What is the recommended use and administration of Gardasil (human papillomavirus vaccine)?

Gardasil (HPV Vaccine): Recommended Use and Administration

Gardasil 9 is FDA-approved for males and females aged 9-45 years and should be administered as a 2-dose series (0,6-12 months) for ages 9-14 years or a 3-dose series (0,2,6 months) for ages 15-45 years, given intramuscularly in the deltoid or anterolateral thigh. 1

Age-Based Dosing Schedule

Ages 9-14 Years

• 2-dose regimen: First dose at enrollment, second dose 6-12 months later 1
• Alternative 3-dose regimen: 0,2,6 months if preferred 1
• Critical 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 1

Ages 15-45 Years

• 3-dose regimen only: 0,2,6 months 1
• This applies to both males and females 1

Administration Technique

• Route: Intramuscular injection in deltoid muscle or anterolateral thigh 1
• Dose volume: 0.5 mL per dose 1
• Preparation: Shake well immediately before use to maintain suspension 1
• Post-administration observation: Observe patients for 15 minutes due to syncope risk 1
• Do not mix with other vaccines in the same syringe 1

Approved Indications

For Females (Ages 9-45)

• Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16,18,31,33,45,52,58 1
• Prevention of genital warts caused by HPV types 6 and 11 1
• Prevention of precancerous lesions (CIN, AIS, VIN, VaIN, AIN) 1

For Males (Ages 9-45)

• Prevention of anal, oropharyngeal and other head and neck cancers caused by vaccine HPV types 1
• Prevention of genital warts caused by HPV types 6 and 11 1
• Prevention of anal intraepithelial neoplasia (AIN) 1

Optimal Timing for Vaccination

The vaccine is most effective when given before sexual activity begins, which is why routine vaccination at ages 11-12 years is recommended. 2

• Antibody responses are highest in girls aged 9-15 years 2
• The vaccine does not alter the outcome of established HPV infection with vaccine types 2
• Vaccination can still be given to sexually active individuals, though benefit may be diminished depending on prior HPV exposure 2, 3

Special Populations and Circumstances

Can Be Given When:

• Patient has abnormal or equivocal Papanicolaou test result 2
• Patient is breastfeeding 2
• Patient is immunocompromised due to disease or medication 2
• Patient has current HPV infection (safe but may have reduced benefit for those specific types) 4

Pregnancy Considerations:

• Not recommended during pregnancy 2
• Inquire about pregnancy in sexually active patients, but pregnancy test not required 2
• If pregnancy occurs during vaccination series, postpone remaining doses until after pregnancy 2
• Report pregnancies to registry: 1-800-986-8999 2

Contraindications

Absolute contraindication: Hypersensitivity to yeast or any vaccine component, or severe allergic reaction after previous dose 2, 1

Precautions

• Defer vaccination in patients with moderate or severe acute illness 2
• Have patient sit or lie down for 15 minutes post-injection due to syncope risk 2, 1
• Appropriate medical treatment must be readily available for anaphylactic reactions 1

Minimum Dosing Intervals (If Schedule Interrupted)

• Minimum interval between doses 1 and 2: 4 weeks 2
• Minimum interval between doses 2 and 3: 12 weeks 2
• If dose given too early, it should not be counted as valid and must be repeated more than 4 weeks after the invalid dose 5

Co-Administration with Other Vaccines

• HPV vaccine can be administered at the same visit as all other recommended vaccines 2
• Must be given in separate syringes at different injection sites 1

Critical Limitations

Vaccination does NOT eliminate the need for cervical cancer screening. 1

• The vaccine protects against only the HPV types included (not all cancer-causing types) 1
• Not all cervical, vulvar, vaginal, anal, oropharyngeal and head and neck cancers are caused by HPV 1
• The vaccine is not a treatment for existing HPV infection, genital lesions, or cancers 1
• Vaccination may not result in protection in all recipients 1

Common Adverse Effects

• Most common: Headache (occurs in up to 50% of patients) 2
• Local injection site reactions 1
• Syncope (can occur with tonic-clonic movements) 1
• No severe complications directly linked to vaccine administration (no increased risk of Guillain-Barré syndrome, stroke, venous thromboembolism, seizures, or anaphylaxis) 2

Efficacy Considerations by Age

Ages 9-26 Years

• High-level protection demonstrated in clinical trials 6, 7
• Protection documented for up to 8 years 6
• High seroconversion rates in both males and females 6

Ages 27-45 Years

• FDA-approved but efficacy less clear than in younger individuals 3
• Benefit decreases with increasing likelihood of prior HPV exposure 2, 3
• Individuals with 4 or more lifetime sexual partners have higher likelihood of prior exposure to vaccine types 2, 3
• Still safe and may provide benefit if not exposed to all vaccine HPV types 3, 4