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