Executive Summary
The Food and Drug Administration has approved a new human papillomavirus vaccine: Gardasil 9 from Merck Sharp & Dohme Corp. The new vaccine covers nine HPV types: HPV 6 and HPV 11, the two low-risk types that cause most cases of genital warts, as well as seven high-risk types: HPV 16, 18, 31, 33, 45, 52, and 58.
- Gardasil 9 is administered as three shots, with the initial dose followed by additional shots given two and six months later.
- The vaccine has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers. It is approved for use in females ages 9 through 26 and males ages 9 through 15.
Get ready to include a new human papillomavirus (HPV) vaccine at your facility. The Food and Drug Administration (FDA) has approved Gardasil 9 from Kenilworth, NJ-based Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.
The new vaccine covers nine HPV types: HPV 6 and HPV 11, the two low-risk types that cause most cases of genital warts, as well as seven high-risk types: HPV 16, 18, 31, 33, 45, 52, and 58. The new vaccine is administered as three shots, with the initial dose followed by shots given two and six months later. (Contraceptive Technology Update reported on the vaccine. See, “Potential HPV vaccine shows promise: What could it mean for young women?” January 2014.)
The Gardasil 9 vaccine helps prevent infection against the same four types of HPV as the Gardasil quadrivalent vaccine, as well as five other high risk types: 31, 33, 45, 52, and 58. The vaccine has the potential to prevent approximately 90% of cervical, vulvar, vaginal, and anal cancers. It is approved for use in females ages 9 through 26 and males ages 9 through 15.
“The development and approval of the nine-valent HPV vaccine is a major advancement in preventing the transmission of HPV,” said William Smith, executive director of the National Coalition of STD Directors in a statement. “With this vaccine, virtually eradicating cervical, anal, and other genital cancers as well as genital warts within a generation is possible if actual scale up in vaccination occurs.”
Gardasil 9 joins two other approved HPV vaccines: Gardasil, the quadrivalent vaccine, and Cervarix, a bivalent vaccine manufactured by Philadelphia-based GlaxoSmithKline that protects against HPV types 16 and 18 in females. At press time, the 9-valent vaccine was scheduled for release in February 2015. The federal Advisory Committee on Immunization Practices (ACIP) was set to vote on recommendations for the vaccine and coverage under the Vaccines for Children program at its February 2015 meeting. Managed care coverage typically follows ACIP recommendations.
Review the results
To test the new vaccine, researchers conducted a randomized, controlled clinical study in the United States and abroad in some 14,000 females ages 16-26 who tested negative for vaccine HPV types at the start of the study . Women enrolled in the study received Gardasil or Gardasil 9.
Study findings indicate the nonovalent vaccine was 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types: 31, 33, 45, 52, and 58. Researchers also found that Gardasil 9 is as effective as Gardasil for the prevention of diseases caused by the four shared HPV types (6, 11, 16, and 18) based on similar antibody responses in participants in clinical studies. 1 Due to the low incidence of anal cancer caused by the five additional HPV types, the prevention of anal cancer is based on Gardasil’s demonstrated effectiveness of 78%, as well as additional data on antibodies in males and females who received Gardasil 9. 2
Safety data indicate the most commonly reported adverse reactions as injection site pain, swelling, redness, and headaches. As with any vaccine, patients might faint after getting a vaccination, with fainting more common in teens than in young children or adults, according to the Centers for Disease Control and Prevention. 3 To keep patients from getting hurt from fainting, a 15-minute waiting period for people of all ages is recommended after any vaccination.
Impact of new vaccine?
HPV vaccines have been on the market in the United States since 2006, when the original Gardasil was approved. The approval of Cervarix followed in 2009.
Despite efforts to promote vaccine uptake, recent national data indicate the number of girls and boys ages 13-17 receiving HPV vaccination is unacceptably low, despite a slight increase in vaccination coverage since 2012.4 While the data suggest about 57% of teen girls and 35% of teen boys received one or more doses of HPV vaccine, nearly 86% of adolescents had received one dose of the tetanus, diphtheria, and pertussis vaccine.4 (To read more on this topic, see the CTU article, “HPV vaccine continues to be underutilized,” October 2014.)
Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles, says the availability of the new and improved vaccine will give clinicians something new to say to patients and, she hopes, will reinvigorate professional enthusiasm for the vaccine. Patients who have been vaccinated should not return for the new vaccine; the incremental benefit is not worth the cost, she states.
The Centers for Disease Control and Prevention has developed the “You Are The Key” website (http://1.usa.gov/1eGPIdM) with resources to assist healthcare professionals in strengthening their recommendation for HPV vaccine. (Need a resource for talking with parents about vaccination for HPV? Download free talking points at http://1.usa.gov/1phjRrM.)
- Joura E, on behalf of the V503-001 study team. Efficacy and immunogenicity of a novel 9-valent HPV L1 virus-like particle vaccine in 16- to 26-year-old women. Presented at the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) Congress. Florence, Italy; November 2013.
- Van Damme P, on behalf of the V503-002 study team. Immunogenicity and safety of a novel 9-valent HPV L1 virus-like particle vaccine in boys and girls 9-15 years old; comparison to women 16-26 years old. Presented at the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) Congress. Florence, Italy; November 2013.
- Centers for Disease Control and Prevention. Fainting (syncope) after vaccination. Accessed at http://1.usa.gov/1yatFZu.
- Stokley S, Jeyarajah J, Yankey D, et al, Immunization Services Division, National Center for Immunization and Respiratory Diseases, CDC. Human papillomavirus vaccination coverage among adolescents, 2007-2013, and postlicensure vaccine safety monitoring, 2006-2014 — United States. MMWR 2014; 63(29):620-624.
