From the Guidelines
Gardasil 9 (Human Papillomavirus 9-valent Vaccine) was released in December 2014, as approved by the U.S. Food and Drug Administration (FDA) 1.
Key Points
- The vaccine protects against nine HPV types, including types 6,11,16,18,31,33,45,52, and 58, which cause approximately 90% of cervical cancers and other HPV-related cancers.
- Gardasil 9 also prevents genital warts caused by HPV types 6 and 11.
- The vaccine is typically administered as a two-dose series for individuals who begin vaccination before their 15th birthday, with doses given 6-12 months apart, or as a three-dose series for those who start at age 15 or older, with the second dose given 1-2 months after the first and the third dose given 6 months after the first dose, as recommended by the ACIP 1.
Vaccine Development and Approval
The development and approval of Gardasil 9 were based on clinical trials and studies that demonstrated its efficacy and safety in protecting against HPV-related cancers and genital warts 1.
Recommendations for Use
The ACIP recommends routine vaccination with Gardasil 9 for individuals 11 through 12 years of age, with the option to start vaccination as early as age 9 years for children and youth with any history of sexual abuse or assault who have not initiated or completed the series 1.
- Individuals who receive the first dose of the vaccine at 15 years of age or older, and persons who are immunocompromised, should complete a 3-dose schedule at 0,1 to 2, and 6 months 1.
- Males 22 through 26 years of age also may receive the vaccine, especially if they are immune suppressed, have HIV infection, or have sex with men 1.
From the FDA Drug Label
Initial U. S. Approval: 2014 Gardasil 9 (Human Papillomavirus 9-valent Vaccine) was released in 2014 2.
From the Research
Gardasil 9 Release Information
- The Gardasil 9 (Human Papillomavirus 9-valent Vaccine) was approved by the Food and Drug Administration (FDA) on December 10,2014, for use in females aged 9 through 26 years and males aged 9 through 15 years 3.
- The vaccine was later recommended by the Advisory Committee on Immunization Practices (ACIP) in February 2015 for routine vaccination at age 11 or 12 years, as well as for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously 3.
- According to another study, Gardasil 9 was licensed in 2014, expanding the indications for Gardasil to include males and a vaccine with extended HPV coverage 4.
- Postlicensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS) from December 2014 through December 2017 confirmed the safety of the 9-valent human papillomavirus vaccine for females and males aged 9 to 26 years 5.