Gardasil 9

Human Papillomavirus Vaccine - Gardasil 9

OFFICE ADMINISTERED - Intramuscular

FDA-Approved Indication:

• Indicated in individuals 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58; genital warts caused by HPV types 6 and 11; precancerous or dysplastic lesions caused by HPV

Limitations of use:

• Vaccination with Gardasil 9 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

• Gardasil 9 has not been demonstrated to provide protection against disease caused by:

  • HPV types not covered by the vaccine

  • HPV types to which a person has previously been exposed through sexual activity

• Not all vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers are caused by HPV, and Gardasil 9 protects only against those vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58

• Gardasil 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers; CIN; VIN; VaIN; or AIN

• Vaccination with Gardasil 9 may not result in protection in all vaccine recipients

Recommendations for use of HPV vaccine:

• HPV vaccination is recommended for all persons through age 26 years: 2- or 3-dose series depending on age at initial vaccination or condition:

  • Age 15 years or older at initial vaccination: 3-dose series at 0, 1-2 months, 6 months (minimum intervals: dose 1 to dose 2: 4 weeks/ dose 2 to dose 3: 12 weeks/ dose 1 to dose 3: 5 months; repeat dose if administered too soon)

  • Age 9-14 years at initial vaccination and received 1 dose or 2 doses less than 5 months apart: 1 additional dose

  • Age 9-14 years at initial vaccination and received 2 doses at least 5 months apart: HPV vaccination series complete, no additional dose needed

• Interrupted schedules: if the vaccination schedule is interrupted, the series does not need to be restarted

• No additional dose is recommended after completing the series with recommended dosing intervals using any HPV vaccine

Dosing:

• HPV vaccine is administered as follows:

  • Ages 9-14 years

    • 2-dose regimen: 0, 6 to 12 months

    • 3-dose regimen: 0, 2, and 6 months

  • Ages 14-45 years

    • 3-dose regimen: 0, 2, and 6 months

• Each dose of HPV vaccine (Gardasil 9) is 0.5 mL, administered intramuscularly

• HPV vaccine can be administered at the same visit when other age-appropriate vaccines are provided, such as Tdap, Td, and MCV4

• Each vaccine should be administered by using a separate syringe at a different anatomic site

• Whenever possible, the same HPV vaccine product should be used for all doses in the series

Special situations:

• Immunocompromising conditions, including HIV infection:

  • 3-dose series as above, regardless of age at initial vaccination

• Pregnancy:

  • HPV vaccination not recommended until after pregnancy; no intervention needed if vaccinated while pregnant; pregnancy testing not needed before vaccination

• Shared clinical decision-making:

  • For previously unvaccinated adults aged 27 to 45 years of age who have a low likelihood of prior HPV exposure (e.g., no prior sexual experience or a limited number of prior sexual partners), but have a future risk of HPV exposure (e.g., new sexual partners), HPV vaccination is recommended

  • Ideally, the vaccine should be administered before potential exposure to HPV through sexual contact

Contraindications to use of vaccine:

• Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil 9 or Gardasil

Precautions:

• HPV vaccine can be administered to patients with minor acute illnesses (e.g., diarrhea or mild upper respiratory tract infections, with or without fever)

• Vaccination of people with moderate or severe acute illnesses should be deferred until after the illness improves

Recommendations for Use of HPV Vaccines:

• ACIP recommends that routine HPV vaccination be initiated at age 11 or 12 years.  The vaccination series can be started beginning at age 9 years.  Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.  Catch-up HPV vaccination is not recommended for all adults aged >26 years.  Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated.  HPV vaccines are not licensed for use in adults aged >45 years

• Three prophylactic HPV vaccines are licensed for use in the United States: 9-valent (9vHPV, Gardasil 9), quadrivalent (4vHPV, Gardasil), and bivalent (2vHPV, Cervarix).  As of late 2016, only 9vHPV is available in the United States. All HPV vaccines protect against HPV 16 and 18, types that cause about 66% of cervical cancers and the majority of other HPV-attributable cancers in the United States (1, 12).  9vHPV targets five additional cancer-causing types, which account for about 15% of cervical cancers (12).  4vHPV and 9vHPV also protect against HPV 6 and 11, types that cause anogenital warts

References:

1. Merck & Co., Inc. Gardasil-9 [package insert]. U.S. Food and Drug Administration website. https://www.fda.gov/media/90064/download. Revised August 2020. Accessed November 10, 2020.

2. Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2019;68:698–702. DOI: http://dx.doi.org/10.15585/mmwr.mm6832a3

3. Giuliano, A. R., Isaacs-Soriano, K., Torres, B. N., Abrahamsen, M., Ingles, D. J., Sirak, B. A., Quiterio, M., & Lazcano-Ponce, E. (2015). Immunogenicity and safety of Gardasil among mid-adult aged men (27-45 years)--The MAM Study. Vaccine, 33(42), 5640–5646. https://doi.org/10.1016/j.vaccine.2015.08.072

4. Muñoz, N., Manalastas, R., Jr, Pitisuttithum, P., Tresukosol, D., Monsonego, J., Ault, K., Clavel, C., Luna, J., Myers, E., Hood, S., Bautista, O., Bryan, J., Taddeo, F. J., Esser, M. T., Vuocolo, S., Haupt, R. M., Barr, E., & Saah, A. (2009). Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet (London, England), 373(9679), 1949–1957. https://doi.org/10.1016/S0140-6736(09)60691-7

5. Luxembourg A. 9vHPV immunogenicity and safety trial in mid-adult females.  Advisory Committee on Immunization Practices (ACIP). Atlanta, GA. June 26, 2019. Accessed November 10, 2020.