Gardasil

See also: HPV vaccines

Gardasil
Gardasil quadrivalent HPV [types 6, 11, 16, 18]
Vaccine description
TargetFor Gardasil 9: Human papillomavirus, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Vaccine typeProtein subunit
Clinical data
Trade namesGardasil, Gardisil, Silgard, others
AHFS/Drugs.comMonograph
MedlinePlusa607016
License data
Pregnancy
category
Routes of
administration		Intramuscular injection
ATC code
Legal status
Legal status
Identifiers
PubChem SID
DrugBank
ChemSpider
  • none
UNII
KEGG
 ☒NcheckY (what is this?)  (verify)

Gardasil is an HPV vaccine for use in the prevention of certain strains of human papillomavirus (HPV).[10][7][8][9][11] It was developed by Merck & Co.[12] High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women.[13] The HPV strains that Gardasil protects against are sexually transmitted,[14] specifically HPV types 6, 11, 16 and 18.[15][16] HPV types 16 and 18 cause an estimated 70% of cervical cancers,[17][18] and are responsible for most HPV-induced anal,[19] vulvar, vaginal,[20] and penile cancer cases.[19] HPV types 6 and 11 cause an estimated 90% of genital warts cases.[21] HPV type 16 is responsible for almost 90% of HPV-positive oropharyngeal cancers,[22] and the prevalence is higher in males than females.[22] 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.[23]

The vaccine was approved for medical use in the United States in 2006,[24][25] initially for use in females aged 9–26.[26] In 2007, the Advisory Committee on Immunization Practices recommended Gardasil for routine vaccination of girls aged 11 and 12 years.[27] As of August 2009, vaccination was recommended for both males and females before adolescence and the beginning of potential sexual activity.[15][6][28] By 2011, the vaccine had been approved in 120 other countries.[29]

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).[6][30][31] In 2018, the FDA approved expanded use of Gardasil 9 for individuals 27 to 45 years old.[32]

  1. ^ "Human papillomavirus vaccine Use During Pregnancy". Drugs.com. 11 February 2019. Archived from the original on 5 April 2020. Retrieved 3 April 2020.
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  3. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
  4. ^ Cite error: The named reference Gardasil 9 SmPC was invoked but never defined (see the help page).
  5. ^ "Gardasil- human papillomavirus quadrivalent- types 6, 11, 16, and 18 vaccine, recombinant injection, suspension". DailyMed. 2 December 2020. Archived from the original on 21 April 2022. Retrieved 31 March 2022.
  6. ^ a b c "Gardasil 9- human papillomavirus 9-valent vaccine, recombinant injection, suspension". DailyMed. 20 August 2021. Archived from the original on 5 April 2020. Retrieved 31 March 2022.
  7. ^ a b "Silgard EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 6 April 2020. Retrieved 3 April 2020.
  8. ^ a b "Gardasil 9 EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 6 April 2020. Retrieved 3 April 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. ^ a b "Gardasil EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 11 June 2022. Retrieved 6 July 2022.
  10. ^ "Silgard European Public Assessment Report". European Medicines Agency. 25 September 2009. Archived from the original on 25 December 2008. Retrieved 5 December 2009.
  11. ^ Waknine Y (2 October 2006). "International Approvals: Singulair and Gardasil/Silgard". Medscape Today. Archived from the original on 20 May 2013. Retrieved 18 December 2008.
  12. ^ Richwine L (20 August 2009). "U.S. health officials back safety of Merck vaccine". Reuters. Archived from the original on 27 August 2009. Retrieved 12 November 2009.
  13. ^ Gizzo S, Noventa M, Nardelli GB (September 2013). "Gardasil administration to hr-HPV-positive women and their partners". Trends in Pharmacological Sciences. 34 (9): 479–80. doi:10.1016/j.tips.2013.07.001. PMID 23896431.
  14. ^ "Genital HPV Infection - Fact Sheet". www.cdc.gov. U.S. Centers for Disease Control and Prevention (CDC). Archived from the original on 11 September 2012. Retrieved 18 April 2020.
  15. ^ a b Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER, et al. (Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control Prevention (CDC)) (March 2007). "Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR. Recommendations and Reports. 56 (RR-2): 1–24. PMID 17380109. Archived (PDF) from the original on 24 September 2015.
  16. ^ Centers for Disease Control Prevention (CDC) (May 2010). "FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR. Morbidity and Mortality Weekly Report. 59 (20): 630–2. PMID 20508594. Archived (PDF) from the original on 24 September 2015.
  17. ^ Lowy DR, Schiller JT (May 2006). "Prophylactic human papillomavirus vaccines". The Journal of Clinical Investigation. 116 (5): 1167–73. doi:10.1172/JCI28607. PMC 1451224. PMID 16670757.
  18. ^ Muñoz N, Bosch FX, Castellsagué X, Díaz M, de Sanjose S, Hammouda D, et al. (August 2004). "Against which human papillomavirus types shall we vaccinate and screen? The international perspective". International Journal of Cancer. 111 (2): 278–85. doi:10.1002/ijc.20244. PMID 15197783.
  19. ^ a b Gao G, Smith DI (2016). "Human Papillomavirus and the Development of Different Cancers". Cytogenetic and Genome Research. 150 (3–4): 185–193. doi:10.1159/000458166. PMID 28245440. Archived from the original on 17 July 2020. Retrieved 19 April 2020.
  20. ^ Cite error: The named reference VulvarCA was invoked but never defined (see the help page).
  21. ^ "Human papillomavirus vaccines: WHO position paper, May 2017". Weekly Epidemiological Record. 92 (19): 241–268. May 2017. hdl:10665/255353. PMID 28530369.
  22. ^ a b Anjum F, Zohaib J (4 December 2020). "Oropharyngeal Squamous Cell Carcinoma". Definitions (Updated ed.). Treasure Island (FL): StatPearls Publishing. doi:10.32388/G6TG1L. PMID 33085415. S2CID 229252540. Bookshelf ID: NBK563268. Archived from the original on 11 June 2021. Retrieved 7 February 2021 – via NCBI. {{cite book}}: |work= ignored (help)
  23. ^ "Human Papillomavirus (HPV) Vaccines". National Cancer Institute. Archived from the original on 21 June 2008. Retrieved 18 April 2020.
  24. ^ "Gardasil". U.S. Food and Drug Administration. 15 June 2017. Archived from the original on 22 July 2017. Retrieved 3 April 2020.
  25. ^ "FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus" (Press release). U.S. Food and Drug Administration (FDA). 8 June 2006. Archived from the original on 19 October 2009. Retrieved 13 November 2009. Public Domain This article incorporates text from this source, which is in the public domain.
  26. ^ "Gardasil". Britannica Academic. April 2018. Archived from the original on 13 April 2020. Retrieved 7 May 2019.
  27. ^ Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, et al. (January 2015). "Safety of quadrivalent human papillomavirus vaccine (Gardasil) in pregnancy: adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013". Vaccine. 33 (4): 519–22. doi:10.1016/j.vaccine.2014.11.047. PMC 6524774. PMID 25500173. Archived from the original on 13 April 2020. Retrieved 7 May 2019.
  28. ^ "Gardasil Vaccine Safety". U.S. Food and Drug Administration (FDA). 20 August 2009. Archived from the original on 3 May 2019. Retrieved 21 October 2019.
  29. ^ Haupt RM, Sings HL (November 2011). "The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil". The Journal of Adolescent Health. 49 (5): 467–75. doi:10.1016/j.jadohealth.2011.07.003. PMID 22018560.
  30. ^ "Gardasil 9". U.S. Food and Drug Administration (FDA). 10 October 2018. Archived from the original on 23 April 2019. Retrieved 3 April 2020.
  31. ^ "FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV" (press release). U.S. Food and Drug Administration (FDA). 10 December 2014. Archived from the original on 10 January 2015. Retrieved 28 February 2015. Public Domain This article incorporates text from this source, which is in the public domain.
  32. ^ Cite error: The named reference FDA 27-45 was invoked but never defined (see the help page).