HPV Vaccine Recommendations Including Guidance for Ages 27 to 45

SUMMARY:

Previously, US guidelines called for two doses when vaccination began before age 15, and three doses for those starting at age 15 or older or for individuals who were immunocompromised. The Department of Health and Human Services (HHS) supports a one‑dose recommendation based on international alignment with other high‑income countries and emerging scientific evidence indicating that one dose provides protection comparable to two doses. This directive has been published by the CDC. However, it is important to note that the US does not yet have a single‑dose HPV vaccine licensed for use. Furthermore, ACOG and AAP, based on current evidence, do not support this change in dosing. 

HHS/CDC Recommendations

• Routine vaccination
  • Age 11 to 12 years
  • Can be started at age 9 years
• Catch-up vaccination
  • Age 13 to 26 years
  • If not adequately vaccinated
• Shared clinical decision-making
  • Some adults ages 27 to 45 years
  • If not adequately vaccinated

Dosing Schedule 

• HHS/CDC
  • Change to 1-dose regimen for children and adolescents 
• AAP and ACOG
  • <15 years: 2 doses spaced 6 to 12 months apart
  • ≥15 years: 3-dose schedule
    • Initial dose | Second dose at 1 to 2 months | Third dose at 6 months  

ACOG HPV vaccine recommendations 

• Routine HPV vaccination is recommended for females and males 
• Target age is 11 to 12 years but can be given through age 26
  • Can be given from age of 9 
• Do not test for HPV DNA prior to vaccination
  • Vaccinate even if patient was tested and is HPV DNA positive
•  If not vaccinated between 11 to 12 years
  • Vaccinate between 13 to 26 years (catch up period)
  • Offer regardless of sexual activity, prior exposure to HPV, or sexual orientation 
• Women 27 to 45 years and previously unvaccinated
  • Use shared clinical decision making
• ACOG “does not recommend that an individual who received the quadrivalent HPV vaccine be revaccinated with 9-valent HPV vaccine, including those aged 27 to 45 years who previously completed some, but not all, of the vaccine series when they were younger”
• Pregnancy
  • HPV vaccine is not recommended during pregnancy
  • Pregnancy testing prior to HPV vaccination not recommended
  • If vaccination schedule is interrupted by pregnancy, resume postpartum with the next dose
  • HPV vaccine can and should be given to breastfeeding women ≤26 who have not been vaccinated
  • The CDC encourages pregnant patients and healthcare professionals to report to the manufacturer and VAERS system if vaccine was administered during pregnancy | How and where to report is described in “CDC: HPV Vaccine Safety” in Learn More-Primary Sources below  
• Counsel to expect mild local discomfort and that this is not a cause for concern
  • Watch adolescents for at least 15 minutes following vaccination due to risk of fainting in this population

ACS

• The ACS overall endorses national guidance except for the approach to take with individuals who are 27 to 45 years and not adequately vaccinated

The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit

Adjuvant HPV Vaccine to Prevent CIN Recurrence 

• ACOG recommends considering adjuvant HPV vaccine for unvaccinated individuals 27 to 45 years who are undergoing treatment for CIN 2+

Learn More – Primary Sources:

HHS: Childhood Immunization Schedule by Recommendation Group

NIH: One dose of HPV vaccine as effective as two | National Institutes of Health

Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices (MMWR) 

CDC: Clinical Overview of HPV 

ACOG Committee Opinion 809: Human Papillomavirus Vaccination 

ACOG Practice Advisory: Adjuvant Human Papillomavirus Vaccination for Patients Undergoing Treatment for Cervical Intraepithelial Neoplasia 2+ 

AAP: How Pediatricians Can Recommend HPV Vaccination to Parents and Caregivers 

CDC HPV Vaccine Safety 

CDC: HPV Educational Materials For Clinicians 

ACS: Human Papillomavirus Vaccination 2020 Guideline Update 

AAP’s 2026 immunization schedule keeps routine recommendations intact after overhaul of federal schedule

SGO: The New U.S. Childhood Vaccine Schedule: A Key Change for HPV Immunization

ASCCP-Practice-Advisory-Childhood-Immunization-Recommends-Single-Dose-HPV-Vaccine

Gardasil Now FDA Approved for Individuals 27 to 45 Years Old

SUMMARY:

According to the CDC

The 9-valent HPV vaccine protects against nine HPV types, including seven types that can cause cancer. Of the 32,500 cancers that HPV has caused every year, 30,000 are caused by strains that could have been prevented by the 9-valent HPV vaccine.

• Previously, Gardasil 9 was approved for males and females ages 9 to 26
• Based on current research, the FDA has now extended approval to include individuals ages 27 to 45
  • The Gardasil 9 age extension was approved using ‘priority review status’, which is an expedited review of medical products that address a serious or life-threatening condition
• ACOG has responded with a Practice Advisory (October 2019) that addresses the following considerations
  • Further review of data, including cost-effectiveness is still necessary
  • CDC and ACIP are reviewing the data, in conjunction with ACOG
  • Current guidelines “remain in effect” and ObGyns and other health professionals are “encouraged” to discuss the vaccine with women who are >26 years and are interested in vaccination
  • In women 27 to 45 years, decisions regarding vaccination should
    • Be individualized
    • Involve shared decision making
    • Include clinical judgement

KEY POINTS:

• The original Gardasil vaccine was approved in 2006 and covered 4 HPV types but is no longer distributed in the US
• Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) was approved in 2014 and includes the original 4 HPV types plus another 5 pathogenic types

Effectiveness

• Gardasil studies were considered ‘relevant’ for Gardasil 9 review because both vaccines are manufactured similarly and cover 4 common HPV types
• In one study, 3,200 women 27 through 45 years of age were followed for an average of 3.5 years
  • Gardasil was 88 percent effective in the prevention of a combined endpoint of HPV related lesions and cancer (persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer)
  • “The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study”
• Males age 27 through 45 years
  • Effectiveness: ‘Inferred’ from the above data
  • Efficacy: Derived from Gardasil data in males age 16 through 26 years
  • Immunogenicity: Derived from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months

Safety

• Gardasil 9 was evaluated in approximately 13,000 males and females
• Most common reported adverse reactions
  • Injection site pain
  • Swelling
  • Redness
  • Headaches

Learn More – Primary Sources:

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

CDC: HPV Vaccination Schedules & Recommendations