HPV Vaccine Overview and Timing
The HPV vaccine (Gardasil 9) is a prophylactic vaccine that prevents infection from nine types of human papillomavirus (HPV 6,11,16,18,31,33,45,52, and 58), and should be routinely administered at age 11 or 12 years, though it can be started as early as age 9 years. 1
What the HPV Vaccine Protects Against
Gardasil 9 prevents HPV-related diseases that significantly impact both morbidity and mortality:
In females (ages 9-26):
- Cervical cancer
- Vulvar and vaginal cancers
- Anal cancer
- Precancerous cervical, vulvar, vaginal, and anal lesions
- Genital warts 2
In males (ages 9-26):
- Anal cancer
- Precancerous anal lesions
- Genital warts 2
The vaccine targets the HPV types responsible for approximately 90% of cervical cancers and most other HPV-associated malignancies. HPV types 16 and 18 alone cause the majority of HPV-associated cancers, while types 6 and 11 cause most genital warts. 1
When to Administer: Age-Based Dosing Schedule
Routine Vaccination (Ages 11-12 years)
ACIP routinely recommends HPV vaccination at age 11 or 12 years, with the option to start as early as age 9 years. 1 This timing is critical because vaccination is most effective before any HPV exposure through sexual activity. 3
Dosing Schedules by Age
Ages 9-14 years: 2-dose regimen 2
- Dose 1: Initial vaccination
- Dose 2: Given 6-12 months after the first dose
- Important caveat: If the second dose is given earlier than 5 months after the first dose, a third dose must be administered at least 4 months after the second dose 2
Ages 15-26 years: 3-dose regimen 2
- Dose 1: Initial vaccination
- Dose 2: 2 months after the first dose
- Dose 3: 6 months after the first dose
Catch-Up Vaccination
All persons through age 26 years who have not been adequately vaccinated should receive catch-up HPV vaccination. 1 This represents a 2019 harmonization of recommendations that previously had different age cutoffs for males and females.
Ages 27-45 Years: Shared Clinical Decision-Making
For adults aged 27-45 years, ACIP does not recommend routine catch-up vaccination for all individuals. However, shared clinical decision-making is recommended for some unvaccinated persons in this age range who may be at risk for new HPV infection. 1, 3
Consider vaccination in this age group for patients who:
- Have new sexual partners
- Are at ongoing risk for HPV acquisition
- Have not been previously exposed to vaccine-type HPV
The FDA expanded approval for Gardasil 9 to age 45 in 2018, but the benefit decreases with age as most sexually active adults have already been exposed to HPV. 1
Critical Clinical Considerations
What the Vaccine Does NOT Do
- Does not eliminate the need for cervical cancer screening - women must continue routine screening 2
- Does not treat existing HPV infections 2
- Does not protect against HPV types to which someone has already been exposed 2
- Does not protect against non-vaccine HPV types or other sexually transmitted infections 2
Administration Details
- Given as an intramuscular injection, typically in the deltoid muscle 2
- Observe patients for 15 minutes after administration due to syncope risk - fainting can occur and may result in falls with injury 2
- Shake vial well before use to maintain suspension 2
Contraindications
Do not administer to anyone with:
- Severe allergic reaction to a previous dose of Gardasil 9 or Gardasil
- Severe yeast allergy
- Allergy to amorphous aluminum hydroxyphosphate sulfate or polysorbate 80 2
Special Populations
- Pregnancy: Not recommended during pregnancy, though inadvertent exposure does not appear to increase risk of major birth defects or miscarriage 4
- Immunocompromised persons (including HIV): Recommended through age 26 if not previously vaccinated 5
- Men who have sex with men: Recommended through age 26 if not previously vaccinated 5
Common Pitfall to Avoid
The most significant missed opportunity is failing to vaccinate at the routine age of 11-12 years. Vaccination rates in the United States remain unacceptably low compared to other adolescent vaccines. 6 Every clinical encounter with an eligible patient—including visits for abnormal Pap smears—represents an opportunity to discuss and administer the HPV vaccine. 7