune systems, safer sex practices and existing screening programs will not perpetuate the existing gaps in care and leave the actual rate of deaths from cervical cancer unchanged."
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| <ref>[http://www.cmaj.ca/cgi/rapidpdf/cmaj.070944v1 Canadian Medical Association Journal August 1, 2007]</ref>
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| ==References==
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| {{reflist|2}}
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| <br />
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| ==External links==
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| *[http://blog.vaccineethics.org/labels/Gardasil.html News and commentary on Gardasil from the Ethics of Vaccines project at the University of Pennsylvania Center for Bioethics]
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| *[http://www.rochester.edu/pr/Review/V68N3/feature1.html A Cancer Vaccine is Born] (press release from [[University of Rochester]]) *[http://www.gardasil.com/ Gardasil web site]
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| *[http://www.aar.com.au/pubs/bt/21feb06/bio07.htm AAR.com.au]
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| *[http://www.nlm.nih.gov/medlineplus/hpv.html MedlinePlus on HPV]
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| *[http://www.cdc.gov/std/hpv CDC STD Human Papillomavirus (HPV) Infection]
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| *[http://www.igardasil.com/ iGardasil.com] ("informational" website)
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| *[http://www.nytimes.com/2006/06/30/health/30vaccine.html?ex=1309320000&en=73611cb06d9b311d&ei=5090 Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up] Gardiner Harris, 30 June 2006, ''[[The New York Times]]''
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| *[http://cervicalcancer.healthdiaries.com The Cervical Cancer Blog]
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| *[http://www.overturnrp65.com Blog Documenting Efforts to Overturn TX Gardasil Mandate]
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| *[http://www.fda.gov/cber/products/hpvmer060806.htm FDA Product Approval Information - Licensing Action]
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| *[http://www.fda.gov/cber/label/hpvmer013007LB.pdf Data on clinical trials]
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| *[http://www.cdc.gov/nip/ACIP/minutes/acip-min-jun06.txt Advisory Committee on Immunization Practices Minutes]
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| *[http://www.indypendent.org/?p=750 HPV and You: Girls learn about HPV from the commercials, not the classroom - The Indypendent, Myra Hellerstein and Amanda Thieroff]
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| {{Vaccines}}
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| [[Category:Vaccines]]
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