By Stan Deresinski, MD
Dr. Deresinski is Clinical Professor of Medicine, Stanford University.
Dr. Deresinski has served as a one time consultant for Cubist and Bayer.
The U.S. FDA approved a new human papillomavirus (HPV) vaccine in December of 2014.1 Two HPV vaccines have been available for several years — a bivalent vaccine (HP2) containing L1 protein of the oncogenic types 16 and 18 as well as a quadrivalent vaccine (HP4)containing type 16 and 18 together with types 6 and 11 (which cause genital warts). The Advisory Committee on Immunization Practices (ACIP) has recently updated their recommendations for the use of these vaccines:
“ACIP recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. Vaccination also is recommended for females aged 13 through 26 years and for males aged 13 through 21 years who were not vaccinated previously. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not previously vaccinated.”
The new vaccine, in contrast to these two, contains capsid proteins of 9 HPV types. It has been approved for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58; pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11. GARDASIL 9 is also approved for use in boys 9 to 15 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Three doses are administered intramuscularly at 0, 6, and 12 months. Local reactions at the injection site commonly occur.
The efficacy of HP9 in 16- through 26-year-old girls and women was assessed in an active comparator-controlled, double-blind, randomized clinical trial (Study 1) that included a total of 14,204 women who were enrolled and vaccinated without pre-screening for the presence of HPV infection. Participants were followed up with a median duration of 40 months (range 0 to 64 months) after the last vaccination. Multiple evaluations each demonstrated efficacy rates in excess of 90%.
This vaccine represents a significant public health advance that has the potential to reduce the worldwide incidence of invasive cervical cancer by 90% or more.3
- FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV. http://da.gov.
- Markowitz LE, Dunne EF Sariaya M, et al. Human papillomavirus vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Recommendations and Reports. August 29, 2014 / 63(RR05);1-30.
- Serrano B, Alemany L, Tous S, et al. Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease. Infect Agent Cancer 2012;7:38.