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gardasil-9
Gardasil 9 (HPV9)
Nonavalent HPV L1 VLP vaccine; types 6/11/16/18/31/33/45/52/58 from *S. cerevisiae*. Prevents ~90% of cervical cancers and most HPV anogenital/oropharyngeal cancers. 2-dose (ages ≤14) or 3-dose schedule. FDA 2014; Swedish registry: 88% reduction in invasive cervical cancer.
Entry Metadata
| Field | Value |
|---|---|
| ID | gardasil-9 |
| Name | Gardasil 9 (HPV9) |
| Status | draft |
| Last reviewed | 2026-06-04 |
| Platform | 07 — VHP |
| Delivery system | Aluminum-containing adjuvant (AAHS — amorphous aluminum hydroxyphosphate sulfate, 500 µg per dose); intramuscular injection |
| Adjuvants | AAHS (amorphous aluminum hydroxyphosphate sulfate) |
| Route | intramuscular |
| Dose — two dose young | Ages 9–14: 2 doses, 6–12 months apart (non-inferior to 3-dose in 16–26 year olds) |
| Dose — three dose older | Ages 15–26 (or immunocompromised): 3 doses at 0, 2, 6 months |
| Dose — catch up fda | Ages 27–45: shared decision-making (FDA-approved 2018 extension; ACIP recommends selective use) |
| Developer | Merck Sharp & Dohme (MSD) |
| Partners | CSL Behring (manufacturing) |
| Cold chain | 2°C–8°C; do not freeze; 3-year shelf life |
| FDA (2014-12-10) | Licensed (BLA 125508) |
| EMA (2015-06-10) | Marketing Authorization |
| WHO (2017-09-28) | Prequalified |
| FDA (2018-10-05) | BLA expanded — through age 45 |
Cross-Atlas Connections
Sources
- Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711-23. · PubMed 25693011
- World Health Organization. Human papillomavirus vaccines: WHO position paper, December 2022. Wkly Epidemiol Rec. 2022;97(50):645-672.
- Lei J, Ploner A, Elfström KM, et al. HPV Vaccination and the Risk of Invasive Cervical Cancer. N Engl J Med. 2020;383(14):1340-1348. · PubMed 33007079