Gardasil: Difference between revisions

{{Short description|Human papillomavirus vaccine}}

{{See also| HPV vaccines}}

{{Use dmy dates|date=March 2022}}

{{cs1 config |name-list-style=vanc |display-authors=6}}

{{Infobox drug

| Verifiedfields = changed

| verifiedrevid = 448706716

| drug_name =

| type = vaccine

| width =

| alt =

| caption = Gardasil quadrivalent HPV [types 6, 11, 16, 18]

<!-- Vacine data -->

| target = For Gardasil 9: Human papillomavirus, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

| vaccine_type = protein

<!-- Clinical data -->

| pronounce =

| tradename = Gardasil, Gardisil, Silgard, others

| DailyMedID = Gardasil

| pregnancy_AU = B2

| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{cite web | title=Human papillomavirus vaccine Use During Pregnancy | website=Drugs.com | date=11 February 2019 | url=https://www.drugs.com/pregnancy/human-papillomavirus-vaccine.html | access-date=3 April 2020 | archive-date=5 April 2020 | archive-url=https://web.archive.org/web/20200405152555/https://www.drugs.com/pregnancy/human-papillomavirus-vaccine.html | url-status=live }}</ref>

| pregnancy_category=

| routes_of_administration = [[Intramuscular]] injection

| ATC_supplemental = {{ATC|J07|BM03}}

<!-- Legal status -->

| legal_AU = S4

| legal_AU_comment = <ref>{{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2015 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 | access-date=10 April 2023}}</ref>

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| legal_BR_comment =

| legal_CA = Rx-only

| legal_CA_comment = <ref>{{cite web | title=Health Canada New Drug Authorizations: 2015 Highlights | website=[[Health Canada]] | date=4 May 2016 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2015-highlights.html | access-date=7 April 2024}}</ref>

| legal_DE = <!-- Anlage I, II, III or Unscheduled -->

| legal_DE_comment =

| legal_NZ = <!-- Class A, B, C -->

| legal_NZ_comment =

| legal_UK = POM

| legal_UK_comment = <ref name="Gardasil 9 SmPC" />

| legal_US = Rx-only

| legal_US_comment = <ref name="Gardasil FDA label">{{cite web | title=Gardasil- human papillomavirus quadrivalent- types 6, 11, 16, and 18 vaccine, recombinant injection, suspension | website=DailyMed | date=2 December 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30952400-0572-4431-9150-3a41affffb9a | access-date=31 March 2022 | archive-date=21 April 2022 | archive-url=https://web.archive.org/web/20220421112820/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30952400-0572-4431-9150-3a41affffb9a | url-status=live }}</ref><ref name="Gardasil 9 FDA label">{{cite web | title=Gardasil 9- human papillomavirus 9-valent vaccine, recombinant injection, suspension | website=DailyMed | date=20 August 2021 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a21f4f4b-b891-4f25-b747-cb9ec7d865d6 | access-date=31 March 2022 | archive-date=5 April 2020 | archive-url=https://web.archive.org/web/20200405152553/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a21f4f4b-b891-4f25-b747-cb9ec7d865d6 | url-status=live }}</ref>

| legal_EU = Rx-only

| legal_EU_comment = <ref name="Silgard EPAR" /><ref name="Gardasil 9 EPAR" /><ref name="Gardasil EPAR" />

| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->

| legal_UN_comment =

| legal_status = Rx-only

<!-- Identifiers -->

| CAS_number =

| CAS_supplemental =

| PubChem =

| IUPHAR_ligand =

| DrugBank = DB10299

| DrugBank2 = DB10300

| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}

| ChemSpiderID = none

| UNII = 61746O90DY

| UNII2 = Z845VHQ61P

| KEGG = D10192

| ChEBI =

| ChEMBL =

| NIAID_ChemDB =

| PDB_ligand =

| synonyms =

'''Gardasil''' is an [[HPV vaccine]] for use in the prevention of certain [[strain (biology)|strains]] of [[human papillomavirus]] (HPV).<ref name=silgard>{{cite web | url = https://www.emea.europa.eu/humandocs/Humans/EPAR/silgard/silgard.htm | title = Silgard European Public Assessment Report | publisher = [[European Medicines Agency]] | date = 25 September 2009 | access-date = 5 December 2009 | url-status = dead | archive-url = https://web.archive.org/web/20081225130419/https://www.emea.europa.eu/humandocs/Humans/EPAR/silgard/silgard.htm | archive-date = 25 December 2008 }}</ref><ref name="Silgard EPAR">{{cite web | title=Silgard EPAR | date=17 September 2018 | publisher=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/silgard | access-date=3 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406090611/https://www.ema.europa.eu/en/medicines/human/EPAR/silgard | url-status=live }}</ref><ref name="Gardasil 9 EPAR">{{cite web | title=Gardasil 9 EPAR | date=17 September 2018 | publisher=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil-9 | access-date=3 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406090607/https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil-9 | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="Gardasil EPAR">{{cite web | title=Gardasil EPAR | date=17 September 2018 | publisher=European Medicines Agency | url=https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil | access-date=6 July 2022 | archive-date=11 June 2022 | archive-url=https://web.archive.org/web/20220611072549/https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil | url-status=live }}</ref><ref>{{cite web| vauthors = Waknine Y |url=https://www.medscape.com/viewarticle/545374|title=International Approvals: Singulair and Gardasil/Silgard|date=2 October 2006|work=Medscape Today|access-date=18 December 2008|url-status=live|archive-url=https://web.archive.org/web/20130520232942/https://www.medscape.com/viewarticle/545374|archive-date=20 May 2013}}</ref> It was developed by [[Merck & Co.]]<ref>{{cite news | url = https://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUSN2052127820090820 | title = U.S. health officials back safety of Merck vaccine | work = Reuters | date = 20 August 2009 | access-date = 12 November 2009 | vauthors = Richwine L | url-status = live | archive-url = https://web.archive.org/web/20090827011806/https://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20%26%20Specialty/idUSN2052127820090820 | archive-date = 27 August 2009 }}</ref> High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women.<ref>{{cite journal | vauthors = Gizzo S, Noventa M, Nardelli GB | title = Gardasil administration to hr-HPV-positive women and their partners | journal = Trends in Pharmacological Sciences | volume = 34 | issue = 9 | pages = 479–80 | date = September 2013 | pmid = 23896431 | doi = 10.1016/j.tips.2013.07.001 }}</ref> The HPV strains that Gardasil protects against are sexually transmitted,<ref name="CDCHPVFacts">{{cite web |title=Genital HPV Infection - Fact Sheet |url=https://www.cdc.gov/std/hpv/stdfact-hpv.htm |website=www.cdc.gov |publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) |access-date=18 April 2020 |archive-date=11 September 2012 |archive-url=https://web.archive.org/web/20120911095019/http://www.cdc.gov/STD/HPV/STDFact-HPV.htm |url-status=live }}</ref> specifically HPV types 6, 11, 16 and 18.<ref name=pmid_17380109>{{cite journal | vauthors = Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER | title = Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) | journal = MMWR. Recommendations and Reports | volume = 56 | issue = RR-2 | pages = 1–24 | date = March 2007 | pmid = 17380109 | url = https://www.cdc.gov/mmwr/pdf/rr/rr5602.pdf | url-status = live | collaboration = Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control Prevention (CDC) | archive-url = https://web.archive.org/web/20150924044909/https://www.cdc.gov/mmwr/pdf/rr/rr5602.pdf | archive-date = 24 September 2015 }}</ref><ref name=pmid_20508594>{{cite journal | title = FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP) | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 59 | issue = 20 | pages = 630–2 | date = May 2010 | pmid = 20508594 | url = https://www.cdc.gov/mmwr/pdf/wk/mm5920.pdf | url-status = live | archive-url = https://web.archive.org/web/20150924044945/https://www.cdc.gov/mmwr/pdf/wk/mm5920.pdf | archive-date = 24 September 2015 | author1 = Centers for Disease Control Prevention (CDC) }}</ref> HPV types 16 and 18 cause an estimated 70% of [[cervical cancer]]s,<ref name="pmid16670757">{{cite journal | vauthors = Lowy DR, Schiller JT | title = Prophylactic human papillomavirus vaccines | journal = The Journal of Clinical Investigation | volume = 116 | issue = 5 | pages = 1167–73 | date = May 2006 | pmid = 16670757 | pmc = 1451224 | doi = 10.1172/JCI28607 | doi-access = free }}</ref><ref name="Muñoz2004">{{cite journal | vauthors = Muñoz N, Bosch FX, Castellsagué X, Díaz M, de Sanjose S, Hammouda D, Shah KV, Meijer CJ | title = Against which human papillomavirus types shall we vaccinate and screen? The international perspective | journal = International Journal of Cancer | volume = 111 | issue = 2 | pages = 278–85 | date = August 2004 | pmid = 15197783 | doi = 10.1002/ijc.20244 | doi-access = free }}</ref> and are responsible for most HPV-induced [[anal cancer|anal]],<ref name="Gao2016">{{cite journal | vauthors = Gao G, Smith DI | title = Human Papillomavirus and the Development of Different Cancers | journal = Cytogenetic and Genome Research | volume = 150 | issue = 3–4 | pages = 185–193 | date = 2016 | pmid = 28245440 | doi = 10.1159/000458166 | url = https://www.karger.com/Article/FullText/458166 | doi-access = free | access-date = 19 April 2020 | archive-date = 17 July 2020 | archive-url = https://web.archive.org/web/20200717070359/https://www.karger.com/Article/FullText/458166 | url-status = live }}</ref> [[vulvar cancer|vulvar]], [[vaginal cancer|vaginal]],<ref name=VulvarCA /> and [[penile cancer|penile]] cancer cases.<ref name="Gao2016"/> HPV types 6 and 11 cause an estimated 90% of [[genital wart]]s cases.<ref name=WHO2017>{{cite journal | title = Human papillomavirus vaccines: WHO position paper, May 2017 | journal = Weekly Epidemiological Record | volume = 92 | issue = 19 | pages = 241–268 | date = May 2017 | pmid = 28530369 | hdl = 10665/255353 }}</ref> HPV type 16 is responsible for almost 90% of [[HPV-positive oropharyngeal cancer|HPV-positive]] [[oropharyngeal cancer]]s,<ref name="Anjum-Zohaib 2020">{{cite book | vauthors = Anjum F, Zohaib J |title=Definitions |chapter=Oropharyngeal Squamous Cell Carcinoma |date=4 December 2020 |chapter-url=https://www.ncbi.nlm.nih.gov/books/NBK563268/ |work=StatPearls |place=Treasure Island (FL) |publisher=StatPearls Publishing |edition=Updated |id=Bookshelf ID: NBK563268 |doi=10.32388/G6TG1L |pmid=33085415 |s2cid=229252540 |via=[[NCBI]] |access-date=7 February 2021 |archive-date=11 June 2021 |archive-url=https://web.archive.org/web/20210611150638/https://www.ncbi.nlm.nih.gov/books/NBK563268/ |url-status=live }}</ref> and the [[Gardasil#Males|prevalence is higher in males]] than females.<ref name="Anjum-Zohaib 2020"/> Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease.<ref name="NCIHPVVaccines">{{cite web |title=Human Papillomavirus (HPV) Vaccines |url=https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet#should-hpv-vaccines-be-given-to-women-who-are-already-infected-with-hpv-or-have-cervical-cell-changes |website=National Cancer Institute |access-date=18 April 2020 |archive-date=21 June 2008 |archive-url=https://web.archive.org/web/20080621065557/http://www.cancer.gov/cancertopics/factsheet/risk/HPV-vaccine#should-hpv-vaccines-be-given-to-women-who-are-already-infected-with-hpv-or-have-cervical-cell-changes |url-status=live }}</ref>

The vaccine was approved for medical use in the United States in 2006,<ref>{{cite web | title=Gardasil | publisher=U.S. [[Food and Drug Administration]] | date=15 June 2017 | archive-date=22 July 2017 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm | archive-url=https://wayback.archive-it.org/7993/20170722021013/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm | url-status=dead | access-date=3 April 2020 }}</ref><ref>{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm |title=FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus |publisher=U.S. [[Food and Drug Administration]] (FDA) |date=8 June 2006 |access-date=13 November 2009 |url-status=dead |archive-url=https://web.archive.org/web/20091019080918/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm |archive-date=19 October 2009 }} {{PD-notice}}</ref> initially for use in females aged 9–26.<ref>{{cite journal |date=April 2018 |title=Gardasil |url=https://academic.eb.com/levels/collegiate/article/Gardasil/471521 |journal=Britannica Academic |url-access=subscription |access-date=7 May 2019 |archive-date=13 April 2020 |archive-url=https://web.archive.org/web/20200413165303/https://academic.eb.com/?target=%2Flevels%2Fcollegiate%2Farticle%2FGardasil%2F471521 |url-status=live }}</ref> In 2007, the [[Advisory Committee on Immunization Practices]] recommended Gardasil for routine vaccination of girls aged 11 and 12 years.<ref>{{cite journal | vauthors = Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, Broder K | title = Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013 | journal = Vaccine | volume = 33 | issue = 4 | pages = 519–22 | date = January 2015 | pmid = 25500173 | pmc = 6524774 | doi = 10.1016/j.vaccine.2014.11.047 | url = https://journals.scholarsportal.info/details/0264410x/v33i0004/519_soqhpvvaers2.xml | access-date = 7 May 2019 | archive-date = 13 April 2020 | archive-url = https://web.archive.org/web/20200413190213/https://journals.scholarsportal.info/details/0264410x/v33i0004/519_soqhpvvaers2.xml | url-status = live }}</ref> As of August 2009, vaccination was recommended for both males and females before adolescence and the beginning of potential sexual activity.<ref name="pmid_17380109" /><ref name="Gardasil 9 FDA label" /><ref name="FDAgardasil">{{cite web | url=https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/gardasil-vaccine-safety | title=Gardasil Vaccine Safety | date=20 August 2009 | publisher=U.S. [[Food and Drug Administration]] (FDA) | access-date=21 October 2019 | url-status=live | archive-url=https://web.archive.org/web/20190503215341/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/gardasil-vaccine-safety | archive-date=3 May 2019 }}</ref> By 2011, the vaccine had been approved in 120 other countries.<ref>{{cite journal | vauthors = Haupt RM, Sings HL | title = The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil | journal = The Journal of Adolescent Health | volume = 49 | issue = 5 | pages = 467–75 | date = November 2011 | pmid = 22018560 | doi = 10.1016/j.jadohealth.2011.07.003 }}</ref>

In 2014, the US [[Food and Drug Administration]] (FDA) approved a nine-valent version, Gardasil 9, to protect against infection with the strains covered by the first generation of Gardasil as well as five other HPV strains responsible for 20% of cervical cancers (types 31, 33, 45, 52, and 58).<ref name="Gardasil 9 FDA label" /><ref>{{cite web |title=Gardasil 9 |work=U.S. [[Food and Drug Administration]] (FDA) | archive-date=23 April 2019 |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9 |date=10 October 2018 | archive-url=https://wayback.archive-it.org/7993/20190423063914/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm426445.htm | access-date=3 April 2020 |url-status=live }}</ref><ref name=Gardasil9>{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm|type=press release|title=FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV|date=10 December 2014|publisher=U.S. [[Food and Drug Administration]] (FDA)|access-date=28 February 2015|url-status=dead|archive-url=https://web.archive.org/web/20150110233107/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm|archive-date=10 January 2015}} {{PD-notice}}</ref> In 2018, the FDA approved expanded use of Gardasil 9 for individuals 27 to 45 years old.<ref name="FDA 27-45" />

==Types==

Gardasil is available as Gardasil which protects against 4 types of HPV (6, 11, 16, 18) and Gardasil 9 which protects against an additional 5 types (31, 33, 45, 52, 58).<ref name="Gardasil FDA label" /><ref name="Gardasil 9 FDA label" /><ref name="Gardasil 9 EPAR" /><ref name="Gardasil EPAR" /><ref name=BNF82>{{cite book | title=British National Formulary (BNF)|date=September 2021 - March 2022|publisher=BMJ Group and the Pharmaceutical Press|location=London|isbn=978-0-85711-413-6|edition=82|pages=1362–1390|chapter=14. Vaccines}}</ref>

==Medical uses==

{{See also|HPV vaccine#Prevalence of genital HPV}}

{{Cleanup|section|reason=that there is need for expert review to fill content gaps, add missing refs, make it read smoothly. |date=December 2019}}

In the United States, Gardasil is indicated for:<ref name="FDA Gardasil 9">{{cite web | title=Gardasil 9 | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=12 June 2020 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9 | access-date=15 June 2020 | archive-date=15 October 2019 | archive-url=https://web.archive.org/web/20191015075027/https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9 | url-status=live }} {{PD-notice}}</ref>

* girls and women 9 through 45 years of age for the prevention of the following diseases:<ref name="FDA Gardasil 9" />

** Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58.<ref name="FDA Gardasil 9" />

** Genital warts (condyloma acuminata) caused by HPV types 6 and 11.<ref name="FDA Gardasil 9" />

* girls and women 9 through 45 years of age for the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:<ref name="FDA Gardasil 9" />

** Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS).<ref name="FDA Gardasil 9" />

** Cervical intraepithelial neoplasia (CIN) grade 1.<ref name="FDA Gardasil 9" />

** Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.<ref name="FDA Gardasil 9" />

** Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.<ref name="FDA Gardasil 9" />

** Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.<ref name="FDA Gardasil 9" />

* boys and men 9 through 45 years of age for the prevention of the following diseases:<ref name="FDA Gardasil 9" />

** Anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.<ref name="FDA Gardasil 9" />

** Genital warts (condyloma acuminata) caused by HPV types 6 and 11.<ref name="FDA Gardasil 9" />

* boys and men 9 through 45 years of age for the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:<ref name="FDA Gardasil 9" />

** Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.<ref name="FDA Gardasil 9" />

In the European Union, Gardasil is indicated for active immunization of individuals from the age of nine years against the following HPV diseases:<ref name="Gardasil 9 EPAR" />

* Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types<ref name="Gardasil 9 EPAR" />

* Genital warts (Condyloma acuminata) caused by specific HPV types.<ref name="Gardasil 9 EPAR" />

Gardasil is a vaccine to prevent HPV, that, for maximum effect, is recommended for individuals prior to their becoming sexually active.<ref name="NCIHPVVaccines" /> Moreover, evidence supports the conclusion that women who were already infected with one or more of the four HPV types targeted by the vaccine (HPV types 6, 11, 16, or 18) were protected from clinical disease caused by the remaining HPV types in the vaccine.<ref name="NCIHPVVaccines"/>{{failed verification|date=October 2020}} HPV types 16 and 18 cause an estimated 70% of [[cervical cancer]]s,<ref name="pmid16670757"/><ref name="Muñoz2004"/> and are responsible for most HPV-induced [[anal cancer|anal]] cancers.<ref name="Gao2016"/> Gardasil also protects against [[vulvar cancer|vulvar]] and [[vaginal cancer]]s caused by HPV types 16 and 18,<ref name=VulvarCA>{{cite press release | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm | title = FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers | access-date = 11 November 2009 | date = 12 September 2008 | publisher = U.S. [[Food and Drug Administration]] (FDA) | url-status = dead | archive-url = https://web.archive.org/web/20100306073734/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm | archive-date = 6 March 2010 }} {{PD-notice}}</ref> as well as most [[penile cancer]]s caused by these two HPV types.<ref name="Wang2013">{{cite journal | vauthors = Wang JW, Roden RB | title = Virus-like particles for the prevention of human papillomavirus-associated malignancies | journal = Expert Review of Vaccines | volume = 12 | issue = 2 | pages = 129–41 | date = February 2013 | pmid = 23414405 | pmc = 3835148 | doi = 10.1586/erv.12.151 }}</ref>

In addition, protection against HPV types 6 and 11 may eliminate up to 90% of the cases of [[genital wart]]s.<ref name=WHO2017 /> Common [[plantar wart]]s—e.g., caused by HPV types 1, 2, and 4<ref>{{cite web |url=https://virus.stanford.edu/papova/HPV.html |title=Humanitas Papiloma Virus |access-date=26 February 2018 |url-status=live |archive-url=https://web.archive.org/web/20170228135643/http://virus.stanford.edu/papova/HPV.html |archive-date=28 February 2017 }}</ref>—are not prevented by this vaccine.

In 2010, Gardasil was approved by the FDA for prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people aged 9 through 26 years.<ref>{{cite press release | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237941.htm | title = FDA: Gardasil approved to prevent anal cancer | publisher = U.S. [[Food and Drug Administration]] (FDA) | date = 22 December 2010 | access-date = 4 January 2011 | url-status = dead | archive-url = https://web.archive.org/web/20141218134237/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237941.htm | archive-date = 18 December 2014 }} {{PD-notice}}</ref>

HPV infections, especially HPV 16, contribute to some [[head and neck cancer]] (HPV is found in an estimated 26–35% of head and neck squamous cell carcinoma).<ref name="doi:10.1186/1758-3284-1-36">{{cite journal | vauthors = Goon PK, Stanley MA, Ebmeyer J, Steinsträsser L, Upile T, Jerjes W, Bernal-Sprekelsen M, Görner M, Sudhoff HH | title = HPV & head and neck cancer: a descriptive update | journal = Head & Neck Oncology | volume = 1 | issue = 1 | pages = 36 | date = October 2009 | pmid = 19828033 | pmc = 2770444 | doi = 10.1186/1758-3284-1-36 | doi-access = free }}</ref><ref>{{cite book | vauthors = Vousden KH |title=Cell transformation by human papillomaviruses|work=Viruses and Cancer|year=1994|publisher=Press Syndicate of the University of Cambridge|location=New York|isbn=9780521454728|pages=27–46}}</ref> In principle, HPV vaccines may help reduce incidence of such cancers caused by HPV, but this has not been demonstrated.<ref name="TimeThroatCA">{{cite magazine| url = http://content.time.com/time/health/article/0,8599,1619814,00.html | vauthors = Masters C | title = Oral Sex Can Add to HPV Cancer Risk| magazine = [[Time (magazine)|Time]]| date = 11 May 2007| url-status = live| archive-url = https://web.archive.org/web/20200404062413/http://content.time.com/time/health/article/0,8599,1619814,00.html | archive-date = 4 April 2020 }}</ref>{{update inline|date=August 2019}} In June 2020, the FDA approved the use of Gardasil for the prevention of head and neck cancers.<ref>{{cite press release | title=FDA Approves Merck's Gardasil 9 for the Prevention of Certain HPV-Related Head and Neck Cancers | website=Merck | date=12 June 2020 | url=https://www.merck.com/news/fda-approves-mercks-gardasil-9-for-the-prevention-of-certain-hpv-related-head-and-neck-cancers/ | access-date=15 June 2020 | archive-date=30 May 2021 | archive-url=https://web.archive.org/web/20210530172015/https://www.merck.com/news/fda-approves-mercks-gardasil-9-for-the-prevention-of-certain-hpv-related-head-and-neck-cancers/ | url-status=live }}</ref><ref>{{cite web | title=Gardasil Supplement Accelerated Approval | url=https://www.fda.gov/media/138949/download | format=PDF | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=12 June 2020 | access-date=15 June 2020 | archive-date=16 June 2020 | archive-url=https://web.archive.org/web/20200616051240/https://www.fda.gov/media/138949/download | url-status=live }}</ref>

The FDA approved Gardasil 9 for women and men aged 27 to 45 based on the vaccine being 88% effective against persistent HPV infections that cause certain types genital warts and cancers in females. Vaccine efficacy in males in this age group was inferred.<ref name="FDA 27-45">{{cite press release | title=FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=5 October 2018 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-gardasil-9-include-individuals-27-through-45-years-old | archive-url=https://web.archive.org/web/20191014194303/https://www.fda.gov/news-events/press-announcements/fda-approves-expanded-use-gardasil-9-include-individuals-27-through-45-years-old | archive-date=14 October 2019 | url-status=live | access-date=14 October 2018}}</ref>

===Efficacy===

A 2020 longitudinal study tracking over 1.6 million Swedish girls and women over an eleven-year period found half as many cervical cancer cases in all women who had been vaccinated, and amongst women who had been vaccinated before the age of 17 a 78% reduction in cervical cancer, "a substantially reduced risk of invasive cervical cancer at the population level."<ref>{{cite journal | vauthors = Lei J, Ploner A, Elfström KM, Wang J, Roth A, Fang F, Sundström K, Dillner J, Sparén P | title = HPV Vaccination and the Risk of Invasive Cervical Cancer | journal = The New England Journal of Medicine | volume = 383 | issue = 14 | pages = 1340–1348 | date = October 2020 | pmid = 32997908 | doi = 10.1056/NEJMoa1917338 | doi-access = free }}</ref>

An alternative vaccine known as [[Cervarix]] protects against two oncogenic strains of HPV, 16 and 18.<ref name=pmid_20508593>{{cite journal | author = Centers for Disease Control Prevention | title = FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP) | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 59 | issue = 20 | pages = 626–9 | date = May 2010 | pmid = 20508593 | url = https://www.cdc.gov/mmwr/pdf/wk/mm5920.pdf | access-date = 9 September 2017 | archive-date = 24 September 2015 | archive-url = https://web.archive.org/web/20150924044945/http://www.cdc.gov/mmwr/pdf/wk/mm5920.pdf | url-status = live }}</ref>

The [[National Cancer Institute]] says, "To date, protection against the targeted HPV types has been found to last for at least 10 years with Gardasil, at least 9 years with Cervarix, and at least 6 years with Gardasil 9. Long-term studies of vaccine efficacy that are still in progress will help scientists better understand the total duration of protection."<ref name="National Cancer Institute HPV Q&A" />

Gardasil has been shown to be partially effective (approximately 38%) in preventing cervical cancer caused by ten other high-risk HPV types.<ref>{{cite journal | vauthors = Schieszer J | url=https://www.mdmag.com/journals/internal-medicine-world-report/2007/2007-11/2007-11_24 | title=HPV Vaccine Protects Against 10 "Other" Strains | journal=Internal Medicine World Report | date=November 2007 | url-status=live | archive-url=https://web.archive.org/web/20081204084852/http://www.imwr.com/issues/articles/2007-11_24.asp | archive-date=4 December 2008 }}</ref>

Antibody levels at month 3 (one month post-dose number two) are substantially higher than at month 24 (18 months post-dose number three), suggesting that protection is achieved by month 3 and perhaps earlier.<ref name="Gardasil 9 FDA label" /> In 2014, the [[World Health Organization]] (WHO) recommended that countries offer the vaccine in a two dose schedule to girls aged under 15, with each dose at least six months apart.<ref name=WHO2017 /><ref>{{cite web | author = World Health Organization | title = Summary of the SAGE April 2014 meeting | date = April 2014 | url = https://www.who.int/immunization/sage/meetings/2014/april/report_summary_april_2014/en/ | access-date = 2 June 2015 | url-status = dead | archive-url = https://web.archive.org/web/20150731031733/https://www.who.int/immunization/sage/meetings/2014/april/report_summary_april_2014/en/ | archive-date = 31 July 2015 }}</ref> The United Kingdom, [[Switzerland]], Mexico, and [[Quebec]] province of Canada are among the countries or territories that have implemented this {{as of|June 2015|lc=yes}}. The CDC recommended the vaccines be delivered in two shots over six months.<ref>{{cite press release|url=https://www.cdc.gov/media/releases/2016/p1020-hpv-shots.html|title=CDC recommends only two HPV shots for younger adolescents|publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) |access-date=7 October 2017|url-status=live|archive-url=https://web.archive.org/web/20170323234605/https://www.cdc.gov/media/releases/2016/p1020-hpv-shots.html|archive-date=23 March 2017|date=19 October 2016}}</ref>

===Males===

Gardasil is also effective in males, providing protection against genital warts, anal warts, [[anal cancer]], and some potentially [[precancerous|precancerous lesions]] caused by some HPV types.<ref name=pmid_20508594/><ref name="pmid21288094">{{cite journal | vauthors = Giuliano AR, Palefsky JM, Goldstone S, Moreira ED, Penny ME, Aranda C, Vardas E, Moi H, Jessen H, Hillman R, Chang YH, Ferris D, Rouleau D, Bryan J, Marshall JB, Vuocolo S, Barr E, Radley D, Haupt RM, Guris D | title = Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males | journal = The New England Journal of Medicine | volume = 364 | issue = 5 | pages = 401–11 | date = February 2011 | pmid = 21288094 | pmc = 3495065 | doi = 10.1056/NEJMoa0909537| doi-access = free }}</ref><ref>{{cite web | vauthors = Carter M |title=Gardasil safe and effective in young men |url=https://www.aidsmap.com/news/feb-2011/gardasil-safe-and-effective-young-men |website=aidsmap.com |publisher=NAM aidsmap |language=en |date=7 February 2011 |access-date=24 January 2022 |archive-date=24 January 2022 |archive-url=https://web.archive.org/web/20220124211600/https://www.aidsmap.com/news/feb-2011/gardasil-safe-and-effective-young-men |url-status=live }}</ref> Gardasil vaccine has been shown to decrease the risk of young men contracting genital warts.<ref name=Gaymenvacc>{{cite web | url = http://info.cancerresearchuk.org/news/archive/cancernews/2007-02-23-gay-men-seeking-hpv-vaccine | title = Gay men seeking HPV vaccine | work = [[Cancer Research UK]] | date = 23 February 2007 | access-date = 12 November 2009 | url-status = dead | archive-url = https://web.archive.org/web/20100324231910/http://info.cancerresearchuk.org/news/archive/cancernews/2007-02-23-gay-men-seeking-hpv-vaccine | archive-date = 24 March 2010 }}</ref> In the United States, the FDA approved administration of the Gardasil vaccine to males between ages 9 and 26 in 2009.<ref>{{cite press release | url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm | title=FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=16 October 2009 | access-date=12 November 2009 | url-status=dead | archive-url=https://web.archive.org/web/20091024164856/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm | archive-date=24 October 2009 }} {{PD-notice}}</ref><ref>{{cite web | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186991.htm | title=October 16, 2009 Approval Letter – Gardasil | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=16 October 2009 | access-date=12 November 2009 | url-status=dead | archive-url=https://web.archive.org/web/20091024081639/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm186991.htm | archive-date=24 October 2009 }}</ref> The FDA approved administration of the Gardasil 9 vaccine to males between ages 9 and 15 in 2014, and extended the age indication, by including males between ages 16 and 26, in 2015.<ref>{{cite web | url=https://www.cdc.gov/hpv/downloads/9vhpv-fda.pdf | title=FDA licensure of 9-valent human papillomavirus vaccine to include males aged 16–26 years | publisher=[[Centers for Disease Control and Prevention|U.S. Centers for Disease Control and Prevention]] (CDC) | date=14 December 2015 | access-date=10 October 2016 | url-status=live | archive-url=https://web.archive.org/web/20170130213511/https://www.cdc.gov/hpv/downloads/9vhpv-fda.pdf | archive-date=30 January 2017 }}</ref><ref>{{cite web | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil-9-hcp-info.pdf | title=Provider Information: Gardasil 9 VIS | publisher=[[Centers for Disease Control and Prevention|U.S. Centers for Disease Control and Prevention]] (CDC) | date=December 2015 | access-date=10 October 2016 | url-status=live | archive-url=https://web.archive.org/web/20170211153114/https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil-9-hcp-info.pdf | archive-date=11 February 2017 }}</ref><ref>{{cite web | url=https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf | title=Highlights of Prescribing InformationI: Gardasil 9 | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=14 December 2015 | access-date=10 October 2016 | url-status=live | archive-url=https://web.archive.org/web/20161010062722/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf | archive-date=10 October 2016 }}</ref> In the UK, HPV vaccines are licensed for males aged 9 to 15 and for females aged 9 to 26.<ref>{{cite news | url=https://news.bbc.co.uk/1/hi/health/6342105.stm | title=Gay men seek 'female cancer' jab | work=[[BBC News Online]] | date=23 February 2007 | access-date=12 November 2009 | vauthors = Roberts M | url-status=live | archive-url=https://web.archive.org/web/20090130110634/https://news.bbc.co.uk/1/hi/health/6342105.stm | archive-date=30 January 2009 }}</ref>

[[Men who have sex with men]] (MSM) are particularly at risk for conditions associated with HPV types 6, 11, 16, and 18; diseases and cancers that have a higher incidence among MSM include anal intraepithelial neoplasias, anal cancers, and genital warts. HPV type 16 is also responsible for almost 90% of [[HPV-positive oropharyngeal cancer|HPV-positive]] [[Oropharyngeal squamous cell carcinomas|oropharyngeal squamous-cell carcinoma]] (OPSCC),<ref name="Anjum-Zohaib 2020"/> a form of cancer that affects the [[Oropharynx|mouth, tonsils, and throat]];<ref name="Anjum-Zohaib 2020"/><ref name=NEJoM>{{cite journal | vauthors = D'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, Westra WH, Gillison ML | title = Case-control study of human papillomavirus and oropharyngeal cancer | journal = The New England Journal of Medicine | volume = 356 | issue = 19 | pages = 1944–56 | date = May 2007 | pmid = 17494927 | doi = 10.1056/NEJMoa065497 | doi-access = free }}</ref> the prevalence of HPV-positive oropharyngeal cancers is higher in males than females.<ref name="Anjum-Zohaib 2020"/> A 2005 study found that 95% of [[HIV]]-infected gay men also had anal HPV infection, of whom 50% had precancerous HPV-caused lesions.<ref>{{cite web | url = http://www.aidsmap.com/en/news/44e54c4a-27d9-45fe-8533-a0e7c70499b8.asp | title = HAART is not reducing risk of anal cancer in gay men | vauthors = Bernard EJ | work = AIDSmap | date = 29 August 2005 | access-date = 8 June 2006 | url-status = dead | archive-url = https://web.archive.org/web/20060619111758/http://www.aidsmap.com/en/news/44e54c4a-27d9-45fe-8533-a0e7c70499b8.asp | archive-date = 19 June 2006 }}</ref>

Gardasil is given in three injections over six months. The second injection is two months after the first, and the third injection is six months after the first shot was administered.<ref name=pmid_17380109/><ref name="Gardasil 9 FDA label" /> Alternatively, in some countries it is given as two injections with at least six months between them, for individuals aged 9 years up to and including 13 years.<ref name="Gardasil 9 SmPC">{{cite web | title=Gardasil 9 suspension for injection - Summary of Product Characteristics (SmPC) | website=(emc) | date=24 January 2020 | url=https://www.medicines.org.uk/emc/product/7330 | access-date=3 April 2020 | archive-date=6 April 2020 | archive-url=https://web.archive.org/web/20200406051722/https://www.medicines.org.uk/emc/product/7330 | url-status=live }}</ref><ref>{{cite web | title=Gardasil suspension for injection - Summary of Product Characteristics (SmPC) | website=(emc) | date=7 May 2019 | url=https://www.medicines.org.uk/emc/product/261/ | access-date=3 April 2020 | archive-date=4 April 2020 | archive-url=https://web.archive.org/web/20200404064555/https://www.medicines.org.uk/emc/product/261/ | url-status=live }}</ref>

==Adverse effects==

{{As of|April 2014}}, more than 170&nbsp;million doses of Gardasil had been distributed worldwide.<ref name=NYTimes2014>{{cite news | vauthors = McNeil Jr DJ | author-link=Donald McNeil Jr. | title=Expansion in Use of Cancer Vaccine | website=[[The New York Times]] | date=31 March 2014 | url=https://www.nytimes.com/2014/04/01/health/an-expansion-in-use-of-cancer-vaccine.html | access-date=20 December 2019 | archive-date=6 February 2016 | archive-url=https://web.archive.org/web/20160206142351/http://www.nytimes.com/2014/04/01/health/an-expansion-in-use-of-cancer-vaccine.html | url-status=live }}</ref> The vaccine was tested in thousands of females (ages 9 to 26).<ref name=CDC:STDfactsheet>{{cite web|url=https://www.cdc.gov/std/hpv/STDFact-HPV-vaccine-young-women.htm|title=HPV Vaccine Information For Young Women|publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC)|access-date=14 June 2009|url-status=live|archive-url=https://web.archive.org/web/20090628203926/https://www.cdc.gov/std/hpv/STDFact-HPV-vaccine-young-women.htm|archive-date=28 June 2009}}</ref> The US [[Food and Drug Administration]] (FDA) and the US [[Centers for Disease Control and Prevention]] (CDC) consider the vaccine to be safe. It does not contain [[mercury (element)|mercury]], [[thiomersal]], live viruses or dead viruses, but virus-like particles, which cannot reproduce in the human body.<ref name=CDC:STDfactsheet />

The vaccine has mostly minor side effects, such as pain around the injection area.<ref name=CDC:STDfactsheet /> Fainting is more common among adolescents receiving the Gardasil vaccine than in other kinds of vaccinations. Patients should remain seated for 15 minutes after they receive the HPV vaccine.<ref name="Gardasil 9 FDA label" /> There have been reports that the shot is more painful than other common vaccines, and the manufacturer [[Merck & Co.|Merck]] partly attributes this to the virus-like particles within the vaccine.<ref>{{cite news| url = https://abcnews.go.com/Health/PainManagement/story?id=4082103| title = Cervical cancer shots are gaining reputation as painful| vauthors = Stobbe M | work = [[ABC News]]| agency = [[Associated Press]]| date = 9 February 2009| access-date = 4 April 2020| archive-date = 12 November 2020| archive-url = https://web.archive.org/web/20201112040823/https://abcnews.go.com/Health/PainManagement/story?id=4082103| url-status = live}}</ref> General side effects of the shot may include joint and muscle pain, fatigue, physical weakness and general malaise.<ref name="Gardasil 9 FDA label" /><ref>{{cite news| url = https://www.washingtontimes.com/news/2008/jul/10/merck-fda-expand-gardasil-warnings| title = Merck, FDA expand Gardasil warnings| vauthors = Fagan A | work = [[The Washington Times]]| date = 10 July 2008| url-status = live| archive-url = https://web.archive.org/web/20080717080917/https://www.washingtontimes.com/news/2008/jul/10/merck-fda-expand-gardasil-warnings/| archive-date = 17 July 2008 }}</ref>

The FDA and the CDC said that with millions of vaccinations "by chance alone some serious adverse effects and deaths" will occur in the time period following vaccination, but they have nothing to do with the vaccine.<ref name=NYTIMES0808>{{cite news | vauthors = Rosenthal E |work=[[The New York Times]] |date=19 August 2008 |url=https://www.nytimes.com/2008/08/20/health/policy/20vaccine.html |title=Drug Makers' Push Leads to Cancer Vaccines' Fast Rise |access-date=20 August 2008 |url-status=live |archive-url=https://web.archive.org/web/20090409005806/https://www.nytimes.com/2008/08/20/health/policy/20vaccine.html |archive-date=9 April 2009 }}</ref> More than twenty women who received the Gardasil vaccine have died, but these deaths have not been causally connected to the shot, as [[correlation does not imply causation]].<ref name=NYTIMES0808 /> Where information has been available, the cause of death was explained by other factors.<ref name=GARDASIL-SAFETY-FDA>{{cite web| url = https://www.cdc.gov/vaccinesafety/Vaccines/HPV/HPVArchived.html| title = Information from FDA and CDC on Gardasil and its Safety (Archived)| publisher = U.S. [[Centers for Disease Control and Prevention]] (CDC)| date = 22 July 2008| url-status = dead| archive-url = https://web.archive.org/web/20130902055251/https://www.cdc.gov/vaccinesafety/Vaccines/HPV/HPVArchived.html| archive-date = 2 September 2013| access-date = 9 September 2017}}</ref><ref name=Health_Concerns>{{cite web| url = https://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html| title = Reports of Health Concerns Following HPV Vaccination| publisher = U.S. [[Centers for Disease Control and Prevention]] (CDC)| date = 26 October 2010| url-status = live| archive-url = https://web.archive.org/web/20130917105741/https://www.cdc.gov/vaccinesafety/Vaccines/HPV/gardasil.html| archive-date = 17 September 2013}}</ref> Likewise, a small number of cases of [[Guillain–Barré syndrome]] (GBS) have been reported following vaccination with Gardasil, though there is no evidence linking GBS to the vaccine.<ref name="FDAgardasil" /><ref name=pmid_19690307>{{cite journal | vauthors = Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J | title = Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine | journal = JAMA | volume = 302 | issue = 7 | pages = 750–7 | date = August 2009 | pmid = 19690307 | doi = 10.1001/jama.2009.1201 | doi-access = }}</ref><ref name=HPV-VacQandA>{{cite web| url=https://www.cdc.gov/vaccines/vpd-vac/hpv/hpv-vacsafe-effic.htm| title=HPV Vaccine – Questions & Answers for the Public|access-date=22 August 2008 |date=18 July 2008 |archive-url = https://web.archive.org/web/20080306064618/https://www.cdc.gov/vaccines/vpd-vac/hpv/hpv-vacsafe-effic.htm |archive-date = 6 March 2008}}</ref> It is unknown why a person develops GBS, or what initiates the disease.<ref>{{cite web| url = https://www.ninds.nih.gov/disorders/gbs/detail_gbs.htm| title = Guillain–Barré Syndrome Fact Sheet| publisher = National Institute of Neurological Disorders and Stroke (NINDS)| date = 6 May 2010| url-status = live| archive-url = https://web.archive.org/web/20160805044252/https://www.ninds.nih.gov/disorders/gbs/detail_gbs.htm| archive-date = 5 August 2016}}</ref>

The FDA and the CDC monitor events to see if there are patterns, or more serious events than would be expected from chance alone.<ref name=GARDASIL-SAFETY-FDA /> The majority (68%) of side effects data were reported by the manufacturer, but in about 90% of the manufacturer reported events, no follow-up information was given that would be useful to investigate the event further.<ref name=medscape>{{cite web |url=https://www.medscape.com/viewarticle/707634 | vauthors = Chustecka Z |title=HPV Vaccine: Debate Over Benefits, Marketing, and New Adverse Event Data |work=Medscape Today |date=18 August 2009 |access-date=27 August 2009 |url-status=live |archive-url=https://web.archive.org/web/20101114225759/https://www.medscape.com/viewarticle/707634 |archive-date=14 November 2010 }}</ref> In February 2009, the [[Spanish National Health System#Ministry of Health and SocialPolicy|Spanish Ministry of Health]] suspended use of one batch of Gardasil after health authorities in the [[Valencia, Spain|Valencia]] region reported that two girls had become ill after receiving the injection. Merck has stated that there was no evidence Gardasil was responsible for the two illnesses.<ref name=Spainreuters>{{cite news |url=https://www.reuters.com/article/rbssHealthcareNews/idUSLA56308620090210 |first=Raquel |last=Castillo |title=Spain halts batch of Merck's Gardasil |work=Reuters |date=10 February 2009 |access-date=10 February 2009 |url-status=live |archive-url=https://web.archive.org/web/20090213041037/https://www.reuters.com/article/rbssHealthcareNews/idUSLA56308620090210 |archive-date=13 February 2009 }}</ref>

<!-- Overall, the HPV vaccine has a good safety record and causes no serious adverse effects.<ref name=safety>{{cite journal| vauthors=Vichnin M, Bonanni P, Klein NP, Garland SM, Block SL, Kjaer SK | title=An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015. | journal=Pediatr Infect Dis J | year= 2015 | volume= 34 | issue= 9 | pages= 983–91 | pmid=26107345 | doi=10.1097/INF.0000000000000793 |type=Review| url=https://flore.unifi.it/bitstream/2158/1051025/1/00006454-201509000-00017.pdf }}</ref> -->

==Ingredients==

The following are the ingredients found in the different formulations of HPV vaccines:<ref name="Harper2017">{{cite journal | vauthors = Harper DM, DeMars LR | title = HPV vaccines - A review of the first decade | journal = Gynecologic Oncology | volume = 146 | issue = 1 | pages = 196–204 | date = July 2017 | pmid = 28442134 | doi = 10.1016/j.ygyno.2017.04.004 | url = https://www.gynecologiconcology-online.net/article/S0090-8258(17)30774-6/fulltext#s0010 | doi-access = free | access-date = 19 April 2020 | archive-date = 11 December 2021 | archive-url = https://web.archive.org/web/20211211092745/https://www.gynecologiconcology-online.net/article/S0090-8258%2817%2930774-6/fulltext#s0010 | url-status = live }}</ref>

* Major capsid protein L1 [[epitope]] of HPV types 6, 11, 16, and 18 (Gardasil)

* Major capsid protein L1 epitope of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (Gardasil-9)

* Major capsid protein L1 epitope of HPV types 16 and 18 (Cervarix)

* amorphous [[aluminum hydroxyphosphate sulfate]] ([[adjuvant]])

* [[sodium chloride]]

* [[yeast]] protein

* [[L-histidine]]

* [[polysorbate 80]]

* [[borax|sodium borate]]<ref name="Gardasil 9 FDA label" />

* [[sodium dihydrogen phosphate]] dihydrate (Cervarix only)

* 3-O-Desacyl-4′-monophosphoryl lipid (MPL) A (Cervarix only)

* [[Aluminum hydroxide]] (Cervarix only)

* [[Cabbage looper|''Trichoplusia ni'']] insect cells (Cervarix only)

===Biotechnology===

The HPV major [[capsid]] protein, L1, can spontaneously self-assemble into [[virus-like particle]]s (VLPs) that resemble authentic HPV [[virion]]s. Gardasil contains [[recombinant virus|recombinant]] VLPs assembled from the L1 proteins of HPV types 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. The L1 proteins are produced by separate [[ethanol fermentation|fermentations]] in recombinant ''[[Saccharomyces cerevisiae]]'' and self-assembled into VLPs.<ref>{{cite web|url=https://www.merck.ca/static/pdf/GARDASIL-PM_E.pdf |title=Gardasil Product Monograph |publisher=Merck Canada Inc.|access-date=3 April 2020|url-status=live|archive-url=https://web.archive.org/web/20200404051022/https://www.merck.ca/static/pdf/GARDASIL-PM_E.pdf|archive-date=4 April 2020 }}</ref>

==Public health==

{{Main|HPV vaccines}}

The [[National Cancer Institute]] writes:

{{blockquote|Widespread HPV vaccination has the potential to reduce cervical cancer incidence around the world by as much as 90%. In addition, the vaccines may reduce the need for screening and subsequent medical care, biopsies, and invasive procedures associated with follow-up from abnormal cervical screening, thus helping to reduce health care costs and anxieties related to follow-up procedures.<ref name="National Cancer Institute HPV Q&A">{{cite web| url=https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet | title=Human Papillomavirus (HPV) Vaccines | publisher=[[National Cancer Institute]] (NCI)| date=9 September 2019 | access-date=2020-04-03| url-status=live| archive-url=https://web.archive.org/web/20200404063003/https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-vaccine-fact-sheet | archive-date=2020-04-04 }}</ref>}}

{{update|section|date=July 2009}}

Whether the effects are temporary or lifelong, widespread vaccination could have a substantial public health impact. As of 2018, studies have proven that cervical cancer rates have dropped significantly since the introduction of Gardasil.<ref name="Jenco_2018">{{cite journal|url=http://www.aappublications.org/news/2018/08/09/cervicalcancer080918|title=Cervical cancer declines follow HPV vaccine introduction| vauthors = Jenco M |date=9 August 2018|journal=AAP News|access-date=2 October 2018|archive-date=14 April 2021|archive-url=https://web.archive.org/web/20210414045351/https://www.aappublications.org/news/2018/08/09/cervicalcancer080918|url-status=live}}</ref> Before Gardasil was introduced in 2006, 270,000 women died of cervical cancer worldwide in 2002.<ref name="pmid15860602">{{cite journal | vauthors = Cohen J | title = Public health. High hopes and dilemmas for a cervical cancer vaccine | journal = Science | volume = 308 | issue = 5722 | pages = 618–21 | date = April 2005 | pmid = 15860602 | doi = 10.1126/science.308.5722.618 | s2cid = 31712160 }}</ref> As of 2014, the mortality rate from cervical cancer has dropped 50% from 1975 which is due to the Gardasil vaccination along with increased focus on cervical screening.<ref>{{cite web|url=https://www.cancer.net/cancer-types/cervical-cancer/statistics|title=Cervical Cancer: Statistics|date=January 2018|access-date=2 October 2018|archive-date=27 September 2021|archive-url=https://web.archive.org/web/20210927134856/https://www.cancer.net/cancer-types/cervical-cancer/statistics|url-status=live}}</ref> Acting FDA administrator [[Andrew von Eschenbach]] said the

vaccine will have "a dramatic effect" on the health of women around the world.<ref name="FDAapproval">{{cite news| url = http://www.nbcnews.com/id/13206572| title = FDA approves first vaccine for cervical cancer| work = NBC News| agency = [[Associated Press]]| date = 16 June 2006| access-date = 8 June 2006| archive-date = 6 August 2020| archive-url = https://web.archive.org/web/20200806135804/http://www.nbcnews.com/id/13206572| url-status = live}}</ref> Gardasil is an important tool in reducing cervical cancer rates even in countries where screening programs are routine. The [[National Cancer Institute]] estimated that 9,700 women would develop cervical cancer in 2006, and 3,700 would die.<ref name="National Cancer Institute SEER">{{cite web | url = http://seer.cancer.gov/statfacts/html/cervix.html | title = SEER Stat Fact Sheets: Cervix Uteri | archive-url = https://web.archive.org/web/20140706125134/http://seer.cancer.gov/statfacts/html/cervix.html | archive-date=6 July 2014 | work = [[National Cancer Institute]] | access-date = 30 March 2007 }}</ref>

Merck and [[CSL Limited]] are expected{{update inline|date=October 2019}} to market Gardasil as a cancer vaccine, rather than an [[Sexually transmitted disease|STD]] vaccine. In the early years of Gardasil's introduction it was unclear how widespread the use of the three-shot series would be, in part because of its $525 list price ($175 each for three shots).<ref name="Gardisil Vaccine - Vaccination">{{cite web|title=Health Blue Book|url=http://healthcarebluebook.com/page_Results.aspx?id=324&dataset=MD&g=Gardisil++Vaccine|access-date=15 August 2012|archive-date=11 December 2021|archive-url=https://web.archive.org/web/20211211092655/https://www.healthcarebluebook.com/ui/home|url-status=live}}</ref> But as of 2013, vaccine coverage has been rising.<ref name="Jenco_2018" /> In 2013, about 55% of girls ages 13–17 years had at least one dose of the vaccination covered, up from 29% in 2007. Coverage for women ages 18–34 also has increased significantly since 2007.<ref name="Jenco_2018" />

Studies using different pharmacoeconomic models predict that vaccinating young women with Gardasil in combination with screening programs may be more cost effective than screening alone.<ref>{{cite journal | vauthors = Stanley M | title = Prevention strategies against the human papillomavirus: the effectiveness of vaccination | journal = Gynecologic Oncology | volume = 107 | issue = 2 Suppl 1 | pages = S19-23 | date = November 2007 | pmid = 17938013 | doi = 10.1016/j.ygyno.2007.07.068 }}</ref> These results have been important in decisions by many countries to start vaccination programs.<ref>{{cite journal | vauthors = Pallecaros A, Vonau B | title = Human papilloma virus vaccine--more than a vaccine | journal = Current Opinion in Obstetrics & Gynecology | volume = 19 | issue = 6 | pages = 541–6 | date = December 2007 | pmid = 18007131 | doi = 10.1097/GCO.0b013e3282f1a91b | s2cid = 2309744 }}</ref> For example, the Canadian government approved $300&nbsp;million to buy the HPV vaccine in 2008 after deciding from studies that the vaccine would be cost-effective especially by immunizing young women.<ref>{{cite journal | vauthors = Morris SK, Nguyen CK | title = The human papillomavirus vaccine in Canada | journal = Canadian Journal of Public Health | volume = 99 | issue = 2 | pages = 114–6 | year = 2008 | pmid = 18457284 | pmc = 6975757 | doi = 10.1007/BF03405456 }}</ref> Marc Steben, an investigator for the vaccine, wrote that the financial burden of HPV related cancers on the Canadian people was already $300&nbsp;million per year in 2005, so the vaccine could reduce this burden and be cost-effective.<ref>{{cite journal | vauthors = Steben M | title = Rebuttal: Do you approve of spending $300 million on HPV vaccination? Yes | journal = Canadian Family Physician | volume = 54 | issue = 3 | pages = 342, 344 | date = March 2008 | pmid = 18337521 | pmc = 2278341 }}</ref>

Since penile and anal cancers are much less common than cervical cancer, HPV vaccination of young men is likely to be much less cost-effective than for young women yet is still recommended due to the existent risk (including oral cancer).<ref name=NYTIMES0808 />

The August 2009 issue of the ''[[Journal of the American Medical Association]]'' had an article reiterating the safety of Gardasil<ref name=pmid_19690307 /> and another questioning the way it was presented to doctors and parents.

{{blockquote|The new vaccine against 4 types of human papillomavirus (HPV), Gardasil, like other immunizations appears to be a cost-effective intervention with the potential to enhance both adolescent health and the quality of their adult lives. However, the messages and the methods by which the vaccine was marketed present important challenges to physician practice and medical professionalism. By making the vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the subpopulations most at risk practically ignored. The vaccine manufacturer also provided educational grants to professional medical associations (PMAs) concerned with adolescent and women's health and oncology. The funding encouraged many PMAs to create educational programs and product-specific speakers' bureaus to promote vaccine use. However, much of the material did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits. As important and appropriate as it is for PMAs to advocate for vaccination as a public good, their recommendations must be consistent with appropriate and cost-effective use.<ref>{{cite journal | vauthors = Rothman SM, Rothman DJ | title = Marketing HPV vaccine: implications for adolescent health and medical professionalism | journal = JAMA | volume = 302 | issue = 7 | pages = 781–6 | date = August 2009 | pmid = 19690311 | doi = 10.1001/jama.2009.1179 }}</ref>}}

According to the CDC, as of 2012, use of the HPV vaccine had cut rates of infection with HPV-6, -11, -16 and -18 in half in American teenagers (from 11.5% to 4.3%) and by one third in American women in their early twenties (from 18.5% to 12.1%).<ref name=Forbes>{{cite web| vauthors = Haelle T |author-link=Tara Haelle|url=https://www.forbes.com/sites/tarahaelle/2016/02/23/hpv-infection-rates-plummet-in-young-women-due-to-vaccine/|title=HPV Infection Rates Plummet In Young Women Due To Vaccine|work=Forbes|date=23 February 2016|access-date=23 February 2016|url-status=live|archive-url=https://web.archive.org/web/20160226093032/https://www.forbes.com/sites/tarahaelle/2016/02/23/hpv-infection-rates-plummet-in-young-women-due-to-vaccine/|archive-date=26 February 2016}}</ref>

==History==

Research findings that pioneered the development of the vaccine began in 1991 by investigators [[Jian Zhou]] and [[Ian Frazer]] in The [[University of Queensland]], Australia. Researchers at [[UQ]] found a way to form non-infectious virus-like particles (VLP), which could also strongly activate the immune system. Subsequently, the final form of the vaccine was developed in parallel, by researchers at [[Georgetown University]] Medical Center, the [[University of Rochester]], the [[University of Queensland]] in Australia, and the US [[National Cancer Institute]].<ref>{{cite journal | vauthors = McNeil C | title = Who invented the VLP cervical cancer vaccines? | journal = Journal of the National Cancer Institute | volume = 98 | issue = 7 | pages = 433 | date = April 2006 | pmid = 16595773 | doi = 10.1093/jnci/djj144 | doi-access = free }}</ref>

In December 2014, the FDA approved Gardasil 9, which protects against nine strains of HPV.<ref>{{cite press release |url=https://www.merck.com/news/fda-approves-mercks-hpv-vaccine-gardasil9-to-prevent-cancers-and-other-diseases-caused-by-nine-hpv-types-including-types-that-cause-about-90-of-cervical-cancer-cases/ |title=FDA Approves Merck's HPV Vaccine, GARDASIL 9, to Prevent Cancers and Other Diseases Caused by Nine HPV types – Including Types that Cause About 90% of Cervical Cancer Cases |website=Merck |date=11 December 2014 |access-date=6 July 2022 |archive-date=6 July 2022 |archive-url=https://web.archive.org/web/20220706214543/https://www.merck.com/news/fda-approves-mercks-hpv-vaccine-gardasil9-to-prevent-cancers-and-other-diseases-caused-by-nine-hpv-types-including-types-that-cause-about-90-of-cervical-cancer-cases/ |url-status=live }}</ref><ref>{{cite web | title=Gardasil 9 | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9 | id=STN: 125508 | date=21 February 2020 | access-date=4 April 2020 | archive-date=15 October 2019 | archive-url=https://web.archive.org/web/20191015075027/https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9 | url-status=live }}</ref>

==Society and culture==

===United States===

A few conservative groups, such as the [[Family Research Council]] (FRC), have expressed their fears that vaccination with Gardasil might give girls a false sense of security regarding sex and lead to promiscuity,<ref name="FDAapproval" /><ref name="independent"/><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 | vauthors = Barillas M |work=Spero News |date=14 September 2006 |access-date=26 January 2007 |url-status=dead |archive-url=https://web.archive.org/web/20061114194535/http://www.speroforum.com/site/article.asp?idCategory=33&idsub=128&id=5444&t=GARDASIL+vaccine+touted+in+Michigan |archive-date=14 November 2006 }}</ref><ref>{{cite web|url=http://downloads.frc.org/EF/EF07H25.pdf|title=Gardasil: What Parents should know about the new HPV vaccine| vauthors = Gaul M |publisher=[[Family Research Council]]|year=2007|access-date=13 September 2011|archive-date=13 July 2021|archive-url=https://web.archive.org/web/20210713061821/https://downloads.frc.org/EF/EF07H25.pdf|url-status=live}}</ref> but no evidence exists to suggest that girls who were vaccinated went on to engage in more sexual activity than unvaccinated girls.<ref>{{cite journal | vauthors = Bednarczyk RA, Davis R, Ault K, Orenstein W, Omer SB | title = Sexual activity-related outcomes after human papillomavirus vaccination of 11- to 12-year-olds | journal = Pediatrics | volume = 130 | issue = 5 | pages = 798–805 | date = November 2012 | pmid = 23071201 | doi = 10.1542/peds.2012-1516 | doi-access = free }}</ref> Merck, the manufacturer of the vaccine, has lobbied that state governments make vaccination with Gardasil mandatory for school attendance,<ref>{{cite news|url=https://www.nytimes.com/2007/02/21/business/21merck.html|title=Merck to halt lobbying for vaccine for girls| vauthors = Pollack A, Saul S |date=21 February 2007|access-date=4 July 2018|work=[[The New York Times]]|archive-date=12 April 2018|archive-url=https://web.archive.org/web/20180412124123/https://www.nytimes.com/2007/02/21/business/21merck.html|url-status=live}}</ref> which has upset some conservative and [[Libertarianism|libertarian]] groups.<ref name="FDAapproval" /><ref>{{cite journal| vauthors = Houppert K |url=http://www.thenation.com/doc/20070326/houppert/print|title=Who's Afraid of Gardasil?|journal=[[The Nation]]|date=26 March 2007|access-date=11 November 2009}}</ref><ref name="independent">{{cite news|url=https://www.independent.co.uk/news/business/news/moral-majority-take-on-gsk-and-merck-over-cancer-drugs-481844.html|title=Moral majority take on GSK and Merck over cancer drugs| vauthors = Fortson D |work=[[The Independent]]|date=11 June 2006|access-date=12 June 2006|url-status=live|archive-url=http://archive.wikiwix.com/cache/20060614122733/https://www.independent.co.uk/news/business/news/moral-majority-take-on-gsk-and-merck-over-cancer-drugs-481844.html|archive-date=14 June 2006}}</ref>

The governor of Texas, [[Rick Perry]], issued an executive order [[Rick Perry#Healthcare|adding Gardasil]] to the state's required vaccination list, which was later overturned by the Texas legislature. Even though Perry also allowed parents to opt out of the program more easily, Perry's order was criticized, by fellow presidential candidates [[Rick Santorum]] and [[Michele Bachmann]] during the 2012 [[2012 Republican Party presidential debates and forums|Republican Party presidential debate]] as being an overreach of state power in a decision properly left to parents.<ref>{{cite news|title=In Republican Race, a Heated Battle Over the HPV Vaccine|url=https://www.nytimes.com/2011/09/14/us/politics/republican-candidates-battle-over-hpv-vaccine.html | vauthors = Gabriel T, Grady D |work=[[The New York Times]]|date=13 September 2011|access-date=14 September 2011|url-status=live|archive-url=https://web.archive.org/web/20110914111415/https://www.nytimes.com/2011/09/14/us/politics/republican-candidates-battle-over-hpv-vaccine.html|archive-date=14 September 2011}}</ref>

===Japan===

In June 2013, the Japanese government issued a notice that "cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16" while an investigation is conducted into certain adverse events including pain and numbness in 38 girls.<ref>{{cite web | work = Japan Times | date = 16 June 2013 | url = http://www.japantimes.co.jp/news/2013/06/15/national/cervix-vaccine-issues-trigger-health-notice/ | title = Cervix vaccine issues trigger health notice | archive-url = https://web.archive.org/web/20131203033434/http://www.japantimes.co.jp/news/2013/06/15/national/cervix-vaccine-issues-trigger-health-notice/ | archive-date= 3 December 2013| access-date = 9 July 2013 }}</ref> The vaccines sold in Japan are Cervarix, made by [[GSK plc]] (formerly GlaxoSmithKline) of the United Kingdom, and Gardasil, made by Merck Sharp & Dohme. An estimated 3.28&nbsp;million people have received the vaccination; 1,968 cases of possible side effects have been reported.<ref>{{cite web | work = The Asahi Shimbun | date = 15 June 2013 | url = http://ajw.asahi.com/article/behind_news/social_affairs/AJ201306150057 | title = Health ministry withdraws recommendation for cervical cancer vaccine | archive-url = https://web.archive.org/web/20130619025016/http://ajw.asahi.com/article/behind_news/social_affairs/AJ201306150057 | archive-date = 19 June 2013 | access-date = 9 July 2013 }}</ref> In January 2014, the Vaccine Adverse Reactions Review Committee concluded that there was no evidence to suggest a causal association between the HPV vaccine and the reported adverse events, but did not reinstate proactive recommendations for its use.<ref name=lancet-japan>{{cite journal | vauthors = Hanley SJ, Yoshioka E, Ito Y, Kishi R | title = HPV vaccination crisis in Japan | journal = Lancet | volume = 385 | issue = 9987 | pages = 2571 | date = June 2015 | pmid = 26122153 | doi = 10.1016/S0140-6736(15)61152-7 | doi-access = free }}</ref> A study on girls in [[Sapporo]] showed that since the Japanese government's suspension of recommending the vaccine, completion rates for the full course of vaccination have dropped to 0.6%.<ref name=lancet-japan /> On 26 November 2021, the Ministry of Health, Labour, and Welfare of Japan officially issued an announcement to resume active recommendations of the HPV vaccine after 8.5 years of suspension and municipalities are expected to restart such active recommendations from April 2022.<ref name=lancet-onco-japan>{{cite journal | vauthors= Haruyama R, Obara H, Fujita N | title= Japan resumes active recommendations of HPV vaccine after 8·5 years of suspension | journal= Lancet Oncology | volume=23 | issue=2 | pages=197–198 | date= February 2022 | doi= 10.1016/S1470-2045(22)00002-X | pmid= 35114115 | s2cid= 246455402 }}</ref>

== References ==

== Further reading ==

{{refbegin}}

* {{cite web | url = https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000732/WC500051550.pdf | title = Silgard | work = EPAR summary for the public | publisher = European Medicines Agency | date = May 2014 | access-date = 4 April 2020 | archive-date = 18 June 2018 | archive-url = https://web.archive.org/web/20180618053115/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000732/WC500051550.pdf | url-status = dead }}

* {{cite journal | vauthors = Shi L, Sings HL, Bryan JT, Wang B, Wang Y, Mach H, Kosinski M, Washabaugh MW, Sitrin R, Barr E | title = GARDASIL: prophylactic human papillomavirus vaccine development--from bench top to bed-side | journal = Clinical Pharmacology and Therapeutics | volume = 81 | issue = 2 | pages = 259–64 | date = February 2007 | pmid = 17259949 | doi = 10.1038/sj.clpt.6100055 | s2cid = 21647764 }}

* {{cite journal | url = http://www.rochester.edu/pr/Review/V68N3/feature1.html | title = A Cancer Vaccine is Born | vauthors = Ireland C | journal = Rochester Review | publisher = [[University of Rochester]] | volume = 68 | issue = 3 | year = 2006 }}

* {{cite news | vauthors = Harris G | url = https://www.nytimes.com/2006/06/30/health/30vaccine.html | title = Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up | work = [[The New York Times]] | date = 30 June 2006 }}

* {{cite web | title=Gardasil | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil | id=STN: 125126 | date=24 October 2019 }}

* {{cite news | vauthors = Hellerstein M, Amanda T | url = https://indypendent.org/2007/02/hpv-and-you-girls-learn-about-hpv-from-the-commercials-not-the-classroom/ | title = HPV and You: Girls learn about HPV from the commercials, not the classroom | work = [[The Indypendent]] | date = 1 February 2007 }}

* {{cite news | vauthors = McNeil Jr DG | author-link = Donald McNeil Jr. | url = https://www.nytimes.com/2006/08/29/health/29hpv.html | title = How a Vaccine Search Ended in Triumph | work = [[The New York Times]] | date = 29 August 2006 }}

{{refend}}

== External links ==

* {{cite web | title=HPV (Human Papillomavirus) Vaccine Information Statement | date=2 June 2022 | publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv.html }}

* {{MeshName|Papillomavirus Vaccines}}

* {{cite web | title=Gardasil–Presence of DNA Fragments Expected, No Safety Risk | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=21 October 2011 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/fda-information-gardasil-presence-dna-fragments-expected-no-safety-risk }}

* {{cite web | title=FDA Study-No association between VTE and Gardasil Vaccination | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=23 April 2015 | url=https://www.fda.gov/vaccines-blood-biologics/biologics-post-market-activities/fda-sentinel-study-finds-no-association-between-venous-thromboembolism-and-gardasil-vaccination }}

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[[Category:Cancer vaccines]]

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[[Category:Drugs developed by Merck & Co.]]

[[Category:Protein subunit vaccines]]

[[Category:Cervical cancer]]