Nonavalent HPV vaccine
A vaccine against nine HPV types that prevents about 90% of cervical cancers, and now works with a single dose.
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.
1.L1 protein particles mimic the virus shell without DNA
- 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
- Medicare
- Part D (self-administered)
Medicare Part D covers ACIP-recommended vaccines, including HPV vaccine for eligible adults through age 45, at no cost since 2023 under the Inflation Reduction Act; Part B does not cover it. Most Medicare beneficiaries are outside the recommended age range.
- Commercial insurance
- covered on label
ACA-compliant commercial plans cover ACIP-recommended vaccines with no cost sharing in network, including HPV vaccination through age 26 and shared decision-making for 27 to 45. Medicaid and the Vaccines for Children programme cover children and adolescents.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap) · Medicare.gov: Vaccines covered by Part D at no cost · HealthCare.gov: Preventive care benefits for adults. Not medical or financial advice; verify with your plan.
- Appraised for
- National HPV vaccination programme
- Notes
- Not a TA: HPV vaccination is a national immunisation programme on JCVI advice. Gardasil 9 has been the programme vaccine since 2022, offered to all children aged 12-13 (single dose since 2023) and to men who have sex with men up to 45 via sexual health clinics.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: Gardasil 9 (HPV vaccine). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 8 Jun 2006ApprovalUS
Original quadrivalent Gardasil approved
- 10 Dec 2014ApprovalUS
Gardasil 9 approved
- Dec 2022Label changeWHO
One-dose schedule endorsed (SAGE)
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Prevention of HPV-related cancers and precancers, ages 9-26; extended to 45 in 2018 |
| WHO | 2022 | Single-dose schedule recommended for girls 9-20 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Injection-site pain | 90% | — |
| Syncope (adolescents) | — | — |
Observe 15 minutes after injection. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Nonavalent HPV vaccine" OR ABSTRACT:"Nonavalent HPV vaccine" OR TITLE:"Gardasil 9" OR ABSTRACT:"Gardasil 9") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Nonavalent HPV vaccine, not a curated reading list.
Pages like this
not linked directly; found by shared links- TermHPV-positive (p16) head and neck cancer
Shares Harald zur Hausen, Vulvar cancer, Anal cancer (squamous cell carcinoma), Oncogenic viruses.
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Shares Single-dose HPV vaccination plus HPV self-sampling to reach WHO elimination in low-income countries, Harald zur Hausen, Anal cancer (squamous cell carcinoma), Oncogenic viruses.
- Key paperSwedish registry study: HPV vaccination almost eliminates cervical cancer when given before 17
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- TechnologyThermal ablation and cryotherapy for cervical precancer
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- PersonDenise A. Galloway
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- IdeaEliminate infection-caused cancers: HPV, hepatitis B and C, H. pylori and EBV
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- IdeaSwitch every country to single-dose HPV vaccination and add catch-up to age 26
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- IdeaHPV self-testing with same-day treatment as the national cervical programme
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