The Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Gardasil 9 (human papillomavirus 9-valent vaccine [recombinant]; Merck) to include a 2-dose regimen for individuals aged 9 to 14 years.
The second dose may be administered 6 to 12 months after the initial dose and each dose comes in a single-dose 0.5ml vial. The FDA confirmed that Merck have fulfilled the pediatric requirement for ages 9 to <15 for the application. The pediatric study requirement for 0 to <9 years of age and 15 to <17 years of age have been waived by the FDA because the 2-dose regimen does not represent meaningful benefit compared to existing therapies for these ages.
Gardasil 9 is indicated for use in females aged 9 to 26 for the prevention of cervical, vulvar, vaginal, and anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. It is indicated for use in males and females for precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (e.g. anal intraepithelial neoplasia grades 1, 2, and 3); and for individuals aged 9 to 26 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
It is also indicated for the prevention of genital warts caused by HPV 6 and 11.
For more information visit FDA.gov.