What is the recommended dosing schedule for Gardasil (Human Papillomavirus vaccine)?

Recommended Dosing Schedule for Gardasil (Human Papillomavirus Vaccine)

The recommended dosing schedule for Gardasil (Human Papillomavirus Vaccine) is 0,2, and 6 months for individuals aged 15-45 years, while individuals aged 9-14 years can receive either a 2-dose schedule at 0 and 6-12 months or a 3-dose schedule at 0,2, and 6 months. 1

Age-Based Dosing Recommendations

• For individuals 9 through 14 years of age, two options are available:

  • 2-dose schedule: First dose at month 0, second dose at 6-12 months 1
  • 3-dose schedule: Doses at 0,2, and 6 months 1

• For individuals 15 through 45 years of age:

  • 3-dose schedule: Doses at 0,2, and 6 months 1

Important Considerations

• If the second dose in a 2-dose schedule is administered earlier than 5 months after the first dose, a third dose should be administered at least 4 months after the second dose 1

• The vaccine is administered as a 0.5-mL intramuscular injection 1

• Gardasil is indicated for both males and females 9 through 45 years of age 1

• The vaccine should be stored at 2°C-8°C (36°F-46°F) and should not be frozen 2

Special Populations

• Immunocompromised individuals should receive the 3-dose schedule regardless of age 3

• HIV-positive individuals should receive a 3-dose series 3

Efficacy and Protection

• Vaccination is most effective when administered before potential exposure to HPV through sexual activity; however, individuals who are sexually active should still be vaccinated 2

• History of genital warts, abnormal Papanicolaou test, or positive HPV DNA test is not evidence of prior infection with all vaccine HPV types; HPV vaccination is still recommended for these individuals 2

• The vaccine has high efficacy in preventing persistent HPV infection, cervical cancer precursor lesions, vaginal and vulvar cancer precursor lesions, and genital warts caused by HPV types covered by the vaccine 2

Common Pitfalls to Avoid

• Not completing the full vaccination series: A vaccine series does not need to be restarted, regardless of the time elapsed between doses 4

• Assuming that vaccination eliminates the need for cervical cancer screening: Vaccination with Gardasil does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider 1

• Administering the vaccine to individuals with hypersensitivity to yeast (a vaccine component) or after a previous severe allergic reaction to Gardasil 1

• Failing to observe patients for 15 minutes after administration, as syncope (sometimes with tonic-clonic movements) has been reported following HPV vaccination 1

Recent Developments

While the FDA-approved dosing schedule remains as described above, it's worth noting that some recent evidence suggests a single-dose schedule may be effective for younger populations. The National Advisory Committee on Immunization in Canada has updated recommendations for individuals 9 to 20 years of age to receive one dose of 9vHPV vaccine, while maintaining a 2-dose schedule for individuals 21 years of age and older 3. However, the FDA-approved schedule should be followed in the United States until official recommendations change.

Human Papillomavirus vaccines continue to be an important tool in preventing HPV-related cancers and diseases, with established safety and efficacy profiles across multiple studies 5, 6.