What is the new Human Papillomavirus (HPV) vaccine?

From the Guidelines

The newest HPV vaccine available is the nonavalent HPV vaccine, which prevents infection with 7 oncogenic HPV types and 2 HPV types that cause most genital warts, associated with 90% of cervical cancers. This vaccine is recommended for 11- and 12-year-olds with a 2-dose schedule, 6 months apart, and can be started at age 9 1. For those who receive the vaccine at 15-26 years for women and 15-21 years for men, a 3-dose schedule, at 0,2, and 6 months, is recommended 1. The nonavalent HPV vaccine has been shown to be universally safe and effective, and its use is advised for men who have sex with men, bisexual men, and transgender people up to the age of 26, as well as 9- to 26-year-old individuals who are immunocompromised 1.

Key Points

• The nonavalent HPV vaccine offers broader protection than earlier vaccines, covering types responsible for about 90% of cervical cancers and most genital warts 1.
• Vaccination before transplant is recommended, and the vaccine is safe in solid organ transplant (SOT) recipients, although immunogenicity may be lower in this population 1.
• The US Food and Drug Administration (FDA) has licensed the vaccine for adults up to age 45, but the Advisory Committee on Immunization Practices (ACIP) has not adjusted their recommended age range for the vaccine 1.

Administration and Safety

• The standard regimen for the nonavalent HPV vaccine is two doses for those who start the series before age 15, given 6 months apart, and three doses for those starting at age 15 or older, or who are immunocompromised (0,2, and 6 months) 1.
• Side effects of the vaccine are generally mild and may include pain at the injection site, headache, or fever 1.

From the FDA Drug Label

GARDASIL 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6,11,16,18,31,33,45,52, and 58. The new Human Papillomavirus (HPV) vaccine is GARDASIL 9, a 9-valent vaccine that protects against HPV Types 6,11,16,18,31,33,45,52, and 58 2 2.

• It is a non-infectious recombinant vaccine prepared from purified virus-like particles (VLPs) of the major capsid (L1) protein of the HPV types.
• Each 0.5-mL dose contains approximately 30-60 mcg of HPV L1 protein and 500 mcg of aluminum (provided as AAHS).

From the Research

Overview of the New Human Papillomavirus (HPV) Vaccine

• The new HPV vaccine is a 9-valent vaccine (9vHPV) that targets nine HPV types: HPV types 6,11,16, and 18, which are also targeted by the quadrivalent HPV vaccine (qHPV), plus five additional high cancer risk HPV types (HPV types 31,33,45,52, and 58) 3.
• The 9vHPV vaccine has been shown to generate a response to HPV types 6,11,16, and 18 that is non-inferior to qHPV 3.
• The vaccine has been proven to be safe and well tolerated, with evidence of efficacy against five additional HPV type-related diseases, including a risk reduction of 96.7% against high-grade cervical, vulvar, or vaginal disease in females aged 16-26 years 3.

Comparison with Other HPV Vaccines

• The 9vHPV vaccine offers greater protection against HPV infection compared to the quadrivalent and bivalent vaccines, with the potential to prevent up to an additional 14% of anogenital cancers and up to 30% of high-risk precancerous cervical lesions 4.
• The vaccine is recommended for females aged 9-26 years and males aged 9-26 years, with a three-dose schedule 4.
• The 9vHPV vaccine has been shown to be effective in preventing infection and disease related to HPV types 31,33,45,52, and 58, which are not covered by other HPV vaccines 4.

Safety and Efficacy

• The safety and efficacy of the 9vHPV vaccine have been extensively studied, with evidence from multiple clinical trials and reviews 3, 4, 5.
• The vaccine has been shown to be safe and well tolerated, with a low risk of adverse effects 5.
• The efficacy of the vaccine in preventing HPV-related diseases has been demonstrated in multiple studies, with a significant reduction in the incidence of high-grade cervical, vulvar, and vaginal lesions 3, 4.