{"entity":{"id":"gardasil-9","kind":"drug","name":"Nonavalent HPV vaccine","aka":[],"tldr":"A vaccine against nine HPV types that prevents about 90% of cervical cancers, and now works with a single dose.","summary":"Approved 2014 (US), covering HPV 6, 11, 16, 18, 31, 33, 45, 52, 58. Population data from Sweden (NEJM 2020) and Scotland (JNCI 2024) show ~90% and near-100% reductions in invasive cervical cancer in women vaccinated at 12-13. WHO recommends one- or two-dose schedules since 2022 (KEN SHE, IARC India); FDA label remains two doses under 15 and three doses at 15-45. Also prevents anal, oropharyngeal, vulvar, vaginal, and penile cancers and genital warts. Global coverage of girls with at least one dose was ~27% in 2023, the binding constraint on elimination.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Gardasil","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Nonavalent%20HPV%20vaccine"}],"tags":[],"related":[],"cancers":["cervical","head-and-neck","anal-hsil-precursor","vaginal-squamous-cell-carcinoma"],"sections":[],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":["ken-she"],"people":[],"bottlenecks":[],"keyPapers":["paper-basu-single-dose-hpv-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"brand":"Gardasil 9","modality":"Prophylactic vaccine (virus-like particles)","mechanism":"Recombinant L1 capsid proteins self-assemble into virus-like particles that induce high-titre neutralising antibodies preventing persistent oncogenic HPV infection.","approvals":[{"region":"US","year":2014,"indication":"Prevention of HPV-related cancers and precancers, ages 9-26; extended to 45 in 2018"},{"region":"WHO","year":2022,"indication":"Single-dose schedule recommended for girls 9-20"}],"mechanismSteps":["L1 protein particles mimic the virus shell without DNA","The immune system makes neutralising antibodies","Antibodies at the cervix block HPV from entering basal cells","No persistent infection, so no precancer or cancer"],"dosing":{"route":"Intramuscular","schedule":"1 dose (WHO, age 9-20) or 2 doses 6-12 months apart (age 9-14); 3 doses at 15-45 (US label)","monitoring":"None routine"},"toxicity":[{"event":"Injection-site pain","anyGradePct":90},{"event":"Syncope (adolescents)","note":"Observe 15 minutes after injection"}],"access":[],"regulatoryEvents":[{"date":"2006-06-08","type":"approval","region":"US","note":"Original quadrivalent Gardasil approved"},{"date":"2014-12-10","type":"approval","region":"US","note":"Gardasil 9 approved"},{"date":"2022-12","type":"label-change","region":"WHO","note":"One-dose schedule endorsed (SAGE)"}]},"route":"/drugs/gardasil-9/","neighbours":{"cancer":[{"id":"anal","kind":"cancer","name":"Anal cancer (squamous cell carcinoma)","route":"/cancers/anal/"},{"id":"anal-hsil-precursor","kind":"cancer","name":"Anal high-grade squamous intraepithelial lesions (precursor)","route":"/cancers/anal-hsil-precursor/"},{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-associated-vulvar-cancer","kind":"cancer","name":"HPV-associated vulvar squamous cell carcinoma","route":"/cancers/hpv-associated-vulvar-cancer/"},{"id":"hpv-positive-oropharyngeal-cancer","kind":"cancer","name":"HPV-positive oropharyngeal cancer","route":"/cancers/hpv-positive-oropharyngeal-cancer/"},{"id":"localised-penile-cancer","kind":"cancer","name":"Localised penile cancer (organ-confined, node-negative)","route":"/cancers/localised-penile-cancer/"},{"id":"penile","kind":"cancer","name":"Penile cancer","route":"/cancers/penile/"},{"id":"rare-childhood-cancers","kind":"cancer","name":"Rare cancers of childhood (NCI PDQ umbrella)","route":"/cancers/rare-childhood-cancers/"},{"id":"vaginal","kind":"cancer","name":"Vaginal cancer","route":"/cancers/vaginal/"},{"id":"vaginal-squamous-cell-carcinoma","kind":"cancer","name":"Vaginal squamous cell carcinoma (HPV-associated)","route":"/cancers/vaginal-squamous-cell-carcinoma/"},{"id":"vulvar","kind":"cancer","name":"Vulvar cancer","route":"/cancers/vulvar/"}],"technology":[{"id":"hpv-vaccine","kind":"technology","name":"HPV & HBV vaccination","route":"/technologies/hpv-vaccine/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"},{"id":"serum-institute-of-india","kind":"company","name":"Serum Institute of India","route":"/companies/serum-institute-of-india/"}],"trial":[{"id":"iarc-india-hpv-dose-study","kind":"trial","name":"IARC India HPV vaccine dose study (one, two or three doses)","route":"/trials/iarc-india-hpv-dose-study/"},{"id":"ken-she","kind":"trial","name":"KEN SHE (single-dose HPV vaccine)","route":"/trials/ken-she/"}],"paper":[{"id":"paper-basu-single-dose-hpv-lancet-oncol-2021","kind":"paper","name":"Vaccine efficacy against persistent HPV 16/18 infection at 10 years after one, two and three doses of quadrivalent HPV vaccine in girls in India","route":"/key-papers/paper-basu-single-dose-hpv-lancet-oncol-2021/"}],"idea":[{"id":"idea-single-dose-hpv-self-sampling-elimination","kind":"idea","name":"Single-dose HPV vaccination plus HPV self-sampling to reach WHO elimination in low-income countries","route":"/ideas/idea-single-dose-hpv-self-sampling-elimination/"}],"person":[{"id":"douglas-lowy","kind":"person","name":"Douglas R. Lowy","route":"/people/douglas-lowy/"},{"id":"harald-zur-hausen","kind":"person","name":"Harald zur Hausen","route":"/people/harald-zur-hausen/"},{"id":"ian-frazer","kind":"person","name":"Ian Frazer","route":"/people/ian-frazer/"},{"id":"jian-zhou","kind":"person","name":"Jian Zhou","route":"/people/jian-zhou/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-prevention-adoption","kind":"bottleneck","name":"Prevention we already have is not deployed","route":"/bottlenecks/b-prevention-adoption/"}],"pathway":[{"id":"oncogenic-viruses","kind":"pathway","name":"Oncogenic viruses","route":"/pathways/oncogenic-viruses/"}],"drug":[{"id":"cervavac","kind":"drug","name":"CERVAVAC (quadrivalent HPV vaccine, India)","route":"/drugs/cervavac/"},{"id":"hpv-bivalent-vaccine","kind":"drug","name":"HPV bivalent vaccine (types 16 and 18)","route":"/drugs/hpv-bivalent-vaccine/"},{"id":"hpv-quadrivalent-vaccine","kind":"drug","name":"HPV quadrivalent vaccine (types 6, 11, 16 and 18)","route":"/drugs/hpv-quadrivalent-vaccine/"}],"roadmap":[{"id":"prevention-roadmap","kind":"roadmap","name":"Cancer prevention roadmap: tobacco control and vaccines → biomarker-guided chemoprevention → interception in carriers","route":"/roadmaps/prevention-roadmap/"}],"collection":[{"id":"nhs-hpv-vaccination","kind":"collection","name":"NHS HPV vaccination programme","route":"/collections/nhs-hpv-vaccination/"},{"id":"us-vaccines-for-children","kind":"collection","name":"Vaccines for Children program (US)","route":"/collections/us-vaccines-for-children/"}]}}