What is the recommended dosage age for Gardasil (Human Papillomavirus vaccine)?

From the Guidelines

Gardasil (HPV recombinant vaccine) is recommended for routine vaccination at ages 11-12 years, though it can be started as early as age 9. The standard dosing schedule varies by age: for individuals who begin vaccination before their 15th birthday, a 2-dose schedule is recommended with the second dose given 6-12 months after the first dose 1. For those who start at age 15 or older, or who are immunocompromised, a 3-dose schedule is required, with the second dose given 1-2 months after the first dose and the third dose given 6 months after the first dose.

Key Points

• Each dose is 0.5 mL administered intramuscularly, typically in the deltoid muscle of the upper arm or in the anterolateral area of the thigh.
• Catch-up vaccination is recommended for all persons through age 26 who were not adequately vaccinated previously.
• The vaccine provides protection against HPV types that cause most cervical cancers and other HPV-related diseases, including genital warts.
• The earlier age recommendation aims to ensure protection before potential exposure to HPV through sexual contact. Some studies have shown that the nonavalent HPV vaccine has high efficacy against oncogenic HPV types associated with cervical cancer when administered before exposure 1. Additionally, the vaccine has been shown to be universally safe and effective.

Important Considerations

• The US Food and Drug Administration (FDA) recently licensed the vaccine for adults up to age 45, but as of this time the ACIP has not adjusted their recommended age range for the vaccine.
• Men who have sex with men, bisexual men, and transgender people up to the age of 26 are also advised to receive the 3-dose regimen.
• 9- to 26-year-old individuals who are immunocompromised are advised to receive the 3-dose schedule. It is essential to note that vaccination before transplant is recommended, and the HPV vaccine was found to be safe in transplant recipients, although immunogenicity may be lower in this population 1.

From the FDA Drug Label

Across all clinical trials, at least 99.2% of individuals included in the analyses for each of the nine vaccine HPV types became seropositive by Month 7. Anti-HPV GMTs at Month 7 among 9- through 15-year-old girls and boys and 16- through 26-year-old boys and men were comparable to anti-HPV responses among 16- through 26-year-old girls and women in the combined database of immunogenicity studies for GARDASIL 9 Effectiveness of GARDASIL 9 against persistent infection and disease related to vaccine HPV types in 9- through 14-year-old girls and boys who received a 2-dose regimen was inferred from non-inferiority comparison conducted in the PPI population in Study 8 of GMTs following vaccination with GARDASIL 9 among 9- through 14-year-old girls and boys who received a 2-dose regimen (at 0,6 months or 0,12 months) with those among 16- through 26-year-old girls and women who received a 3-dose regimen (at 0,2,6 months)

The recommended dosage age for Gardasil (Human Papillomavirus vaccine) is 9 through 26 years of age for a 2 or 3 dose regimen, and 27 through 45 years of age as indicated by the studies 2 and 2.

• The vaccine can be administered to 9- through 14-year-old girls and boys using a 2-dose regimen.
• For 16- through 26-year-old girls and women, a 3-dose regimen is used.
• For 27- through 45-year-old women, the vaccine can be administered, but the efficacy in this age group has not been fully established.

From the Research

Recommended Dosage Age for Gardasil

The recommended dosage age for Gardasil (Human Papillomavirus vaccine) is as follows:

• For routine vaccination, the Advisory Committee on Immunization Practices (ACIP) recommends vaccination at age 11 or 12 years 3.
• ACIP also recommends vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously 3.
• Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously 3.
• The FDA has approved Gardasil for use in females aged 9 through 26 years and males aged 9 through 15 years 3.
• A 2-dose schedule is recommended for girls and boys who initiate the vaccination series at ages 9 through 14 years, while three doses remain recommended for persons who initiate the vaccination series at ages 15 through 26 years and for immunocompromised persons 4.

Key Considerations

• The vaccine is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine, patients with bleeding abnormalities or patients on anticoagulant therapy, and during pregnancy 5.
• The cost of the vaccine, estimated at $300-500 per course, may be a barrier to access for many women in developing countries 5.
• Long-term studies are needed to establish the real status of the vaccine in cancer prevention and to determine the longevity of protection offered by the vaccine 5.