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October 9, 2018
FDA has granted Gardasil 9 priority review status for the application
The Food and Drug Administration (FDA) has extended the approval of Gardasil 9 (human papillomavirus vaccine 9 [HPV]recombinant; Merck) to include the use of the vaccine in women and men aged 27 to 45 years. Previously, the HPV vaccine was indicated for women and men aged 9 to 26 years.
Broader Age Approval Based on Data from a Clinical Trial Evaluating the Efficacy of Gardasil (Recombinant Quadrivalent Human Papillomavirus Vaccine) in 3253 Females Aged 27 to 45, with a Median Follow-up Duration 3.5-year dose 3. The results showed that the efficacy of Gardasil against the combined incidence of persistent HPV-related infections 6, 11, 16 and 18, genital warts, vulvar intraepithelial neoplasia, neoplasia vaginal intraepithelial, vulvar cancer, vaginal cancer, dysplasia (cervical intraepithelial neoplasia of all grades) [CIN] ), anal intraepithelial neoplasia and cervical cancer in the per-protocol efficacy population were 87.7% (95% CI: 75.4%, 94.6%).
As part of a long-term extension of this study, subjects (N = 600) randomized to the Gardasil group of the baseline study were monitored for HPV genital warts 6, 11, 16 and 18 and cervical dysplasia; The median duration of follow-up after dose 3 was 8.9 years. No cases of HPV-related CIN grade 6, 11, 16 or 18 nor genital warts were observed in the population-based efficacy protocol (PPE) during the extension phase long-term.
For men, the effectiveness of Gardasil was inferred from efficacy data in women aged 27 to 45 years and corroborated by the immunogenicity data from a study in which 150 men (27 to 45 years) received a 3-dose Gardasil regimen over 6 months.
Since the vaccines are made in the same way, the efficacy of Gardasil in these patient populations is relevant for Gardasil 9, which covers the same 4 types of HPV (6, 11, 16, 18) plus 5 other types of HPV ( 31, 33, 45, 52 and 58). The quadrivalent vaccine is no longer distributed in the United States.
Gardasil 9 is supplied in 0.5 ml single dose vials and 0.5 ml single dose pre-filled syringes.
For more information, visit Merck.com.
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