Good news for more patients. FDA Approved Merck’s 9-valent HPV Vaccine to cover More Patients. Merck announced that the US Food and Drug Administration (FDA) has approved an expanded age indication for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age.
This indication is a key milestone in transitioning from GARDASIL®[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] to GARDASIL 9 in the United States. Merck will continue to communicate with customers during this transition to ensure the appropriate availability of each product.
During its February 2015 meeting, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to include GARDASIL 9 in the recommendations for use of HPV vaccines. GARDASIL 9 was added to the routine recommendations for vaccination of 11- and 12-year-old females and males. At that time, the ACIP also added recommendations for GARDASIL 9 for females aged 13 to 26 and for males aged 13 to 21 who have not been vaccinated previously or have not completed the 3-dose series. Gardasil9 Full Prescribing Information