Gardasil 9 is indicated for active immunisation against premalignant lesions and cancers affecting the cervix, vulva, vagina and anus and genital warts caused by certain HPV types. The new vaccine is active against HPV types 6, 11, 16 and 18 (in common with the quadrivalent HPV vaccine Gardasil, currently used in the national immunisation programme) and types 31, 33, 45, 52 and 58.
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Summary of Product Characteristics
Manufacturer: Sanofi Pasteur MSDThe HPV virus types 16, 18, 31, 33, 45, 52 and 58 are implicated in approximately 90% of cervical cancer cases, 90% of HPV-related anal cancers and 80% of high-grade cervical lesions worldwide. The remaining two virus types (6 and 11) are responsible for 90% of genital wart cases.
For individuals aged 9 to 14 years the vaccine can be administered in a two- or three-dose schedule. For individuals aged 15 years and over, a three-dose schedule should be followed. The second dose of the two-dose schedule is given 5 to 13 months after the first dose; the second and third doses of the three-dose schedule are given at 2 and 6 months after the first.
Efficacy of Gardasil 9 against HPV types 6, 11, 16 and 18 was assessed in three different populations, girls aged 9 to 15 years (n=600) and men and women aged 16 to 26 years (n=500 and n=6,792, respectively). Immune responses at 7 months for Gardasil 9 were non-inferior to responses for quadrivalent HPV vaccine.
Efficacy of Gardasil 9 against HPV types 31, 33, 45, 52 and 58 was assessed in a pivotal study involving 14,215 women aged 16 to 26 years, using quadrivalent HPV vaccine as a comparator. Gardasil 9 showed 96.7% efficacy (95% CI 80.9–99.8) in preventing high-grade cervical, vulvar or vaginal disease related to the five virus types and 96.0% efficacy (95% CI 94.4–97.2) in preventing persistent infection associated with the five strains.
Another study evaluated the safety (primary objective) and immunogenicity (secondary objective) of Gardasil 9 in women and girls (aged 12 to 26 years, n=924) who had previously been vaccinated with quadrivalent HPV vaccine. At least 12 months had elapsed between completion of the quadrivalent vaccine schedule and the start of the Gardasil 9 three-dose schedule.
Seropositivity to all nine virus types ranged from 98.3 to 100% by month 7. The researchers found that the geometric mean titres (GMTs) to HPV types 6, 11, 16 and 18 were higher than in individuals in other studies who had not previously received the quadrivalent vaccine while the GMTs to types 31, 33, 45, 52 and 58 were lower. However, the clinical significance of these observations is unknown.
Gardasil 9 was well tolerated in clinical trials, with injection site reactions and headache the most commonly reported adverse effects.