HPV quadrivalent vaccine (types 6, 11, 16 and 18)
Gardasil was the first HPV vaccine, licensed in 2006 to prevent cervical and other genital cancers and genital warts. It has been replaced in most countries by the nine-type version, Gardasil 9.
Overview
The quadrivalent HPV vaccine was approved by the FDA in June 2006 for females aged 9 to 26 to prevent cervical, vulvar and vaginal cancers and precancers and genital warts caused by HPV 6, 11, 16 and 18, on the FUTURE I and II trials, with males (2009) and anal cancer prevention (2010) added; the EU authorised Gardasil in September 2006. It was the first vaccine indicated to prevent a cancer, and population data from Australia, Scandinavia and the UK have since shown large falls in cervical precancer and invasive cancer in vaccinated cohorts. Gardasil 9, covering five further oncogenic types, replaced it in the US in 2017 and in most programmes since. Syncope after injection and injection-site reactions are the main adverse effects; extensive surveillance has found no link to autoimmune disease.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2006 | Prevention of cervical, vulvar and vaginal cancers and precancers and genital warts caused by HPV 6, 11, 16 and 18 in females 9 to 26 (males 2009; anal cancer 2010); superseded by Gardasil 9 |
| EU | 2006 | Prevention of premalignant genital lesions, cervical cancer and genital warts from age 9 (Gardasil); anal lesions and cancer added later |
Trials
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Latest papers
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